Cancer PainNCT05917171
Pilot Trial of an Online Pain Coping Skills Training Program in Spanish
A study testing painTRAINER in people with Cancer Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The goal of this pilot study is to assess the feasibility and acceptability of an 8-week online pain coping skills training program designed specifically for Spanish-speaking Hispanic and Latine populations experiencing cancer-related pain. The main questions aim to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- painTRAINER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2023to 1 Dec 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of invasive cancer treated with either single modality therapy or any combination of therapies.
- Is ≤ 5 years since completion of definitive cancer therapy.
- May be off treatment, receiving adjuvant or maintenance therapy or have cancer that is stable/controlled.
- Pain score ≥ 4 (PROMIS Pain Intensity (1a) scale) on "Most Days" or more (Graded Chronic Pain Scale).
- Pain of new onset or significantly exacerbated since cancer diagnosis or initiation of cancer treatment.
- If taking analgesics, the analgesic regimen must be stable; unexpected dose adjustments are allowed.
Show all 9Show fewer
- Expected capable of completing study activities (clinician judgment) with ECOG performance status ≤ 2.
- Age ≥18 years at the time of study entry.
- Identify as Hispanic or Latine AND able to read and speak Spanish.
Who cannot join
- Has a disability that precludes completion of study activities.
- Reports only preexisting pain conditions unrelated to cancer or cancer treatment.
- Has a known or suspected diagnosable substance use disorder or opioid overuse disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Developing a Culturally Appropriate Non-Opioid Pain Coping Skills Training Intervention for Spanish-Speaking Patients With Cancer Pain Using a Community Engaged Approach
The goal of this pilot study is to assess the feasibility and acceptability of an 8-week online pain coping skills training program designed specifically for Spanish-speaking Hispanic and Latine populations experiencing cancer-related pain. The main questions aim to answer are: 1. what is the feasibility of this program for engaging and recruiting Spanish speaking members of the Hispanic and Latine community?; 2. How well is the program accepted by Spanish speaking members of the Hispanic and Latine community?. Participants will answer questions about their cancer related pain before and after they participate in an 8-week pain coping skills training program offered online.
Read the detailed description
Cancer-related pain is a significant adverse effect of cancer and cancer treatment, which poses significant management challenges for patients. Compared to non-Hispanic whites, Spanish-speaking Hispanic patients routinely experience disparities in cancer-related care that negatively impact quality of life, including more significant barriers in accessing quality care, less adequate pain management, and later-stage cancer diagnosis and treatment initiation. Limited English proficiency is a particularly difficult barrier among primarily Spanish-speaking Hispanic patients, as communication challenges with providers contributes to poorer pain outcomes and suboptimal pain management. To support Spanish-speaking populations and strive towards more equitable care (e.g., accessible, convenient, and cost-effective), this study is leveraging its prior work in Pain Coping Skills Training (PCST) through the cultural and linguistic translation of an online PCST program, painTRAINER. This evidence-based program, delivered online over eight weeks, facilitates development of pain coping skills to improve pain outcomes while also reducing reliance on opioids for pain management.
This pilot study follows a community-engaged and community-driven approach for translating and adapting the painTRAINER program into a linguistically and culturally appropriate version optimized for diverse Spanish-speaking adults experiencing cancer-related pain.
The study team integrated Spanish-speaking staff, community members, community-based organizations, and key stakeholders as members of the research team to guide the program adaptation process. Community partners include key members of the Hispanic community and leaders from various community organizations, who have participated on the study's Community Advisory Board (CAB) and on a Community-based Programmatic Review Panel (PRP). Both groups include members from diverse Spanish speaking countries with diversity in age, gender, and educational background and have been integral in guiding the translation and adaptation process. This group continue to play a key role in future phases of the project such as participant recruitment, implementation, data analysis and interpretation, and dissemination of findings.
