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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This study has been withdrawn prior to enrollment.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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01738685
First Posted: November 30, 2012
Last Update Posted: November 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Van Londen, Gijsberta, University of Pittsburgh
  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Van Londen, Gijsberta, 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
Control.
Nutritional Education.
Other: Nutritional Education.
Behavioral Intervention
Behavioral Intervention.
Behavioral: Behavioral Intervention.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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): NCT01738685


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

Responsible Party: Van Londen, Gijsberta, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01738685     History of Changes
Other Study ID Numbers: PRO12050094
First Submitted: November 15, 2012
First Posted: November 30, 2012
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by Van Londen, Gijsberta, University of Pittsburgh:
Breast Cancer.
Adjuvant Endocrine therapy.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases