The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors

NCT ID: NCT03980093

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-08-31

Brief Summary

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This pilot trial compares two online interventions to improve adherence to anti-hormonal medication among women with the most common form of breast cancer (estrogen receptor-positive).

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Education plus Values

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.

Values

Intervention Type BEHAVIORAL

An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.

Education

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.

Interventions

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Education

Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.

Intervention Type BEHAVIORAL

Values

An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Women in Colorado treated for Stage 0 to III estrogen receptor-positive breast cancer who have completed primary cancer treatment (surgery, chemotherapy, and/or radiation) and within the past 2.5 years, have been prescribed anti-hormonal therapy
2. Take their anti-hormonal therapy medication at least occasionally and have at least 1 more year left on their prescription
3. Report at least 1 factor that makes taking their anti-hormonal therapy medication difficult
4. Have internet access
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Colorado, Boulder

OTHER

Sponsor Role lead

Responsible Party

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Joanna Arch

Associate Professor, Department of Psychology and Neuroscience

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanna J Arch, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Locations

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Rocky Mountain Cancer Centers

Greenwood Village, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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R21CA218723

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-0234

Identifier Type: -

Identifier Source: org_study_id

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