Breast CancerNCT03980093
The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
A study testing Education and Values in people with Breast Cancer, run by University of Colorado, Boulder at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Education and Values
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Cancer Centers
Greenwood Village, Colorado, 80111
About this study
Official title: 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).
- Conditions
- Breast Cancer
- Being tested
- Education, Values
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.
ValuesBehavioural
An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.
| Study group | Role | What they receive |
|---|---|---|
| Education plus Values | Experimental | Not described Receives: Behavioral: Education; Behavioral: Values |
| Education | Active comparator | Not described Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence assessed by electronic pillbox (Wisepill box)
Measured: Change from baseline through 6 month follow-up
Secondary outcomes (4)
Self-reported medication adherence
Reported anti-hormonal medication pills missed, past 30 days, with a validated self-reported medication adherence item
Measured: Change from baseline to 3 and 6 month follow-up
Positive and negative emotional associations with taking anti-hormonal medication
Emotional Attitudes Scale, adapted to focus on anti-hormonal medication
Measured: Change from baseline through 6 month follow-up
Intentions to adhere to anti-hormonal medication in the next year and next several years
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
Measured: Change from baseline through 6 month follow up
Medication nonpersistence assessed by electronic pillbox (Wisepill box)
Measured: Baseline through 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Apr 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Joanna Arch, University of Colorado, Boulder
- Investigators
- Joanna J Arch, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980093
- Sponsor's protocol ID
- 18-0234
- Other IDs
- R21CA218723
- Status last verified
- Nov 2022
- First submitted
- 29 Apr 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03980093
- Acronym / sponsor ID
- 18-0234
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education plus Values | Experimental | Behavioral: Education, Behavioral: Values |
| Education | Active comparator | Behavioral: Education |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationOnline medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them. | Behavioural | Education, Education plus Values |
| ValuesAn Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values. | Behavioural | Education plus Values |
Primary outcome
Medication adherence assessed by electronic pillbox (Wisepill box)
Time frame: Change from baseline through 6 month follow-up
4 secondary outcomes
Self-reported medication adherence
Time frame: Change from baseline to 3 and 6 month follow-up
Positive and negative emotional associations with taking anti-hormonal medication
Time frame: Change from baseline through 6 month follow-up
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
Medication nonpersistence assessed by electronic pillbox (Wisepill box)
Time frame: Baseline through 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna J Arch, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Values in people with Breast Cancer, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence assessed by electronic pillbox (Wisepill box) (time frame: Change from baseline through 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.