Pittsburgh, Pennsylvania 15232

  • Breast Cancer Female

Purpose:

Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated with physical and emotional concerns. I propose to evaluate the feasibility and preliminary effectiveness of a behavioral intervention to facilitate problem identification, provide education, coaching for breast cancer survivors with symptoms while on AET. Therefore, the intervention intends to empower women to engage in better self-care and seek out resources they need, which, in turn, will lead to better symptom management.


Criteria:

Inclusion Criteria: - Age ≥ 50. - Nonmetastatic bread cancer survivors reporting being bothered by 1 or more symptoms related to their treatment with AET (for > 0 months and < 6 months). - Possess a household or cell telephone. - Ability to provide informed consent. Exclusion Criteria: - Clinically significant cognitive impairment. - Communication barrier limiting ability to participate in telephone assessments.


Study is Available At:


Original ID:

PRO12050094


NCT ID:

NCT01738685


Secondary ID:


Study Acronym:

Relief


Brief Title:

Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy


Official Title:

Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy.


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Female


Minimum Age:

50 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

No funding.


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:G van Londen, MD, MS
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:December 2012
Completion Date:December 2015
Completion Type:Anticipated
Primary Completion Date:June 2014
Primary Completion Type:Anticipated
Verification Date:November 2016
Last Changed Date:November 11, 2016
First Received Date:November 15, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Satisfaction determined by the Client Satisfaction Survey
Time Frame:Up to 6 months.
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Nutritional Education.
Arm Name:Control.
Intervention Type:Behavioral
Name:Behavioral Intervention.
Arm Name:Behavioral Intervention

Study Arms

Study Arm Type:Other
Arm Name:Behavioral Intervention
Description:Behavioral Intervention.
Study Arm Type:Other
Arm Name:Control.
Description:Nutritional Education.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.