Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Bennett, 2021

Type of study: RCT

Setting:

oncology outpatient clinics, multi-center study

Country: UK

Source of funding: government

Inclusion criteria:

1. Aged 16 years or over

2. Diagnosis of advanced incurable disease (locally advanced or metastatic) in one of the following disease areas: breast, colon or rectal, non-small cell lung cancer, prostate, upper GI

3. Experiencing cancer related pain (tumour or treatment related) (as assessed by the Clinician) with an average pain score of = 4 on the “average pain” item of the Brief Pain Inventory

4. Has the potential to benefit from palliative care support as assessed by the Clinician

5. An expected prognosis of 12 weeks or more

6. The patient is living at home

7. The patient lives in the local catchment area for a participating hospice

8. The patient is able and willing to provide written informed consent

Exclusion criteria:

1. Previously referred to palliative care team

2. The patient has insufficient literacy, or proficiency in English to contribute to the data collection required for the research

3. Patients will be excluded if they lack capacity to provide informed consent to this trial

4. Patients with dominant chronic pain that is not cancer related (tumour or treatment)

N total at baseline:

Intervention: 80

Control: 81

Important prognostic factors²:

For example

age ± SD:

I:62.5 ± 11.73

C: 65.7 ± 11.29

Sex:

I: 52.2% M

C: 60% M

Groups comparable at baseline? yes

Describe intervention (treatment/procedure/test):

Usual care plus Supported Self-Management (SSM) intervention delivered within the oncology clinic and palliative care services by locally assigned community palliative care nurses (health professional), consisting of self-management/educational support and pain monitoring

Describe  control (treatment/procedure/test):

Usual care:

An initial palliative care visit took place

Length of follow-up:

12 weeks

Loss-to-follow-up:

Intervention:

6 weeks (n=29, 36.3%)/12 weeks (n=39, 48.8%)

Reason

• Died, n=7/17

• Too unwell, n=3/2

• Withdrawal, n=2/3

• Unable to contact, n=10/8

• Contacted not returned, n=5/8

• Administrative error, n=2/1

Control:

6 weeks (n=25, 30.9%)/12 weeks (n=35, 43.2%)

Reason

• Died, n=6/12

• Too unwell, n=5/9

• Withdrawal, n=2/3

• Unable to contact, n=9/7

• Contacted not returned, n=3/3

• Administrative error, n=0/1

Incomplete outcome data:

The primary outcome (pain severity) was available for all time points for 78 (48.4%) participants, for at least one follow-up time point for 37 (23.0%) participants and for baseline only for 45 (28.0%) participants, and was not available at any time point for one (0.6%) participant

Outcome measures and effect size (include 95%CI and p-value if available):

BPI Pain severity score

Average pain

Baseline

I: 5.6 (1.36); N=79      

C: 5.4 (1.47); N=81

6 weeks

I: 4.6 (2.00); N=51      

C: 4.1 (1.97); N=56

12 weeks

I: 3.8 (2.09); N=40

C: 3.7 (2.56); N=45

EORTC QLQ-C30 Summary Score

(scores 0-100; higher score = high QoL and functioning)

Baseline

I: 57.4 (17.20); N=77      
C: 54.1 (16.53); N=79

6 weeks

I: 61.4 (16.73); N=51      

C: 57.0 (15.80); N=53

12 weeks

I: 65.6 (17.11); N=39      

C: 62.4 (17.16); N=45

Author’s conclusion:

The authors’ programme of research has revealed new insights into how patients with advanced cancer manage their pain and the challenges faced by health professionals in identifying those who need more help. Our clinical trial failed to show an added benefit of our interventions to enhance existing community palliative care support, although both the decision model and the economic evaluation of the trial indicated that supported self-management could result in lower health-care costs.

Jahn, 2014

Type of study: RCT

Setting: inpatients, multi-center study

Country: Germany

Source of funding: non-commercial

Inclusion criteria:

1) patients on hospital wards that frequently admitted oncological patients (≥10% admitted per year)

2) consent for participation

3) 18-80 years

4) NRS ≥3 for average pain intensity

5) persisting pain for >3 days

Exclusion criteria:

1) limited performance status (ECOG<4)

2) documented ongoing drug or alcohol abuse

3) surgery within the last 3 days

4) showing signs of disorientation

5) unable to read, write and understand German

N total at baseline:

Intervention: 128

Control: 135

Important prognostic factors²:

For example

age ± SD:

I:58 ± 12

C: 56 ± 13

Sex:

I: 59% M

C: 60% M

Groups comparable at baseline? No, differences in ECOG status, malignancy types, metastases, amount of pain medication, sufficiency of pain management, adherence to pain medication, anxiety and depression

Describe intervention (treatment/procedure/test):

SCION-PAIN

Counseling on pain management (pharmacological, non-pharmacological and pain-related discharge management) on day

Plus

30 mins by study nurse) and day 2 (30 minutes by trained nurse)

Plus

Follow-up counseling on every 3^rd day (20 mins by trained nurse)

Plus

Day before discharge: pain related discharge management (10 mins by study nurse)

Plus

2-3 days after discharge: pain related discharge management (20 mins by study nurse)

Describe  control (treatment/procedure/test):

Standard pharmacological pain treatment

Length of follow-up:

4 weeks after discharge from hospital

Primary outcome: pain intensity after 1 week

Loss-to-follow-up:

Intervention:

26 (20%)

Reasons: 16 withdrew, 10 died

Control:

30 (22%)

Reasons: 19 withdrew, 11 died

Incomplete outcome data:

As above

Outcome measures and effect size (include 95%CI and p-value if available):

Pain intensity:

(BPI 0-10)

Average and worst pain difference between groups (DNR; NS).

Average and worst pain significantly lower in SCION-PAIN group after 4 weeks of follow-up (secondary outcome).

HRQoL measured by EORTC QLQ C30

Adjusted mean difference  1.20 (-7.54 to 9.95)

Author’s conclusion:

This trial reveals the positive impact of a nursing intervention to improve patients’ self-management of cancer pain.

Koller, 2013

Type of study: RCT

Setting: outpatients

Country: Germany

Source of funding: non-commercial

Inclusion criteria:

1) cancer pain ≥3 on a 0-10 NRS

2) ≥18 years

3) ability to read, write and understand German

4) estimated life expectancy >6 months

5) access to a telephone

6) living within a 1 hour car ride from the clinic

Exclusion criteria:

1) patients with a family caregiver who was involved substantially in their pain self-management

2) hospitalization for ≥2 weeks during the 10 week intervention period

N total at baseline:

Intervention: 19

Control: 20

Important prognostic factors²:

For example

age ± SD:

I: 61 ± 11

C: 59 ± 11

Sex:

I: 47% M

C: 55% M

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

PRO-SELF education program

6 visits (max 1 hour) and 4 phone calls (5-10 minutes) over 10 weeks by intervention nurse

Describe  control (treatment/procedure/test):

Standard treatment

With same number of visits as intervention group, but general health was discussed

Length of follow-up:

22 weeks

Loss-to-follow-up:

Intervention:

11 (58%)

Reasons not described

Control:

10 (50%)

Reasons not described

Incomplete outcome data:

Intention to –treat analysis,

Outcome measures and effect size (include 95%CI and p-value if available):

Pain intensity:

(NRS 0-10)

Average pain: mean

Baseline

I: 3.80 (2.01); N=19

C: 4.18 (1.79); N=20

6 weeks

I: 2.58 (1.73); N=15

C: 2.66 (1.89); N=17

10 weeks

I: 2.54 (1.87); N=12

C: 2.98 (2.31) ;N=15

14 weeks

I: 2.74 (1.59); N=11

C: 2.42 (1.84); N=11

22 weeks

I: 2.60 (2.21)

C: 2.81 (2.07)

Self-efficacy:

(SEQ 0-100), median

Baseline

I: 57.7 (46.7/66.3); N=19

C: 59.3 (52.0/64.7); N=20

6 weeks

I: 69.3 (56.0/86.7); N=15
C: 63.3 (52.0/73.0); N=17

10 weeks

I: 68.3 (58.5/82.7); N=12

C: 70.0 (61.3/77.3); N=15

14 weeks

I: 67.3 (59.3/75.3); N=11

C: 68.7 (53.3/75.5); N=11

22 weeks

I: 70.0 (59.2/85); N=8

C: 64.3 (54.2/78.7); N=10

Author’s conclusion:

Pain self-management related knowledge improved significantly and effect sizes for pain reduction were determined by this pilot study. Findings from this pilot RCT provide the basis for planning a larger RCT

Koller, 2018

Type of study: pilot RCT

Setting:

Inpatient

Country: Germany

Source of funding:

Non-commercial

Inclusion criteria:

patients had pain scores of 3 or higher out of 10, they needed to self-manage their pain after discharge, had a life expectancy greater than 3 months as assessed by the treating physicians, and could understand, read, and write German.

Exclusion criteria

Patients were excluded if the treating physician perceived severe cognitive deficits that would prevent patients from participating

actively in selfmanagement support.

N total at baseline:

Intervention: 19

Control: 20

Important prognostic factors²:

For example

age  (SD):

I: 55.3 (10.2)

C: 58.1 (11.2)

Sex:

I: 40.0% M

C: 63.2% M

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

• The intervention consisted of an in-hospital visit before discharge and telephone calls after

discharge.

• In-person visits after discharge were scheduled only if patients had routine follow-up visits due

to their cancer treatment.

• Laminated cards were used to visualize the intervention's content for the patients.

• Patients received a corresponding booklet

that summarized the information from the

intervention session and a pillbox to  organize their oral medication.

Describe  control (treatment/procedure/test):

• Received routine cancer care that did not include any cancer pain self-management support.

• After the 6-week study period,

patients in the CG were offered pain self-management support.

Length of follow-up:

6 weeks

Loss-to-follow-up:

Intervention

in-hospital (n=1)/1 week (n=5)/6 weeks (n=3)

Reasons:

• Withdrew consent: n=1/0/0
• Died: n=0/2/1
• Too ill: n=0/2
• Not known n=0/1/1
• Did not send questionnaire 2: n=0/1/-
• Hospitalized >2wk: n=0/0/1

Control

in-hospital (n=1)/1 week (n=4)/6 weeks (n=1)

Reasons:

• Died: n=1/1/1
• Too ill: n=0/1/0
• Not known: n=0/2/0
• Did not send questionnaire 2: n=0/4/0

Incomplete outcome data:

See above

Outcome measures and effect size (include 95%CI and p-value if available):

Average pain T0

I: 4.0 (1.56)

C: 4.9 (1.41)

Average pain change T1

I: -1.43 (SD 1.95); N=14

C: -1.09 (SD 1.97); N=11

Average pain change T2

I: -2.45 (SD 1.51); N=11

C: -1.71 (SD 1.77); N=14

Self-efficacy T0

I: 3.1 (1.48)

C: 3.1 (1.01)

Change in self-efficacy T1

I: 0.14 (2.25); N=14

C: -0.86 (1.59); N=11

Change in self-efficacy T2

I: 1.57 (1.44); N=11

C: 0.20 (1.53); N=14

QoL physical health T0

I: 27.1 (8.61)

C: 26.3 (6.05)

Change in physical QoL T1

I: 1.04 (6.01); N=13

C: -0.58 (3.91); N=11

Change in physical QoL T2

I: 9.46 (13.03); N=12

C: 3.39 (7.52); N=14

QoL mental health

T0

I: 42.9 (12.02)

C: 45.9 (7.91)

Change in mental QoL T1

I: 7.35 (18.04); N=13

C: -1.46 (14.70); N=11

Change in mental QoL T2

I: 9.48 (15.16); N=12 

C: 4.11 (13.38); N=14

Author’s conclusion:

The core effects of the interventions seem to involve function-related outcomes as well as self-efficacy. Because these effects are most meaningful for patients with cancer-related pain, the contribution of ANtiPain to physician-based pharmaceutical cancer pain management may be exceptionally valuable. Therefore, ANtiPain may be a promising intervention to improve cancer pain management when integrated into clinical practice.

Kravitz, 2011/ 2012

Type of study: RCT

Setting: outpatients

Country: United States

Source of funding: non-commercial

Inclusion criteria:

1) cognitively intact, English speaking adults with cancer

2) 18-80 years

3) lung, breast, prostate, head or neck, esophageal, colorectal, bladder or gynecologic cancer

4) worst pain score ≥4 (0-10 scale) for the past two weeks or pain that interfered “moderately” with functioning

Exclusion criteria:

1) surgical procedure scheduled within 6 weeks

2) enrolment in hospice

3) followed by pain management specialist beyond a single consultation

4) inability to receive and/or complete mailed enrolment materials

N total at baseline:

Intervention: 157

Control: 150

Important prognostic factors²:

For example

age ± SD:

I: 60 ± 9

C: 57 ± 10

Sex:

I: 22% M

C: 20% M

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Tailored education and coaching:

Self-administered questionnaire, followed by conversation with trained health educator

And follow-up phone calls at 2, 6 and 12 weeks

Describe  control (treatment/procedure/test):

Enhanced usual care

Length of follow-up:

12 weeks

Loss-to-follow-up:

Intervention:

15 (12%)

Reasons: 2 deceased, 5 too sick, 8 reason unknown

Control:

18 (13%)

Reasons: 1 deceased, 3 too sick, 14 reason unknown

Incomplete outcome data:

Intervention:

126 / 157 analyzed (80%)

Reasons: 27 did not receive intervention, 4 lost to follow-up

Control:

132/150 analyzed (88%)

Reasons: 15 did not receive intervention, 3 lost to follow-up

Outcome measures and effect size (include 95%CI and p-value if available):

Pain intensity:

(0-10 scale)

2 week

I: 6.2 (2.1); N=121

C: 6.2 (2.1); N=128

6 week

I: 6.1 (2.2); N=120

C: 5.8 (2.2); N=126

12 week

I: 5.9 (2.3); N=115

C: 5.6 (2.5); N=117

Self-efficacy:

(CPSE)

Pain control self-efficacy, scale 1–5

week 2

I: 3.7 (1.1); N=121

C:3.6 (1.0); N=128

week 6

I: 3.4 (1.1); N=120

C: 3.4 (1.1); N=124

week 12

I: 3.4 (1.2); N=114

C:3.5 (1.2); N=116

SF-12; scale 0-100

Week 6:

Mental health score

I: 45.9 (10.9); N=115

C:46.3 (11.0); N=123

Physical health score

I: 33.2 (9.9); N=115

C: 32.4 (10.3); N=123

Author’s conclusion:

Tailored intervention and coaching, compared with enhanced usual care, resulted in improved pain communication self-efficacy and temporarily improvement in pain –related impairment, but no improvement in pain severity.

Musavi, 2021

Type of study: RCT

Setting: Oncology Specialty Clinic

Country: Iran

Source of funding: academic

Inclusion criteria:

18–80 years old,

having a pain score of 3–10 on the VAS scale, being able to perform pain self-management, having

the ability to communicate, having written and reading literacy, and also having no history of using complementary medicine approaches in the past or at present

Exclusion criteria:

inability to participate in the study due to the disease’s deterioration or death and not completing the questionnaires

N total at baseline:

Intervention: 40

Control: 35

Important prognostic factors²:

For example

age ± SD:

I: 47.80±12.23

C: 46.28±8.31

Sex:

I: 45 % M

C: 37.1 % M

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

• The needs assessment form was delivered to the intervention group patients to complete.

• Then, pain self-management education was performed in the three steps of providing information, skills development and guidance in the intervention group.

• First step was accomplished by providing information in the hospital and at the time of hospitalization.

• Second step, the patients were practically trained to use the VAS scale and implement complementary medicine approaches, face-to-face and in the presence of the accompanying person. They were also taught how to perform pharmaceutical pain relief.

• Third step, guidance, included weekly and monthly follow-up evaluation of pain severity and the quality of life.

Describe  control (treatment/procedure/test):

Routine training.

An educational pamphlet was provided to the control group at the end of the research.

Length of follow-up:

3 months

Loss-to-follow-up:

N=7 (8.5%) in total, not reported per arm. Reasons include increased pain and the deterioration of the patient’s condition, which made them reluctant to continue.

Incomplete outcome data:

See above

Outcome measures and effect size (include 95%CI and p-value if available):

Pain severity:

Baseline

I: 63.75±18.44

C: 67.14±20.00

1 month

I: 35.41±23.31

C: 70.95±20.34

3 month

I: 37.08±16.66

C: 78.57±14.89

General QoL

Baseline

I: 48.12±15.38

C: 39.76±12.47

1 month

I: 77.91±13.41

C: 51.66±12.75

3 months

I: 78.33±12.90

C: 35.71±14.93

Author’s conclusion:

This study revealed a positive impact of pain

self-management on reducing pain severity and improving the indicators of the quality of life in patients with metastatic cancer. It is then recommended that nurses,

nursing students, and other healthcare team members apply these findings to effectively instruct metastatic cancer

patients and their families in pain control. Empowering

patients in pain self-management can reduce the costs imposed on families and the health system.

Raphaelis, 2020

Type of study: multi-center RCT

Setting: Oncology Specialty Clinic

Country: Austria

Source of funding: non-commercial

Inclusion criteria:

over 18 years old, had cancer-related pain ≥3 within the last 2 weeks on an 11-point NRS, or a regular cancer pain medication and a necessity to practice pain-self-management after discharge

Exclusion criteria:

cognitive, linguistic, emotional, or physical problems that would hamper study participation

N total at baseline:

Intervention: 61

Control: 92

Important prognostic factors²:

For example

age (IQR) :

I: 58.6 (52-68)

C: 58.9 (49-73)

Sex:

I: 49 % M

C: 43 % M

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

A face-to-face in-hospital session by a trained nurse to prepare discharge according to key strategies,  information on pain self-management, and skills building.

After discharge, cancer pain self-management was coached via phone calls.

Describe  control (treatment/procedure/test):

Standard care: routine pain assessment, documentation and pain medication but not structured pain self-management support.

Length of follow-up:

3 months

Loss-to-follow-up:

Intervention

During allocation (n=16)/ T1 (N=11)/ T2 (N=4)/ T3 (N=7)

• Did not receive intervention N=16/0/0/0
• Died; N=0/3/3/1
• Not reached; N=0/5/0/4
• Too ill; N=0/2/1/2
• Withdrew consent; N=0/1/0/0

Control

During allocation (n=0)/ T1 (N=20)/ T2 (N=7)/ T3 (N=7)

• Died; N=0/9/2/5
• Not reached; N=0/5/2/1
• Too ill; N=0/1/2/1
• Withdrew consent; N=0/4/1/0
• Other priorities; N=0/1/0/0

Incomplete outcome data:

See above

Outcome measures and effect size (include 95%CI and p-value if available):

Pain severity:

Average pain

Presented graphically.

Both groups show a reduction in pain scores from baseline, to 2 weeks, 4 weeks and 8 weeks.

Self-efficacy

No data available, but the group-by-time effect was significant for self-efficacy (p = .033)

 QoL  (generic question of the EORTC-C30)

Presented graphically.

Both groups show a very slight increase in QoL score, although the increase is steeper from baseline to 2 weeks for the intervention group

Author’s conclusion:

The implementation of ANtiPain improved meaningful patient outcomes on wards that applied the intervention routinely. Our analyses showed that the implementation benefited from being embedded in larger scale projects to improve cancer pain management and that the selection of wards with a high percentage of oncology patients may be crucial.

Note:
Average pain at baseline is higher in control group than intervention group (clinically relevant difference). Therefore, pain scores will not be compared.

Rustoen, 2014

Type of study: RCT

Setting: outpatients

Country: Norway

Source of funding: non-commercial

Inclusion criteria:

Adult (≥18 years old) outpatients with cancer who were able to read, write, and understand Norwegian were recruited for this study. Patients had a Karnofsky Performance Status (KPS) score of 50 or greater (range, 60Y90), an average pain intensity score of 2.5 or greater on a 0- to 10-point NRS, and radiographic evidence of bone metastasis.

Exclusion criteria:

None

N total at baseline:

Intervention: 87

Control: 92

Important prognostic factors²:

For example

age  (SD):

I: 64.3 (11.4)

C: 66.8 (12.7)

Sex:

I: 47.1% M

C: 55.4 % M

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Specially trained oncology intervention nurse visited the patients in their home at Weeks 1, 3 and 6 and conducted telephone interviews at Weeks 2, 4 and 5.

• At the Week 1 visit, the PRO-SELF nurse

conducted an academic detailing session.

• At Weeks 2, 4 and 5, the PRO-SELF nurse

contacted patients by phone and reviewed their pain intensity scores and analgesic intake.

• At Weeks 3 and 6, the PRO-SELF nurse made home visits where the educational material was reinforced, and additional coaching about pain management took place.

Describe  control (treatment/procedure/test):

• A booklet about cancer pain management

• Home visits and nurse telephone interviews same with IG Pain management diary recorded their pain intensity scores and analgesic intake

Length of follow-up:

6 weeks

Loss-to-follow-up:

Intervention:

Baseline:

6 (6.5%) did not fill in the pain diary

Post-test:

12 (13%) did not fill in the pain diary

Control:

Baseline:

10 (11.5%) did not fill in the pain diary

Post-test:

20 (23%) did not fill in the pain diary

Incomplete outcome data:

See above

Outcome measures and effect size (include 95%CI and p-value if available):

Pain intensity:

Presented graphically. A slight decrease in average pain was shown, with a similar effect in both groups.

Author’s conclusion:

Possible reasons for the lack of efficacy include an inadequate dose

of the psychoeducational intervention, inadequate changes in analgesic prescriptions, and/or the impact of attention provided to the control group. Additional research is needed to evaluate the efficacy of psycho-educational interventions to relieve pain in patients with advanced cancer.

Syrjala, 2008

Type of study: multisite RCT

Setting: outpatients

Country: United States

Source of funding: non-commercial

Inclusion criteria:

1) cancer diagnosis with disease-related persistent pain

2) ambulatory functional status

3) cancer treatment expected to be stable over the next 6 months

4) age over 18

5) English reading and writing proficiency adequate to participate in intervention and assessment

Exclusion criteria:

1) active alcohol or other substance abuse

2) major psychiatric diagnosis

N total at baseline:

Intervention: 48

Control: 45

Important prognostic factors²:

For example

age ± SD:

I: 58 ± 13

C: 54 ± 12

Sex:

I:42 % M

C:29 % M

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Pain education plus training (30-45) including a 15 minute video and patient could take notes

Plus

Phone call after 72 hrs (10 min)

Describe  control (treatment/procedure/test):

Nutrition education plus training (30-45) including a 15 minute video and patient could take notes

Plus

Phone call after 72 hrs (10 min)

Length of follow-up:

6 months

Loss-to-follow-up:

Intervention:

20 (43%)

Reasons: 7 too ill, 14 died, 1 voluntarily dropped

Control:

20 (47%)

Reasons: 6 too ill, 13 died, 2 voluntarily dropped, 1 cognitive impairments

Incomplete outcome data:

Intervention:

3 (7%)

Control:

10 (22%)

(Reasons not described)

Outcome measures and effect size (include 95%CI and p-value if available):

Pain intensity:

(BPI 0-10)

Average pain: -0.81 ± 0.36 points lower in video + booklet group compared to control (p=0.03) (change from baseline)

Graph shows clinically relevant difference between groups at 1 month, but not at the other time stamps

Worst pain: 0.27 ± 0.38 points lower in video + booklet group compared to control (NS)

Author’s conclusion:

Using video and print materials with brief individualized training, effectively improved pain management over time for cancer patients of varying diagnostic and demographic groups

Knoerl, 2018

Type of study: pilot RCT

Setting: outpatients

Country:

USA

Source of funding: none reported

Inclusion criteria:

1) were older than 25 years of age,

2) self-reported ≥4 of 10 worst CIPN pain that persisted 3 months or longer after the cessation of neurotoxic chemotherapy,

3) had at least National Cancer Institute Common Terminology Criteria for Adverse Events grade

1 sensory CIPN

4) had a stable analgesic medication regimen (≤10% change in dosage in the 2 weeks before study enrollment)

5) were able to access/use a computer.

Exclusion criteria:

1) a prognosis of <3 months

2) peripheral neuropathy from other causes

3) planned to receive neurotoxic chemotherapy

while enrolled in the study 4) participated in cognitive-behavioral pain management in the past.

N total at baseline:

Intervention: 30

Control: 30

Important prognostic factors²:

For example

age (SD):

I: 58.93 (9.33)

C: 63.37 (8.36)

Sex:

I: 23% M

C: 27% M

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Usual care from primary provider

Plus

8-week Proactive

Self-Management Program for Effects of Cancer Treatment (PROSPECT): Participants completes a link ‘Steps For Me’. Website recommends modules based on patient’s responses. Patient may use modules as much as they desired; no additional encouragement to access modules were made

Describe  control (treatment/procedure/test):

Usual care from primary provider; received access to intervention after

completion of study-related surveys

Length of follow-up:

8 weeks

Loss-to-follow-up:

Intervention:

Baseline:

N=1 (3%)

Reasons: dropped out

Later lost to follow-up:

N=6 (21%)

Reasons: unable to contact (n=3); personal decision (n=3)

Control:

Baseline:

N=2 (7%)

Reasons: dropped out

Later lost to follow-up:

N=4 (14%)

Reasons: unable to contact (n=3); personal decision (n=1)

Incomplete outcome data:

Intervention

19/23 completed the primary aim

19/23 completed  the secondary aim

Control

19/24 completed the primary aim

23/24 completed the secondary aim

Outcome measures and effect size (include 95%CI and p-value if available):

Pain Intensity:

Average pain, mean (SD)

Baseline

I: 4.37 (1.89)

C: 3.91 (2.52)

Week 4

I: 4.37 (2.11)

C: 5.25 (2.36)

Week 8

I: 4.58 (1.87)

C: 5.35 (1.99)

QoL scale 0-100, mean (SD)

EORTC QLQ CIPN

CIPN sensory

Week 4

I: 44.80 (23.10)

C: 41.67 (18.70)

CIPN sensory

Week 8

I: 40.41 (18.66)

C: 41.95 (17.37)

CIPN Motor

Week 4

I: 30.23 (23.59)
C: 23.24 (13.57)

CIPN Motor

Week 8

I: 26.91 (17.71)

C: 22.75 (13.3)

Author’s conclusion:

This pilot study provides preliminary evidence supporting the efficacy of a self-guided cognitive-behavioral pain

management intervention for improving worst pain intensity in individuals with chronic painful CIPN

Valenta, 2022

Type of study: multicenter RCT

Setting: outpatients

Country: Switzerland

Source of funding: non-commercial

Inclusion criteria:

1) experienced any type

of cancer pain with an average pain of >3 on a 0–10 numeric rating scale

(NRS) during the last two weeks

2) had an estimated life expectancy of >6 months; 3) were aged ≥18 years;

4) were able to understand,

read, and write German

5) had access to a telephone

Exclusion criteria:

1) had cognitive dysfunction or hearing impairment

2) were hospitalized for >2 weeks during the study

 3) experienced only

neuropathic pain

N total at baseline:

Intervention: 18

Control: 16

Important prognostic factors²:

For example

age (SD):

I: 66.6 (14.5)

C: 64.1 (11.0)

Sex:

I: 65% M

C: 56% M

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

PRO-SELF© Plus Pain Control Programs based on three key strategies: nurse coaching, self-care skills building to manage pain and associated

Describe  control (treatment/procedure/test):

usual care (i.e.,

their physicians assessed pain and prescribed analgesic medications)

Length of follow-up:

6 weeks

Loss-to-follow-up:

Intervention:

Baseline: N=1 (5.6%)

Reasons: too ill

During study period: N=5 (29.4%)

Reasons: family caregiver too sick (n=1); too ill (n=1); hospitalized (n=1); died (n=2)

Control

Baseline: N=7 (43.8%)

Reason: too ill (n=3); hospitalized > 2wk (n=1); died (n=2); no pain anymore (n=1)

During study period: N=0

Reasons: -

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Pain intensity:

Average pain

Week 0

I: 4.3 (1.8); N=17

C: 3.7 (1.3); N=9

Week 4

I: 2.6 (1.4); N=12

C: 3.0 (1.1); N=9

Week 6

I: 2.0 (1.2); N=12

C: 3.1 (1.3); N=9

SEQ score

Week 0

I: 69.2 (18.5); N=17

C: 69.9 (10.1); N=9

Week 4

I: NA

C: NA

Week 6

I: 79.9 (17.8); N=12

C: 67.3 (12.8); N=9

Author’s conclusion:

This study was the first to test the efficacy of a psychoeducational cancer pain self-management

intervention in a German-speaking context, with most patients receiving palliative care. Clinicians can recommend the use of pain management diaries. Tailoring interventions to an individual's situation and dynamic pain

trajectory may improve patients' pain self-management.

Kelleher, 2021

Type of study: pilot RCT

Country: USA

Source of funding: non-commercial

Inclusion criteria:

1) ≥21 years old,

2) completed active cancer

treatment

3) reported pain and psychological distress at ≥3

on a 0-10 scale since completing cancer treatment

4) English-speaking

Exclusion criteria:

1) cognitive impairment or severe psychiatric condition based on chart

review

2) receipt of pain coping skills training <6 months,

3) initial diagnosis of metastatic cancer

N total at baseline:

Intervention: 14

Control: 17

Important prognostic factors²:

For example

Age (SD)

59.5 (10.5), not reported per group

Sex:

61% (not reported per group)

Groups comparable at baseline? NR

Describe intervention (treatment/procedure/test):

Telephone-based coping skills training (CST): five 45-60 minute sessions of a cognitive-behavioral theory-based protocol to manage pain and distress

Describe  control (treatment/procedure/test):

Standard care:  informational

pamphlets related to survivorship health and cancer center services

Length of follow-up:

3 months

Loss-to-follow-up:

Intervention:

During study period:

N=1 (5.9%)

Reasons: lost to follow-up

3 months

N=1 (6.3%)

Reasons: lost to follow-up

Control:

N=0 (0%)

Incomplete outcome data:

NR

Outcome measures and effect size

pain severity (4-item Pain Severity subscale of the Brief Pain Inventory (BPI) scale 0-10)

baseline

I: 2 [SD=2];

C: 2 [SD=2];

post-treatment

I: 3 [SD=2];

C: 2[SD=2]

3-month follow-up

I: 2 [SD=2])

C: 1 [SD=2]

self-efficacy for pain control (Self- Efficacy for Pain Management subscale of the Chronic Pain Self-Efficacy Scale; 10-100)

post-treatment

I: 71 [SD=24]

C: 66 [SD=23]

3-month follow-up

I: 72 [SD=27]

C: 65 [SD=25]

HRQoL (27-item Functional

Assessment of Cancer Therapy-General (FACT-G); scale 0-108)

baseline

I: 80 [SD=14];

C: 76 [SD=12]

posttreatment

I: 80 [SD=16];

C: 80 [SD=13]

3-month follow-up

I: 83 [SD=15])

C: 77 [SD=15]

Author’s conclusion:

Findings suggest that a telephone-based CST intervention has strong feasibility, evidenced by accrual, low attrition,

and adherence to intervention sessions and assessments. Likewise, participant engagement and acceptability with CST were high.

Kwekkeboom, 2012

Type of study: pilot RCT

Country: USA

Source of funding: non-commercial

Inclusion criteria:

Participants were receiving treatment for advanced (metastatic or recurrent) colorectal, lung, prostate,

or gynecologic cancers and had experienced pain, fatigue, and sleep disturbance in the past

week. To qualify, severity of at least two of the

three symptoms had to be rated as 3 or more on a 0-10 NRS.

Exclusion criteria:

Patients with postoperative or neuropathic pain were excluded, as were persons

who had been hospitalized for mental health reasons within the last three months.

N total at baseline:

Intervention: 43

Control: 43

Important prognostic factors²:

For example

Age (SD):

I: 60.44 (10.76)

C: 60.14 (11.54)               

Sex:

I: 33% M

C: 49% M

Groups comparable at baseline? groups did not differ on study variables at

Time 1, with the exception of depressed mood. Participants in the waitlist group reported more depressed mood (mean [SD] = 10.07 [8.24]) than those in the intervention group.

Describe intervention (treatment/procedure/test):

patient-controlled cognitive-behavioral (CB) intervention

The 12 CB strategies were presented in 4

categories: symptom-focused imagery, nature-focused imagery, relaxation exercises, and nature sounds

Describe  control (treatment/procedure/test):

Waitlist, usual care

Length of follow-up:

8 weeks

Loss-to-follow-up:

Intervention:

N = 5 (11.6%)

Reasons: discontinued intervention  (n=5)

Control:

N = 1 (2%)

Reasons: discontinued intervention

Incomplete outcome data:

A per-protocol analysis was conducted

Outcome measures and effect size (include 95%CI and p-value if available):

Pain intensity:

(NRS 0-10)

Baseline

I: 1.97 (1.64); N=43

C: 2.49 (1.88); N=43

End of week 2

I: 1.65 (1.61); N=36

C: 2.23 (1.96); N=42

Author’s conclusion:

Findings suggest that the CB intervention may be an efficacious approach to treating the pain, fatigue, and sleep disturbance symptom cluster.

Eaton, 2021

Type of study: pilot RCT

Country: USA

Source of funding: non-commercial

Inclusion criteria:

1) having moderate or higher pain intensity on average during the last week (3 or greater on a 0-to-10 pain intensity numeric scale)

2) having completed active cancer treatment other than hormonal or maintenance therapy 3 months or longer ago

3) being 18 years or older 4) having functional fluency in English

5) being able and willing to participate in the study.

Exclusion criteria:

NR

N total at baseline:

Intervention: 21

Control: 19

Important prognostic factors²:

For example

Age (SD):

I: 49.1 (13.06)

C: 56.42 (12.39)               

Sex:

I: 24% M

C: 21% M

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

4 weeks of listening to a hypnosis recording daily (relaxation induction followed by suggestions for relaxation and comfort, as well as posthypnotic suggestions for permanence of the benefits experienced with the recording and for self-hypnosis practice)

Describe  control (treatment/procedure/test):

Wait-list control

Length of follow-up:

8 weeks

Loss-to-follow-up:

Intervention:

Did not receive intervention

N = 1 (%)

Did not complete week 4

N=1 (5%)

Did not complete week 8

N=5 (24%)

Control:

Did not receive intervention

N = 5 (26%)

Did not complete week 4

N=1 (5%)

Did not complete week 8

N=5 (26%)

Incomplete outcome data:

As above mentioned

Outcome measures and effect size (include 95%CI and p-value if available):

Pain intensity:

(NRS 0-10)

Baseline

I: 6.62 (1.47); N=21

C: 6.89 (1.49); N=19

week 4

I: 6.15 (2.18); N=20

C: 6.61 (1.38); N=18

Week 8

I: 6.06 (2.14); N=16

C: 6.57 (1.79); N=14

Author’s conclusion:

The intervention was feasible and acceptable among the majority of the 40 participants, but the single recording and variability in dose (e.g., number of times the recording was listened to) may have limited the intervention’s effect in reducing pain. However, for a substantial portion of the participants, the reduction in pain was found to be clinically significant.

Study reference

(first author, publication year)

Was the allocation sequence adequately generated?

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

LOW

Some concerns

HIGH

Bennett, 2021

Probably yes;

Reason: A computer-generated minimisation programme incorporating a random element was used to randomise participants to either the UC plus SSM arm or the UC arm.

Unclear;

Reason: Not reported

Probably no;

Reason: Participants, clinicians, research nurses in the recruiting clinics and palliative care nurses were, of

necessity, aware of treatment allocation, but the collection of patient outcomes via the IMPACCT trial

researcher was blinded.

Probably yes;

Reason: Loss to follow-up was infrequent in intervention and control group. Adequate imputation methods (multiple imputation) were used.

Definitely yes;

Reason: All relevant outcomes were reported

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding

Jahn, 2014

Definitely yes;

Reason: 1) Pair-matched

randomization of patients on a ward 2) concurrently on all wards prior to study 3) by a reproducible SAS PROC PLAN 4) by an external department

Probably yes;

Reason: the allocation procedure on the

cluster and individual levels was concealed by an external department.

Definitely no

Reason: the patients were not informed of their group assignment; however, the intervention

nurses and assessment nurses were not blinded, which might have resulted in patients becoming aware of their group assignment due to nurses' unsealing of information

Probably yes

Reason: Loss to follow-up was similar in both groups.

