Mini-AFTERc Intervention for Fear of Cancer Recurrence

University of St Andrews

Status: Unknown

Conditions: Fear of Cancer; Breast Cancer

Treatments: Behavioral: Mini-AFTERc

Study type: Interventional

Funder types: Other

Identifiers

NCT03763825

249571

Details and patient eligibility

About

People treated for breast cancer often live with an ongoing fear that the cancer will recur. This fear may develop and impact on their mental health and quality of life. 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 pilot trial 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.

Full description

The objectives of this pilot trial are as follows:

1. To develop a procedure for training breast cancer nurses (BCN) in the delivery of the Mini-AFTERc intervention and introduce the intervention into current NHS service provision for breast cancer patients.
2. To collect data to pilot and test recruitment (of breast cancer nurses and breast cancer patients), the fidelity of intervention elements, the acceptability to participants (primary and secondary outcomes) and detailed economic indicators for a full trial.
3. Apply a formal decision making framework (ADePT) to determine a profile of factors to reveal potential difficulties and appraise solutions prior to a full trial.

This study is a multicentre controlled pilot trial of the Mini-AFTERc intervention and will take place in 4 breast cancer centres in NHS Scotland health boards, including Fife, Highlands, Lothian and Tayside. Two centres will deliver the intervention (Fife and Lothian) and 2 centres will deliver usual care to patients, acting as control centres (Highlands and Tayside). 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). Breast cancer nurses will deliver the intervention by telephone in intervention centres, which will be audio recorded. 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 conduct data analysis and trial evaluation. Screening and follow-up data will be quantitatively analysed, including structured equation modelling. Interviews will be subject to framework analysis based on normalisation process theory (NPT). The pilot trial will be systematically evaluated using a process of 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.

Enrollment: 133 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient inclusion criteria for screening:

• Completed primary cancer treatment.
• Cancer-free.
• Female.
• Responsible clinician agrees to their participation.

Patient inclusion criteria for trial:

• Score 'moderate' (≥10 and <15) on the Fear of Cancer Recurrence 4-item scale (FCR4) during screening.

Patient exclusion criteria:

• Not completed primary cancer treatment.
• Not cancer-free.
• Male.
• A diagnosed psychotic disorder, known to the cancer service, for which the patient is currently receiving treatment.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

Intervention group

Experimental group

Description:

Patient will receive the Mini-AFTERc intervention after completion of primary breast cancer treatment.

Treatment:

Behavioral: Mini-AFTERc

Control group

No Intervention group

Description:

Patients will receive usual care after completion of primary breast cancer treatment.