NCT01738685

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

November 15, 2012

Last Update Submit

November 11, 2016

Conditions

Breast Cancer Female

Keywords

Breast Cancer.Adjuvant Endocrine therapy.

Outcome Measures

Primary Outcomes (1)

  • Satisfaction determined by the Client Satisfaction Survey

    Up to 6 months.

Study Arms (2)

Control.

OTHER

Nutritional Education.

Other: Nutritional Education.

Behavioral Intervention

OTHER

Behavioral Intervention.

Behavioral: Behavioral Intervention.

Interventions

Behavioral Intervention.BEHAVIORAL
Behavioral Intervention
Nutritional Education.OTHER
Control.

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Clinically significant cognitive impairment.
  • Communication barrier limiting ability to participate in telephone assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • G van Londen, MD, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 30, 2012

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

December 1, 2015

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations

US(1)