Definitely yes

Reason: All relevant outcomes were reported;

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding

Koller, 2013

Probably yes:

Reason: Computerized permuted blocks procedure, 1:1.

Probably yes;

Reason: Sequentially numbered opaque envelopes

Probably no;

Reason: Clinicians and outcome assessors were blinded. Participants were not.

Probably no

Reason: Loss to follow-up was frequent (almost half in both groups).

Definitely yes

Reason: All relevant outcomes were reported;

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding, loss to follow-up

Koller, 2018

Probably yes;

Reason: computerised procedure to generate the randomisation list

Probably yes;

Reason: Sequentially numbered opaque envelopes

Probably no;

Reason: no blinding for participants

and research nurses

Probably yes;

Reason: the missing outcome data were balanced in numbers across the groups, with similar reasons for missing data across groups

Probably yes;

Reason: all relevant outcomes seem reported, however it is not sure the trial was registered before the study was conducted

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding

Kravitz, 2012

Probably yes;

Reason: Computer-generated blocked randomization

Unclear;

Reason: not reported

Probably no;

Reason: Patients (but not physicians or study personnel) were aware of their assigned intervention;

Probably yes

Reason: Loss to follow-up was similar in both groups.

Probably no;

Reason: study protocol is not available. Results for two follow-up periods for SF-12 outcomes are missing

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding

Musavi, 2021

Probably yes;

Reason: A statistician

prepared the randomization list.

Probably yes;

Reason: sealed envelopes were used

Definitely no;

Reason: the study is not blinded

Probably no

Reason: Loss to follow-up was infrequent and assumably similar in both groups. No ITT analysis was done, hence dropouts were not analyzed.

Definitely yes;

Reason: all relevant outcomes were reported

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: No blinding, loss to follow-up

Raphaelis, 2020

Probably no;

Reason: randomization was performed on ward level with a stepped wedge approach.

Unclear;

Reason: not reported

Probably no

Reason: Study nurses who collected all data for T1-T3 via post or online questionnaires were blinded to group allocation. Blinding of subjects is not reported, but they are assumed to be unmasked

Probably yes;

Reason: loss to follow-up was similar in both groups

Definitely yes;

Reason: all relevant outcomes were reported

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding

Syrjala, 2008

Probably yes;

Reason: Randomly assigned in blocks

based on stratification

Unclear;

Reason: not reported

Probably no

Reason: physicians and nurses were not informed of patient randomizations, but patients potentially could reveal their randomization by bringing study materials to medical

appointments

Probably no;

Reason: missing data. Bias due to possible violation of

intention to treat

analysis

Definitely yes;

Reason: all relevant outcomes were reported

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding, loss to follow-up

Rustoen, 2014

Probably no;

Reason: randomization was performed by lot. No further details.

Unclear;

Reason: not reported

Probably no;

Reason: Study protocol mentions blinding of subjects, however this seems impossible concerning the intervention. Study was assumed to be unmasked.

Probably yes;

Reason: loss to follow-up is infrequent and similar in both groups.

Definitely yes;

Reason: all relevant outcomes were reported

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: no blinding

Knoerl, 2018

Probably no;

Reason: study was randomized, but no method of randomization is described.

Unclear;

Reason: not reported

Probably no;

Reason: subjects were not blinded. Study protocol mentions blinding of the investigator.

Probably yes;

Reason: loss to follow-up is infrequent and similar in both groups.

Definitely yes;

Reason: all relevant outcomes were reported

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: unknown randomization method, lack of blinding

Valenta 2022

Probably yes;

Reason: computer generated randomization lists.

Unclear;

Reason: not reported

Probably no;

Reason: data collectors could not be blinded. Treating clinicians were blinded. Blinding of subjects is not mentioned, but it is assumed they could not be blinded.

Probably no;

Reason: loss to follow-up is frequent and higher in the control group.

Definitely yes;

Reason: all relevant outcomes were reported

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding, loss to follow-up

Kelleher, 2021

Probably yes;

Reason: A random number assignment procedure was conducted by a study member with no participant interaction

Unclear;

Reason: not reported

Probably no;

Reason: subjects were blinded to the hypothesis of the study, but could probably not be blinded to the intervention. Other blinding is not mentioned and therefore not assumed.

Probably yes;

Reason: loss to follow-up is infrequent in intervention and control group

Definitely yes;

Reason: all relevant outcomes were reported

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding

Kwekkeboom, 2012

Probably yes;

Reason: randomization sequence was created by the study’s statistician

Probably yes;

Reason: envelopes were opened by a research nurse

Probably no;

Reason: Neither

the patient nor the research nurse was blinded to group assignment.

Probably yes;

Reason: loss to follow-up is infrequent in intervention and control group

Definitely yes;

Reason: all relevant outcomes were reported

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding

Eaton, 2021

Probably no;

Reason: study was randomized, but method of randomization is not described.

Unclear;

Reason: not reported

Probably no;

Reason: The research assistant was blind to study-group assignment until the structured interview was conducted. Other blinding is not mentioned.

Probably yes;

Reason: loss to follow-up is similar in both groups.

Definitely yes;

Reason: all relevant outcomes were reported

Definitely yes;

Reason: No other problems noted

Some concerns (all outcomes)

Reason: lack of blinding