Cancer, BreastNCT04861896
A Research Study for Latina Women With Breast Cancer
A study testing "My Guide" (psychoeducation & self-management program) in people with Cancer, Breast and Cancer-related Problem/Condition, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Breast, Cancer-related Problem/Condition, Quality of Life
- What is being tested?
- "My Guide" (psychoeducation & self-management program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 7 Nov 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cancer, Breast, Cancer-related Problem/Condition, Quality of Life, Hormone Dependent Neoplasms, Adherence, Medication
- Being tested
- "My Guide" (psychoeducation & self-management program)
- Medical subject headings
- Breast Neoplasms, Neoplasms, Hormone-Dependent, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"My Guide" (psychoeducation & self-management program)Behavioural
12-week long health promotion Smartphone application to support patient's side effects self-management and adherence to endocrine therapy.
| Study group | Role | What they receive |
|---|---|---|
| "My Guide" (psychoeducation & self management program) | Experimental | Smartphone-based program plus standard clinical care. Receives: Behavioral: "My Guide" (psychoeducation & self-management program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T3 (immediately following 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.
Measured: T3 (immediately following 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.
Measured: T3 (immediately following 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.
Measured: T3 (immediately following 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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
Secondary outcomes (2)
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.
Measured: T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
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.
Measured: T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Apr 2021
- Primary completion25 Oct 2022
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betina Yanez, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861896
- Sponsor's protocol ID
- STU00201961B
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2021
- Last updated
- 8 Nov 2023
- 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 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04861896
- Acronym / sponsor ID
- STU00201961B
- Conditions
- Cancer, Breast, Cancer-related Problem/Condition, Quality of Life, Hormone Dependent Neoplasms, Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 27 Apr 2021 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "My Guide" (psychoeducation & self management program) | Experimental | Behavioral: "My Guide" (psychoeducation & self-management program)Smartphone-based program plus standard clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| "My Guide" (psychoeducation & self-management program)12-week long health promotion Smartphone application to support patient's side effects self-management and adherence to endocrine therapy. | Behavioural | "My Guide" (psychoeducation & self management program) |
Primary outcome
Acceptability of My Guide: Usefulness
Time frame: T3 (immediately following 12 week intervention)
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
Time frame: T3 (immediately following 12 week intervention)
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
Time frame: T3 (immediately following 12 week intervention)
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
Time frame: T3 (immediately following 12 week intervention)
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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).
Time frame: T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
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.
2 secondary outcomes
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G7)
Time frame: T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
Change in Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms
Time frame: T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
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 8 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "My Guide" (psychoeducation & self-management program) in people with Cancer, Breast and Cancer-related Problem/Condition, run by Northwestern University 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 7 inclusion and 7 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 8 Nov 2023. 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?
Acceptability of My Guide: Usefulness (time frame: T3 (immediately following 12 week intervention)). The study lists 10 primary outcomes in all. 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 8 Nov 2023.