Clinical trial NCT03763825: Mini-AFTERc Intervention for Fear of Cancer Recurrence
Official title: A Pilot Trial of the Mini-AFTERc Intervention to Manage Fear of Cancer Recurrence in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Fear of Cancer
Keywords: fear of recurrence
cancer
brief intervention
telephone counselling
following primary cancer treatment
Lead sponsor: University of St Andrews
Sponsor class: OTHER
Collaborators: name: University of Stirling
name: University of Surrey
name: Swansea University
name: Chief Scientist Office of the Scottish Government
First posted: 2018-12-04
Enrollment: 133
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Patient satisfaction with nurse communication during the Mini-AFTERc intervention
timeFrame: 1 week post intervention
Secondary outcomes:
measure: Fear of cancer recurrence level - FCR4
timeFrame: 3 months
measure: Depression and anxiety symptoms - Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months
measure: Health-related quality of life - EuroQol 5 Dimension Measure of Quality of Life (EQ-5D)
timeFrame: 3 months
measure: Nurses' perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews
timeFrame: Within 1 month of delivering final intervention
measure: Recruitment rate
timeFrame: Duration of the pilot trial (Approx 2 years)
measure: Retention rate
timeFrame: Duration of the pilot trial (Approx 2 years)
measure: Attrition rate
timeFrame: Duration of the pilot trial (Approx 2 years)
measure: Patient perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews
timeFrame: Within 1 month of final follow-up questionnaire
Other outcomes:
Locations:
city: Dunfermline
country: United Kingdom
facility: Queen Margaret Hospital
state: NHS Fife
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
state: NHS Highlands
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: NHS Lothain
city: Perth
country: United Kingdom
facility: Perth Royal Infirmary
state: NHS Tayside
Study officials:
References:
citation: Davidson J, Malloch M, Humphris G. A single-session intervention (the Mini-AFTERc) for fear of cancer recurrence: A feasibility study. Psychooncology. 2018 Nov;27(11):2668-2670. doi: 10.1002/pon.4724. Epub 2018 Apr 30. No abstract available.
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citation: Brandt NG, McHale CT, Humphris GM. Development and Testing of a Novel Measure to Assess Fidelity of Implementation: Example of the Mini-AFTERc Intervention. Front Psychol. 2020 Nov 25;11:601813. doi: 10.3389/fpsyg.2020.601813. eCollection 2020.
citation: McHale CT, Cruickshank S, Torrens C, Armes J, Fenlon D, Banks E, Kelsey T, Humphris GM. A controlled pilot trial of a nurse-led intervention (Mini-AFTERc) to manage fear of cancer recurrence in patients affected by breast cancer. Pilot Feasibility Stud. 2020 May 7;6:60. doi: 10.1186/s40814-020-00610-4. eCollection 2020.