Evidencetabellen Arbeid

6. Evidence tabel arbeid

Vraag 2: Effect van interventies gericht op arbeid

Systematic reviews

Study ID	Method	Patient characteristics	Intervention(s)	Results	Critical appraisal of review quality
de Boer 2011	· SR + MA · Funding/CoI: o Coronel Institute of Occupational Health, Netherlands. o Cochrane Occupational Safety and Health Review Group, Finland. o University of Birmingham, UK. o Uniformed Services University of the Health Sciences, USA. o SIG Pathways to Work. University Research Programme, Netherlands. o Finnish Work Environment Fund, Finland. o No CoI known · Search date: Feb 2010 · Databases: CENTRAL, Medline, Embase, Cinahl, OSH-ROM, PsycInfo, DARE, ClinicalTrials.gov, Trialregister.nl, Controlled-trials.com · Study designs: RCTs, quasi-RCTs, cluster-RCTs, controlled before-after studies (CBAs) · N included studies: 14 RCTs and 4 CBAs	· Eligibility criteria: adults (18+) with cancer and were in paid employment (employee or self-employed) at the time of diagnosis; all cancer types · Patient characteristics: o N=1652 o Breast cancer: 8 studies; prostate cancer: 3 studies	Any type of intervention with the aim to enhance return-to-work: · Psychological · Vocational · Physical · Multidisciplinary vs. Usual care	Diversionary activities (critical): Not reported Physical activity (critical): see Quality of life Self-efficacy (critical): Not reported Cognitive functioning (critical): see Quality of life Job satisfaction (critical): not reported Job loss (critical): not reported (Partial) return to work (important): · Psychological interventions: o 2 RCTs (Lepore 2003): RR = 1.21, 95%CI 0.96-1.51 o 3 CBAs (Capone 1980, Gordon 1980): RR = 1.52, 95%CI 1.19-1.94 · Vocational interventions: no evidence · Physical interventions (1 RCT: Rogers 2009, physical training programme): OR = 1.20, 95%CI 0.32-4.54 · Multidisciplinary interventions (3 RCTs: Berglund 1994, Burgio 2006, Maguire 1983): RR = 1.15, 95%CI 1.01-1.30 Quality of life (important): · Psychological interventions: o 2 RCTs (Lepore 2003): § Physical functioning: MD = 1.43, 95%CI -0.71 to 3.57 § Mental functioning: MD = 0.14, 95%CI -1.62 to 1.91 · Vocational interventions: no evidence · Physical interventions (1 RCT: Rogers 2009, physical training programme): MD = -4.60, 95%CI -11.99 to 2.79 · Multidisciplinary interventions (1 RCT: Berglund 1994): MD = -0.07, 95%CI -0.33 to 0.19 Fatigue (important): Not reported	· Good quality Cochrane review · In general, high risk of bias for included studies, because of lack of ITT analysis, absence of blinding and unclear allocation concealment · Included relevant RCTs: Berglund 1994, Burgio 2006, Lepore 2003, Maguire 1983 (quasi-RCT), Rogers 2009 · Included relevant CBAs: Capone 1980, Gordon 1980 · Medical interventions: no comparison with usual care (so excluded from this overview) · No separate analysis for interventions during or after curative treatment: o Berglund 1994: after o Burgio 2006: during o Capone 1980: during o Gordon 1980: during o Lepore 2003: after o Maguire 1983: during o Rogers 2009: after
Egan 2013	· SR · Funding/CoI: funded by the Canadian Institutes of Health Research (Grant # KPE-117820) and the Bruyère Research Institute; CoI not reported · Search date: Jan 2000 - Jan 2012 · Databases: PubMed, Embase, Cinahl, PsycInfo, RehabDATA · Study designs: SR, RCTs · N included studies: unclear	· Eligibility criteria: adults (18+) that survived cancer · Patient characteristics: o Not reported in detail	Treatments that could be provided by rehabilitation professions	Narrative presentation of results of de Boer 2011 and Tamminga 2010 See evidence report	· SR of low to moderate quality: outcomes are not clearly described; no search terms provided; data extraction not described; no pooling; study quality not taken into account
Tamminga 2010	· SR · Funding/CoI: granted by the Stichting Insituut GAK (SIG); no CoI · Search date: Oct 2008 · Databases: PubMed, Embase, Cinahl, PsycInfo · Study designs: all · N included studies: 23	· Eligibility criteria: adults (18+) diagnosed with cancer · Patient characteristics: o Mean age 48y o Mainly breast cancer	Interventions aiming at the improvement of return to work, employment status, or work retention through improvement of work-environment-related or person-related factors	Diversionary activities (critical): not reported Physical activity (critical): not reported Self-efficacy (critical): not reported Job satisfaction (critical): not reported Job loss (critical): not reported Cognitive functioning (critical): not reported (Partial) return to work (important): 7 studies (of which 4 controlled trials) · Rate of return-to-work in intervention group: range 37-89%, median 76% · Controlled trials (N=4): o Capone 1980: OR 0.24, 95%CI 0.06-1.02 o Maguire 1983: OR 0.37, 95%CI 0.15-0.93 o Berglund 1993: OR 3.50 (0.65-18.98) o Berglund 1994: OR 0.63 (0.27-1.50) Quality of life (important): not reported Fatigue (important): not reported	· SR of good quality; no pooling performed because of heterogeneity · Mix of studies comparing different interventions or one intervention with usual care

Primaire studies

Study ID	Method	Patient characteristics	Interventions	Results	Critical appraisal of study quality
Björneklett 2013	· Design: RCT · Funding/CoI: the County · Council of Västmanland, the Swedish Social Insurance Agency, the Västmanland Research Fund against Cancer and the National Federation of Cancer and Traffic Injury; no CoI · Setting: single centre, Sweden · Sample size: N=382 · Duration: recruitment April 2002 – Nov 2007	· Eligibility criteria: women with newly diagnosed primary breast cancer, no previous malignancy, the physical and mental capability to participate in group interventions and to fill in questionnaires and an expected survival time of more than 12 months; patients with a physical disability were excluded, as were patients with severe visual or hearing impairments, serious mental illness, dementia or active alcohol abuse, and patients who had participated in group rehabilitations · A priori patient characteristics: o Age: 30-84y o Breast-conserving surgery N=293, mastectomy N=89 o No between-group differences	Support-intervention program (N=191): · information-based support program supplemented with relaxation, qi-gong and liberating dance · within 4 months of ending adjuvant treatment · on a residential basis for one week, followed by four days of follow-up two months later vs. Routine control group (N=191)	Physical activity (critical): not reported Job satisfaction (critical): not reported Job loss (critical): not reported Self-efficacy (critical): not reported Return to work (critical): not reported Surrogate outcomes: · Sick leave: no significant differences at 2 (44.3% vs. 45.7%, p=0.853), 6 (36.2% vs. 32.6%, p=0.599) and 12 months (27.1% vs. 25.3%, p=0.783) Quality of life (critical): not reported	Level of evidence: high risk of bias · Randomization with closed envelopes (potential unblinded allocation); no blinding of patients; blinding of assessors not reported; no intention-to-treat analysis · Analyses limited to patients aged <65y: 121 in intervention group, 115 in control group
Hubbard 2013 Kyle 2011	· Design: RCT · Funding/CoI: Macmillan Cancer Support and Scottish Centre for Healthy Working Lives; no CoI · Setting: 3 NHS hospitals, Scotland · Sample size: N=22 · Duration: recruitment Sep 2010 – Dec 2011; follow-up 12 months	· Eligibility criteria: women with invasive breast cancer or DCIS first treated with surgery; 18-65y; paid employment or self-employed; living or working in Lothian or Tayside, Scotland, UK · A priori patient characteristics: o Mean age 50.5y o Stage II: 44.4% o Full-time employment: 61.1% o Mean number of hours worked: 32.5 hours/week	Vocational rehabilitation service (Working Health Services, WHS) (N=8): · telephone contacts with case manager · face-to-face meeting with case manager · referral to other service vs. Usual care (N=14)	Physical activity (critical): FACT-B, physical well-being subscale, mean (SD) · 6 months: 23.1 (3.9) vs. 21.9 (6.5); MD = 1.2, 95%CI -7.2 to 4.8, p=0.68 · 12 months: 25.0 (1.4) vs. 23.8 (5.2); MD = 1.2, 95%CI -5.6 to 3.2, p=0.56 Job satisfaction (critical): not reported Job loss (critical): · All participants had the same job role at 12 months as they had reported before their cancer diagnosis Self-efficacy (critical): not reported Return to work (critical): not reported Surrogate outcomes: · Sick leave at 6 months: MD = 53.1, 95%CI ‑15.8 to 122.0, p=0.122 · Sick leave at 12 months: MD = 2.0, 95%CI ‑3.4 to 7.3, p=0.441 Quality of life (critical): FACT-B scale, mean (SD) · 6 months: 109.0 (17.9) vs. 98.9 (21.4); MD = 10.1, 95%CI -31.7 to 11.5, p=0.333 · 12 months: 113.7 (18.5) vs. 107.1 (19.8); MD = 6.6, 95%CI -27.3 to 14.2, p=0.51	Level of evidence: high risk of bias · No blinding of patients; blinded outcome assessment · Several drop-outs were excluded from the analysis (1 intervention group, 3 in control group) · Changes in protocol due to low recruitment rates · WHS provides support to people who are employed in companies with < 250 employees where occupational health services are not routinely available. WHS adopts a biopsychosocial model and a multi-disciplinary approach whereby case management is used to assess individuals’ needs to enable work retention or return through signposting or direct referral to a range of supportive services according to need, such as physiotherapy, occupational therapy, occupational health nurse, occupational health doctor, counsellor/ psychological therapy and complementary therapy
