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

Primary Purpose

Breast Cancer Female

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention.
Nutritional Education.
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Female focused on measuring Breast Cancer., Adjuvant Endocrine therapy.

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control.

Behavioral Intervention

Arm Description

Nutritional Education.

Behavioral Intervention.

Outcomes

Primary Outcome Measures

Satisfaction determined by the Client Satisfaction Survey

Secondary Outcome Measures

Full Information

First Posted
November 15, 2012
Last Updated
November 11, 2016
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01738685
Brief Title
Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy
Acronym
Relief
Official Title
Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No funding.
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
Breast Cancer., Adjuvant Endocrine therapy.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control.
Arm Type
Other
Arm Description
Nutritional Education.
Arm Title
Behavioral Intervention
Arm Type
Other
Arm Description
Behavioral Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention.
Intervention Type
Other
Intervention Name(s)
Nutritional Education.
Primary Outcome Measure Information:
Title
Satisfaction determined by the Client Satisfaction Survey
Time Frame
Up to 6 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G van Londen, MD, MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

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

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