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Table 1 eRAPID RCT in systemic cancer treatment: Participant completed primary and secondary outcomes measures

From: Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID): a randomised controlled trial in systemic cancer treatment

Questionnaire title and brief description Item information/response format and scoring Example questions Time points
Primary outcome- Quality of Life
Quality of life: FACT-G [36]
27 item cancer specific QOL measure four subscales covering physical, social or family, emotional and functional wellbeing 5 point scale (0 not at all – 4 very much) • I have nausea Baseline, 6, 12, 18 weeks and 12 months
• I am forced to spend time in spend
Higher subscale and total scores indicate better QOL (score range 0–108). • I get support from my friends
• I worry that my condition will get worse
• I have accepted my illness
Secondary outcomes- health economic/clinical process data
EQ-5D-5 L [38]
6 item descriptive health profile (measuring mobility, self-care, usual activities, pain, anxiety/depression) and a single index value for health status that can be used as part of a health-economic evaluation. 5 items measured on 5 point scale and single global health item rated from 0 (worst health) to 100 (best health) Self-care Baseline, 6, 12, 18 weeks and 12 months
• I have no problems washing of dressing myself
• I have slight problems washing or dressing myself
• I have moderate problems washing or dressing myself
• I have severe problems washing or dressing myself
• I am unable to wash or dress myself
Use of Resources
Assessment of financial impact of cancer treatment covering: Varied tick boxes and free text options. • Please complete the boxes below to tell is about any non-hospital health care contacts you have had in the last 6 weeks 6, 12, 18 weeks and 12 months
- Employment status
- Contacts with community health care services (GP, district nurses etc)
- Medications costs • Please tell us about any medications you have been prescribed in the last 6 weeks and who prescribed it
- Cancer related travel costs
- Cancer related food/drink costs
- Additional expenses
• Please tell us about any additional travel costs related to your cancer or cancer treatment you have incurred in the last 6 weeks
EORTC-QLQ C30 [39]
30-item questionnaire with five functional scales (physical, emotional, cognitive, social, role), three symptom scales (fatigue, pain, nausea/vomiting), a global health related quality of life scale, and six single items (anorexia, insomnia, dyspnoea, diarrhoea, constipation, financial difficulties) Questions are rated on a 4 or 7 point response scales. • Do you have any trouble taking a long walk Baseline, 6, 12, 18 weeks and 12 months
• During the past week…
The scales and single-item responses are recalculated into a score from 0 to 100.
- Have you lacked appetite?
• A high functional scale score represents a high level of functioning - Were you tired?
- Did you feel depressed?
• A high score for the global health status/QOL represents a high QOL
• A high score for a symptom scale/item represents a high/worse level of symptomatology
Secondary outcomes- Self-efficacy
Self-Efficacy for Managing Chronic Disease [34]
6-Item scale covering several domains common across chronic diseases (symptom control, role function, emotional functioning and communicating with physicians) Items rated from 1- (not at all confident) to 10 (totally confident) • How confident are you that you can keep physical discomfort or pain of your disease from interfering with the things you want to do? Baseline and 18 weeks
The score for the scale is calculated from the mean of the six items. • How confident are you that you can do things other than just taking medication to reduce how much you illness affects your everyday life?
Cancer Behaviour Inventory-Brief (CBI-B) [40]
A measure of self-efficacy for coping with cancer. 14 items (adapted from full 33 item measure) Items are rated on a 9-point scale ranging from 1 (“not all confident”) to 9 (“totally confident”) Please read each numbered item. Then rate that item on how confident you are that you can accomplish that behaviour. Baseline and 18 weeks
- Maintaining independence
- Expressing feelings about cancer
A total score is calculated as the sum of all 12 items. - Asking physicians’ questions
- Coping with physical changes
Patient Activation Measure (PAM) [41]
13-item scale for measuring the level of patient engagement in their healthcare (knowledge, skill and confidence for self-management) Statements rated on 4 point scale from disagree strongly to agree strongly and additional N/A option. • When all is said and done I am the person who is responsible for taking care of my health Baseline, 18 weeks and 12 months
• I am confident I follow through on medical treatments I may need to do at home
Responses are combined to provide a single score of between 0 and 100 with higher scores representing higher levels of patient activation. • I know what treatments are available for my health problems.
Scores can be classified into one of four groups, known as ‘levels of activation’.
Secondary outcomes- eRAPID/IT system performance
System Usability Scale (SUS) [42]
10 item instrument to assess views of usability of an IT systems. Each statement rated from 1 strongly disagree to 5 strongly agree. • I think that I would like to use this system frequently 18 weeks
• I thought there was too much inconsistency in this system
Responses are calculated into a total score ranging from 0 to 100 with higher scores representing better system usability. • I felt very confident using the system
eRAPID end of study questionnaire
15 statements/free text boxes to assess participant views of using eRAPID and suggestions for improvements Statements rated on 3–5 response option scales (e.g. very easy-very difficult) and free text boxes for comments. • How easy or difficult was it to learn how to use the eRAPID system? 18 weeks
• How did you feel about the amount of time it took to complete the symptom questions?
• To what extent do you feel that the symptom questionnaire was useful for the doctors and nurses you saw during your treatment?
• Have you got any suggestions about how the eRAPID system could be improved?