Mini-AFTERc Intervention for Fear of Cancer Recurrence

Breast Cancer Clinical Trial

— Mini-AFTERc  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03763825
• Other study ID #: 249571
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: December 2018
• Source: University of St Andrews
• Contact: Gerry M Humphris, PhD
• Phone: +44 (0) 1334463565
• Email: gmh4[@]st-andrews.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 133
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fear of Cancer
• Recurrence

Intervention

Behavioral:
• Mini-AFTERc
Structured 30-45 minute telephone discussion based on health psychology theory and CBT principles.

Locations

Country	Name	City	State
United Kingdom	Queen Margaret Hospital	Dunfermline	NHS Fife
United Kingdom	Western General Hospital	Edinburgh	NHS Lothain
United Kingdom	Raigmore Hospital	Inverness	NHS Highlands
United Kingdom	Perth Royal Infirmary	Perth	NHS Tayside

Sponsors (5)

Lead Sponsor	Collaborator
University of St Andrews	Chief Scientist Office of the Scottish Government, Swansea University, University of Stirling, University of Surrey

Country where clinical trial is conducted

United Kingdom, 

References & Publications (11)

Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, Sinclair L. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013 Oct 25;14:353. doi: 10.1186/1745-6215-14-353. — View Citation

Cruickshank S, Steel E, Fenlon D, Armes J, Scanlon K, Banks E, Humphris G. A feasibility study of the Mini-AFTER telephone intervention for the management of fear of recurrence in breast cancer survivors: a mixed-methods study protocol. Pilot Feasibility Stud. 2017 Jul 20;4:22. doi: 10.1186/s40814-017-0161-8. eCollection 2018. Erratum in: Pilot Feasibility Stud. 2017 Oct 24;3:48. — View 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. — View Citation

Hartung TJ, Friedrich M, Johansen C, Wittchen HU, Faller H, Koch U, Brähler E, Härter M, Keller M, Schulz H, Wegscheider K, Weis J, Mehnert A. The Hospital Anxiety and Depression Scale (HADS) and the 9-item Patient Health Questionnaire (PHQ-9) as screening instruments for depression in patients with cancer. Cancer. 2017 Nov 1;123(21):4236-4243. doi: 10.1002/cncr.30846. Epub 2017 Jun 27. — View Citation

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. — View Citation

Humphris G, Ozakinci G. The AFTER intervention: a structured psychological approach to reduce fears of recurrence in patients with head and neck cancer. Br J Health Psychol. 2008 May;13(Pt 2):223-30. doi: 10.1348/135910708X283751. Review. — View Citation

Humphris GM, Watson E, Sharpe M, Ozakinci G. Unidimensional scales for fears of cancer recurrence and their psychometric properties: the FCR4 and FCR7. Health Qual Life Outcomes. 2018 Feb 9;16(1):30. doi: 10.1186/s12955-018-0850-x. — View Citation

Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004 Dec;21(6):699-705. Epub 2004 Nov 4. — View Citation

Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63. — View Citation

Vodermaier A, Millman RD. Accuracy of the Hospital Anxiety and Depression Scale as a screening tool in cancer patients: a systematic review and meta-analysis. Support Care Cancer. 2011 Dec;19(12):1899-908. doi: 10.1007/s00520-011-1251-4. Epub 2011 Sep 4. Review. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction with nurse communication during the Mini-AFTERc 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	Fear of cancer recurrence level - FCR4	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
Secondary	Depression and anxiety symptoms - Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Health-related quality of life - EuroQol 5 Dimension Measure of Quality of Life (EQ-5D)	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
Secondary	Nurses' perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews	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
Secondary	Recruitment rate	Assess number of patients recruited at each site, including those who decline to participate.	Duration of the pilot trial (Approx 2 years)
Secondary	Retention rate	Assess number of patients who complete the trial.	Duration of the pilot trial (Approx 2 years)
Secondary	Attrition rate	Assess number of patients who do not complete the trial, withdraw or drop-out.	Duration of the pilot trial (Approx 2 years)
Secondary	Patient perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews	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

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