CLASP5 (renewed online): pilot and randomised controlled trial Previous title: CLASP Renewed Online Feasibility Study

Current outcome measures as of 08/09/2017:
Feasibility trial assessments:
1.Suitability of recruitment screening measures is assessed using Baseline Screening Measures at baseline
2. Acceptability of all trial procedures is assessed at baseline, six months and 12 months
3. Acceptability of the intervention assessed by uptake, usage and drop-out using website usage data as well as conducting qualitative interviews with participants from each cancer type to assess acceptability and feasibility of website
4. Appropriateness of human support module is measured using uptake, adherence, number of sessions completed and also by focus groups or interviews with health care workers to elicit views about the website, support arm and study
5. Suitability of outcome measures is assessed at six and 12 months
6. Providing no extensive changes are made to the intervention or trial procedures following the feasibility study the data collected will also be used as an internal pilot so taken forward for the full trial. The acceptance checklist for clinical effectiveness pilot trials (ACCEPT) will be used to assess whether pilot trial data can be taken forward to the main trial.

Provisional ‘stop-go’ criteria for feasibility trial:
1. To achieve a target recruitment rate of 70% measured by the number of participants who log onto the website and give consent at six months after the start of the pilot trial:
1.1. Recruitment exceeds 70% of the recruitment predicted (N>42), the main trial goes ahead with plans for increased practice recruitment
1.2. Recruitment is 50-70% of the recruitment predicted (N=30-42), then a discussion with PGfAR is instituted and assuming a plan for increasing recruitment is reasonable, the trial proceeds with monthly recruitment updates, and withdrawal of funding should recruitment not pick up
1.3. Recruitment is <50% predicted (N<30) there should be a discussion with the PGfAR Board and unless there is a credible plan to increase recruitment, progression to the main trial should be halted

Previous outcome measures:
Feasibility primary outcome measures:
1. To achieve a target recruitment rate of 70% measured by the number of participants who log onto the website and give consent at six months after the start of the pilot trial:
1.1. Recruitment exceeds 70% of the recruitment predicted (N>42), the main trial goes ahead with plans for increased practice recruitment
1.2. Recruitment is 50-70% of the recruitment predicted (N=30-42), then a discussion with PGfAR is instituted and assuming a plan for increasing recruitment is reasonable, the trial proceeds with monthly recruitment updates, and withdrawal of funding should recruitment not pick up
1.3. Recruitment is <50% predicted (N<30) there should be a discussion with the PGfAR Board and unless there is a credible plan to increase recruitment, progression to the main trial should be halted

Current outcome measures as of 08/09/2017:
Outcome measures for both feasibility and main trial
1.Primary outcome. Quality of life is measured using the EORTC Quality of Life Questionnaire-c30 as primary outcome (EORTC QLQ-c30; (Aaronson et al., 1993)), at baseline, six (the primary time point) and 12 months.
Secondary outcomes:
2. EORTC 30 subscales (particularly: Physical functioning and Emotional wellbeing)
3. Health related quality of life is measured using the EQ-5D-5L for health economics analyses (Herdman et al., 2011; Van Hout et al., 2012) at baseline, six and 12 months
4. Perceptions of human support is measured using the Treatment Appraisal Questionnaire(TAQ; (Bishop, Yardley, & Lewith, 2008) at six months.
5. Anxiety and depression is measured using the Hospital Anxiety and Depression Scale (HADS; (Zigmond & Snaith, 1983)), at baseline and 12 months
6. Fear of relapse is measured using the Fear of Relapse/Recurrence Scale (FRRS; (Greenberg et al., 1997)) modified to 3 items, at baseline and 12 months
7. Quality of life is measured using the Measure Yourself Concerns and Wellbeing questionnaire for Quality of Life (MYCAW; (Paterson, Thomas, Manasse, Cooke, & Peace, 2007) at baseline and 12 months
8. Resource use (including consultations and their reasons) and personal costs data for heath economics will be documented between baseline and 12 months
9. A modified Patient Enablement Instrument (PEI; (Howie et al., 1999; Little et al., 2008)) is measured at 12 months
Measures among those in the intervention groups:
10. Website satisfaction measure, modified for this study is measured at 12 months
11. Problematic Experiences of Therapy Scale and single item measures of self-reported adherence to website recommendations for physical activity, mental wellbeing, diet measured at 12 months (as used in POWeR trial)
12. Website usage and entries. We will analyse all website usage, which is unobtrusively automatically collected by the LifeGuide system, including time spent on each page and entries (e.g. goal setting and goal-related progress in physical activity, healthy eating, weight, and engagement with pages on fatigue and mood management).
Other measures:
13. Gender, age, marital status, years of education, ethnicity, height and weight will be documented at baseline. Cancer status and treatments prior to the trial will also be documented. Any other similar cancer support management programmes received during the trial with be documented at 12 months. Physical activity amounts is measured using a questionnaire asking about physical activity amounts, validated in a previous study (Physical Activity Checker from Diabetes Literacy trial) at baseline.

Previous outcome measures:
Feasibility secondary outcomes measures:
1.Suitability of recruitment screening measures is assessed using Baseline Screening Measures at baseline
2. Acceptability of all trial procedures is assessed at baseline, six months and 12 months
3. Acceptability of the intervention assessed by uptake, usage and drop-out using LIFEGUIDE data as well as conducting qualitative interviews with participants from each cancer type to assess acceptability and feasibility of website at 6 months
4. Appropriateness of human support module is measured using uptake, adherance, number of sessions and also by focus group participation of health care workers to elicit views about the website, support arm and study at 6 months
5. Suitability of outcome measures is assessed at six and 12 months
6. Target sample size for the trial is measured using analysis of power calculation at six moths
7. Cost is measured using a Health economist analysis using EQ-5 D-5L at baseline,6mths and 12 mths. The economic analysis of both the costs and quality of life will be mainly descriptive for the feasibility trial and will include means and standard deviations.
8. The feasibility study analysis are descriptive. However in line with the acceptance checklist for clinical effectiveness pilot trials (ACCEPT) checklist, whether pilot trial data can be taken forward to the main trial depending on trial modifications will be explored and recorded. Providing the trial goes ahead and no extensive changes are made to the intervention or trial procedures following the feasibility study the data collected will also be used as an internal pilot so taken forward for the full trial.