Sherman 2012	· Design: RCT · Funding/CoI: not reported · Setting: 3 major medical centers and 1 community hospital, US · Sample size: N=249 · Duration: unclear	· Eligibility criteria: women with confirmed diagnosis of early-stage breast cancer; no previous history of cancer; who had identified a person most intimately involved in the breast cancer experience who was named their “partner”; no concurrent, uncontrolled, chronic medical illness; no history of psychiatric hospitalization or drug abuse · A priori patient characteristics: o Mean age 53.8y o Full time employment: 52.8%	Group 1: usual care vs. Group 2: usual care + four phase-specific psychoeducational videos: (a) Coping With Your Diagnosis, (b) Recovering From Surgery, (c) Understanding Adjuvant Therapy, and (d) Your Ongoing Recovery vs. Group 3: usual care + telephone counseling intervention vs. Group 4: usual care + phase-specific psychoeducational videotapes and telephone counseling	Diversionary activities (critical): not reported Physical activity (critical): not reported Self-efficacy (critical): not reported Cognitive functioning (critical): not reported (Partial) return to work (important): not reported Surrogate outcomes: · Vocational well-being (subscale of PAIS): significant main effect for time (p=0.024), but no significant group or group x time interactions Quality of life (important): not reported Fatigue (important): not reported	Level of evidence: low risk of bias
Tamminga 2013	· Design: RCT · Funding/CoI: Stichting Insituut Gak; no CoI related to topic · Setting: 6 centres, the Netherlands · Sample size: N=133 · Duration: recruitment May 2009 – Dec 2010 o Follow-up: 12 months	· Eligibility criteria: cancer patients 18-60y who had been treated with curative intent (expected 1-year survival rate of approximately 80%); exclusion of patients who were not sufficiently able to speak, read, or write Dutch, had a severe mental disorder or other severe comorbidity, and for whom the primary diagnosis of cancer had been made more than two months previously · A priori patient characteristics: o Mean age: 47.5 vs. 47.6y o Female: 99% vs. 100% o Breast cancer: 64% vs. 60%	Hospital-based work support intervention: patient education and support at the hospital and improvement of communication between treating and occupational physicians; gradual return-to-work plan (N=65) vs. Usual care (N=68)	Physical activity (critical): · SF-36, physical functioning subscale at 12m: 81 vs. 79, p=0.95 Job satisfaction (critical): not reported Job loss (critical): · 4/65 vs. 5/68 Self-efficacy (critical): not reported Return to work (critical): · At 12m: 79% in both groups (p=0.97); RR = 1.03 (95%CI 0.84-1.2) · HR for partial return-to-work: 1.03 (95%CI 0.64-1.6) · HR for full return-to-work: 0.88 (95%CI 0.53-1.5) Quality of life (critical): · No significant differences between groups: o VAS at 12m: 73 vs. 70, p=0.26 o SF-36: no differences on subscales	Level of evidence: high risk of bias · No blinding of patients or outcome assessors · Unclear if allocation was concealed · Follow-up data at 12 months: N=128

Study ID

Method

Patient characteristics

Interventions

Results

Critical appraisal of study quality

Björneklett 2013

· Design: RCT

· Funding/CoI: the County

· Council of Västmanland, the Swedish Social Insurance Agency, the Västmanland Research Fund against Cancer and the National Federation of Cancer and Traffic Injury; no CoI

· Setting: single centre, Sweden

· Sample size: N=382

· Duration: recruitment April 2002 – Nov 2007

· Eligibility criteria: women with newly diagnosed primary breast cancer, no previous malignancy, the physical and mental capability to participate in group interventions and to fill in questionnaires and an expected survival time of more than 12 months; patients with a physical disability were excluded, as were patients with severe visual or hearing impairments, serious mental illness, dementia or active alcohol abuse, and patients who had participated in group rehabilitations

· A priori patient characteristics:

o Age: 30-84y

o Breast-conserving surgery N=293, mastectomy N=89

o No between-group differences

Support-intervention program (N=191):

· information-based support program supplemented with relaxation, qi-gong and liberating dance

· within 4 months of ending adjuvant treatment

· on a residential basis for one week, followed by four days of follow-up two months later

vs.

