Malignant neoplasms of independent (primary) multiple sites Cancer Cancer
Conditions
Interventions
This study consists of a website intervention. Renewed Online is a website intervention which offers lifestyle advice and wellbeing support for cancer survivors.The intervention has been developed usi
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/03/2018: 1. Aged 18 years or over 2. Identifiable from GP case records 3. Have had breast, prostate or colorectal cancer. 4. Have finished primary cancer treatment (e.g. chemotherapy/radiotherapy courses) within last 10 years and primary treatment completed at least 1 month ago. This does not include active surveillance for prostate cancer patients or hormone therapy for any participants. 5. Have internet access 6. Have impaired quality of life (measured by EORTC) Previous inclusion criteria 1. Be aged 18 yrs 2. Be identifiable from GP case records 3. Have had breast, prostate or colorectal cancer. 4. Have finished primary cancer treatment (eg chemotherapy/radiotherapy courses) within last 10 years. This does not include active surveillance for prostate cancer patients or hormone therapy for any participants. 5. Have internet access 6. Have impaired quality of life
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 15/03/2018: 1. Currently have cancer 2. Have had more than one other type of cancer (other than breast, prostate or colon) in the last 5 year 3. Have metastatic cancer 4. Receiving any cancer treatment other than hormone therapy currently or during the last month 5. Expecting to start any cancer treatment during the study period 6. Have severe mental health problems and/or major uncontrolled depression/schizophrenia or dementia 7. Had sarcoma/lymphoma of breast 8. Another participant of the study living in the same household 9. Currently have untreated cancer unless on active surveillance for prostate cancer Previous exclusion criteria 1. Currently have cancer 2. Have had more than one other type of cancer (other than breast, prostate or colon) in the last 5 year 3. Have metastatic cancer 4. Receiving any cancer treatment other than hormone therapy currently or during the last month 5. Expecting to start any cancer treatment during the study period 6. Have severe mental health problems and/or major uncontrolled depression/schizophrenia or dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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), | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, incl | — |
Countries
England, United Kingdom
Contacts
Public ContactPaul Little
Outcome results
None listed