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

This study has been withdrawn prior to enrollment.
(No funding.)
Information provided by (Responsible Party):
Van Londen, Gijsberta, University of Pittsburgh Identifier:
First received: November 15, 2012
Last updated: November 11, 2016
Last verified: November 2016
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.

Condition Intervention
Breast Cancer Female
Behavioral: Behavioral Intervention.
Other: Nutritional Education.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy.

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Satisfaction determined by the Client Satisfaction Survey [ Time Frame: Up to 6 months. ]

Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nutritional Education.
Other: Nutritional Education.
Behavioral Intervention
Behavioral Intervention.
Behavioral: Behavioral Intervention.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01738685

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: G van Londen, MD, MS University of Pittsburgh
  More Information

Responsible Party: Van Londen, Gijsberta, Assistant Professor, University of Pittsburgh Identifier: NCT01738685     History of Changes
Other Study ID Numbers: PRO12050094
Study First Received: November 15, 2012
Last Updated: November 11, 2016

Keywords provided by University of Pittsburgh:
Breast Cancer.
Adjuvant Endocrine therapy.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on May 23, 2017