NCT02357927

Brief Summary

This is a controlled trial of the Mini-AFTERc intervention to reduce fears of recurrence in breast cancer patients. The sample will be collected in NHS Fife Breast Cancer Services (n=32). The intervention is a short telephone counseling service of 20 minutes delivered by the patient's breast cancer specialist nurse. Dependent measures consist of the ACCRE FoR 4 item measure and the EORTC Intervention overall satisfaction scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

February 3, 2015

Last Update Submit

January 19, 2016

Conditions

Fear

Keywords

fears of recurrencecancerbrief interventiontelephone counselingfollowing primary cancer treatment

Outcome Measures

Primary Outcomes (1)

  • ACCRE 4-Item Fears of Recurrence Questionaire

    1 month

Secondary Outcomes (1)

  • EORTC Intervention satisfaction single global item

    1 month

Study Arms (2)

control

PLACEBO COMPARATOR

simple general telephone call

Behavioral: telephone call

Mini-AFTERc Intervention

EXPERIMENTAL

20-30 minute structured conversation with breast cancer patient using Mini-AFTERc Manual

Behavioral: Mini-AFTERc

Interventions

Mini-AFTERcBEHAVIORAL

20-30 minute structured conversation following guidelines and instruction within the Mini-AFTERc 20 page manual

Mini-AFTERc Intervention
telephone callBEHAVIORAL

this consists of a 20-30 minute conversation about the general well-being of the patient with no specific reference to recurrence fears unless raised by the patient explicitly themselves

control

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • breast cancer patient completed treatment
  • female

You may not qualify if:

  • psychiatric illness
  • cognitive deficit (e.g. dementia)
  • no access to telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breast Cancer Services, Queen Margaret Hospital

Dunfermline, Fife, KY12 0SU, United Kingdom

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Gerry Humphris, PhD

    University of St Andrews

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Health Psychology

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 6, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

GB(1)