Social Determinants of HealthNCT05301114
Social Risk Factors and Discrimination in Cancer Survivorship
A study testing Community Health Worker support in people with Social Determinants of Health and Breast Cancer, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The objective of the proposed study is to scale social risk factor screening and referral for cancer survivors and to solidify information exchange between clinical and community settings in order to improve survivor health and well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Determinants of Health, Breast Cancer, Prostate Cancer
- What is being tested?
- Community Health Worker support
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2022to 30 Jun 2026
- 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 stage I-III cancer and completed curative treatment (surgery, radiation, chemotherapy) or finalized treatment plan (e.g. watch and wait); OR Stage IV cancer approximately 6 months from diagnosis
- Black or African American race
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Scaling Social Determinants of Health Screening, Social Support, and Anti-Racism Training to Reduce Inequities in Minority Cancer Survivor Health and Well-Being in Washington, D.C.
The objective of the proposed study is to scale social risk factor screening and referral for cancer survivors and to solidify information exchange between clinical and community settings in order to improve survivor health and well-being. This will be completed through three primary aims: 1) To ascertain workflow and map community resources needed to facilitate social risk factor screening and referral for breast and prostate cancer survivors in Washington, District of Columbia. 2) To determine impact of Community Health Worker (CHW) support on Black breast and prostate cancer survivor health and wellbeing as measured through quality of life (QOL) and social connection. 3) To determine impact of anti-racism training for staff and clinicians at three cancer centers on patient-reported discrimination.
Read the detailed description
Despite improvements in cancer outcomes over time, significant disparities remain between Black and White cancer survivors. It is estimated that clinical care, including access to care and quality of care, accounts for an estimated 20% of health outcomes, while other factors, including social determinants of health (SDoH) and an individual's social risk factors, explain 80% of health outcomes. The goal of this research is thus to simultaneously target unequitable health care systems and accelerate the evidence base for scalable social determinants of health screening and referral to reduce inequities in cancer survivor health and well-being. This project is intended to establish sustainable clinical-community linkages and improve survivor health and well-being. Understanding the burden of social needs in this population, the available community resources, and solidifying integrated, closed-loop referral systems to address those needs is critical to improving quality of life for cancer survivors. The long-term goal of this research is to develop scalable interventions to address social needs and support for cancer survivors.
The study aims to: 1) improve care coordination and information exchange through mapping available resources for cancer survivors across Washington DC and building a universal screening and referral process at three cancer centers in DC; 2) determine impact of Community Health Worker (CHWs) support on cancer survivor health and wellbeing as measured through social connection and quality of life; 3) determine impact of anti-racism (inclusive of SDOH) training for staff and clinicians at three cancer centers on provider cultural competency and patient reported perceived discrimination.
Furthermore, this work evaluates the implementation, impact, and causal mechanisms of SDOH collection and referral to reduce racial inequities among cancer survivors. The investigators include innovative approaches to linking clinics and communities drawing on systems engineering and social network analyses and supported by ongoing DC efforts to bolster health information exchange systems to address social needs. Our approach is also integrated with existing community resources including key community-based organizations in the Washington DC region.
Results from this study will provide the foundation for future research examining the intervention's generalizability to other marginalized cancer survivors and sustainability of the proposed screening and referral system. Findings will also provide a basis for further research on community health workers to support our target population, to improve shared resources in supporting cancer survivors, and to maintain relevance within the evolving health information exchange environment.
- Being tested
- Community Health Worker support
- Keywords
- Health Equity, Community Health Worker, Social Support, Community Based Organizations, Social Determinants of Health, Breast Cancer, Prostate Cancer, Health Disparities
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker supportBehavioural
Participant will receive weekly or monthly support (via phone or in person) from a community health worker. The community health worker will be responsible for continuously assessing the patient's social needs, providing referrals to community based organizations, and assisting with the patient's non-medical needs as they progress through survivorship (e.g. social support, referrals, etc). Individuals who identify no risk factor will receive monthly phone calls, while individuals who identify 1-3 risk factors will receive monthly home visits with interim phone calls for 6 months. Those who identify 4 or more risk factors or have intensive needs such as behavioral health will receive the same services as the medium risk group and will also be connected with the social work teams within each institution.
| Study group | Role | What they receive |
|---|---|---|
| Intervention participants | Experimental | Among patients who completed the social needs screening as a part of standard of care, all stage I-IV Black cancer survivors will be invited to participate in a six-month community health worker intervention. The community health worker will assess social needs and provide six months of support. Receives: Behavioral: Community Health Worker support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Self-Efficacy
This study will use the following Patient-Reported Outcomes Measurement Information System® (PROMIS) self-efficacy for managing chronic conditions 4-item measures: managing daily activities, managing emotions, managing medications and treatments, and managing social interactions. The minimum score on these overall scales is a 16 and the maximum score is 80, in which a higher number represents a higher level of self-efficacy for managing chronic conditions. PROMIS raw scores are then transformed to a t-scale with a mean of 50 and a standard deviation of 10.
Measured: 6 months
Health-related quality of life (QOL)
QOL will be measured using the Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 computer adaptive test, a collection of 4-item adaptive forms assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, as well as a single global pain item. For the 4-item forms, the lowest score is 4 and the highest score is 16. Higher scores represent higher levels of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, respectively. The single pain item has a minimum score of 0 and a maximum score of 10, in which a higher score represents a higher level of pain. PROMIS raw scores are then transformed to a t-scale with a mean of 50 and a standard deviation of 10.
Measured: 6 months
Social connectedness
To measure social connectedness, this study will draw from the item banks for the following Patient-Reported Outcomes Measurement Information System® (PROMIS) 2.0 adult item measures: Social Isolation, Emotional Support, Informational Support, and Instrumental Support. Each scale is scored with a minimum score of 4 and a maximum score of 20, in which higher scores represent higher levels of social isolation, emotional support, instrumental support, and informational support, respectively. PROMIS raw scores are then transformed to a t-scale with a mean of 50 and a standard deviation of 10.
Measured: 6 months
Acceptability of the CHW intervention
A four-item Likert scale will be delivered to relevant clinicians to provide feedback on acceptability of the intervention
Measured: 12 months
Appropriateness of the CHW intervention
A four-item Likert scale will be delivered to relevant providers to provide feedback on appropriateness of the intervention, whereby higher scores indicate greater perceived appropriateness.
Measured: 12 months
Feasibility of the CHW intervention
A four-item Likert scale will be delivered to relevant providers to provide feedback on feasibility of the intervention, whereby higher scores indicate greater perceived feasibility.
Measured: 12 months
Sustainability Assessment
This study will use the Program Sustainability Assessment Tool annually to assess environmental support, funding stability, partnerships, organizational capacity, program evaluation, program adaptation, communications and strategic planning. The minimum score for this evaluation is 0 and the maximum score is 56. A higher score represents a higher level of program sustainability. Individual categories can also be assessed with a minimum score of 0 and a maximum score of 7 in each, in which a higher score represents higher sustainability in that category.
Measured: 12 months
Secondary outcomes (1)
Social risk factors
Social risk factors screeners will be administered on the following domains: food insecurity, housing instability, utilities, paying for the basics, employment, transportation, and mental health. These scales are measured uniquely to the electronic health record systems in which they are implemented. Each need is assigned a single point and summed for an overall score.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start5 May 2022
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Social Determinants of HealthStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University, Howard University, Georgetown University
- Responsible party
- Sponsor
- Investigators
- Hannah Arem, PhD, Principal investigator, Medstar Health Research InstituteMandi Pratt-Chapman, PhD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301114
- Sponsor's protocol ID
- 4397
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glasgow RE, Kwan BM, Matlock DD. Realizing the full potential of precision health: The need to include patient-reported health behavior, mental health, social determinants, and patient preferences data. J Clin Transl Sci. 2018 Jun;2(3):183-185. doi: 10.1017/cts.2018.31. Epub 2018 Sep 13.
PubMed 30370072Clarke TC, Christ SL, Soler-Vila H, Lee DJ, Arheart KL, Prado G, Caban-Martinez A, Fleming LE. Working with cancer: health and employment among cancer survivors. Ann Epidemiol. 2015 Nov;25(11):832-8. doi: 10.1016/j.annepidem.2015.07.011. Epub 2015 Aug 4.
PubMed 26320705Weaver KE, Rowland JH, Bellizzi KM, Aziz NM. Forgoing medical care because of cost: assessing disparities in healthcare access among cancer survivors living in the United States. Cancer. 2010 Jul 15;116(14):3493-504. doi: 10.1002/cncr.25209.
PubMed 20549763Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
PubMed 17443116Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
PubMed 20685078Hahn EA, Devellis RF, Bode RK, Garcia SF, Castel LD, Eisen SV, Bosworth HB, Heinemann AW, Rothrock N, Cella D; PROMIS Cooperative Group. Measuring social health in the patient-reported outcomes measurement information system (PROMIS): item bank development and testing. Qual Life Res. 2010 Sep;19(7):1035-44. doi: 10.1007/s11136-010-9654-0. Epub 2010 Apr 25.
PubMed 20419503
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Social Determinants of Health Screening, Social Support, and Anti-Racism Training to Reduce Inequities in Minority Cancer Survivor Health and Well-Being in Washington, D.C.
- ClinicalTrials.gov ID
- NCT05301114
- Acronym / sponsor ID
- 4397
- Keywords
- Health Equity, Community Health Worker, Social Support, Community Based Organizations, Social Determinants of Health, Breast Cancer, Prostate Cancer, Health Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- George Washington University, Howard University, Georgetown University
- Study start
- 5 May 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 29 Mar 2022 (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 objective of the proposed study is to scale social risk factor screening and referral for cancer survivors and to solidify information exchange between clinical and community settings in order to improve survivor health and well-being. This will be completed through three primary aims: 1) To ascertain workflow and map community resources needed to facilitate social risk factor screening and referral for breast and prostate cancer survivors in Washington, District of Columbia. 2) To determine impact of Community Health Worker (CHW) support on Black breast and prostate cancer survivor health and wellbeing as measured through quality of life (QOL) and social connection. 3) To determine impact of anti-racism training for staff and clinicians at three cancer centers on patient-reported discrimination.
Detailed description
Despite improvements in cancer outcomes over time, significant disparities remain between Black and White cancer survivors. It is estimated that clinical care, including access to care and quality of care, accounts for an estimated 20% of health outcomes, while other factors, including social determinants of health (SDoH) and an individual's social risk factors, explain 80% of health outcomes. The goal of this research is thus to simultaneously target unequitable health care systems and accelerate the evidence base for scalable social determinants of health screening and referral to reduce inequities in cancer survivor health and well-being. This project is intended to establish sustainable clinical-community linkages and improve survivor health and well-being. Understanding the burden of social needs in this population, the available community resources, and solidifying integrated, closed-loop referral systems to address those needs is critical to improving quality of life for cancer survivors. The long-term goal of this research is to develop scalable interventions to address social needs and support for cancer survivors.
The study aims to: 1) improve care coordination and information exchange through mapping available resources for cancer survivors across Washington DC and building a universal screening and referral process at three cancer centers in DC; 2) determine impact of Community Health Worker (CHWs) support on cancer survivor health and wellbeing as measured through social connection and quality of life; 3) determine impact of anti-racism (inclusive of SDOH) training for staff and clinicians at three cancer centers on provider cultural competency and patient reported perceived discrimination.
Furthermore, this work evaluates the implementation, impact, and causal mechanisms of SDOH collection and referral to reduce racial inequities among cancer survivors. The investigators include innovative approaches to linking clinics and communities drawing on systems engineering and social network analyses and supported by ongoing DC efforts to bolster health information exchange systems to address social needs. Our approach is also integrated with existing community resources including key community-based organizations in the Washington DC region.
Results from this study will provide the foundation for future research examining the intervention's generalizability to other marginalized cancer survivors and sustainability of the proposed screening and referral system. Findings will also provide a basis for further research on community health workers to support our target population, to improve shared resources in supporting cancer survivors, and to maintain relevance within the evolving health information exchange environment.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention participants | Experimental | Behavioral: Community Health Worker supportAmong patients who completed the social needs screening as a part of standard of care, all stage I-IV Black cancer survivors will be invited to participate in a six-month community health worker intervention. The community health worker will assess social needs and provide six months of support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of stage I-III cancer and completed curative treatment (surgery, radiation, chemotherapy) or finalized treatment plan (e.g. watch and wait); OR Stage IV cancer approximately 6 months from diagnosis
- Black or African American race
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 |
|---|---|---|
| Community Health Worker supportParticipant will receive weekly or monthly support (via phone or in person) from a community health worker. The community health worker will be responsible for continuously assessing the patient's social needs, providing referrals to community based organizations, and assisting with the patient's non-medical needs as they progress through survivorship (e.g. social support, referrals, etc). Individuals who identify no risk factor will receive monthly phone calls, while individuals who identify 1-3 risk factors will receive monthly home visits with interim phone calls for 6 months. Those who identify 4 or more risk factors or have intensive needs such as behavioral health will receive the same services as the medium risk group and will also be connected with the social work teams within each institution. | Behavioural | Intervention participants |
Primary outcome
Patient Self-Efficacy
Time frame: 6 months
This study will use the following Patient-Reported Outcomes Measurement Information System® (PROMIS) self-efficacy for managing chronic conditions 4-item measures: managing daily activities, managing emotions, managing medications and treatments, and managing social interactions. The minimum score on these overall scales is a 16 and the maximum score is 80, in which a higher number represents a higher level of self-efficacy for managing chronic conditions. PROMIS raw scores are then transformed to a t-scale with a mean of 50 and a standard deviation of 10.
