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Completed

NCT Number: NCT03980093

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

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Cancer Centers

Greenwood Village, Colorado, 80111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

include:

  • 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
  • Take their anti-hormonal therapy medication at least occasionally and have at least 1 more year left on their prescription
  • Report at least 1 factor that makes taking their anti-hormonal therapy medication difficult
  • Have internet access

Treatment and study plan

Education

Behavioral

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

Values

Behavioral

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

Primary outcomes

  1. Medication adherence assessed by electronic pillbox (Wisepill box)

    Time frame: Change from baseline through 6 month follow-up

Secondary outcomes

  1. Self-reported medication adherence

    Time frame: Change from baseline to 3 and 6 month follow-up

    Reported anti-hormonal medication pills missed, past 30 days, with a validated self-reported medication adherence item

  2. Positive and negative emotional associations with taking anti-hormonal medication

    Time frame: Change from baseline through 6 month follow-up

    Emotional Attitudes Scale, adapted to focus on anti-hormonal medication

  3. Intentions to adhere to anti-hormonal medication in the next year and next several years

    Time frame: Change from baseline through 6 month follow up

    Anti-Hormonal Medication Intentions Scale (average score on a 1 to 7 scale; higher=better outcome, e.g., stronger intentions to adhere), adapted from the Health Behavior Intentions Scale

  4. Medication nonpersistence assessed by electronic pillbox (Wisepill box)

    Time frame: Baseline through 6 month follow-up

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 10, 2019
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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