Self-management for people with cancer Cancer
Conditions
Interventions
This study will employ a feasibility, randomised wait-list control group design, to explore the feasibility of a trial of the digital Hope Programme for PWC.
Randomisation is via Qual
Sponsors
Coventry University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of any type of cancer, at any stage 2. Adult (18 years or over) 3. Located in the United Kingdom 4. Access to the internet and a device that will allow them to engage with the intervention 5. Fluent in English to be able to engage with all the material in the intervention 6. Not recruited via the NHS
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcome measures 1. Recruitment rates for participation and randomisation will be collected through Qualtrics. All eligible participants identified by MCS will be sent a link to the Qualtrics study survey, so we will calculate recruitment rates from those providing consent and/or completing baseline questionnaires 2. Retention and follow-up rates. Follow up will be online. Participants who become lost to follow up will be identified through Qualtrics as those not completing post programme questionnaires. It is possible that these participants may still complete some or all of the Hope programme, and so participant retention can be identified separately through engagement with the Hope platform. Participants who explicitly request to be withdrawn from the study will be categorized accordingly, but we will not contact participants to obtain reasons for not completing questionnaires. 3. Adherence rates. The Hope platform collects user engagement data such as login frequency and duration, which assists the moderators with participant engagement and experience. Participants also have the option of receiving system generated automatic nudge reminders sent to their email address. We will analyse this user engagement data to generate usage patterns and provide an overview of session attendance and participant engagement. 4. Sample size and effect size estimation. To inform sample size estimation for a future definitive trial, we will calculate the standard deviations of the continuous secondary outcomes pertaining to depression, anxiety, mental wellbeing and confidence to manage their cancer. To estimate potential effect sizes for a primary outcome in a future definitive trial, namely change in scores on key secondary outcome measures from pre- to post programme, we will calculate the difference between the mean difference pre and post programme for the intervention and control groups and divide by | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sociodemographic and health questionnaire at baseline only, requesting the following personal information from participants: gender, age, ethnicity, marital status, highest level of education, employment and occupation, and some details about their cancer diagnosis and any other medical conditions. Preprogramme and postprogramme (i.e. 6 weeks post-randomisation): 2. The Patient Health Questionnaire (PHQ-9) (depression) 3. The Generalized Anxiety Disorder scale (GAD7) (anxiety) 4. The Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) (mental wellbeing) 5. The Patient Activation Measure (PAM®) (knowledge, skills and confidence in patients and the extent to which people feel engaged and confident in taking care of their condition) | — |
Countries
England, United Kingdom
Contacts
Public ContactHayley Wright
Outcome results
None listed