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A Single Session Intervention For Fear Of Recurrence In Breast Cancer Patients (Mini-AFTER)

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ClinicalTrials.gov Identifier: NCT02357927
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Prof G Humphris, University of St Andrews

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.

Condition or disease Intervention/treatment Phase
Fear Behavioral: Mini-AFTERc Behavioral: telephone call Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Single Session Intervention For Fear Of Recurrence In Breast Cancer Patients (The Mini AFTERc): A Controlled Trial
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Placebo Comparator: control
simple general telephone call
Behavioral: telephone call
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

Experimental: Mini-AFTERc Intervention
20-30 minute structured conversation with breast cancer patient using Mini-AFTERc Manual
Behavioral: Mini-AFTERc
20-30 minute structured conversation following guidelines and instruction within the Mini-AFTERc 20 page manual




Primary Outcome Measures :
  1. ACCRE 4-Item Fears of Recurrence Questionaire [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. EORTC Intervention satisfaction single global item [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breast cancer patient completed treatment
  • female

Exclusion Criteria:

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

Information from the National Library of Medicine

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): NCT02357927


Locations
United Kingdom
Breast Cancer Services, Queen Margaret Hospital
Dunfermline, Fife, United Kingdom, KY12 0SU
Sponsors and Collaborators
University of St Andrews
Investigators
Principal Investigator: Gerry Humphris, PhD University of St Andrews

Publications:
Responsible Party: Prof G Humphris, Chair of Health Psychology, University of St Andrews
ClinicalTrials.gov Identifier: NCT02357927     History of Changes
Other Study ID Numbers: StAMedSchoolSEC
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Prof G Humphris, University of St Andrews:
fears of recurrence
cancer
brief intervention
telephone counseling
following primary cancer treatment

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes