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

Sponsor

University of Pittsburgh (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01738685

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female	Behavioral: Behavioral Intervention. Other: Nutritional Education.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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.

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Control. Nutritional Education.	Other: Nutritional Education.
Other: Behavioral Intervention Behavioral Intervention.	Behavioral: Behavioral Intervention.

Arm

Intervention/Treatment

Other: Control.

Nutritional Education.

Other: Nutritional Education.

Other: Behavioral Intervention

Behavioral Intervention.

Behavioral: Behavioral Intervention.

Outcome Measures

Primary Outcome Measures

Satisfaction determined by the Client Satisfaction Survey [Up to 6 months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Van Londen, Gijsberta, Assistant Professor, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT01738685

Other Study ID Numbers:

PRO12050094

First Posted:

Nov 30, 2012

Last Update Posted:

Nov 15, 2016

Last Verified:

Nov 1, 2016

Keywords provided by Van Londen, Gijsberta, Assistant Professor, University of Pittsburgh

Breast Cancer.

Adjuvant Endocrine therapy.

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Nov 15, 2016