Introduction
Methods
Design
Participants
Sample size calculation and randomization
Intervention
Patient-reported outcomes
Primary outcome
Depressive symptoms
Secondary outcomes
Fatigue
Health-related quality of life
Cognitive functioning
Use of supportive care
Patient satisfaction
Statistical analysis
Results
Participants
Glioma intervention group
N = 45 | Glioma waiting list control group
N = 44 | P value | Glioma total group
N = 82 | Non-CNS control group
N = 26 | P value | |
---|---|---|---|---|---|---|
Age M (SD) | 43.58 (11.69) | 46.43 (12.28) | 0.265 | 44.88 (11.97) | 52.81 (9.28) | 0.003* |
Sex N (%) | ||||||
Male | 19 (42.2%) | 18 (40.9%) | 0.536 | 37 (45.1%) | 9 (34.6%) | 0.345 |
Female | 26 (57.8%) | 26 (59.1%) | 45 (54.9%) | 17 (65.4%) | ||
Educational level N (%) | ||||||
Low | 4 (8.9%) | 6 (13.6%) | 0.734 | 8 (9.8%) | 0 (0%) | 0.252 |
Middle | 21 (46.7%) | 18 (40.9%) | 36 (43.9%) | 13 (50.0%) | ||
High | 20 (44.4%) | 20 (45.5%) | 38 (46.3%) | 13 (50.0%) | ||
Medication use at start of studyb N (%) | ||||||
Antidepressants | 5 (11.1%) | 5 (11.4%) | 0.970 | 9 (10.9%) | 3 (11.5%) | 0.937 |
Antipsychotics | 1 (2.2%) | 0 (0%) | 0.320 | 1 (1.2%) | 0 (0%) | 0.572 |
Psychostimulants | 0 (0%) | 0 (0%) | N/a | 0 (0%) | 1 (3.8%) | 0.074 |
Antiepileptics | 35 (77.8%) | 33 (75.0%) | 0.758 | 63 (76.8%) | 0 (0%) | N/a |
Corticosteroids | 3 (6.7%) | 4 (9.1%) | 0.671 | 6 (7.3%) | 3 (11.5%) | 0.497 |
Benzodiazepines | 8 (17.8%) | 6 (13.6%) | 0.592 | 13 (15.9%) | 4 (15.4%) | 0.954 |
Mild opioid analgesics | 1 (2.2%) | 0 (0%) | 0.320 | 1 (1.2%) | 1 (3.8%) | 0.387 |
Disease status during studyc N (%) | ||||||
Stabile disease or remission | 29 (64.4%) | 31 (70.5%) | 0.600 | 56 (68.3%) | 11 (42.3%) | 0.278 |
Disease progression | 6 (13.3%) | 6 (13.6%) | 10 (12.2%) | 2 (7.7%) | ||
Active treatment | 10 (22.2%) | 6 (13.6%) | 15 (18.3%) | 7 (26.9%) | ||
Other support in the past 4 weeks (at baseline) N (%) | ||||||
Primary care physician | 17 (37.8%) | 19 (43.2%) | 0.669 | 36 (43.9%) | 11 (42.3%) | 1.000 |
Psychologist, psychiatrist, or counsellor | 13 (28.9%) | 11 (25%) | 0.813 | 24 (29.3%) | 11 (42.3%) | 0.155 |
Social worker | 3 (6.7%) | 5 (11.4%) | 0.479 | 8 (9.8%) | 3 (11.5%) | 0.711 |
Alcohol/drugs coach | 1 (2.2%) | 0 (0%) | 1.000 | 1 (1.2%) | 0 (0%) | 1.000 |
Self-help group | 1 (2.2%) | 5 (11.4%) | 0.106 | 6 (7.3%) | 3 (11.5%) | 0.424 |
Company physician | 10 (22.2%) | 6 (13.6%) | 0.410 | 16 (19.5%) | 4 (15.4%) | 1.000 |
Physiotherapist | 10 (22.2%) | 9 (20.5%) | 1.000 | 19 (23.2%) | 7 (26.9%) | 0.599 |
Alternative healer | 5 (11.1%) | 5 (11.4%) | 1.000 | 10 (12.2%) | 6 (23.1%) | 0.194 |
Tumor typea N (%) | ||||||
Pontine glioma | 0 (0%) | 1 (2.3%) | 0.707 | |||
Ganglioglioma | 1 (2.2%) | 0 (0%) | ||||
Astrocytoma | 21 (46.7%) | 17 (38.6%) | ||||
Oligodendroglioma | 10 (22.2%) | 11 (25.0%) | ||||
Oligoastrocytoma | 6 (13.3%) | 7 (15.9%) | ||||
Glioblastoma | 6 (13.3%) | 7 (15.9%) | ||||
Unspecified glioma | 1 (2.2%) | 0 (0%) | ||||
Meningioma | 0 (0%) | 1 (2.3%) | ||||
Glioma grade N (%) | ||||||
Grade II | 26 (57.8%) | 23 (52.3%) | 0.898 | |||
Grade III | 13 (28.9%) | 13 (29.5%) | ||||
Grade IV | 6 (13.3%) | 7 (15.9%) | ||||
Epilepsy N (%) | ||||||
Yes | 23 (51.1%) | 23 (52.3%) | 0.913 | |||
No | 22 (48.9%) | 21 (47.7%) | ||||
Type of surgery N (%) | ||||||
None | 0 (0%) | 1 (2.3%) | 0.168 | |||
Biopsy | 4 (8.9%) | 9 (20.5%) | ||||
Resection | 41 (91.1%) | 34 (77.3%) | ||||
Treatments received at start of study N (%) | ||||||
Radiation therapy | 30 (66.7%) | 29 (65.9%) | 0.940 | |||
Chemotherapy | 18 (40.0%) | 24 (54.5%) | 0.169 | |||
Cognitive complaints M (SD) | 24.7 (6.6) | 22.6 (5.9) | 0.122 | |||
Disease-specific symptomsd M (SD) | ||||||
Future uncertainty | 42.6 (19.6) | 52.1 (21.7) | 0.033* | |||
Visual disorder | 19.8 (20.4) | 21.0 (19.8) | 0.778 | |||
Communication deficits | 26.2 (23.0) | 30.6 (23.9) | 0.380 | |||
Headaches | 28.9 (27.2) | 33.3 (33.7) | 0.495 | |||
Seizures | 10.4 (21.1) | 16.7 (24.4) | 0.196 | |||
Drowsiness | 26.7 (27.2) | 36.4 (28.6) | 0.104 | |||
Bothered by hair loss | 11.9 (21.5) | 17.4 (30.9) | 0.325 | |||
Bothered by itching skin | 19.3 (27.1) | 19.7 (27.2) | 0.940 | |||
Weakness of legs | 10.4 (21.1) | 10.6 (20.0) | 0.957 |
Effects of the intervention on depression, fatigue and HRQOL
Glioma intervention group vs. glioma waiting list control group
Intention to treat | Per protocol | |||||
---|---|---|---|---|---|---|
Glioma intervention group | Glioma waiting list control group | P value, ES, 95% CI | Glioma intervention group | Glioma waiting list control group | P value, ES, 95% CI | |
Depression (CES-D) M (SD) | ||||||
Baseline |
N = 45 21.96 (5.9) |
N = 43 24.98 (6.9) |
N = 35 21.51 (6.1) |
N = 28 24.07 (6.6) | ||
After intervention |
N = 19 18.84 (6.4) |
N = 34 23.09 (7.1) |
p = 0.390, ES = 0.190, 95% CI = − 4.49 to 2.67 |
N = 18 19.61 (5.7) |
N = 26 23.50 (6.1) |
p = 0.454, ES = 0.038, 95% CI = − 6.17 to 2.79 |
After 12 weeks |
N = 19 19.63 (7.5) |
N = 37 22.38 (6.3) |
p = 0.614, ES = 0.042, 95% CI = − 2.67 to 4.49 |
N = 18 19.89 (7.6) |
N = 28 22.86 (5.7) |
p = 0.954, ES = 0.012, 95% CI = − 3.82 to 4.05 |
Fatigue (CIS) M (SD) | ||||||
Baseline |
N = 45 88.27 (22.0) |
N = 43 99.81 (18.4) |
N = 35 91.06 (20.5) |
N = 28 101.71 (18.4) | ||
After intervention |
N = 19 81.58 (25.8) |
N = 33 99.39 (16.3) |
p = 0.054* ES = 0.306, 95% CI = − 17.63 to 0.15 |
N = 18 83.94 (24.3) |
N = 25 101.08 (16.2) |
p = 0.112, ES = 0.327, 95% CI = − 18.13 to 1.93 |
After 12 weeks |
N = 19 80.16 (27.0) |
N = 37 96.00 (17.3) |
p = 0.238, ES = 0.210, 95% CI = − 3.85 to 15.25 |
N = 18 79.94 (27.8) |
N = 28 96.50 (16.5) |
p = 0.310, ES = 0.298, 95% CI = − 5.35 to 16.59 |
Health-related quality of life (SF-36 MCS), M (SD) | ||||||
Baseline |
N = 45 36.71 (7.9) |
N = 44 32.74 (9.4) |
N = 35 36.99 (7.7) |
N = 28 31.79 (10.4) | ||
After intervention |
N = 19 38.34 (10.3) |
N = 34 32.97 (8.9) |
p = 0.326, ES = 0.159, 95% CI = − 2.08 to 6.20 |
N = 18 37.78 (10.3) |
N = 26 31.38 (8.5) |
p = 0.349, ES = 0.132, 95% CI = − 2.50 to 6.99 |
After 12 weeks |
N = 19 40.23 (9.6) |
N = 37 33.53 (9.9) |
p = 0.433, ES = 0.310, 95% CI = − 6.32 to 2.73 |
N = 18 40.56 (9.8) |
N = 28 32.4 (8.9) |
p = 0.431, ES = 0.325, 95% CI = − 7.24 to 3.13 |
Health-related quality of life (SF-36 PCS), M (SD) | ||||||
Baseline |
N = 45 47.63 (10.9) |
N = 44 45.55 (9.1) |
N = 35 46.88 (11.1) |
N = 28 46.82 (9.5) | ||
After intervention |
N = 19 51.17 (11.4) |
N = 34 46.95 (10.1) |
p = 0.141, ES = 0.211, 95% CI = − 1.07 to 7.36 |
N = 18 51.07 (11.7) |
N = 26 48.47 (10.5) |
p = 0.347, ES = 0.239, 95% CI = − 2.48 to 6.98 |
After 12 weeks |
N = 19 48.57 (9.8) |
N = 37 47.25 (10.7) |
p = 0.993, ES = 0.075, 95% CI = − 4.01 to 4.04 |
N = 18 48.16 (9.9) |
N = 28 47.43 (11.5) |
p = 0.882, ES = 0.063, 95% CI = − 5.08 to 4.38 |
Total glioma group vs. non-CNS control group
Intention to treat | Per protocol | |||||
---|---|---|---|---|---|---|
Glioma total group | Non-CNS control group | P value, ES, 95% CI | Glioma total group | Non-CNS control group | P value, ES, 95% CI | |
Depression (CES-D) M (SD) | ||||||
Baseline |
N = 82 22.14 (6.1) |
N = 26 25.08 (6.6) |
N = 63 22.11 (5.9) |
N = 24 25.08 (6.7) | ||
After intervention |
N = 42 19.52 (7.5) |
N = 13 20.31 (6.3) |
p = 0.267, ES = 0.300 95% CI = − 1.70 to 6.09 |
N = 38 19.82 (6.9) |
N = 13 20.31 (6.3) |
p = 0.272, ES = 0.401, 95% CI = − 1.75 to 6.18 |
After 12 weeks |
N = 41 20.85 (8.5) |
N = 12 25.41 (7.1) |
p = 0.467, ES = 0.302, 95% CI = − 6.36 to 2.93 |
N = 38 20.42 (8.4) |
N = 12 25.42 (7.1) |
p = 0.418, ES = 0.218, 95% CI = − 6.66 to 2.78 |
After 12 months |
N = 35 18.60 (9.3) |
N = 7 18.14 (7.0) |
p = 0.390, ES = 0.499, 95% CI = − 3.31 to 8.42 |
N = 33 17.85 (9.0) |
N = 7 18.14 (6.9) |
p = 0.447, ES = 0.433, 95% CI = − 3.76 to 8.00 |
Fatigue (CIS) M (SD) | ||||||
Baseline |
N = 82 91.76 (20.2) |
N = 26 96.85 (13.5) |
N = 63 93.48 (18.9) |
N = 24 96.75 (13.0) | ||
After intervention |
N = 42 89.74 (24.9) |
N = 13 86.74 (18.1) |
p = 0.208, ES = 0.426, 95% CI = − 3.59 to 16.35 |
N = 38 91.02 (23.5) |
N = 13 86.69 (18.1) |
p = 0.241, ES = 0.430, 95% CI = − 4.06 to 16.00 |
After 12 weeks |
N = 41 90.12 (27.2) |
N = 12 90.42 (15.2) |
p = 0.503, ES = 0.252, 95% CI = − 8.16 to 16.54 |
N = 38 88.53 (27.1) |
N = 12 90.42 (15.2) |
p = 0.716, ES = 0.078, 95% CI = − 10.12 to 14.69 |
After 12 months |
N = 34 87.94 (24.2) |
N = 7 94.57 (23.7) |
p = 0.587, ES = 0.081, 95% CI = − 20.69 to 11.78 |
N = 32 86.19 (23.9) |
N = 7 94.57 (23.7) |
p = 0.438, ES = 0.289, 95% CI = − 22.60 to 9.86 |
Health-related quality of life (SF-36 MCS) M (SD) | ||||||
Baseline |
N = 82 35.27 (9.0) |
N = 26 29.73 (7.3) |
N = 63 34.94 (8.5) |
N = 24 29.58 (7.2) | ||
After intervention |
N = 41 36.79 (10.2) |
N = 13 35.20 (8.3) |
p = 0.159, ES = 0.455, 95% CI = − 8.43 to 1.40 |
N = 37 36.53 (9.9) |
N = 13 35.20 (8.3) |
p = 0.201, ES = 0.489, 95% CI = − 8.10 to 1.72 |
After 12 weeks |
N = 41 37.42 (10.2) |
N = 12 33.48 (13.0) |
p = 0.385, ES = 0.184, 95% CI = − 7.50 to 2.92 |
N = 38 37.92 (10.2) |
N = 12 33.48 (13.0) |
p = 0.478, ES = 0.112, 95% CI = − 7.26 to 3.42 |
After 12 months |
N = 35 39.83 (9.2) |
N = 7 33.34 (10.4) |
p = 0.601, ES = 0.109, 95% CI = – 5.12 to 8.80 |
N = 33 40.24 (9.3) |
N = 7 33.34 (10.4) |
p = 0.545, ES = 0.187, 95% CI = − 4.89 to 9.19 |
Health-related quality of life (SF-36 PCS) M (SD) | ||||||
Baseline |
N = 82 47.46 (10.7) |
N = 26 44.44 (9.6) |
N = 63 47.13 (11.2) |
N = 24 44.52 (9.9) | ||
After intervention |
N = 41 50.05 (10.7) |
N = 13 47.81 (11.7) |
p = 0.734, ES = 0.074, 95% CI = − 5.24 to 3.70 |
N = 37 50.06 (11.24) |
N = 13 47.81 (11.7) |
p = 0.822, ES = 0.033, 95% CI = − 4.93 to 3.92 |
After 12 weeks |
N = 41 48.41 (9.9) |
N = 12 49.07 (11.4) |
p = 0.549, ES = 0.350, 95% CI= – 6.76 to 3.62 |
N = 38 48.66 (9.6) |
N = 12 49.07 (11.4) |
p = 0.662, ES = 0.276, 95% CI = − 6.80 to 4.35 |
After 12 months |
N = 35 47.61 (11.3) |
N = 7 53.88 (7.9) |
p = 0.035*, ES = 0.883, 95% CI = − 13.08 to − 0.49 |
N = 33 48.32 (11.0) |
N = 7 53.86 (7.9) |
p = 0.053*, ES = 0.744, 95% CI = – 13.09 to 0.08 |