Prior studies show that PCST is effective, engaging, and acceptable to English-speaking patients, and also is an accessible, convenient, and cost-effective pain management tool when delivered online. PainTRAINER's effectiveness for pain management is well established via NIH-funded trials. Results from previous studies show critical implications in the development and delivery of pain management for underserved cancer populations to foster equity in care and reduce reliance on opioid medications. The community-engaged and culturally-informed process to fully adapt and translate the painTRAINER program will yield an effective Spanish-language PCST program that fills a gap in cancer-pain management by further expanding access to quality care among Hispanic patients. Community partnerships are key to the successful adaptation and future intervention efforts of the Spanish-language version of painTRAINER. The availability of effective and culturally-appropriate pain management options for Spanish-speaking patients will provide communities with tools and resources necessary not only for managing pain and enhancing quality of life, but for empowering Spanish-speaking patients to be strong advocates for their health.
- Conditions
- Cancer Pain
- Being tested
- painTRAINER
- Keywords
- pain coping skills, cancer-related pain, pain management
- Medical subject headings
- Cancer Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
painTRAINERBehavioural
painTRAINER is an 8 week online behavioral pain coping skills training program derived from cognitive behavioral therapy approaches, which includes 45 minute behavioral coping sessions to be completed over 8 weeks. Weekly sessions are guided by an automated coach that teaches skills for coping with pain.
| Study group | Role | What they receive |
|---|---|---|
| painTRAINER intervention | Experimental | 40 Spanish speaking Hispanic and Latine participants will participate in an 8 week online pain coping skills training program designed to address cancer-related pain. Receives: Behavioral: painTRAINER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence - percent of participants who complete the study modules as a measure of retention
To evaluate the feasibility of implementing painTRAINER among Spanish speaking participants, the study will assess participants' adherence to painTRAINER and the capacity to retain them in a clinical trial. The pilot trial can be implemented completely remotely among community dwelling Spanish-speaking Hispanic/Latine individuals with cancer-related pain. The study will calculate the percent of participants who complete the study modules as a measure of retention. Adherence to the program will be defined as the proportion of weekly modules completed (adequate adherence is defined as completion of ≥ 75% of modules, or 6 of the total 8 modules).
Measured: baseline
Adherence - percent of participants who complete the study modules as a measure of retention
To evaluate the feasibility of implementing painTRAINER among Spanish speaking participants, the study will assess participants' adherence to painTRAINER and the capacity to retain them in a clinical trial. The pilot trial can be implemented completely remotely among community dwelling Spanish-speaking Hispanic/Latine individuals with cancer-related pain. The study will calculate the percent of participants who complete the study modules as a measure of retention. Adherence to the program will be defined as the proportion of weekly modules completed (adequate adherence is defined as completion of ≥ 75% of modules, or 6 of the total 8 modules).
Measured: Week 10
Adherence - percent of participants who complete the study modules as a measure of retention
To evaluate the feasibility of implementing painTRAINER among Spanish speaking participants, the study will assess participants' adherence to painTRAINER and the capacity to retain them in a clinical trial. The pilot trial can be implemented completely remotely among community dwelling Spanish-speaking Hispanic/Latine individuals with cancer-related pain. The study will calculate the percent of participants who complete the study modules as a measure of retention. Adherence to the program will be defined as the proportion of weekly modules completed (adequate adherence is defined as completion of ≥ 75% of modules, or 6 of the total 8 modules).
Measured: Week 18
Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate
To assess the acceptability of painTRAINER among Spanish speaking participants, the study will determine the ability to recruit participants into the pilot trial via networks of community partners in the Atrium Health: Wake Forest Baptist catchment area. To characterize our ability to recruit participants, the study will estimate the proportion of eligible participants screened and the proportion of eligible participants who consent to participate. The study also will closely monitor the rate of referrals to the program by providers. Acceptability of the program also will be assessed more subjectively via interviews with participants following completion of or termination from the pilot trial.
Measured: Baseline
Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate
To assess the acceptability of painTRAINER among Spanish speaking participants, the study will determine the ability to recruit participants into the pilot trial via networks of community partners in the Atrium Health: Wake Forest Baptist catchment area. To characterize our ability to recruit participants, the study will estimate the proportion of eligible participants screened and the proportion of eligible participants who consent to participate. The study also will closely monitor the rate of referrals to the program by providers. Acceptability of the program also will be assessed more subjectively via interviews with participants following completion of or termination from the pilot trial.
