NCT03763825

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
133

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

June 13, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

May 31, 2019

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

October 23, 2018

Last Update Submit

May 30, 2019

Conditions

Breast CancerFear of Cancer

Keywords

fear of recurrencecancerbrief interventiontelephone counsellingfollowing primary cancer treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Fear of cancer recurrence level - FCR4

    3 months

  • Depression and anxiety symptoms - Hospital Anxiety and Depression Scale (HADS)

    3 months

  • Health-related quality of life - EuroQol 5 Dimension Measure of Quality of Life (EQ-5D)

    3 months

  • Nurses' perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews

    Within 1 month of delivering final intervention

  • Recruitment rate

    Duration of the pilot trial (Approx 2 years)

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Mini-AFTERc

Control group

NO INTERVENTION

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

Interventions

Mini-AFTERcBEHAVIORAL

Structured 30-45 minute telephone discussion based on health psychology theory and CBT principles.

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completed primary cancer treatment.
  • Cancer-free.
  • Female.
  • Responsible clinician agrees to their participation.
  • Score 'moderate' (≥10 and \<15) on the Fear of Cancer Recurrence 4-item scale (FCR4) during screening.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Queen Margaret Hospital

Dunfermline, NHS Fife, KY12 0SU, United Kingdom

Location

Raigmore Hospital

Inverness, NHS Highlands, IV2 3UJ, United Kingdom

Location

Western General Hospital

Edinburgh, NHS Lothain, EH4 2XU, United Kingdom

Location

Perth Royal Infirmary

Perth, NHS Tayside, PH1 1NX, United Kingdom

Location

Related Publications (13)

  • 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.

    PMID: 29624779BACKGROUND

  • 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.

    PMID: 29471823BACKGROUND

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PMID: 6880820BACKGROUND

  • 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.

    PMID: 21479777BACKGROUND

  • 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. doi: 10.1093/fampra/cmh621. Epub 2004 Nov 4.

    PMID: 15528286BACKGROUND

  • 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.

    PMID: 28748105BACKGROUND

  • 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.

    PMID: 18492319BACKGROUND

  • 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.

    PMID: 24160371BACKGROUND

  • 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.

    PMID: 20961442BACKGROUND

  • Hartung TJ, Friedrich M, Johansen C, Wittchen HU, Faller H, Koch U, Brahler E, Harter 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.

    PMID: 28654189BACKGROUND

  • 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.

    PMID: 21898134BACKGROUND

  • 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.

    PMID: 33324299DERIVED

  • 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.

    PMID: 32399254DERIVED

MeSH Terms

Conditions

Breast NeoplasmsPathophobiaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Gerry M Humphris, PhD

CONTACT

+44 (0) 1334463565gmh4@st-andrews.ac.uk

Calum T McHale, PhD

CONTACT

+44 (0)1334461895ctm2@st-andrews.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health Psychology

Study Record Dates

First Submitted

October 23, 2018

First Posted

December 4, 2018

Study Start

June 13, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

May 31, 2019

Record last verified: 2018-12

Locations

GB(4)