Purpose
Methods
Sample
Pilot-testing
Equivalence testing
Study design
Pilot-testing
Equivalence testing
Data analysis
Pilot-testing
Equivalence testing
Results
Sample
Pilot-testing
Variable | Pilot-testing sample (n = 5) |
---|---|
Age, years | |
Median | 51 |
Min–max | (29–64) |
Gender, n | |
Male/female | 3/2 |
Living status, n | |
Living as a couple | 3 |
Living alone | 2 |
Occupation, n | |
Full- or part-time employment | 4 |
Retired | 1 |
Education, n | |
Left high school with no qualifications | 1 |
Completed high school with qualifications | 3 |
Other | 2 |
Type of cancer, n | |
Breast* | 1 |
Lung* | 1 |
Bowel* | 2 |
Other* | 4 |
Therapy | |
Surgery** | 1 |
Chemotherapy** | 3 |
Other | 2 |
Equivalence testing
Variable | Randomisation group | Total (n = 63) | |
---|---|---|---|
Paper version first (n = 31) | Phone version first (n = 32) | ||
Age, years | |||
n (Missing) | 31 (0) | 32 (0) | 63 (0) |
Mean (SD) | 56.84 (13.83) | 54.16 (11.36) | 55.48 (12.61) |
Median | 59.00 | 54.50 | 58.00 |
Min–max | 24.00–78.00 | 31.00–79.00 | 24.00–79.00 |
Gender, n (%) | |||
Male | 12 (38.7%) | 10 (31.3%) | 22 (34.9%) |
Female | 19 (61.3%) | 22 (68.8%) | 41 (65.1%) |
Living status, n (%) | |||
Living alone | 6 (19.4%) | 3 (9.4%) | 9 (14.3%) |
Living as a couple | 23 (74.2%) | 25 (78.1%) | 48 (76.2%) |
Other | 2 (6.5%) | 4 (12.5%) | 6 (9.5%) |
Occupation, n (%) | |||
Full/part-time employment | 11 (35.5%) | 19 (59.4%) | 30 (47.6%) |
Homemaker/housewife | 1 (3.2%) | 2 (6.3%) | 3 (4.8%) |
Student | 1 (3.2%) | 0 (0.0%) | 1 (1.6%) |
Unemployed | 2 (6.5%) | 1 (3.1%) | 3 (4.8%) |
Retired | 9 (29.0%) | 6 (18.8%) | 15 (23.8%) |
Other | 4 (12.9%) | 4 (12.5%) | 8 (12.7%) |
Full/part-time employment and Homemaker | 3 (9.7%) | 0 (0.0%) | 3 (4.8%) |
Education level, n (%) | |||
Left high school with no qualifications | 2 (6.5%) | 4 (12.5%) | 6 (9.5%) |
Completed high school with qualifications | 10 (32.3%) | 12 (37.5%) | 22 (34.9%) |
Bachelor’s degree | 6 (19.4%) | 4 (12.5%) | 10 (15.9%) |
Post-graduate degree | 8 (25.8%) | 8 (25.0%) | 16 (25.4%) |
Other | 5 (16.1%) | 4 (12.5%) | 9 (14.3%) |
Type of cancer, n (%) | |||
Breast | 10 (32.3%) | 8 (25.0%) | 18 (28.6%) |
Prostate | 5 (16.1%) | 2 (6.3%) | 7 (11.1%) |
Lung | 5 (16.1%) | 1 (3.1%) | 6 (9.5%) |
Bowel | 1 (3.2%) | 3 (9.4%) | 4 (6.3%) |
Other | 9 (29.0%) | 17 (53.1%) | 26 (41.3%) |
Kidney (metastatic) | 0 (0.0%) | 1 (3.1%) | 1 (1.6%) |
Lung (non-small cell) | 1 (3.2%) | 0 (0.0%) | 1 (1.6%) |
Treatment*, n (%) | |||
Surgery | 4 (12.9%) | 3 (9.4%) | 7 (11.1%) |
Chemotherapy | 9 (29.0%) | 7 (21.9%) | 16 (25.4%) |
Radiotherapy | 2 (6.5%) | 4 (12.5%) | 6 (9.5%) |
Hormone therapy | 6 (19.4%) | 4 (12.5%) | 10 (15.9%) |
Biological therapy | 2 (6.5%) | 6 (18.8%) | 8 (12.7%) |
Other | 6 (19.4%) | 5 (15.6%) | 11 (17.5%) |
Mixed | 2 (6.5%) | 3 (9.4%) | 5 (7.9%) |
Variable | Patients | Total (n = 63) | |
---|---|---|---|
Second wave of patients (n = 37) | First wave of patients (n = 26) | ||
Age, years | |||
n (Missing) | 37 (0) | 26 (0) | 63 (0) |
Mean (SD) | 52.51 (12.79) | 59.69 (11.27) | 55.48 (12.61) |
Median | 56.00 | 59.50 | 58.00 |
Min–max | 24.00–76.00 | 36.00–79.00 | 24.00–79.00 |
Gender, n (%) | |||
Male | 8 (21.6%) | 14 (53.8%) | 22 (34.9%) |
Female | 29 (78.4%) | 12 (46.2%) | 41 (65.1%) |
Living status, n (%) | |||
Living alone | 7 (18.9%) | 2 (7.7%) | 9 (14.3%) |
Living as a couple | 25 (67.6%) | 23 (88.5%) | 48 (76.2%) |
Other | 5 (13.5%) | 1 (3.8%) | 6 (9.5%) |
Occupation, n (%) | |||
Full/part-time employment | 17 (45.9%) | 13 (50.0%) | 30 (47.6%) |
Homemaker/housewife | 3 (8.1%) | 0 (0.0%) | 3 (4.8%) |
Student | 1 (2.7%) | 0 (0.0%) | 1 (1.6%) |
Unemployed | 3 (8.1%) | 0 (0.0%) | 3 (4.8%) |
Retired | 7 (18.9%) | 8 (30.8%) | 15 (23.8%) |
Other | 3 (8.1%) | 5 (19.2%) | 8 (12.7%) |
Full/part-time employment and homemaker | 3 (8.1%) | 0 (0.0%) | 3 (4.8%) |
Education level, n (%) | |||
Left high school with no qualifications | 3 (8.1%) | 3 (11.5%) | 6 (9.5%) |
Completed high school with qualifications | 12 (32.4%) | 10 (38.5%) | 22 (34.9%) |
Bachelor’s degree | 7 (18.9%) | 3 (11.5%) | 10 (15.9%) |
Post-graduate degree | 9 (24.3%) | 7 (26.9%) | 16 (25.4%) |
Other | 6 (16.2%) | 3 (11.5%) | 9 (14.3%) |
Type of cancer, n (%) | |||
Breast | 11 (29.7%) | 7 (26.9%) | 18 (28.6%) |
Prostate | 2 (5.4%) | 5 (19.2%) | 7 (11.1%) |
Lung | 3 (8.1%) | 3 (11.5%) | 6 (9.5%) |
Bowel | 2 (5.4%) | 2 (7.7%) | 4 (6.3%) |
Other | 17 (45.9%) | 9 (34.6%) | 26 (41.3%) |
Kidney (metastatic) | 1 (2.7%) | 0 (0.0%) | 1 (1.6%) |
Lung (non-small cell) | 1 (2.7%) | 0 (0.0%) | 1 (1.6%) |
Treatment* | |||
Surgery | 6 (16.2%) | 1 (3.8%) | 7 (11.1%) |
Chemotherapy | 11 (29.7%) | 5 (19.2%) | 16 (25.4%) |
Radiotherapy | 2 (5.4%) | 4 (15.4%) | 6 (9.5%) |
Hormone therapy | 4 (10.8%) | 6 (23.1%) | 10 (15.9%) |
Biological therapy | 0 (0.0%) | 8 (30.8%) | 8 (12.7%) |
Other | 11 (29.7%) | 0 (0.0%) | 11 (17.5%) |
Mixed | 3 (8.1%) | 2 (7.7%) | 5 (7.9%) |
Pilot-testing
Equivalence testing
QLQ-C30 scores | All patients | Total (n = 63) | |
---|---|---|---|
Paper first (n = 31) | Phone first (n = 32) | ||
Global health status score | |||
ICC | 0.89 | 0.91 | 0.90 |
95% CI | 0.79–0.95 | 0.81–0.95 | 0.80–0.95 |
Physical functioning score | |||
ICC | 0.81 | 0.94 | 0.89 |
95% CI | 0.64–0.90 | 0.89–0.97 | 0.79–0.95 |
Role functioning score | |||
ICC | 0.76 | 0.89 | 0.84 |
95% CI | 0.56–0.88 | 0.78–0.94 | 0.68–0.92 |
Emotional functioning score | |||
ICC | 0.79 | 0.92 | 0.86 |
95% CI | 0.60–0.89 | 0.84–0.96 | 0.73–0.93 |
Cognitive functioning score | |||
ICC | 0.85 | 0.94 | 0.90 |
95% CI | 0.71–0.92 | 0.87–0.97 | 0.80–0.95 |
Social functioning score | |||
ICC | 0.76 | 0.85 | 0.79 |
95% CI | 0.55–0.87 | 0.70–0.92 | 0.59–0.89 |
Fatigue score | |||
ICC | 0.76 | 0.82 | 0.79 |
95% CI | 0.56–0.88 | 0.66–0.91 | 0.59–0.89 |
Nausea and vomiting | |||
ICC | 0.55 | 0.91 | 0.72 |
95% CI | 0.24–0.76 | 0.83–0.96 | 0.48–0.86 |
Pain | |||
ICC | 0.89 | 0.90 | 0.90 |
95% CI | 0.78–0.94 | 0.80–0.95 | 0.79–0.95 |
Dyspnoea | |||
ICC | 0.78 | 0.79 | 0.76 |
95% CI | 0.59–0.89 | 0.60–0.89 | 0.55–0.88 |
Insomnia | |||
ICC | 0.87 | 0.83 | 0.84 |
95% CI | 0.74–0.93 | 0.68–0.92 | 0.69–0.92 |
Appetite loss | |||
ICC | 0.90 | 0.82 | 0.85 |
95% CI | 0.80–0.95 | 0.65–0.91 | 0.71–0.93 |
Constipation | |||
ICC | 0.90 | 0.90 | 0.90 |
95% CI | 0.81–0.95 | 0.80–0.95 | 0.80–0.95 |
Diarrhoea | |||
ICC | 0.77 | 0.85 | 0.80 |
95% CI | 0.58–0.88 | 0.71–0.92 | 0.62–0.90 |
Financial difficulties | |||
ICC | 0.60 | 0.87 | 0.73 |
95% CI | 0.31–0.79 | 0.75–0.93 | 0.49–0.86 |
QLQ-C30 scores | All patients | |
---|---|---|
Paper first (n = 31) | Phone first (n = 32) | |
Global health status | ||
Mean (SD) | − 0.67 (9.01) | − 0.52 (8.71) |
Min–max | − 16.67 to 33.33 | − 25.00 to 25.00 |
Physical functioning | ||
Mean (SD) | − 2.37 (8.35) | 1.04 (6.36) |
Min–max | − 20.00 to 20.00 | − 6.67 to 26.67 |
Role functioning | ||
Mean (SD) | − 0.54 (15.80) | 5.73 (14.42) |
Min–max | − 33.33 to 33.33 | − 16.67 to 33.33 |
Emotional functioning | ||
Mean (SD) | 0.54 (14.26) | 4.43 (10.37) |
Min–max | − 25.00 to 33.33 | − 25.00 to 25.00 |
Cognitive functioning | ||
Mean (SD) | 1.43 (10.92) | 4.17 (7.98) |
Min–max | − 16.67 to 33.33 | − 16.67 to 22.22 |
Social functioning | ||
Mean (SD) | − 9.68 (19.61) | 1.04 (15.23) |
Min–max | − 50.00 to 33.33 | − 33.33 to 33.33 |
Fatigue | ||
Mean (SD) | 0.72 (16.71) | − 6.25 (14.09) |
Min–max | − 44.44 to 33.33 | − 44.44 to 22.22 |
Nausea and vomiting | ||
Mean (SD) | 4.30 (12.89) | − 2.08 (5.60) |
Min–max | 0.00 to 66.67 | − 16.67 to 0.00 |
Pain | ||
Mean (SD) | 1.08 (14.23) | 1.56 (13.63) |
Min–max | − 16.67 to 50.00 | − 16.67 to 33.33 |
Dyspnoea | ||
Mean (SD) | 2.15 (17.07) | − 8.33 (14.66) |
Min–max | − 33.33 to 66.67 | − 33.33 to 0.00 |
Insomnia | ||
Mean (SD) | 1.08 (16.06) | − 7.29 (20.27) |
Min–max | − 33.33 to 33.33 | − 66.67 to 33.33 |
Appetite loss | ||
Mean (SD) | 3.23 (10.02) | − 0.00 (14.66) |
Min–max | 0.00 to 33.33 | − 33.33 to 33.33 |
Constipation | ||
Mean (SD) | − 1.08 (10.48) | − 2.08 (14.51) |
Min–max | − 33.33 to 33.33 | − 33.33 to 33.33 |
Diarrhoea | ||
Mean (SD) | − 1.08 (20.15) | − 4.17 (14.04) |
Min–max | − 100.00 to 33.33 | − 33.33 to 33.33 |
Financial difficulties | ||
Mean (SD) | 10.75 (30.29) | 5.21 (12.30) |
Min–max | − 66.67 to 66.67 | 0.00 to 33.33 |
QLQ-C30 scores | All patients | Total (n = 63) | |
---|---|---|---|
1st wave (n = 26) | 2nd wave (n = 37) | ||
Global health status score | |||
ICC | 0.92 | 0.89 | 0.90 |
95% CI | 0.83–0.96 | 0.79–0.95 | 0.80–0.95 |
Physical functioning score | |||
ICC | 0.86 | 0.93 | 0.89 |
95% CI | 0.72–0.93 | 0.58–0.96 | 0.79–0.95 |
Role functioning score | |||
ICC | 0.76 | 0.77 | 0.84 |
95% CI | 0.55–0.88 | 0.57–0.88 | 0.68–0.92 |
Emotional functioning score | |||
ICC | 0.84 | 0.87 | 0.86 |
95% CI | 0.69–0.92 | 0.74–0.94 | 0.73–0.93 |
Cognitive functioning score | |||
ICC | 0.90 | 0.90 | 0.90 |
95% CI | 0.81–0.95 | 0.79–0.95 | 0.80–0.95 |
Social functioning score | |||
ICC | 0.82 | 0.75 | 0.79 |
95% CI | 0.67–0.91 | 0.53–0.87 | 0.59–0.89 |
Fatigue score | |||
ICC | 0.77 | 0.82 | 0.79 |
95% CI | 0.57–0.88 | 0.64–0.91 | 0.59–0.89 |
Nausea and vomiting | |||
ICC | 0.47 | 0.96 | 0.72 |
95% CI | 0.14–0.71 | 0.90–0.98 | 0.48–0.86 |
Pain | |||
ICC | 0.85 | 0.94 | 0.90 |
95% CI | 0.71–0.93 | 0.87–0.97 | 0.79–0.95 |
Dyspnoea | |||
ICC | 0.73 | 0.82 | 0.76 |
95% CI | 0.50–0.86 | 0.65–0.91 | 0.55–0.88 |
Insomnia | |||
ICC | 0.78 | 0.89 | 0.84 |
95% CI | 0.59–0.89 | 0.80–0.95 | 0.69–0.92 |
Appetite loss | |||
ICC | 0.85 | 0.85 | 0.85 |
95% CI | 0.70–0.92 | 0.71–0.93 | 0.71–0.93 |
Constipation | |||
ICC | 0.98 | 0.84 | 0.90 |
95% CI | 0.95–0.99 | 0.70–0.92 | 0.80–0.95 |
Diarrhoea | |||
ICC | 0.72 | 0.90 | 0.80 |
95% CI | 0.49–0.86 | 0.79–0.95 | 0.62–0.90 |
Financial difficulties | |||
ICC | 0.52 | 0.79 | 0.73 |
95% CI | 0.20–0.74 | 0.60–0.90 | 0.49–0.86 |
