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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Van Londen, Gijsberta, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01738685
First received: November 15, 2012
Last updated: November 27, 2012
Last verified: November 2012
  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.
Behavioral: Behavioral Intervention.
Other: Nutritional Education.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
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.
Other Name: Behavioral Intervention.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738685

Contacts
Contact: G van Londen, MD, MS 4126922382 vanLondenJ@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: G van Londen, MD, MS         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: G van Londen, MD, MS University of Pittsburgh
  More Information

No publications provided

Responsible Party: Van Londen, Gijsberta, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01738685     History of Changes
Other Study ID Numbers: PRO12050094
Study First Received: November 15, 2012
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 31, 2014