Effect of voice rehabilitation following radiotherapy for laryngeal cancer – a 3-year follow-up of a randomised controlled trial

Figures & data

Table 1. Sociodemographic and clinical data for the study population at baseline and at the 36 months follow-up.

	Baseline			36 months follow-up
	Intervention Group (n = 37)	Control Group (n = 37)	Intervention vs control p-value	Intervention Group (n = 15)	Control Group (n = 22)	Intervention vs control p-value
Gender
Female	4 (11%)	4 (11%)		2 (13%)	4 (18%)
Male	33 (89%)	33 (89%)	1.00	13 (87%)	18 (82%)	1.00
Age
Mean (SD)	65.0 (12.4)	62.6 (9.7)	0.34	64.6 (13.5)	61.5 (9.8)	0.510
Median (range)	64.5 (35.0–86.0)	64.0 (41–82)		64.0 (41–84)	61.0 (42–82)
Tumour classification
0	0 (0.0%)	1 (3%)		0 (0%)	1 (5%)
1	25 (68%)	19 (51%)		11 (73%)	10 (45%)
2	10 (28%)	12 (32%)		3 (20%)	10 (45%)
3	1 (2%)	5 (14%)		1 (7%)	1 (5%)
4	1 (2%)	0 (0.0%)	0.34	0 (0%)	0 (0%)	0.442
Tumour stage
0	0 (0.0%)	1 (3%)		0 (0%)	1 (5%)
I	25 (68%)	19 (51%)		11 (73%)	10 (45%)
II	10 (28%)	12 (32%)		3 (20%)	10 (45%)
III	1 (2%)	5 (14%)		1 (7%)	1 (5%)
IV	1 (2%)	0 (0.0%)	0.34	0 (0%)	0 (0%)	0.442
Tumour site
Glottic	31 (84%)	27 (73%)		13 (87%)	17 (77%)
Supraglottic	6 (16%)	9 (24%)		2 (13%)	5 (23%)
Subglottic	0 (0%)	1 (3%)	0.39	0 (0%)	0 (0%)	0.677
Smoking status
Non-smoker	6 (17%)	2 (5%)		3 (20%)	2 (9%)
Smoker	16 (43%)	20 (54%)		3 (20%)	6 (27%)
Quit smoking > 12 m	15 (40%)	15 (41%)	0.26	9 (60%)	14 (64%)	0.552
Comorbidities according to ACE-27 at baseline
None	14 (39%)	16 (43%)		5 (33%)	8 (36%)
Mild	13 (35%)	17 (46%)		5 (33%)	11 (50%)
Moderate	10 (26%)	4 (11%)	0.212	5 (33%)	3 (14%)	0.366
Radiotherapy
Conventional	27 (73%)	25 (68%)		11 (73%)	12 (55%)
Hyperfractionated	10 (27%)	12 (32%)	0.80	4 (27%)	10 (45%)	0.314

ACE-27 = Adult Comorbidity Evaluation.

Percentages rounded, therefore does not always sum up to 100.

Figure 1. Description of inclusion, exclusion, and discontinuation of participants in the study.

Table 2. S-SECEL scores presented as mean and standard deviation (SD) at baseline, 12 months and 36 months post-radiotherapy for the intervention and control groups.

	Intervention group					Control group					Comparison between groups
				Δ mean within-group change (SD) p-value					Δ mean within-group change (SD) p-value		Δ Baseline – 36 months post-RT	Δ 12–36 months post-RT
	Baseline N= 37	12 m post-RT N = 33	36 m post-RT N = 15	Baseline – 36 m post-RT	12–36 m post-RT	Baseline N = 37	12 m post-RT N = 32	36 m post-RT N = 22	Baseline – 36 m post-RT	12–36 m post-RT
General	5.1 (2.1)	3.7 (2.2)	4.2 (2.8)	−0.9 (2.1) 0.15	0.5 (2.0) 0.41	4.7 (2.8)	4.6 (2.6)	3.8 (2.7)	−0.5 (2.8) 0.40	−0.3 (2.8) 0.39	0.63	0.25
Environ-mental	16.9 (7.2)*	8.8 (8.6)	7.2 (6.2)	−9.7 (6.7) 0.001	0.1 (3.6) 0.75	10.7 (8.5)	10.9 (7.2)	8.7 (6.9)	−2.0 (11.9) 0.29	0 (7.1) 0.90	0.03	0.54
Attitud-inal	8.9 (5.9)*	4.3 (6.8)	3.5 (3.8)	−4.1 (3.7) 0.002	0.7 (2.6) 0.33	5.2 (6.0)	5.9 (7.0)	3.3 (4.3)	−1.8 (7.2) 0.34	−1.3 (5.3) 0.24	0.07	0.14
Total	30.9 (13.3)*	16.8 (16.5)	14.9 (11.1)	−14.6 (10.9) 0.001	1.3 (6.2) 0.36	20.6 (15.8)	21.3 (14.8)	15.8 (12.3)	−4.3 (19.9) 0.22	−1.2 (12.4) 0.18	0.07	0.11

RT = Radiotherapy, m = months, SD = standard deviation.

S-SECEL: Swedish Self-Evaluation of Communication Experiences after Laryngeal Cancer questionnaire. RT = Radiotherapy Min-max subscales: 0–15 (General), 0–42 (Environmental), 0–45 (Attitudinal), 0–102 (Total score). A higher value indicates greater perceived communicative dysfunction.

Threshold values indicating the need for voice rehabilitation: General ≥ 4, Environmental ≥ 16, Attitudinal ≥5, Total ≥20.

Clinically significant improvements: General -2, Environmental -7, Attitudinal -4, Total – 13.

Clinically significant deteriorations: General 1, Environmental 2, Attitudinal 5, Total 8.

*p < 0.05 when compared to control group score.

Table 3. Acoustic and temporal measures presented as mean and standard deviation (SD) at baseline, 12 months and 36 months post-radiotherapy for the control and intervention group.

	Intervention group					Control group					Comparison between groups
				Δ mean within-group change (SD) p-value					Δ mean within-group change (SD) p-value		Δ Baseline – 36 months post-RT	Δ 12–36 months post-RT
	Baseline N = 37	12 m post-RT N = 32	36 m post-RT N = 14	Baseline – 36 m post-RT N = 14	12–36 m post-RT N = 14	Baseline N = 37	12 m post-RT N = 35	36 m post-RT N = 22	Baseline – 36 m post-RT N = 22	12–36 m post-RT N = 22
MPT	15.3 (8.9)*	14.7 (9.4)	14.5 (8.3)	−4.3 (6.7) 0.04	−0.6 (3.6) 0.43	10.5 (7.9)	12.9 (12.0)	13.0 (10.8)	2.2 (7.9) 0.31	0.2 (7.0)0.62	0.02	0.48
Jitterloc	0.9 (0.9)	1.1 (1.0)	0.9 (0.7)	0 (1.2) 0.78	−0.1 (1.0) 0.73	1.1 (1.7)	1.1 (1.2)	0.9 (0.7)	−0.6 (2.4) 0.62	−0.4 (1.4) 0.39	0.87	0.63
Shimmer	0.5 (0.3)	0.5 (0.4)	0.4 (0.2)	−0.1 (0.4) 0.42	−0.1 (0.4) 0.55	0.5 (0.4)	0.6 (0.4)	0.5 (0.3)	−0.1 (0.5) 0.18	−0.1 (0.4) 0.17	0.80	0.77
HNR	17.2 (5.6)	17.1 (7.1)	19.2 (5.7)	1.9 (6.4) 0.33	1.6 (8.5) 0.68	17.6 (5.5)	17.6 (5.7)	17.8 (5.1)	1.8 (8,1) 0.36	1.3 (6.5) 0.29	0.87	0.92

RT = Radiotherapy, m = months, SD = standard deviation, MPT = maximum phonation time, HNR = Harmonics-to-Noise Ratio.

*p < 0.05 when compared to control group score.

Table 4. Perceptual evaluation: Changes within the control- and intervention group during the study time-points.

	Intervention group		Control group		Comparison between groups
	Baseline – 36 months N (%)	12 – 36 months N (%)	Baseline – 36 months N (%)	12 – 36 months N (%)	Baseline – 36 months p	12 – 36 months p
Grade
Improved	7 (50)	8 (57)	7 (32)	7 (30)
Deteriorated	3 (21)	2 (14)	8 (36)	8 (35)	0.46	0.26
No change	4 (29)	4 (29)	7 (32)	8 (35)
Roughness
Improved	2 (14)	5 (36)	5 (23)	8 (35)
Deteriorated	1 (7)	5 (36)	11 (50)	4 (17)	0.03	0.50
No change	11 (79)	4 (28)	6 (27)	11 (48)
Breathiness
Improved	8 (57)	9 (64)	7 (32)	6 (26)
Deteriorated	4 (29)	2 (14)	4 (18)	8 (35)	0.04	0.06
No change	2 (14)	3 (21)	11 (50)	9 (39)
Asthenia
Improved	0	0	1 (5)	1 (5)
Deteriorated	1 (7)	1 (7)	2 (9)	2 (9)	0.45	0.47
No change	13 (93)	13 (93)	9 (86)	20 (87)
Strain
Improved	7 (50)	2 (14)	5 (23)	6 (26)
Deteriorated	6 (43)	5 (36)	8 (35)	7 (30)	0.02	0.50
No change	1 (7)	7 (50)	9 (41)	10 (44)