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A Research Study for Latina Women With Breast Cancer

Primary Purpose

Cancer, Breast, Cancer-related Problem/Condition, Quality of Life

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"My Guide" (psychoeducation & self-management program)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Breast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female
  • Diagnosis of breast cancer, non-metastatic, stage 0-III (A, B, or C)
  • Receiving or received endocrine/hormone therapy within the last 3 years (36 months)
  • At least 18 years of age
  • Able to speak and read English or Spanish
  • Able to provide informed consent
  • Self-identify Hispanic/Latina ethnicity

Exclusion Criteria:

  • Stage IV or metastatic
  • Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
  • Diagnosis of an unmanaged psychotic disorder, bipolar disorder, dissociative disorder, or other diagnoses for which participation in this trial is either inappropriate or dangerous - this includes patients who have a life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., fibromyalgia)
  • Illicit substance or alcohol dependence
  • Suicidal ideation, plan, intent
  • Alzheimer's, dementia, or history of stroke
  • Scheduled reconstruction surgery within 1 month of any study procedures or involvement.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

"My Guide" (psychoeducation & self management program)

Arm Description

Smartphone-based program plus standard clinical care.

Outcomes

Primary Outcome Measures

Acceptability of My Guide: Usefulness
To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.
Acceptability of My Guide: Satisfaction
To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.
Acceptability of My Guide: Learnability
To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.
Acceptability of My Guide: Usability
To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.
Demand of My Guide: Recruitment Rate
We assess demand of the My Guide application through study recruitment. Based on previous psychosocial and behavioral studies in oncology, an 70% recruitment rate is considered an adequate level of demand.
Demand of My Guide: Retention Rate
Another way we assess demand of the My Guide application is through participant retention. Based on previous psychosocial and behavioral studies in oncology, an 70% retention rate is considered an adequate level of demand.
Participant use of My Guide: Number of Login's
We assess participant use of the My Guide application by examining the number of participant logins to the web-based application.
Participant use of My Guide: Duration of Usage
We assess participant use of the My Guide application by examining the duration participant time spent on the website. Based on previous psychosocial and behavioral studies in oncology, an average of 8 hours of use is considered an adequate level of engagement.
Participant use of My Guide: Content Accessed
We assess participant use of the My Guide application by examining the type of content accessed by participants on the website.
Change in Medication adherence will be assessed primarily with the Adherence to Refills and Medication Scale (ARMS).
The ARMS (Adherence to Refills and Medications Scale) survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior.

Secondary Outcome Measures

Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G7)
The FACT-G7 is a validated questionnaire that assesses top-rated symptoms and concerns for a broad spectrum of advanced cancers and serves as a health-related quality of life (HRQoL) measure.
Change in Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms
The PROMIS Self Efficacy for Managing Symptoms survey is a validated, computer adaptive survey to assess how confident participants are in their ability to manage their symptoms and side effects.

Full Information

First Posted
March 31, 2021
Last Updated
January 25, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04861896
Brief Title
A Research Study for Latina Women With Breast Cancer
Official Title
An e-Health Intervention to Improve Symptom Burden and Health-Related Quality of Life Among Hispanic Women Completing Active Treatment for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
April 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to examine the feasibility and preliminary efficacy of a psychosocial eHealth intervention designed to improve hormone therapy adherence among Hispanic/Latinx women with breast cancer. Our proposed secondary outcomes are health-related quality of life and self-efficacy in managing hormone therapy side effects. The intervention components include breast cancer knowledge, hormone/endocrine therapy knowledge, stress awareness and management, social support, and enhanced communication and intimacy skills. The intervention will be delivered via a Smartphone application over a 12-week period. All participants will receive the intervention application (described below). Aside from using the Smartphone application for the recommended 12 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), 6-week follow-up, and 12-week follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Cancer-related Problem/Condition, Quality of Life, Hormone Dependent Neoplasms, Adherence, Medication

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"My Guide" (psychoeducation & self management program)
Arm Type
Experimental
Arm Description
Smartphone-based program plus standard clinical care.
Intervention Type
Behavioral
Intervention Name(s)
"My Guide" (psychoeducation & self-management program)
Intervention Description
12-week long health promotion Smartphone application to support patient's side effects self-management and adherence to endocrine therapy.
Primary Outcome Measure Information:
Title
Acceptability of My Guide: Usefulness
Description
To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.
Time Frame
T3 (immediately following 12 week intervention)
Title
Acceptability of My Guide: Satisfaction
Description
To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.
Time Frame
T3 (immediately following 12 week intervention)
Title
Acceptability of My Guide: Learnability
Description
To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.
Time Frame
T3 (immediately following 12 week intervention)
Title
Acceptability of My Guide: Usability
Description
To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.
Time Frame
T3 (immediately following 12 week intervention)
Title
Demand of My Guide: Recruitment Rate
Description
We assess demand of the My Guide application through study recruitment. Based on previous psychosocial and behavioral studies in oncology, an 70% recruitment rate is considered an adequate level of demand.
Time Frame
12 weeks
Title
Demand of My Guide: Retention Rate
Description
Another way we assess demand of the My Guide application is through participant retention. Based on previous psychosocial and behavioral studies in oncology, an 70% retention rate is considered an adequate level of demand.
Time Frame
12 weeks
Title
Participant use of My Guide: Number of Login's
Description
We assess participant use of the My Guide application by examining the number of participant logins to the web-based application.
Time Frame
12 weeks
Title
Participant use of My Guide: Duration of Usage
Description
We assess participant use of the My Guide application by examining the duration participant time spent on the website. Based on previous psychosocial and behavioral studies in oncology, an average of 8 hours of use is considered an adequate level of engagement.
Time Frame
12 weeks
Title
Participant use of My Guide: Content Accessed
Description
We assess participant use of the My Guide application by examining the type of content accessed by participants on the website.
Time Frame
12 weeks
Title
Change in Medication adherence will be assessed primarily with the Adherence to Refills and Medication Scale (ARMS).
Description
The ARMS (Adherence to Refills and Medications Scale) survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior.
Time Frame
T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
Secondary Outcome Measure Information:
Title
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G7)
Description
The FACT-G7 is a validated questionnaire that assesses top-rated symptoms and concerns for a broad spectrum of advanced cancers and serves as a health-related quality of life (HRQoL) measure.
Time Frame
T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
Title
Change in Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms
Description
The PROMIS Self Efficacy for Managing Symptoms survey is a validated, computer adaptive survey to assess how confident participants are in their ability to manage their symptoms and side effects.
Time Frame
T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Diagnosis of breast cancer, non-metastatic, stage 0-III (A, B, or C) Receiving or received endocrine/hormone therapy within the last 3 years (36 months) At least 18 years of age Able to speak and read English or Spanish Able to provide informed consent Self-identify Hispanic/Latina ethnicity Exclusion Criteria: Stage IV or metastatic Visual, hearing, voice, or motor impairment that would prevent completion of study procedures Diagnosis of an unmanaged psychotic disorder, bipolar disorder, dissociative disorder, or other diagnoses for which participation in this trial is either inappropriate or dangerous - this includes patients who have a life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., fibromyalgia) Illicit substance or alcohol dependence Suicidal ideation, plan, intent Alzheimer's, dementia, or history of stroke Scheduled reconstruction surgery within 1 month of any study procedures or involvement.
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Research Study for Latina Women With Breast Cancer

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