The REACH Study: A Novel Values-Based Intervention to Inc... | NCT03980093

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

NCT03980093

Sponsor

University of Colorado, Boulder

Status

Completed

Last Update Posted

Nov 3, 2022Actual

Enrollment

88Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Education
Values

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21CA218723	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Aug 31, 2020Actual

Completion Date

Aug 31, 2020Actual

First Submitted Date

Apr 29, 2019

First Submission Date that Met QC Criteria

Jun 6, 2019

First Posted Date

Jun 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2022

Last Update Posted Date

Nov 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joanna Arch, Associate Professor, Department of Psychology and Neuroscience, University of Colorado, BoulderPrincipal Investigator

Lead Sponsor

University of Colorado, BoulderOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Education plus Values	Experimental		Behavioral: Education Behavioral: Values
Education	Active Comparator		Behavioral: Education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education	Behavioral	Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.	Education Education plus Values

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medication adherence assessed by electronic pillbox (Wisepill box)		Change from baseline through 6 month follow-up

Secondary Outcomes

Measure	Description	Time Frame
Self-reported medication adherence	Reported anti-hormonal medication pills missed, past 30 days, with a validated self-reported medication adherence item	Change from baseline to 3 and 6 month follow-up
Positive and negative emotional associations with taking anti-hormonal medication

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joanna J Arch, PhD	University of Colorado, Boulder	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rocky Mountain Cancer Centers		Greenwood Village	Colorado	80111	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004522	Educational Status

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided