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

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University of Pittsburgh

Status

Withdrawn

Conditions

Breast Cancer Female

Treatments

Behavioral: Behavioral Intervention.
Other: Nutritional Education.

Study type

Interventional

Funder types

Other

Identifiers

NCT01738685
PRO12050094

Details and patient eligibility

About

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.

Sex

Female

Ages

50+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Control.
Other group
Description:
Nutritional Education.
Treatment:
Other: Nutritional Education.
Behavioral Intervention
Other group
Description:
Behavioral Intervention.
Treatment:
Behavioral: Behavioral Intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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