The ROSETA Pilot Trial
Research type
Research Study
Full title
Refining and Optimising a behavioural intervention to Support Endocrine Therapy - The ROSETA Pilot Trial
IRAS ID
302050
Contact name
Samuel Smith
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Research Summary
The ROSETA project aims to design and adapt four interventions which will help women with early-stage breast cancer adhere to their hormone medication regime. Each intervention targets a different barrier to medication adherence in this population: SMS reminders target memory problems; an information leaflet targets medication beliefs; Acceptance and Commitment Therapy (ACT) supports psychological distress; and a website provides information and signposting to help manage side effects. NHS sites will recruit approximately eighty adult women with stage 1-3a breast cancer, who have been prescribed adjuvant hormone therapy and completed curative hospital-based treatments. NHS sites will be considered eligible on the basis that they have capacity and capability to comply with trial requirements, as well as having access to a Health and Care Professional Council (HCPC) registered practitioner psychologist who can be trained to deliver the ACT intervention.
Participants will be randomly allocated to one of eight experimental groups, which will determine the combination of interventions they receive (ranging from zero to four). The primary objectives of the pilot trial are to establish eligibility, recruitment, retention and follow up rates, as well as availability and feasibility of collecting the necessary data. Interview data will also be collected to gain insight into the barriers and facilitators to trial participation and intervention adherence, as well as intervention fidelity. This will inform the design of the next phase of the ROSETA project, and the decision of whether it is feasible to proceed with a larger trial.
Summary of results
"Adjuvant endocrine therapy (AET) reduces the risk of breast cancer coming back in women with early-stage breast cancer. However, many women struggle to take AET as it is prescribed (medication non-adherence). We developed an intervention with four components, each targeting a key reason why women might not adhere to AET; (1) text messages supporting medication-taking as a habit; (2) an information leaflet highlighting why AET is necessary, and reducing concerns; (3) a psychotherapy programme based on acceptance and commitment therapy to reduce psychological distress; and (4) a website with strategies to self-manage side-effects of AET.
We conducted a small trial to see if it would be feasible to conduct a larger trial. We were interested in understanding:
(1) How many women would take part in the trial;
(2) Whether participants would adhere to the intervention components (e.g., receive the text messages, read the information leaflet, attend the ACT sessions, and/or log in to the website);
(3) Whether data about adherence to AET would be available;
(4) Whether the support is acceptable to women with breast cancer.Women prescribed AET were recruited from five NHS sites across the UK. We used a design, whereby participants were randomly allocated to one of eight conditions. Each condition was made up of different combinations of the four intervention components. Each woman also received the standard care provided by the hospital. We asked women to complete questionnaires after two and four months. We also interviewed 20 women who took part in the trial, and six of the trial therapists. The results were as follows:
(1) 175 women were approached about the study. 141 (81%) were eligible to take part, and 52 (37%) agreed to take part and were randomly allocated to one of the eight conditions. Ten (19%) women requested withdrawal from at least one element of the trial. 43 (83%) completed the questionnaires at two-months, and 41 (79%) completed them at 4-months.
(2) 75% of women received 75% or more of the text messages; 63% read at least some of the information leaflet; 63% completed two out of four of the ACT modules; and 73% registered and logged onto the website at least once.
(3) We could only get data for one out of our three assessments of adherence to AET. We could not get data about whether prescriptions were collected and we had to stop data collection early for one questionnaire about medication adherence.
(4) All four intervention components were considered acceptable to women with breast cancer. The average scores were: 14/20 for text messages, 14.5/20 for the information leaflet, 15/20 for the ACT component, and 15/20 for the website. Women who were interviewed considered the intervention components to be acceptable and made suggestions for improvement.Overall, the results show that a larger trial is possible. However, changes are needed to help us to recruit more participants and to make sure we have enough data about medication adherence."
REC name
Wales REC 3
REC reference
21/WA/0322
Date of REC Opinion
26 Oct 2021
REC opinion
Favourable Opinion