Very low

GRADE

Use of a voice rehabilitation protocol post-(chemo)radiotherapy may result in little to no difference in voice function and speech function when compared to no voice rehabilitation in adult patients treated for laryngeal carcinoma.

Sources: Tuomi, 2014; Karlsson, 2015; Bergstrom, 2016; Bergstrom, 2017; Millgard, 2018; Karlsson, 2021

Very low

GRADE

The evidence is very uncertain regarding the effect of a voice rehabilitation protocol post-radiotherapy, on HRQOL and mental health when compared to no voice rehabilitation in adult patients treated for laryngeal carcinoma.

Sources: Karlsson, 2015; Bergstrom, 2017

No

GRADE

No evidence was found regarding the effect of a voice prehabilitation protocol on voice function, speech function, HRQOL, and mental health in adult patients scheduled to be treated for head & neck cancer.

Source: -

Very low

GRADE

The evidence is very uncertain regarding the effect of a voice rehabilitation protocol using Shaker exercise post-(chemo)radiotherapy on voice function when compared to no voice rehabilitation in adult patients treated for head & neck cancer.

Source: Eriksson, 2021.

No

GRADE

No evidence was found regarding the effect of a voice rehabilitation protocol using Shaker exercise post-(chemo)radiotherapy on speech function, HRQOL or mental health in adult patients treated for head & neck cancer.

Source: -

No

GRADE

No evidence was found regarding the effect of a voice prehabilitation protocol using Shaker exercise on voice function, speech function, HRQOL, and mental health in adult patients scheduled to be treated for head & neck cancer.

Source: -

No

GRADE

No evidence was found regarding the effect of interventions for speech impairment pre- or post-cancer treatment on voice function, speech function, HRQOL or mental health in patients (scheduled to be) treated for head & neck cancer.

Source: -

No

GRADE

No evidence was found regarding the effect interventions for prosthetic voice/speech post-cancer treatment on voice function, speech function, HRQOL or mental health in adult patients treated for head & neck cancer.

Source: -

Tuomi 2014*, Sweden

Laryngeal carcinoma – (chemo)radiotherapy

33/36

Male/Female:

I: 33/0
C: 36/0

Mean age (SD):

I: 66.0 (12.7)

C: 64.0 (9.9)

Primary tumor location:

Glottic:

I: 27/33

C: 27/36

Supraglottic:

I: 6/33

C: 7/36

Subglottic:

I: 0/33

C: 2/36

Primary tumor size:

Tis:

I: 0/33

C: 2/36

T1:

I: 23/33

C: 19/36

T2:

I: 8/33

C: 10/36

T3:

I: 1/33

C: 5/36

T4:

I: 1/33

C: 0/36

Cancer stage grouping:

Stage 0:

I: 0/33

C: 2/36

Stage I:

I: 23/33

C: 19/36

Stage II:

I: 8/33

C: 10/36

Stage III:

I: 1/33

C: 5/36

Stage IV:

I: 1/33

C: 0/36

Cancer treatment: Conventional radiotherapy:

I: 24/33

C: 26/36

Hyperfractionated radiotherapy:

I: 9/33

C: 10/36

Induction chemotherapy:

I: 2/33

C: 1/36

Timing:

1 month after the completion of cancer treatment.

Content:

A combination of direct and indirect therapy approaches including, but not limited to, diaphragmatic breathing, coordination of breathing and phonation, control and variation of pitch, general relaxation, and vocal hygiene.

Frequency:

The sessions took place 2 times/week during the first 2 weeks, once a week during weeks 3-6, and once every second week during the last 2 weeks: a total of 10 sessions. After each session the patients were encouraged to exercise at home with focus on the techniques taught.

The control group did not receive any voice rehabilitation but were given vocal hygiene advice.

1 and 6 months after the completion of cancer treatment:

Voice function:

Audio-perceptual analysis:

-Hoarseness

-Adequate loudness

-Patient self-ratings of voice function/acceptability: Questions on a 100-mm visual analogue scale

Acoustical analysis:

-HNR

-Jitter

-Shimmer

-F0

Aerodynamic analysis:

-MPT

Speech function:

Speech/communication-specific questionnaire:

-S-SECEL environment domain

Karlsson 2015*, Sweden

Laryngeal carcinoma – radiotherapy

37/37

Male/Female:

I: 33/4
C: 33/4

Mean age (SD):

I: 65.0 (12.4)

C: 62.6 (9.7)

Primary tumor location:

Glottic:

I: 31/37

C: 27/37

Supraglottic:

I: 6/37

C: 9/37

Subglottic:

I: 0/37

C: 1/37

Transglottic:

I: 0/37

C: 0/37

Primary tumor size:

