Mini-AFTERc Intervention for Fear of Cancer Recurrence (Mini-AFTERc)

May 30, 2019 updated by: Prof G Humphris, University of St Andrews

A Pilot Trial of the Mini-AFTERc Intervention to Manage Fear of Cancer Recurrence in Breast Cancer Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • NHS Fife
      • Dunfermline, NHS Fife, United Kingdom, KY12 0SU
        • Queen Margaret Hospital
    • NHS Highlands
      • Inverness, NHS Highlands, United Kingdom, IV2 3UJ
        • Raigmore Hospital
    • NHS Lothain
      • Edinburgh, NHS Lothain, United Kingdom, EH4 2XU
        • Western General Hospital
    • NHS Tayside
      • Perth, NHS Tayside, United Kingdom, PH1 1NX
        • Perth Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Patient will receive the Mini-AFTERc intervention after completion of primary breast cancer treatment.
Behavioral: Mini-AFTERc
Structured 30-45 minute telephone discussion based on health psychology theory and CBT principles.
No Intervention: Control group
Patients will receive usual care after completion of primary breast cancer treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with nurse communication during the Mini-AFTERc intervention
Time Frame: 1 week post intervention
Assessed using the Consultation and Relational Empathy (CARE) measure, validated for use in secondary care (Mercer et al. 2004). The CARE measure asks patient to rate their nurses' communication skills on 10 communication and empathy domains (e.g. 'How was your nurse at fully understanding your concerns?'). Patients rate nurses from 1 ('Poor') to 5 ('Excellent') for each of the 10 domains.
1 week post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of cancer recurrence level - FCR4
Time Frame: 3 months
The FCR4 is a 4-item measure designed to assess patient anxiety, worry and strong feelings associated with the return of cancer (e.g. 'I am afraid that my cancer may recur'). The research group has validated the FCR4 as an accurate measure of cancer recurrence fears in breast cancer patients that is fit for routine use in clinical services (Humphris, Watson, Sharpe, & Ozakinci, 2018). Each question in the FCR4 is rated by the patient on a scale of 1 ('Not at all') to 5 ('All the time'). A cumulative score of ≥10 (60 Percentile) across all 4 items is defined as 'moderate' fear of cancer recurrence and a cumulative score of ≥15 is defined as 'high' fear of cancer recurrence.
3 months
Depression and anxiety symptoms - Hospital Anxiety and Depression Scale (HADS)
Time Frame: 3 months
The HADS is a 14-item assessment tool used to screen for anxiety and depression the general medical population (Zigmond & Snaith, 1983). The HADS is well established tool and has been employed in a multitude of medical settings, including oncology, to assess patients' mental health (Hartung et al., 2017; Vodermaier & Millman, 2011). The HADS assesses two domains, depressionand anxiety. Patients report symptoms of depression and anxiety in the last week on a 4-point Likert scale, from 0 (e.g. "Not at all") to 3 (e.g. "Most of the time").
3 months
Health-related quality of life - EuroQol 5 Dimension Measure of Quality of Life (EQ-5D)
Time Frame: 3 months
The EQ-5D is a standardised instrument of health-related quality of life, developed by the EuroQol Group (Herdman et al., 2011). The EQ-5D assesses 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D contains 6-items, 5 of these items assess each of the 5 dimensions and are rated on a 5-level (5L) scale. The final item is a measure of health state, which is rated on a scale of 0 ('worst imaginable health state') to 100 (Best imaginable health state').
3 months
Nurses' perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews
Time Frame: Within 1 month of delivering final intervention
Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of breast cancer nurses. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).
Within 1 month of delivering final intervention
Recruitment rate
Time Frame: Duration of the pilot trial (Approx 2 years)
Assess number of patients recruited at each site, including those who decline to participate.
Duration of the pilot trial (Approx 2 years)
Retention rate
Time Frame: Duration of the pilot trial (Approx 2 years)
Assess number of patients who complete the trial.
Duration of the pilot trial (Approx 2 years)
Attrition rate
Time Frame: Duration of the pilot trial (Approx 2 years)
Assess number of patients who do not complete the trial, withdraw or drop-out.
Duration of the pilot trial (Approx 2 years)
Patient perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews
Time Frame: Within 1 month of final follow-up questionnaire
Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of patients. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).
Within 1 month of final follow-up questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of St Andrews

Collaborators

Swansea University
University of Surrey
Chief Scientist Office of the Scottish Government
University of Stirling

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 13, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

May 31, 2019

Last Update Submitted That Met QC Criteria

May 30, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 249571

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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