Routine control group (N=191)

Physical activity (critical): not reported

Job satisfaction (critical): not reported

Job loss (critical): not reported

Self-efficacy (critical): not reported

Return to work (critical): not reported

Surrogate outcomes:

· Sick leave: no significant differences at 2 (44.3% vs. 45.7%, p=0.853), 6 (36.2% vs. 32.6%, p=0.599) and 12 months (27.1% vs. 25.3%, p=0.783)

Quality of life (critical): not reported

Level of evidence: high risk of bias

· Randomization with closed envelopes (potential unblinded allocation); no blinding of patients; blinding of assessors not reported; no intention-to-treat analysis

· Analyses limited to patients aged <65y: 121 in intervention group, 115 in control group

Hubbard 2013

Kyle 2011

· Design: RCT

· Funding/CoI: Macmillan Cancer Support and Scottish Centre for Healthy Working Lives; no CoI

· Setting: 3 NHS hospitals, Scotland

· Sample size: N=22

· Duration: recruitment Sep 2010 – Dec 2011; follow-up 12 months

· Eligibility criteria: women with invasive breast cancer or DCIS first treated with surgery; 18-65y; paid employment or self-employed; living or working in Lothian or Tayside, Scotland, UK

· A priori patient characteristics:

o Mean age 50.5y

o Stage II: 44.4%

o Full-time employment: 61.1%

o Mean number of hours worked: 32.5 hours/week

Vocational rehabilitation service (Working Health Services, WHS) (N=8):

· telephone contacts with case manager

· face-to-face meeting with case manager

· referral to other service

vs.

Usual care (N=14)

Physical activity (critical): FACT-B, physical well-being subscale, mean (SD)

· 6 months: 23.1 (3.9) vs. 21.9 (6.5); MD = 1.2, 95%CI -7.2 to 4.8, p=0.68

· 12 months: 25.0 (1.4) vs. 23.8 (5.2); MD = 1.2, 95%CI -5.6 to 3.2, p=0.56

Job satisfaction (critical): not reported

Job loss (critical):

· All participants had the same job role at 12 months as they had reported before their cancer diagnosis

Self-efficacy (critical): not reported

Return to work (critical): not reported

Surrogate outcomes:

· Sick leave at 6 months: MD = 53.1, 95%CI ‑15.8 to 122.0, p=0.122

· Sick leave at 12 months: MD = 2.0, 95%CI ‑3.4 to 7.3, p=0.441

Quality of life (critical): FACT-B scale, mean (SD)

· 6 months: 109.0 (17.9) vs. 98.9 (21.4); MD = 10.1, 95%CI -31.7 to 11.5, p=0.333

· 12 months: 113.7 (18.5) vs. 107.1 (19.8); MD = 6.6, 95%CI -27.3 to 14.2, p=0.51

Level of evidence: high risk of bias

· No blinding of patients; blinded outcome assessment

· Several drop-outs were excluded from the analysis (1 intervention group, 3 in control group)

· Changes in protocol due to low recruitment rates

· WHS provides support to people who are employed in companies with < 250 employees where occupational health services are not routinely available. WHS adopts a biopsychosocial model and a multi-disciplinary approach whereby case management is used to assess individuals’ needs to enable work retention or return through signposting or direct referral to a range of supportive services according to need, such as physiotherapy, occupational therapy, occupational health nurse, occupational health doctor, counsellor/ psychological therapy and complementary therapy

Sherman 2012

· Design: RCT

· Funding/CoI: not reported

· Setting: 3 major medical centers and 1 community hospital, US

· Sample size: N=249

· Duration: unclear

· Eligibility criteria: women with confirmed diagnosis of early-stage breast cancer; no previous history of cancer; who had identified a person most intimately involved in the breast cancer experience who was named their “partner”; no concurrent, uncontrolled, chronic medical illness; no history of psychiatric hospitalization or drug abuse

· A priori patient characteristics:

o Mean age 53.8y

o Full time employment: 52.8%

Group 1: usual care

vs.