Tis:

I: -

C: -

T1:

I: -

C: -

T2:

I: -

C: -

T3:

I: -

C: -

T4:

I: -

C: -

Cancer stage grouping:

Stage 0:

I: 0/37

C: 1/37

Stage I:

I: 25/37

C: 19/37

Stage II:

I: 10/37

C: 12/37

Stage III:

I: 1/37

C: 5/37

Stage IV:

I: 1/37

C: 0/37

Cancer treatment: Conventional radiotherapy:

I: 27/37

C: 25/37

Hyperfractionated radiotherapy:

I: 10/37

C: 12/37

Induction chemotherapy:

I: 0/37

C: 0/37

Timing:

1 month after the completion of cancer treatment.

Content:

A combination of direct and indirect therapy approaches including, but not limited to, diaphragmatic breathing, coordination of breathing and phonation, control and variation of pitch, general relaxation, and vocal hygiene. The same protocol as in the study by Tuomi (2014).

Frequency:

The sessions took place 2 times/week during the first 2 weeks, once a week during weeks 3-6, and once every second week during the last 2 weeks: a total of 10 sessions. After each session the patients were encouraged to exercise at home with a focus on the techniques taught.

The control group did not receive any voice rehabilitation but were given vocal hygiene advice.

1 and 6 months after the completion of cancer treatment:

Voice function:

-

Speech function:

Speech/communication-specific questionnaire:

-S-SECEL domains: General, Environmental, Attitudinal, Total score

HRQOL:

HRQOL questionnaire:

-EORTC QLQ-C30 Functional domains: Role, Social, Global QOL

-EORTC QLQ-C30 Single items: Financial difficulties

-EORTC QLQ-H & N35 Symptom scales: Speech, Social contact

Bergstrom 2016*, Sweden

Laryngeal carcinoma – radiotherapy

30/31

Male/Female:

I: 26/4

C: 27/4

Mean age (SD):

I: 65 (?)

C: 62 (?)

Primary tumor location:

Glottic:

I: 24/30

C: 24/31

Supraglottic:

I: 6/30

C: 7/31

Subglottic:

I: 0/30

C: 0/31

Primary tumor size:

Tis:

I: 0/30

C: 2/31

T1:

I: 21/30

C: 14/31

T2:

I: 7/30

C: 7/31

T3:

I: 1/30

C: 5/31

T4:

I: 1/30

C: 0/31

Cancer stage grouping:

Not reported

Cancer treatment: Conventional radiotherapy:

I: 23/30

C: 21/31

Hyperfractionated radiotherapy:

I: 7/30

C: 10/31

Induction chemotherapy:

I: 3?/30

C: 0/31

Timing:

Between 1 and 6 months after the completion of cancer treatment.

Content:

A combination of direct and indirect therapy approaches including, but not limited to, diaphragmatic breathing, coordination of breathing and phonation, control and variation of pitch, general relaxation, and vocal hygiene. The same protocol as in the study by Tuomi (2014).

Frequency:

Ten sessions took place over the period of 10 weeks using a structured hierarchy consisting of both direct and indirect therapy approaches.

The control group did not receive any voice rehabilitation but received general voice education, such as vocal hygiene advice.

1, 6, and 12 months after the completion of cancer treatment:

Voice function:

Audio-perceptual analysis:

-GBRAS Likert scale

Bergstrom 2017*, Sweden

Laryngeal carcinoma – radiotherapy

31/32

Male/Female:

I: 27/4

C: 28/4

Mean age (SD):

I: 65.8 (?)

C:62.1 (?)

Primary tumor location:

Glottic:

I: 25/31

C: 24/32

Supraglottic:

I: 6/31

C: 8/32

Subglottic:

I: 0/31

C: 0/32

Primary tumor size:

Tis:

I: 0/31

C: 1/32

T1:

I: 21/31

C: 16/32

T2:

I: 8/31

C: 10/32

T3:

I: 1/31

C: 5/32

T4:

I: 1/31

C: 0/32

Cancer stage grouping:

Not reported

Cancer treatment: Conventional radiotherapy:

I: 19/31

C: 23/32

Hyperfractionated radiotherapy:

I: 12/31

C: 9/32

Induction chemotherapy:

I: 0/31

C: 0/32

Timing:

Between 1 and 6 months after the completion of cancer treatment.

Content:

A combination of direct and indirect therapy approaches including, but not limited to, diaphragmatic breathing, coordination of breathing and phonation, control and variation of pitch, general relaxation, and vocal hygiene. The same protocol as in the study by Tuomi (2014).

Frequency:

Ten sessions took place over the period of 10 weeks using a structured hierarchy consisting of both direct and indirect therapy approaches.

The control group did not receive any voice rehabilitation but received general voice education, such as vocal hygiene advice.

1, 6, and 12 months after the completion of cancer treatment:

Voice function:

Audio-perceptual analysis:

-Patient self-ratings of voice function/acceptability:

Likert scale (0-3)

Mental health:

Affective symptom questionnaire:

-HADS

Millgard 2018*, Sweden

Laryngeal carcinoma – radiotherapy

37/37

Male/Female:

I: 33/4

C: 33/4

Mean age (SD):

I: 65.2 (12.3)

C: 62.9 (10.0)

Primary tumor location:

Glottic:

I: 31/37

C: 29/37

Supraglottic:

I: 6/37

C: 7/37

Subglottic:

I: 0/37

C: 1/37

Primary tumor size:

Not reported

Cancer stage grouping:

Stage 0:

I: 0/37

C: 2/37

Stage I:

I: 25/37

C: 19/37

Stage II:

I: 10/37

C: 11/37

Stage III:

I: 1/37

C: 5/37

Stage IV:

I: 1/37

C: 0/37

Cancer treatment: Conventional radiotherapy:

I: 27/37

C: 26/37

Hyperfractionated radiotherapy:

I: 10/37

C: 11/37

Induction chemotherapy:

I: 0/37

C: 0/37

Timing:

Between 1 and 6 months after the completion of cancer treatment.

Content:

 A combination of direct and indirect therapy approaches including, but not limited to, diaphragmatic breathing, coordination of breathing and phonation, control and variation of pitch, general relaxation, and vocal hygiene. The same protocol as in the study by Tuomi (2014).

Frequency:

Ten sessions took place over the period of 10 weeks using a structured hierarchy consisting of both direct and indirect therapy approaches. After each session the patients were encouraged to exercise at home with a focus on the techniques taught.

The control group did not receive any voice rehabilitation but received general voice education, such as vocal hygiene advice.

1, 6, 12, and 24 months after the completion of cancer treatment:

Voice function:

Audio-perceptual analysis:

-GBRAS Likert scale

Acoustical analysis:

-CPPS

Karlsson 2021, Sweden

Laryngeal carcinoma – radiotherapy

Baseline:

37/37 à see Karlsson 2015 for patient characteristics

At 36 months follow-up:

15/22

Male/Female:

I: 2/13

C: 4/18

Mean age (SD):

I: 64.6 (13.5)

C:61.5 (9.8)

Primary tumor location:

Glottic:

I: 13/15

C: 17/22

Supraglottic:

I: 2/15

C: 5/22

Subglottic:

I: 0/15

C: 0/22

Primary tumor size:

Tis:

I: 0/15

C: 1/22

T1:

I: 11/15

C: 10/22

T2:

I: 3/15

C: 10/22

T3:

I: 1/15

C: 1/22

T4:

I: 0/15

C: 0/22

Cancer stage grouping:

Stage 0:

I: 0/15

C: 1/22

Stage I:

I: 11/15

C: 10/22

Stage II:

I: 3/15

C: 10/22

Stage III:

I: 1/15

C: 1/22

Stage IV:

I: 0/15

C: 0/22

Cancer treatment: Conventional radiotherapy:

I: 11/15

C: 12/22

Hyperfractionated radiotherapy:

I: 4/15

C: 10/22

Induction chemotherapy:

I: 0/15

C: 0/22

Timing:

Between 1 and 6 months after the completion of cancer treatment.

Content:

A combination of direct and indirect therapy approaches including, but not limited to, diaphragmatic breathing, coordination of breathing and phonation, control and variation of pitch, general relaxation, and vocal hygiene.

The same protocol as in the study by Tuomi (2014).

Frequency:

Ten sessions took place over the period of 10 weeks using a structured hierarchy consisting of both direct and indirect therapy approaches.

The control group did not receive any voice rehabilitation but received general voice education, such as vocal hygiene advice.

1, 12, and 36 months after the completion of cancer treatment:

Voice function:

Audio-perceptual analysis:

-GBRAS Likert scale

Acoustical analysis:

-HNR

-Jitter

-Shimmer

Aerodynamic analysis:

-MPT

Speech function:

Speech/communication-specific questionnaire:

-S-SECEL domains: General, Environmental, Attitudinal, Total score

Eriksson 2021, Sweden

Head & neck cancer – (chemo)radiotherapy

24/26

Male/Female:

I: 16/8

C: 20/6

Mean age (SD):

I: 63.6 (9.0)

C: 63.4 (7.0)

Primary tumor location:

Tonsil:

I: 10/24

C: 10/26

Base of the tongue:

I: 8/24

C: 11/26

Larynx:

I: 5/24

C: 2/26

Hypopharynx:

I: 1/24

C: 3/24

Primary tumor size:

Tis:

I: -

C: -

T1:

I: -

C: -

T2:

I: -

C: -

T3:

I: -

C: -

T4:

I: -

C: -

Cancer stage grouping:

Stage 0:

I: -

C: -

Stage I+II:

I: 4/24

C: 4/26

Stage III+IV:

I: 20/24

C: 22/26

Cancer treatment: Conventional radiotherapy:

I: 22/24

C: 23/26

Hyperfractionated radiotherapy:

I: 2/24

C: 3/26

Brachytherapy after radiotherapy:

17/50

I: unclear

C: unclear

Induction chemotherapy:

9/50

I: unclear

C: unclear

Concomitant chemotherapy:

32/50

I: unclear

C: unclear

Timing:

At least 6 months after the completion of cancer treatment.

All subjects received gold standard dysphagia treatment before randomization. After randomization the Shaker exercise.

Content:

-Gold standard dysphagia treatment before randomization consisting of personalized advice on consistency of food or liquids and on body and head positioning during swallowing. In some subjects also advice on swallowing particular maneuvers.

-Shaker exercise consists of head-lifts from supine position.

Frequency:

Shaker exercise: 60 seconds of sustained head-lifts (isometric) repeated three times with 1 minute rest in between, followed by 30 consecutive repetitions of head-lifts (isokinetic). The program was to be performed three times daily for 8 weeks.

Timing:

At least 6 months after the completion of cancer treatment.

All subjects received gold standard dysphagia treatment before randomization.

Content:

-Gold standard dysphagia treatment before randomization consisting of personalized advice on consistency of food or liquids and on body and head positioning during swallowing. In some subjects also advice on swallowing particular maneuvers.

6 and 8 months after the completion of cancer treatment:

Voice function:

Voice-specific questionnaire:

-VHI

Audio-perceptual analysis:

-GBRAS

Speech function:

-

_{HNR, harmonics to noise ratio; F0, fundamental frequency; MPT, maximum phonation time; S-SECEL, the Swedish version of the Self-Evaluation of Communication Experiences after Laryngeal cancer; HRQOL, health-related quality of life; EORTC QLQ-C30, The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core-30; QOL, quality of life; EORTC QLQ-H&N35, The European Organisation for Research and Treatment of Cancer quality of life Questionnaire Head and Neck 35; HADS, Hospital Anxiety and Depression Scale; GRBAS, the grade, roughness, breathiness, asthenia, and strain scale; CPPS, Smoothed cepstral peak prominence; VHI, voice handicap index.}

_{*Included from the systematic review of Taito (2019)}

Outcome parameter

Intervention group

Control group

Comparison between groups

Δ baseline - 6 months post-RT Mean (SD)

CR

GRBAS

N

Baseline

Mean (SD)

6m post-RT

Mean (SD)

Baseline – 6m post-RT

Mean change (SD)

N

Baseline

Mean (SD)

6m post-RT

Mean (SD)

Baseline – 6m post-RT

Mean change (SD)

Grade

30

1.67 (0.71)

2.00 (0.79)

-0.33 (NR)

31

1.77 (0.61)

1.87 (0.81)

-0.10 (NR)

-0.43 (NR)

No

Roughness

30

1.27 (0.58)

1.40 (0.77)

-0.13 (NR)

31

1.13 (0.62)

1.13 (0.92)

0 (NR)

0.13 (NR)

No

Breathiness

30

1.03 (0.85)

1.23 (0.82)

-0.20 (NR)

31

1.03 (0.91)

1.10 (0.94)

-0.07 (NR)

-0.27 (NR)

No

Asthenia

30

0.07 (0.25)

0.10 (0.31)

-0.03 (NR)

31

0.06 (0.25)

1.23 (0.82)

-1.17 (NR)

-1.20 (NR)

Yes

Strain

30

1.17 (0.83)

1.33 (0.99)

-0.16 (NR)

31

1.16 (0.78)

1.19 (0.91)

-0.03 (NR)

-0.19 (NR)

No

Outcome parameter

Intervention group

Control group

Comparison between groups

Δ baseline - 12 months post-RT Mean (SD)

CR

GRBAS

N

Baseline

Mean (SD)

12m post-RT

Mean (SD)

Baseline – 12m post-RT

Mean change (SD)

N

Baseline

Mean (SD)

12m post-RT

Mean (SD)

Baseline – 12m post-RT

Mean change (SD)

Grade

30

1.67 (0.71)

1.87 (0.63)

-0.20 (NR)

30

1.77 (0.61)

1.74 (0.68)

0.03 (NR)

-0.23 (NR)

No

Roughness

30

1.27 (0.58)

1.07 (0.79)

0.20 (NR)

30

1.13 (0.62)

1.61 (0.62)

-0.48 (NR)

-0.28 (NR)

Yes

Breathiness

30

1.03 (0.85)

1.20 (0.96)

-0.17 (NR)

30

1.03 (0.91)

0.65 (0.92)

0.38 (NR)

-0.55 (NR)

Yes

Asthenia

30

0.07 (0.25)

0.03 (0.18)

0.04 (NR)

30

0.06 (0.25)

0.03 (0.18)

0.03 (NR)

0.01 (NR)

No

Strain

30

1.17 (0.83)

1.23 (0.82)

-0.06 (NR)

30

1.16 (0.78)

1.10 (0.98)

0.06 (NR)

-0.12 (NR)

No

Comparison between groups

• At 6 months, the voice rehabilitation group showed significantly lower breathiness scores compared to the irradiated control group (p=0.049).
• At 12 months, the irradiated control group showed significantly higher roughness scores compared to the voice rehabilitation group (p=0.013).
• At 24 months, the irradiated control group was rated significantly worse across all perceptual parameters compared to the vocally healthy group, whereas no significant differences were observed between the voice rehabilitation group and the vocally healthy group in terms of breathiness and vocal fry.

Comparison within groups

• The voice rehabilitation group showed a statistically significant improvement in breathiness score between 12 and 24 months of follow-up (p=0.012).
• A statistically significant deterioration in vocal fry score was observed within each group.
• In the irradiated control group, 3 patients (8.1%) exhibited a moderate-severe vocal fry score at baseline, increasing to 11 out of 26 patients (44.0%) at 24 months after radiotherapy (p=0.003).
• At 6 months, 2 out of 35 patients (5.7%) in the voice rehabilitation group were rated with a moderate-severe vocal fry score, rising to 4 out of 19 patients (21.1%) at 24 months after radiotherapy (p=0.012).
• The irradiated control group also demonstrated a statistically significant increase of roughness score between 6 and 12 months follow-up (p=0.027).

Comparison of changes between groups

• Comparisons revealed a statistically significant difference between groups regarding the changes in vocal fry score from baseline to 6 months (p=0.046).
• Among the 35 patients in the voice rehabilitation group, 11 (31.4%) demonstrated improvement in vocal fry score, while 7 (19.7%) experienced deteriorated.
• In the irradiated control group, 5 out of the 35 patients (14.3%) showed improvement in vocal fry score, whereas 13 patients (37.2%) exhibited deterioration.
• Statistically significant differences in breathiness changes were observed between groups from baseline to 6 months (p=0.041) and from 12 to 24 months (p=0.022).
• In the voice rehabilitation group, 7 out of 35 patients (20%) showed improvement in breathiness changes, while 15 out of 35 patients (42.8%) showed deterioration from baseline to 6 months.
• In the irradiated control group, 15 out of 35 patients (42.9%) showed improvement in breathiness changes, whereas 9 out of 35 patients (25.7%) experienced deterioration from baseline to 6 months.
• From 12 to 24 months, 10 out of 19 patients (52.6%) in the voice rehabilitation group showed improvement in breathiness changes, while 1 out of 19 patients (5.3%) deteriorated. In contrast, in the irradiated control group, 8 out of 26 patients (30.8%) showed improvement in breathiness changes, while 10 out of 26 patients (38.4%) showed deterioration.

Outcome parameter

Intervention group

Control group

Comparison between groups

Δ baseline - 6 months post-RT Mean (SD)

CR

Study specific question

N

Baseline

Mean (SD)

6m post-RT

Mean (SD)

Baseline – 6m post-RT

Mean change (SD)

N

Baseline

Mean (SD)

6m post-RT

Mean (SD)

Baseline – 6m post-RT

Mean change (SD)

Hoarseness

33

39.0 (24.5)

56.0 (23.1)

18.3 (26.8)

36

47.9 (26.2)

47.8 (24.2)

2.1 (19.3)

16.2 (NR)

Yes

Adequate loudness

33

43.5 (22.9)

61.0 (24.4)

19.0 (24.6)

36

51.3 (25.8)

55.2 (20.9)

4.7 (20.5)

14.3 (NR)

Yes

Study

Outcome parameter

Intervention group

Control group

Comparison between groups

Δ baseline - 6m post-RT

Mean (SD)

CR

Baseline Mean (SD)

6m post-RT Mean (SD)

Baseline – 6m post-RT

Mean change (SD)

Baseline Mean (SD)

6m post-RT Mean (SD)

