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Trial record 26 of 33704 for:    value

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

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ClinicalTrials.gov Identifier: NCT03980093
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joanna Arch, University of Colorado, Boulder

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Education Behavioral: Values Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Education plus Values Behavioral: Education
Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.

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.

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




Primary Outcome Measures :
  1. Medication adherence assessed by electronic pillbox (Wisepill box) [ Time Frame: Change from baseline through 6 month follow-up ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria include:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980093


Contacts
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Contact: Sarah Genung 303-492-7901 reachstudy@colorado.edu

Locations
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United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Greenwood Village, Colorado, United States, 80111
Contact: Jill Mitchell, PhD       Jill.Mitchell@usoncology.com   
Sponsors and Collaborators
University of Colorado, Boulder
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joanna J Arch, PhD University of Colorado, Boulder

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Responsible Party: Joanna Arch, Associate Professor, Department of Psychology and Neuroscience, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT03980093     History of Changes
Other Study ID Numbers: 18-0234
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases