Health and wellbeing after breast, prostate or colorectal cancer Cancer Malignant neoplasm of breast, malignant neoplasm of prostate
Conditions
Interventions
Participants will be randomized to intervention or control groups using minimisation with a 1:1 allocation ratio. Stratification factors will be cancer type (breast, prostate or colorectal) and diseas
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with breast, prostate or colorectal cancer at Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust 2. Aged 16 years or older 3. Own a smartphone (that uses Android or iOS (Apple) operating systems) 4. Able to provide informed consent 5. Has access to a computer and an email address, and is willing to complete online questionnaires
Exclusion criteria
Exclusion criteria: 1. For those with localised disease: more than 6 months after completion of radical treatment (i.e. surgery, radiotherapy, systemic therapy with curative intent) 2. Unable to understand spoken/written English 3. ECOG status >3 4. Diagnosed cognitive impairment (e.g. dementia) 5. Cognitive and/or physical impairment that prevents participation in brisk walking 6. Clinicians’ estimate life expectancy <6 months or receiving end of life care 7. Due to have surgery in next 5 months 8. <6 weeks after surgery 9. Reports achieving 150 minutes of at least moderate-intensity PA weekly 10. Report previous/current use of Active 10 app 11. Report current or previous (within 6 months) participation in a health behaviour change study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A number of primary outcomes will be used to meet the primary objective of determining the feasibility and acceptability of the trial procedures. These outcomes will be: 1. Recruitment rate (percentage of eligible participants who are randomised) 2. Acceptability of randomisation (immediate withdrawal upon informing participants of allocation) 3. Feasibility of administering the intervention (proportion of those in the intervention group who receive the behavioural support calls, and self-report successfully downloading the app. All intervention participants will be sent the letter of endorsement from the clinical team, and the intervention leaflet including the Active 10 app recommendation) 4. Acceptability of the intervention, measured using intervention feedback questionnaires, self-reported app usage and engagement, withdrawal from intervention group (and reasons, where provided) 5. Retention rate (loss to follow-up in both intervention and control participants) 6. Acceptability of outcome assessments (completion rates for baseline and T1 follow-up outcome measures intended for definitive RCT, and proportion of participants who provide consent who complete baseline assessments) 7. Willingness of participants to consent to linkage with HES/NCRAS registries for long-term follow-up (percentage of participants who consent vs not for this aspect of the study) 8. Qualitative methods will also be used to explore the acceptability of the intervention (intervention arm participants), the acceptability of the trial procedures, outcome assessments, randomisation and linkage with HES/NCRAS registries for long-term follow-up (intervention and control arm participants, and study decliners) The study includes a baseline and 3-month assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Initial estimates of the parameters (e.g. mean, standard deviation) for the intended primary outcome measures (activPAL measured brisk walking [>100 steps/minute]) for the sample size calculation for the future definitive RCT measured using ActivPAL accelerometers at baseline 2. Self-reported app usage and engagement measured using a questionnaire (including items from the Digital Behavior Change Intervention Engagement Scale) and qualitative interviews at 3 months 3. Proportion of eligible/ineligible participants and reasons for ineligibility measured using records of the recruitment process before baseline 4. Potential sociodemographic biases in recruitment measured using aggregated data from hospital records (age, gender, ethnicity, Index of Multiple Deprivation [IMD]) of those who were invited and did and did not participate 5. Early indications of the potential cost-effectiveness of the intervention calculated using data from the EuroQol-5D (EQ-5D) and Client Service Receipt Inventory (CSRI) at baseline and 3 months 6. Acceptability of online assessments measured using the number of participants who require help to complete the questionnaires online at baseline or 3 months, or who give this method of data collection as a reason for declining to participate 7. Acceptability of providing informed consent online measured using the number who decline to participate because they state that they are unable/unwilling to provide consent online 8. Fidelity of intervention delivery in the telephone/video calls (Behaviour Change Techniques used) measured using a check-list of content included in the script to assess how many of the planned techniques were covered | — |
Countries
England, United Kingdom
Contacts
Public ContactPhillippa Lally
Outcome results
None listed