Group 2: usual care + four phase-specific psychoeducational videos: (a) Coping With Your Diagnosis, (b) Recovering From Surgery, (c) Understanding Adjuvant Therapy, and (d) Your Ongoing Recovery

vs.

Group 3: usual care + telephone counseling intervention

vs.

Group 4: usual care + phase-specific psychoeducational videotapes and telephone counseling

Diversionary activities (critical): not reported

Physical activity (critical): not reported

Self-efficacy (critical): not reported

Cognitive functioning (critical): not reported

(Partial) return to work (important): not reported

Surrogate outcomes:

· Vocational well-being (subscale of PAIS): significant main effect for time (p=0.024), but no significant group or group x time interactions

Quality of life (important): not reported

Fatigue (important): not reported

Level of evidence: low risk of bias

Tamminga 2013

· Design: RCT

· Funding/CoI: Stichting Insituut Gak; no CoI related to topic

· Setting: 6 centres, the Netherlands

· Sample size: N=133

· Duration: recruitment May 2009 – Dec 2010

o Follow-up: 12 months

· Eligibility criteria: cancer patients 18-60y who had been treated with curative intent (expected 1-year survival rate of approximately 80%); exclusion of patients who were not sufficiently able to speak, read, or write Dutch, had a severe mental disorder or other severe comorbidity, and for whom the primary diagnosis of cancer had been made more than two months previously

· A priori patient characteristics:

o Mean age: 47.5 vs. 47.6y

o Female: 99% vs. 100%

o Breast cancer: 64% vs. 60%

Hospital-based work support intervention: patient education and support at the hospital and improvement of communication between treating and occupational physicians; gradual return-to-work plan (N=65)

vs.

Usual care (N=68)

Physical activity (critical):

· SF-36, physical functioning subscale at 12m: 81 vs. 79, p=0.95

Job satisfaction (critical): not reported

Job loss (critical):

· 4/65 vs. 5/68

Self-efficacy (critical): not reported

Return to work (critical):

· At 12m: 79% in both groups (p=0.97); RR = 1.03 (95%CI 0.84-1.2)

· HR for partial return-to-work: 1.03 (95%CI 0.64-1.6)

· HR for full return-to-work: 0.88 (95%CI 0.53-1.5)

Quality of life (critical):

· No significant differences between groups:

o VAS at 12m: 73 vs. 70, p=0.26

o SF-36: no differences on subscales

Level of evidence: high risk of bias

· No blinding of patients or outcome assessors

· Unclear if allocation was concealed

· Follow-up data at 12 months: N=128

Abbreviations: 95%CI: 95% confidence interval; CoI: conflicts of interest; RCT: randomized controlled trial; SR: systematic review

References

de Boer AG, Taskila T, Tamminga SJ, Frings-Dresen MH, Feuerstein M, Verbeek JH. Interventions to enhance return-to-work for cancer patients. Cochrane Database of Systematic Reviews. 2011;2(2):CD007569.

Egan MY, McEwen S, Sikora L, Chasen M, Fitch M, Eldred S. Rehabilitation following cancer treatment. Disability & Rehabilitation. 2013;35(26):2245-58.

Tamminga SJ, de Boer AGEM, Verbeek JHAM, Frings-Dresen MHW. Return-to-work interventions integrated into cancer care: a systematic review. Occup Environ Med. 2010;67(9):639-48.

Bjorneklett HG, Rosenblad A, Lindemalm C, Ojutkangas M-L, Letocha H, Strang P, et al. A randomized controlled trial of support group intervention after breast cancer treatment: results on sick leave, health care utilization and health economy. Acta Oncol. 2013;52(1):38-47.

Hubbard G, Gray NM, Ayansina D, Evans JMM, Kyle RG. Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial. Trials [Electronic Resource]. 2013;14(175).

Sherman DW, Haber J, Hoskins CN, Budin WC, Maislin G, Shukla S, et al. The effects of psychoeducation and telephone counseling on the adjustment of women with early-stage breast cancer. Applied Nursing Research. 2012;25(1):3-16.

Tamminga SJ, Verbeek JHAM, Bos MMEM, Fons G, Kitzen JJEM, Plaisier PW, et al. Effectiveness of a hospital-based work support intervention for female cancer patients - a multi-centre randomised controlled trial. PLoS ONE [Electronic Resource]. 2013;8(5):e63271.