Mini-AFTERc Intervention for Fear of Cancer Recurrence (Mini-AFTERc)
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| ClinicalTrials.gov Identifier: NCT03763825 |
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Recruitment Status : Unknown
Verified December 2018 by Prof G Humphris, University of St Andrews.
Recruitment status was: Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : May 31, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Fear of Cancer | Behavioral: Mini-AFTERc | Not Applicable |
The objectives of this pilot trial are as follows:
- 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.
- 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.
- 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 (Clinical Trial) |
| Estimated Enrollment : | 133 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Pilot Trial of the Mini-AFTERc Intervention to Manage Fear of Cancer Recurrence in Breast Cancer Patients |
| Estimated Study Start Date : | June 13, 2019 |
| Estimated Primary Completion Date : | September 1, 2020 |
| Estimated Study Completion Date : | September 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention group
Patient will receive the Mini-AFTERc intervention after completion of primary breast cancer treatment.
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Behavioral: Mini-AFTERc
Structured 30-45 minute telephone discussion based on health psychology theory and CBT principles. |
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No Intervention: Control group
Patients will receive usual care after completion of primary breast cancer treatment.
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- 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.
- 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.
- 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").
- 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').
- 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).
- 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.
- Retention rate [ Time Frame: Duration of the pilot trial (Approx 2 years) ]Assess number of patients who complete the trial.
- 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.
- 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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763825
| Contact: Gerry M Humphris, PhD | +44 (0) 1334463565 | gmh4@st-andrews.ac.uk | |
| Contact: Calum T McHale, PhD | +44 (0)1334461895 | ctm2@st-andrews.ac.uk |
| United Kingdom | |
| Queen Margaret Hospital | |
| Dunfermline, NHS Fife, United Kingdom, KY12 0SU | |
| Raigmore Hospital | |
| Inverness, NHS Highlands, United Kingdom, IV2 3UJ | |
| Western General Hospital | |
| Edinburgh, NHS Lothain, United Kingdom, EH4 2XU | |
| Perth Royal Infirmary | |
| Perth, NHS Tayside, United Kingdom, PH1 1NX | |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof G Humphris, Professor of Health Psychology, University of St Andrews |
| ClinicalTrials.gov Identifier: | NCT03763825 |
| Other Study ID Numbers: |
249571 |
| First Posted: | December 4, 2018 Key Record Dates |
| Last Update Posted: | May 31, 2019 |
| Last Verified: | December 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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fear of recurrence cancer brief intervention telephone counselling following primary cancer treatment |
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Breast Neoplasms Recurrence Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Disease Attributes Pathologic Processes |