Pittsburgh, Pennsylvania 15232

  • Breast Cancer Female


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.


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:




Secondary ID:

Study Acronym:


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:


Study Phase:




Minimum Age:

50 Years

Maximum Age:


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:


Study Design:

Allocation: Randomized, Endpoint Classification: E

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


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

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