QLQ-C30 scores | All patients | |
---|---|---|
Age < 60 (n = 40) | Age ≥ 60 (n = 23) | |
Global health status score | ||
ICC | 0.89 | 0.90 |
95% CI | 0.78–0.94 | 0.81–0.95 |
Physical functioning score | ||
ICC | 0.95 | 0.77 |
95% CI | 0.89–0.97 | 0.57–0.88 |
Role functioning score | ||
ICC | 0.84 | 0.81 |
95% CI | 0.69–0.92 | 0.64–0.90 |
Emotional functioning score | ||
ICC | 0.88 | 0.81 |
95% CI | 0.76–0.94 | 0.65–0.90 |
Cognitive functioning score | ||
ICC | 0.90 | 0.88 |
95% CI | 0.80–0.95 | 0.77–0.94 |
Social functioning score | ||
ICC | 0.81 | 0.69 |
95% CI | 0.65–0.91 | 0.45–0.84 |
Fatigue score | ||
ICC | 0.80 | 0.75 |
95% CI | 0.61–0.90 | 0.55–0.87 |
Nausea and vomiting | ||
ICC | 0.63 | 0.92 |
95% CI | 0.35–0.81 | 0.84–0.96 |
Pain | ||
ICC | 0.89 | 0.89 |
95% CI | 0.79–0.95 | 0.80–0.95 |
Dyspnoea | ||
ICC | 0.79 | 0.72 |
95% CI | 0.61–0.90 | 0.49–0.85 |
Insomnia | ||
ICC | 0.88 | 0.72 |
95% CI | 0.76–0.94 | 0.49–0.85 |
Appetite loss | ||
ICC | 0.92 | 0.71 |
95% CI | 0.85–0.96 | 0.48–0.85 |
Constipation | ||
ICC | 0.87 | 0.94 |
95% CI | 0.75–0.94 | 0.88–0.97 |
Diarrhoea | ||
ICC | 0.68 | 0.95 |
95% CI | 0.42–0.83 | 0.90–0.97 |
Financial difficulties | ||
ICC | 0.75 | 0.54 |
95% CI | 0.54–0.87 | 0.23–0.75 |
QLQ-C30 scores | All patients | |
---|---|---|
Male (n = 22) | Female (n = 41) | |
Global health status score | ||
ICC | 0.92 | 0.87 |
95% CI | 0.84–0.96 | 0.75–0.94 |
Physical functioning score | ||
ICC | 0.77 | 0.94 |
95% CI | 0.57–0.88 | 0.89–0.97 |
Role functioning score | ||
ICC | 0.81 | 0.84 |
95% CI | 0.65–0.90 | 0.69–0.92 |
Emotional functioning score | ||
ICC | 0.80 | 0.88 |
95% CI | 0.62–0.90 | 0.76–0.94 |
Cognitive functioning score | ||
ICC | 0.87 | 0.90 |
95% CI | 0.75–0.93 | 0.79–0.95 |
Social functioning score | ||
ICC | 0.83 | 0.73 |
95% CI | 0.68–0.91 | 0.51–0.86 |
Fatigue score | ||
ICC | 0.66 | 0.85 |
95% CI | 0.40–0.82 | 0.71–0.93 |
Nausea and vomiting | ||
ICC | 0.52 | 0.88 |
95% CI | 0.20–0.73 | 0.76–0.94 |
Pain | ||
ICC | 0.88 | 0.91 |
95% CI | 0.76–0.94 | 0.82–0.95 |
Dyspnoea | ||
ICC | 0.69 | 0.83 |
95% CI | 0.45–0.84 | 0.67–0.91 |
Insomnia | ||
ICC | 0.75 | 0.88 |
95% CI | 0.55–0.87 | 0.76–0.94 |
Appetite loss | ||
ICC | 0.87 | 0.84 |
95% CI | 0.74–0.93 | 0.69–0.92 |
Constipation | ||
ICC | 0.87 | 0.90 |
95% CI | 0.75–0.93 | 0.81–0.95 |
Diarrhoea | ||
ICC | 0.68 | 0.90 |
95% CI | 0.44–0.83 | 0.80–0.95 |
Financial difficulties | ||
ICC | 0.62 | 0.74 |
95% CI | 0.34–0.79 | 0.52–0.87 |