Baseline – 6m post-RT

Mean change (SD)

N

N=33

N=33

N=36

N=36

Tuomi, 2014

Jitter

0.98 (0.91)

1.34 (1.90)

0.36 (1.91)

1.03 (1.77)

1.43 (2.23)

0.14 (2.49)

0.22 (NR)

No

Tuomi, 2014

Shimmer

0.54 (0.35)

0.63 (0.52)

0.09 (0.58)

0.52 (0.28)

0.66 (0.52)

0.09 (0.47)

0 (NR)

No

Tuomi, 2014

HNR

17.10 (5.4)

17.20 (6.9)

0.10 (7.1)

17.70 (5.0)

15.40 (6.2)

-1.40 (6.8)

-1.30 (NR)

Yes

N

N=37

N=35

N=37

N=35

Millgard, 2018

Mean CPPS

3.53 (1.06)

3.52 (0.90)

0.01 (NR)

3.25 (1.00)

3.24 (0.99)

0.01 (NR)

0 (NR)

No

N

N=33

N=33

N=36

N=36

Tuomi, 2014

MPT

15.30 (8.7)

14.90 (9.2)

-0.40 (6.1)

10.50 (8.3)

13.50 (13.4)

1.30 (6.6)

-1.70 (NR)

Yes

First author (year)

Outcome parameter

Intervention group

Control group

Comparison between groups

Δ baseline - 12m post-RT Mean (SD)

CR

Baseline Mean (SD)

12m post-RT

Mean (SD)

Baseline – 12m post-RT

Mean change (SD)

Baseline Mean (SD)

12m post-RT

Mean (SD)

Baseline – 12m post-RT

Mean change (SD)

N

N=37

N=32

N=37

N=35

Karlsson (2021)

Jitter

0.9 (0.9)

1.1 (1.0)

0.2 (NR)

1.1 (1.7)

1.1 (1.2)

0 (NR)

0.2 (NR)

No

Karlsson (2021)

Shimmer

0.5 (0.3)

0.5 (0.4)

0 (NR)

0.5 (0.4)

0.6 (0.4)

0.1 (NR)

-0.1 (NR)

No

Karlsson (2021)

HNR

17.2 (5.6)

17.1 (7.1)

0.1 (NR)

17.6 (5.5)

17.6 (5.7)

0 (NR)

0.1 (NR)

No

N

N=37

N=31

N=37

N=33

Millgard (2018)

Mean CPPS

3.53 (1.06)

3.48 (1.11)

0.05 (NR)

3.25 (1.00)

3.44 (1.04)

-0.19 (NR)

-0.14 (NR)

No

N

N=37

N=32

N=37

N=35

Karlsson (2021)

MPT

15.3 (8.9)

14.7 (9.4)

0.6 (NR)

10.5 (7.9)

12.9 (12.0)

2.4 (NR)

-1.8 (NR)

No

Outcome parameter

Intervention group

Control group

Comparison between groups

Δ baseline - 24m post-RT Mean (SD)

CR

Baseline Mean (SD)

24m post-RT

Mean (SD)

Baseline – 24m post-RT

Mean change (SD)

Baseline Mean (SD)

24m post-RT

Mean (SD)

Baseline – 24m post-RT

Mean change (SD)

N

N=37

N=19

N=37

N=26

Mean CPPS

3.53 (1.06)

3.79 (0.90)

-0.26

(NR)

3.25 (1.00)

3.52 (1.18)

-0.27 (NR)

-0.53 (NR)

No

Outcome parameter

Intervention group

Control group

Comparison between groups

Δ baseline - 36m post-RT Mean (SD)

CR

Baseline Mean (SD)

36m post-RT

Mean (SD)

Baseline – 36m post-RT

Mean change (SD)

Baseline Mean (SD)

36m post-RT

Mean (SD)

Baseline – 36m post-RT

Mean change (SD)

N

N=37

N=14

N=37

N=22

Jitter

0.9 (0.9)

1.1 (1.0)

0 (1.2)

1.1 (1.7)

0.9 (0.7)

-0.6 (2.4)

0.87 (NR)

Yes

Shimmer

0.5 (0.3)

0.5 (0.4)

-0.1 (0.4)

0.5 (0.4)

0.5 (0.3)

-0.1 (0.5)

0.80 (NR)

No

HNR

17.2 (5.6)

17.1 (7.1)

1.9 (6.4)

17.6 (5.5)

17.8 (5.1)

1.8 (8.1)

0.87 (NR)

No

MPT

15.3 (8.9)

14.7 (9.4)

-4.3 (6.7)

10.5 (7.9)

13.0 (10.8)

2.2 (7.9)

0.02 (NR)

No

First author (year)

Outcome parameter

Intervention group (N=37)

Control group (N=37)

CR

S-SECEL domains

Baseline

Mean (SD)

6m post-RT

Mean (SD)

Baseline – 6m post-RT

Mean change (SD)

Baseline

Mean (SD)

6m post-RT

Mean (SD)

Baseline – 6m post-RT

Mean change (SD)

Comparison between groups

Δ baseline - 6 months post-RT Mean (CI)

Karlsson (2015)

General

5.1 (2.1)

3.8 (2.2)

-1.3 (2.5)

4.7 (2.9)

4.5 (2.7)

-0.2 (2.3)

0.9

(-0.1 – 1.9)

No

Karlsson (2015)

Environmental

16.9 (7.2)

10.1 (7.2)

-7.0 (6.4)

10.7 (8.6)

11.8 (8.6)

1.1 (9.1)

5.0

(1.6 – 8.5)

No

Tuomi (2014)

16.4 (7.5) (n=33)

9.6 (7.3)

(n=33)

-6.8 (6.7)

10.5 (8.1)

(n=33)

12.0 (8.3)

(n=33)

1.6 (7.7)

-8.4 (-11.8 – -5.00)

No

Karlsson (2015)

Attitudinal

8.9 (5.9)

4.4 (5.9)

-4.6 (4.8)

5.3 (6.0)

7.2 (9.1)

1.9 (8.8)

5.0

(1.7 – 8.3)

No

Karlsson (2015)

Total score

30.9 (13.3)

18.3 (13.8)

-12.9(11.5)

20.7 (16.0)

23.5 (18.6)

2.8 (18.0)

11.4

(4.4 – 18.3)

No

Outcome parameter

Intervention group

Control group

CR

S-SECEL domains

Baseline

Mean (SD)

12m post-RT

Mean (SD)

Baseline – 12m post-RT

Mean change (SD)

Baseline

Mean (SD)

12m post-RT

Mean (SD)

Baseline – 12m post-RT

Mean change (SD)

Comparison between groups

Δ baseline - 12 months post-RT Mean (SD)

N=37

N=33

N=37

N=32

General

5.1 (2.1)

3.7 (2.2)

1.4 (NR)

4.7 (2.9)

4.6 (2.6)

0.1 (NR)

1.3 (NR)

Yes

Environmental

16.9 (7.2)

8.8 (8.6)

8.1 (NR)

10.7 (8.6)

10.9 (7.2)

-0.2 (NR)

7.9 (NR)

Yes

Attitudinal

8.9 (5.9)

4.3 (6.8)

4.6 (NR)

5.3 (6.0)

5.9 (7.0)

-0.6 (NR)

4 (NR)

Yes

Total score

30.9 (13.3)

16.8 (16.5)

14.1 (NR)

20.7 (16.0)

21.3 (14.8)

-0.6 (NR)

13.5 (NR)

Yes

Outcome parameter

Intervention group

Control group

CR

S-SECEL domains

Baseline

Mean (SD)

36m post RT-Mean (SD)

Baseline – 36m post-RT

Mean change (SD)

Baseline

Mean (SD)

36m post RT-Mean (SD)

Baseline – 36m post-RT

Mean change (SD)

Comparison between groups

Δ baseline - 36 months post-RT Mean (SD)

N=37

N=15

N=37

N=22

General

5.1 (2.1)

4.2 (2.8)

-0.9 (2.1)

4.7 (2.9)

3.8 (2.7)

-0.5 (2.8)

0.63 (NR)

No

Environmental

16.9 (7.2)

7.2 (6.2)

-9.7 (6.7)

10.7 (8.6)

8.7 (6.9)

-2.0 (11.9)

0.03 (NR)

No

Attitudinal

8.9 (5.9)

3.5 (3.8)

-4.1 (3.7)

5.3 (6.0)

3.3 (4.3)

-1.8 (7.2)

0.07 (NR)

No

Total score

30.9 (13.3)

14.9 (11.1)

-14.6 (10.9)

20.7 (16.0)

15.8 (12.3)

-4.3 (19.9)

0.07 (NR)

No

Intervention group

Control group

Comparison between groups Δ baseline - 6 months post-RT Mean (CI)

CR

Outcome parameter

N

Baseline

Mean (SD)

6m post-RT

Mean (SD)

Baseline – 6m post-RT

Mean change (SD)

N

Baseline

Mean (SD)

6m post-RT

Mean (SD)

Baseline – 6m post-RT

Mean change (SD)

EORTC QLQ-C30

Global QOL^*

37

60.8 (15.6)

76.4 (18.8)

15.7 (9.3)

37

68.9 (18.8)

68.9 (16.3)

0 (12.6)

-14.2

(-19.3 – 9.0)

Yes

EORTC QLQ-H & N35 Symptom scales^**

Speech

37

43.5 (22.9)

21.9 (20.8)

-21.9 (19.2)

37

28.2 (21.2)

31.8 (23.6)

3.6 (15.9)

20.6

(12.5 – 28.7)

Yes

Social

contact

37

12.3 (13.9)

5.0 (9.7)

-7.0 (10.4)

37

9.0 (13.4)

8.5 (10.9)

-0.5 (9.1)

5.1

(1.6 – 8.5)

No

Intervention group (N=31)

Control group (N=32)

CR

Outcome parameter

Baseline

(N)

6m post-RT (N)

Baseline – 6m post-RT change (N)

Baseline (N)

6m post-RT (N)

Baseline – 6m post-RT change (N)

Comparison between groups Δ baseline - 6 months post-RT (N)

Anxiety

• No case

23

28

5

21

23

2

3

Yes

• Possible/ probable

8

3

5

11

9

2

3

Yes

Depression

• No case

25

29

4

20

25

5

-1

No

• Possible/ probable

6

2

4

12

7

5

-1

No

Intervention group (N=31)

Control group (N=32)

CR

Outcome parameter

Baseline (N)

12m post-RT (N)

Baseline – 12m post-RT change (N)

Baseline (N)

12m post-RT (N)

Baseline – 12m post-RT change (N)

Comparison between groups Δ baseline - 12 months post-RT (N)

Anxiety

• No case

23

29

6

21

24

3

3

Yes

• Possible/ probable

8

2

6

11

8

3

3

Yes

Depression

• No case

25

29

4

20

24

4

0

No

• Possible/ probable

6

2

4

12

8

4

0

No

Outcome parameter

Intervention group

Control group

Comparison between groups Δ baseline – at least 8m post-RT Mean (SD)

CR

VHI domains

Baseline

Mean (SD)

At least 8m post-RT Mean (SD)

Baseline – at least 8m post-RT Mean change (SD)

Baseline Mean (SD)

At least 8m post-RT Mean (SD)

Baseline – at least 8m post-RT Mean change (SD)

N

N=21

N=22

N=23

N=24

Physical domain

7.7 (6.3)

7.2 (6.3)

-0.8 (4.0)

8.1 (9.7)

6.8 (8.6)

-1.1 (4.0)

-1.9 (NR)

No

Functional domain

4.0 (5.4)

4.1 (5.6)

-0.3 (4.1)

5.4 (7.2)

4.6 (8.5)

-0.8 (4.1)

-1.1 (NR)

No

Emotional domain

2.6 (3.8)

3.0 (4.2)

0.3 (4.1)

3.4 (5.3)

2.5 (4.7)

-0.8 (2.7)

-0.5 (NR)

No

Total score

14.2 (14.2)

14.3 (15.3)

-1.0 (10.5)

16.9 (21.1)

13.9 (20.6)

-2.7 (9.4)

-3.7 (NR)

No

Outcome

Measurement method

Outcome parameter/measure

Minimal clinically important difference^*

Voice function

(critical)

Voice-specific questionnaire

VHI

Unclear - a change of 25% in the VHI total score

Audio-perceptual analysis

GBRAS Likert scale

Unclear - a change of 25% in the subscale scores

Patient self-ratings of voice function/acceptability:

-Likert scale (0-3)

-Questions on a 100-mm visual analogue scale

Unclear - a change of 25% in the scores

Acoustical analysis

F0

Unclear - a change of 25% in the score

Jitter (%)

Unclear - a change of 25% in the score

Shimmer (dB)

Unclear - a change of 25% in the score

HNR

Unclear - a change of 25% in the score

CPPS

Unclear - a change of 25% in the score

Aerodynamic analysis

MPT

Unclear - a change of 25% in the score

Speech function (for patient with larynx)

(critical)

Speech/communication-specific questionnaire

S-SECEL

Clinically significant improvements: General -2, Environmental -7, Attitudinal -4, Total – 13. Clinically significant deteriorations: General 1, Environmental 2, Attitudinal 5, Total 8 (Karlsson 2021).

Audio-perceptual analysis

NA

NA

Substitution/prosthetic voice/speech function (for patients without larynx/vocal folds)

(critical)

Audio-perceptual analysis

NA

NA

HRQOL

(important)

HRQOL questionnaire

EORTC QLQ-C30

A change of ≥ 10 points

EORTC QLQ-H&N35

A change of ≥ 10 points

Mental health (important)

Affective symptom questionnaire

HADS

Unclear - a change of 25% in the score