Measured: Week 10
Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate
To assess the acceptability of painTRAINER among Spanish speaking participants, the study will determine the ability to recruit participants into the pilot trial via networks of community partners in the Atrium Health: Wake Forest Baptist catchment area. To characterize our ability to recruit participants, the study will estimate the proportion of eligible participants screened and the proportion of eligible participants who consent to participate. The study also will closely monitor the rate of referrals to the program by providers. Acceptability of the program also will be assessed more subjectively via interviews with participants following completion of or termination from the pilot trial.
Measured: Week 18
Secondary outcomes (7)
Change in Pain interference scores
To determine the preliminary efficacy of painTRAINER as an intervention for pain management, the study will assess whether painTRAINER yields significant improvements in the pain interference (measured by the Brief Pain Inventory) from baseline to the post-intervention assessments for Spanish-speaking cancer survivors with persistent cancer-related pain. Scores are rated via Likert scale for low to high interference.
Measured: baseline, 10 weeks, 18 weeks
Change in Pain severity scores
To determine the preliminary efficacy of painTRAINER as an intervention for pain management, we will assess whether painTRAINER yields significant improvements in pain severity (as measured by the Brief Pain Inventory (BPI)) from baseline to the post-intervention assessments for Spanish-speaking cancer survivors with persistent cancer-related pain. Scores are rated via Likert scale for low to high pain severity.
Measured: baseline, 10 weeks, 18 weeks
Change in Fatigue scores
Fatigue will be assessed via the PROMIS Fatigue questionnaire. Scores are rated via Likert scale for low to high fatigue.
Measured: baseline, 10 weeks, 18 weeks
Change in Sleep disturbance scores
Sleep disturbance will be assessed via the PROMIS Sleep Disturbance questionnaire. Scores are rated via Likert scale for low to high sleep disturbance.
Measured: baseline, 10 weeks, 18 weeks
Change in Pain resilience scores
Pain resilience will be assessed via the PROMIS Pain Resilience Scale. Scores are rated via Likert scale for low to high pain resilience.
Measured: baseline, 10 weeks, 18 weeks
Change in Cognitive Function scores
Cognitive function will be assessed via the PROMIS Cognitive Function scale. Scores are rated via Likert scale for low to high cognitive function.
Measured: baseline, 10 weeks, 18 weeks
Change in Physical Function scores
Physical function will be assessed via the PROMIS Physical Function scale. Scores are rated via Likert scale for low to high physical function.
Measured: baseline, 10 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start27 Jul 2023
- Primary completion7 May 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pilot study to assess feasibility and acceptability.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald B Penzien, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917171
- Sponsor's protocol ID
- IRB00096781
- Status last verified
- Apr 2024
- First submitted
- 14 Jun 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Culturally Appropriate Non-Opioid Pain Coping Skills Training Intervention for Spanish-Speaking Patients With Cancer Pain Using a Community Engaged Approach
- ClinicalTrials.gov ID
- NCT05917171
- Acronym / sponsor ID
- IRB00096781
- Conditions
- Cancer Pain
- Keywords
- pain coping skills, cancer-related pain, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 23 Jun 2023 (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 goal of this pilot study is to assess the feasibility and acceptability of an 8-week online pain coping skills training program designed specifically for Spanish-speaking Hispanic and Latine populations experiencing cancer-related pain. The main questions aim to answer are: 1. what is the feasibility of this program for engaging and recruiting Spanish speaking members of the Hispanic and Latine community?; 2. How well is the program accepted by Spanish speaking members of the Hispanic and Latine community?. Participants will answer questions about their cancer related pain before and after they participate in an 8-week pain coping skills training program offered online.
Detailed description
Cancer-related pain is a significant adverse effect of cancer and cancer treatment, which poses significant management challenges for patients. Compared to non-Hispanic whites, Spanish-speaking Hispanic patients routinely experience disparities in cancer-related care that negatively impact quality of life, including more significant barriers in accessing quality care, less adequate pain management, and later-stage cancer diagnosis and treatment initiation. Limited English proficiency is a particularly difficult barrier among primarily Spanish-speaking Hispanic patients, as communication challenges with providers contributes to poorer pain outcomes and suboptimal pain management. To support Spanish-speaking populations and strive towards more equitable care (e.g., accessible, convenient, and cost-effective), this study is leveraging its prior work in Pain Coping Skills Training (PCST) through the cultural and linguistic translation of an online PCST program, painTRAINER. This evidence-based program, delivered online over eight weeks, facilitates development of pain coping skills to improve pain outcomes while also reducing reliance on opioids for pain management.
This pilot study follows a community-engaged and community-driven approach for translating and adapting the painTRAINER program into a linguistically and culturally appropriate version optimized for diverse Spanish-speaking adults experiencing cancer-related pain.
The study team integrated Spanish-speaking staff, community members, community-based organizations, and key stakeholders as members of the research team to guide the program adaptation process. Community partners include key members of the Hispanic community and leaders from various community organizations, who have participated on the study's Community Advisory Board (CAB) and on a Community-based Programmatic Review Panel (PRP). Both groups include members from diverse Spanish speaking countries with diversity in age, gender, and educational background and have been integral in guiding the translation and adaptation process. This group continue to play a key role in future phases of the project such as participant recruitment, implementation, data analysis and interpretation, and dissemination of findings.
Prior studies show that PCST is effective, engaging, and acceptable to English-speaking patients, and also is an accessible, convenient, and cost-effective pain management tool when delivered online. PainTRAINER's effectiveness for pain management is well established via NIH-funded trials. Results from previous studies show critical implications in the development and delivery of pain management for underserved cancer populations to foster equity in care and reduce reliance on opioid medications. The community-engaged and culturally-informed process to fully adapt and translate the painTRAINER program will yield an effective Spanish-language PCST program that fills a gap in cancer-pain management by further expanding access to quality care among Hispanic patients. Community partnerships are key to the successful adaptation and future intervention efforts of the Spanish-language version of painTRAINER. The availability of effective and culturally-appropriate pain management options for Spanish-speaking patients will provide communities with tools and resources necessary not only for managing pain and enhancing quality of life, but for empowering Spanish-speaking patients to be strong advocates for their health.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pilot study to assess feasibility and acceptability.
| Arm | Type | Receives |
|---|---|---|
| painTRAINER intervention | Experimental | Behavioral: painTRAINER40 Spanish speaking Hispanic and Latine participants will participate in an 8 week online pain coping skills training program designed to address cancer-related pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of invasive cancer treated with either single modality therapy or any combination of therapies.
- Is ≤ 5 years since completion of definitive cancer therapy.
- May be off treatment, receiving adjuvant or maintenance therapy or have cancer that is stable/controlled.
- Pain score ≥ 4 (PROMIS Pain Intensity (1a) scale) on "Most Days" or more (Graded Chronic Pain Scale).
- Pain of new onset or significantly exacerbated since cancer diagnosis or initiation of cancer treatment.
Key exclusion criteria (3 listed)
- Has a disability that precludes completion of study activities.
- Reports only preexisting pain conditions unrelated to cancer or cancer treatment.
- Has a known or suspected diagnosable substance use disorder or opioid overuse disorder.
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 |
|---|---|---|
| painTRAINERpainTRAINER is an 8 week online behavioral pain coping skills training program derived from cognitive behavioral therapy approaches, which includes 45 minute behavioral coping sessions to be completed over 8 weeks. Weekly sessions are guided by an automated coach that teaches skills for coping with pain. | Behavioural | painTRAINER intervention |
Primary outcome
Adherence - percent of participants who complete the study modules as a measure of retention
Time frame: baseline
To evaluate the feasibility of implementing painTRAINER among Spanish speaking participants, the study will assess participants' adherence to painTRAINER and the capacity to retain them in a clinical trial. The pilot trial can be implemented completely remotely among community dwelling Spanish-speaking Hispanic/Latine individuals with cancer-related pain. The study will calculate the percent of participants who complete the study modules as a measure of retention. Adherence to the program will be defined as the proportion of weekly modules completed (adequate adherence is defined as completion of ≥ 75% of modules, or 6 of the total 8 modules).
Adherence - percent of participants who complete the study modules as a measure of retention
Time frame: Week 10
To evaluate the feasibility of implementing painTRAINER among Spanish speaking participants, the study will assess participants' adherence to painTRAINER and the capacity to retain them in a clinical trial. The pilot trial can be implemented completely remotely among community dwelling Spanish-speaking Hispanic/Latine individuals with cancer-related pain. The study will calculate the percent of participants who complete the study modules as a measure of retention. Adherence to the program will be defined as the proportion of weekly modules completed (adequate adherence is defined as completion of ≥ 75% of modules, or 6 of the total 8 modules).
Adherence - percent of participants who complete the study modules as a measure of retention
Time frame: Week 18
To evaluate the feasibility of implementing painTRAINER among Spanish speaking participants, the study will assess participants' adherence to painTRAINER and the capacity to retain them in a clinical trial. The pilot trial can be implemented completely remotely among community dwelling Spanish-speaking Hispanic/Latine individuals with cancer-related pain. The study will calculate the percent of participants who complete the study modules as a measure of retention. Adherence to the program will be defined as the proportion of weekly modules completed (adequate adherence is defined as completion of ≥ 75% of modules, or 6 of the total 8 modules).
Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate
Time frame: Baseline
To assess the acceptability of painTRAINER among Spanish speaking participants, the study will determine the ability to recruit participants into the pilot trial via networks of community partners in the Atrium Health: Wake Forest Baptist catchment area. To characterize our ability to recruit participants, the study will estimate the proportion of eligible participants screened and the proportion of eligible participants who consent to participate. The study also will closely monitor the rate of referrals to the program by providers. Acceptability of the program also will be assessed more subjectively via interviews with participants following completion of or termination from the pilot trial.
Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate
Time frame: Week 10
To assess the acceptability of painTRAINER among Spanish speaking participants, the study will determine the ability to recruit participants into the pilot trial via networks of community partners in the Atrium Health: Wake Forest Baptist catchment area. To characterize our ability to recruit participants, the study will estimate the proportion of eligible participants screened and the proportion of eligible participants who consent to participate. The study also will closely monitor the rate of referrals to the program by providers. Acceptability of the program also will be assessed more subjectively via interviews with participants following completion of or termination from the pilot trial.
Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate
Time frame: Week 18
To assess the acceptability of painTRAINER among Spanish speaking participants, the study will determine the ability to recruit participants into the pilot trial via networks of community partners in the Atrium Health: Wake Forest Baptist catchment area. To characterize our ability to recruit participants, the study will estimate the proportion of eligible participants screened and the proportion of eligible participants who consent to participate. The study also will closely monitor the rate of referrals to the program by providers. Acceptability of the program also will be assessed more subjectively via interviews with participants following completion of or termination from the pilot trial.
7 secondary outcomes
Change in Pain interference scores
Time frame: baseline, 10 weeks, 18 weeks
Change in Pain severity scores
Time frame: baseline, 10 weeks, 18 weeks
Change in Fatigue scores
Time frame: baseline, 10 weeks, 18 weeks
Change in Sleep disturbance scores
Time frame: baseline, 10 weeks, 18 weeks
Change in Pain resilience scores
Time frame: baseline, 10 weeks, 18 weeks
Change in Cognitive Function scores
Time frame: baseline, 10 weeks, 18 weeks
Change in Physical Function scores
Time frame: baseline, 10 weeks, 18 weeks
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 4 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Donald B Penzien, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing painTRAINER in people with Cancer Pain, run by Wake Forest University Health Sciences 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 9 inclusion and 3 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 4 Feb 2025. 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?
Adherence - percent of participants who complete the study modules as a measure of retention (time frame: baseline). The study lists 6 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 4 Feb 2025.