Mini-AFTERc intervention for Fear of Cancer Recurrence: Pilot Trial
Research type
Research Study
Full title
A Pilot Trial of the Mini-AFTERc intervention to manage Fear of Cancer Recurrence in breast cancer patients
IRAS ID
249571
Contact name
Gerald Humphris
Contact email
Sponsor organisation
University of St Andrews
Duration of Study in the UK
1 years, 9 months, 1 days
Research summary
People treated for breast cancer often live with an ongoing fear that the cancer will recur. The Mini-AFTERc study is a pilot trial of a brief cognitive behavioural communication intervention, designed to reduce fear of cancer recurrence (FCR) in breast cancer patients.
This study aims to determine the acceptability and practicality of introducing the Mini-AFTERc intervention into everyday practice, and inform the development of a full randomised controlled trial.
The project will be delivered in 3 phases:
Phase 1 will include the development and delivery of the Mini-AFTERc intervention training package for breast cancer nurses.
Phase 2 will include patient recruitment and data collection. There will be 2 intervention centres and 2 control centres across NHS Scotland. Patients who have completed their primary breast cancer treatment, will be screened for moderate FCR (scoring ≥10 and <15 on the Fear of Cancer Recurrence 4-item Scale; FCR4) at follow-up appointments. Breast cancer nurses will deliver the intervention by telephone in intervention centres. Patients will complete a satisfaction questionnaire after the intervention (CARE and MISS). Follow-up questionnaires measuring fear of cancer recurrence, anxiety and depression and quality of life outcomes (FCR4, HADS, EQ-5D) will be delivered via a smartphone app at 2 weeks, 1 month and 3 months following intervention or 3 weeks, 5 weeks and 13 weeks following screening for the control group. Semi-structured interviews with 20% of patients and all nurses will be conducted to assess experiences and acceptability of the intervention.
Phase 3 will analyse the information produced from the outcome measures and interviews using a process for decision making after pilot and feasibility trials (ADePT).
The findings will help to understand if this brief intervention can be implemented in everyday practice and can reduce FCR. They will also inform the practicality of implementation of a larger-scale randomised trial.
REC name
South East Scotland REC 02
REC reference
18/SS/0135
Date of REC Opinion
29 Nov 2018
REC opinion
Further Information Favourable Opinion