Health-related quality of life (QOL)
Time frame: 6 months
QOL will be measured using the Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 computer adaptive test, a collection of 4-item adaptive forms assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, as well as a single global pain item. For the 4-item forms, the lowest score is 4 and the highest score is 16. Higher scores represent higher levels of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, respectively. The single pain item has a minimum score of 0 and a maximum score of 10, in which a higher score represents a higher level of pain. PROMIS raw scores are then transformed to a t-scale with a mean of 50 and a standard deviation of 10.
Social connectedness
Time frame: 6 months
To measure social connectedness, this study will draw from the item banks for the following Patient-Reported Outcomes Measurement Information System® (PROMIS) 2.0 adult item measures: Social Isolation, Emotional Support, Informational Support, and Instrumental Support. Each scale is scored with a minimum score of 4 and a maximum score of 20, in which higher scores represent higher levels of social isolation, emotional support, instrumental support, and informational support, respectively. PROMIS raw scores are then transformed to a t-scale with a mean of 50 and a standard deviation of 10.
Acceptability of the CHW intervention
Time frame: 12 months
A four-item Likert scale will be delivered to relevant clinicians to provide feedback on acceptability of the intervention
Appropriateness of the CHW intervention
Time frame: 12 months
A four-item Likert scale will be delivered to relevant providers to provide feedback on appropriateness of the intervention, whereby higher scores indicate greater perceived appropriateness.
Feasibility of the CHW intervention
Time frame: 12 months
A four-item Likert scale will be delivered to relevant providers to provide feedback on feasibility of the intervention, whereby higher scores indicate greater perceived feasibility.
Sustainability Assessment
Time frame: 12 months
This study will use the Program Sustainability Assessment Tool annually to assess environmental support, funding stability, partnerships, organizational capacity, program evaluation, program adaptation, communications and strategic planning. The minimum score for this evaluation is 0 and the maximum score is 56. A higher score represents a higher level of program sustainability. Individual categories can also be assessed with a minimum score of 0 and a maximum score of 7 in each, in which a higher score represents higher sustainability in that category.
1 secondary outcome
Social risk factors
Time frame: 3 months
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 16 Oct 2026.
- Background: PubMed 30370072Glasgow RE, Kwan BM, Matlock DD. Realizing the full potential of precision health: The need to include patient-reported health behavior, mental health, social determinants, and patient preferences data. J Clin Transl Sci. 2018 Jun;2(3):183-185. doi: 10.1017/cts.2018.31. Epub 2018 Sep 13.
- Background: PubMed 26320705Clarke TC, Christ SL, Soler-Vila H, Lee DJ, Arheart KL, Prado G, Caban-Martinez A, Fleming LE. Working with cancer: health and employment among cancer survivors. Ann Epidemiol. 2015 Nov;25(11):832-8. doi: 10.1016/j.annepidem.2015.07.011. Epub 2015 Aug 4.
- Background: PubMed 20549763Weaver KE, Rowland JH, Bellizzi KM, Aziz NM. Forgoing medical care because of cost: assessing disparities in healthcare access among cancer survivors living in the United States. Cancer. 2010 Jul 15;116(14):3493-504. doi: 10.1002/cncr.25209.
- Background: PubMed 17443116Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
- Background: PubMed 20685078Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
- Background: PubMed 20419503Hahn EA, Devellis RF, Bode RK, Garcia SF, Castel LD, Eisen SV, Bosworth HB, Heinemann AW, Rothrock N, Cella D; PROMIS Cooperative Group. Measuring social health in the patient-reported outcomes measurement information system (PROMIS): item bank development and testing. Qual Life Res. 2010 Sep;19(7):1035-44. doi: 10.1007/s11136-010-9654-0. Epub 2010 Apr 25.
- 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.
Hannah Arem, PhD principal investigator
Medstar Health Research Institute
Mandi Pratt-Chapman, PhD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker support in people with Social Determinants of Health and Breast Cancer, run by Medstar Health Research Institute 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 2 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 16 Oct 2026. 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?
Patient Self-Efficacy (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05301114, which also lists 6 linked publications.
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 16 Oct 2026.