CancerSHINENCT07751185
Support and Healing Intervention for Adolescents With a Parent Diagnosed With Cancer (SHINE)
A study testing SHINE Psychosocial Intervention and Usual Supportive Care in people with Cancer and Psychological Distress, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
e purpose of this study is to develop and evaluate SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences), a family-centered program designed to support adolescents whose parent has been diagnosed with cancer. The study has two phases. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cancer, Psychological Distress, Adaptation, Psychological
- What is being tested?
- SHINE Psychosocial Intervention and Usual Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent or caregiver aged 18 years or older with a documented diagnosis of Stage I-IV (or equivalent) cancer.
- Parent or caregiver has at least one adolescent child between the ages of 10 and 17 years living in the household.
- Parent/caregiver and adolescent are able to communicate in English or Spanish. Parent or caregiver is willing and able to provide informed consent, and the adolescent is willing and able to provide assent.
- Family is willing and able to participate in study procedures, including intervention sessions and study assessments.
Who cannot join
- Adolescent younger than 10 years or older than 17 years. Parent/caregiver or adolescent unable to communicate in English or Spanish. Parent/caregiver or adolescent with significant cognitive impairment or developmental delay that would prevent meaningful participation in study procedures.
- Family unable or unwilling to complete study procedures or follow-up assessments.
- Parent/caregiver unwilling or unable to provide informed consent, or adolescent unwilling or unable to provide assent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT Southwestern Simmons Comprehensive Cancer Center
Dallas, Texas, 75390
Tian Zhang, M.D., 214/645-9554, Tian.Zhang@UTSouthwestern.edu
About this study
Official title: Support and Healing Intervention for Navigating Parental Cancer Experiences (SHINE): A Mixed-Methods Study to Develop and Pilot-Test a Family-Centered Psychosocial Intervention for Adolescents With a Parent Diagnosed With Cancer
e purpose of this study is to develop and evaluate SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences), a family-centered program designed to support adolescents whose parent has been diagnosed with cancer.
The study has two phases. In the first phase, parents and adolescents will participate in interviews or focus groups to help researchers understand their experiences and identify the types of support that families need. Information from these discussions will be used to refine the SHINE program.
Read more
In the second phase, families will be randomly assigned to either receive the SHINE program or continue with their usual supportive care. The SHINE program consists of approximately four sessions delivered over 8 weeks and focuses on improving communication, coping skills, resilience, and emotional well-being. Adolescents will complete questionnaires before the program begins, immediately after the 8-week intervention period, and 3 months later.
Researchers will evaluate whether SHINE is feasible to deliver, acceptable to families, and shows promise for improving psychosocial outcomes among adolescents coping with a parent's cancer diagnosis.
Read the detailed description
A parental cancer diagnosis can significantly affect the emotional and psychological well-being of children and adolescents. Youth experiencing parental cancer are at increased risk for anxiety, depression, stress, communication difficulties, and impaired coping. Despite these challenges, relatively few evidence-based psychosocial interventions have been developed specifically for this population, and many existing interventions have not incorporated input from adolescents and families during development.
The SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences) study is a mixed-methods investigation designed to develop and pilot-test a family-centered psychosocial intervention for adolescents ages 10-17 whose parent has been diagnosed with Stage I-IV cancer.
The study consists of two sequential phases.
Aim 1 uses qualitative focus groups with parents and individual interviews with adolescents to identify priority psychosocial needs related to parental cancer, including age-appropriate information, family communication, coping strategies, peer support, emotional expression, and ongoing supportive care. Findings from these interviews will be used to refine the SHINE intervention, and a subset of families will participate in additional feedback sessions to finalize intervention materials.
Aim 2 is a pilot randomized controlled trial enrolling approximately 40 families (one parent with cancer and one adolescent child per family). Following completion of baseline assessments, families will be randomized in a 1:1 ratio to either the SHINE intervention or usual supportive care. The SHINE intervention is a modular psychosocial program delivered over approximately 8 weeks through approximately four sessions that may be conducted in person or virtually using HIPAA-compliant platforms.
Primary objectives are to evaluate the feasibility of recruitment, retention, and intervention adherence, as well as participant acceptability and satisfaction. Secondary objectives are to estimate the preliminary effects of SHINE on adolescent psychosocial outcomes, including illness perceptions, coping, resilience, stress, depression, anxiety, peer relationships, family functioning, and communication. Outcomes will be assessed at baseline, immediately following the intervention, and at 3-month follow-up using validated patient-reported outcome measures.
The results of this pilot study will provide feasibility data and preliminary effect size estimates to support future fully powered clinical trials evaluating psychosocial interventions for families affected by parental cancer.
- Conditions
- Cancer, Psychological Distress, Adaptation, Psychological
- Being tested
- SHINE Psychosocial Intervention, Usual Supportive Care
- Keywords
- Parental cancer, Adolescents, Family-centered intervention, Psychosocial intervention, Supportive care, Cancer survivorship, Family communication, Coping, Resilience, Peer support, Pediatric psychosocial oncology, Behavioral intervention, Mixed-methods, Randomized controlled trial, SHINE
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHINE Psychosocial InterventionBehavioural
The SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences) intervention is a family-centered, modular behavioral intervention designed to improve psychosocial outcomes among adolescents with a parent diagnosed with cancer. The intervention consists of approximately four sessions delivered over an 8-week period, either in person or remotely using HIPAA-compliant platforms. Intervention modules address age-appropriate cancer education, family communication, coping skills, resilience, peer support, and emotional well-being. Content is informed by qualitative input from adolescents, parents, and clinical providers and may be tailored to family needs while maintaining a standardized intervention framework.
Usual Supportive CareBehavioural
Participants assigned to this group will receive the standard supportive care services routinely available through UT Southwestern Simmons Comprehensive Cancer Center. These services may include access to oncology social work, counseling, patient navigation, educational resources, and community support programs as clinically indicated. Participants will not receive the SHINE intervention during the study period but will complete the same study assessments as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| SHINE Intervention | Experimental | Participants randomized to this arm will receive the SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences) intervention in addition to usual supportive care. SHINE is a family-centered, modular psychosocial intervention consisting of approximately four sessions delivered over an 8-week period. Sessions focus on age-appropriate cancer education, family communication, coping skills, resilience, emotional support, and peer support. Intervention sessions may be delivered in person at UT Southwestern Simmons Cancer Center or remotely using HIPAA-compliant virtual platforms. Receives: Behavioral: SHINE Psychosocial Intervention |
| Usual Supportive Care | Active comparator | Participants randomized to this arm will receive the usual supportive care available through UT Southwestern Simmons Cancer Center. Usual supportive care may include access to oncology social work services, counseling, community resources, and other supportive services routinely available to families affected by cancer. Participants in this arm will complete the same study assessments as the intervention group but will not receive the SHINE intervention during the study period. Receives: Behavioral: Usual Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment rate will be defined as the percentage of eligible families who enroll in the study.
Measured: From study initiation through completion of participant enrollment (approximately 36 months).
Retention Rate
Retention rate will be defined as the percentage of enrolled families who complete all planned study assessments through the 3-month follow-up.
Measured: Baseline through 3-month follow-up.
Intervention Adherence Rate
Intervention adherence will be defined as the percentage of participants randomized to the SHINE intervention who complete all planned intervention sessions (approximately four sessions over 8 weeks).
Measured: Baseline through completion of the 8-week intervention.
Participant Satisfaction and Acceptability Questionnaire Total Score
Acceptability will be assessed using a study-specific Participant Satisfaction and Acceptability Questionnaire administered immediately following completion of the SHINE intervention. The questionnaire consists of Likert-scale items assessing satisfaction, perceived usefulness, and willingness to recommend the intervention. Total scores range from 1 to 5, with higher scores indicating greater acceptability and satisfaction.
Measured: Immediately following the 8-week intervention
Secondary outcomes (8)
Perceptions of Parental Illness Questionnaire for Cancer (PPIQ-C)
Perceptions of Parental Illness Questionnaire for Cancer (PPIQ-C) Coherence Subscale Score. The Coherence subscale measures adolescents' understanding of their parent's cancer. Scores range from 1 to 5, with higher scores indicating greater illness understanding.
Measured: Baseline, 8 weeks, and 3 months
Communication Self-Efficacy Scale
Change in communication self-efficacy measured using the Communication Self-Efficacy Scale (CSES). Total scores range from 10 to 50. Higher scores indicate greater communication self-efficacy.
Measured: Baseline, 8 weeks, and 3 months
Connor-Davidson Resilience Scale (CD-RISC-25) Total Score
Change in resilience measured using the Connor-Davidson Resilience Scale (CD-RISC-25). The Connor-Davidson Resilience Scale consists of 25 items with total scores ranging from 0 to 100. Higher scores indicate greater resilience.
Measured: Baseline, 8 weeks, and 3 months
Perceived Stress Scale (PSS-10)
Change in stress measured using the Perceived Stress Scale (PSS-10). The Perceived Stress Scale (10-item) total score ranges from 0 to 40. Higher scores indicate greater perceived stress.
Measured: Baseline, 8 weeks, and 3 months
Patient Health Questionnaire for Adolescents (PHQ-A)
Change in depressive symptoms measured using the Patient Health Questionnaire for Adolescents (PHQ-A). Total scores range from 0 to 27. Higher scores indicate more severe depressive symptoms.
Measured: Baseline, 8 weeks, and 3 months
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Change in anxiety measured using the Generalized Anxiety Disorder Scale (GAD-7). Total scores range from 0 to 21. Higher scores indicate more severe anxiety symptoms.
Measured: Baseline, 8 weeks, and 3 months
PROMIS Pediatric Peer Relationships Short Form
Change in peer relationships measured using the PROMIS Pediatric Peer Relationships Short Form. Scores are converted to standardized T-scores (mean = 50; standard deviation = 10). Higher T-scores indicate better peer relationships.
Measured: Baseline, 8 weeks, and 3 months
McMaster Family Assessment Device - General Functioning Subscale
Change in family functioning measured using the McMaster Family Assessment Device - General Functioning (FAD-GF). Mean scores range from 1.0 to 4.0. Higher scores indicate poorer family functioning.
Measured: Baseline, 8 weeks, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to either the SHINE intervention or usual supportive care. The SHINE intervention consists of approximately four family-centered psychosocial sessions delivered over an 8-week period. The control group will receive usual supportive care available through the cancer center. Participants will complete assessments at baseline, post-intervention (8 weeks), and 3-month follow-up.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Messiah, University of Texas Southwestern Medical Center
- Investigators
- Sarah E Messiah, MPH, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751185
- Sponsor's protocol ID
- STU20251757
- Acronym
- SHINE
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications, including participant-level survey data and associated data dictionaries, may be shared with qualified researchers following publication of the primary study results. Qualitative interview transcripts will not be shared in their original form due to the potential risk of participant re-identification; however, de-identified qualitative data or coded thematic datasets may be shared when appropriate and consistent with participant consent and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support and Healing Intervention for Navigating Parental Cancer Experiences (SHINE): A Mixed-Methods Study to Develop and Pilot-Test a Family-Centered Psychosocial Intervention for Adolescents With a Parent Diagnosed With Cancer
- ClinicalTrials.gov ID
- NCT07751185
- Acronym / sponsor ID
- SHINE / STU20251757
- Conditions
- Cancer, Psychological Distress, Adaptation, Psychological
- Keywords
- Parental cancer, Adolescents, Family-centered intervention, Psychosocial intervention, Supportive care, Cancer survivorship, Family communication, Coping
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Aug 2026 (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.
e purpose of this study is to develop and evaluate SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences), a family-centered program designed to support adolescents whose parent has been diagnosed with cancer.
The study has two phases. In the first phase, parents and adolescents will participate in interviews or focus groups to help researchers understand their experiences and identify the types of support that families need. Information from these discussions will be used to refine the SHINE program.
In the second phase, families will be randomly assigned to either receive the SHINE program or continue with their usual supportive care. The SHINE program consists of approximately four sessions delivered over 8 weeks and focuses on improving communication, coping skills, resilience, and emotional well-being. Adolescents will complete questionnaires before the program begins, immediately after the 8-week intervention period, and 3 months later.
Researchers will evaluate whether SHINE is feasible to deliver, acceptable to families, and shows promise for improving psychosocial outcomes among adolescents coping with a parent's cancer diagnosis.
Detailed description
A parental cancer diagnosis can significantly affect the emotional and psychological well-being of children and adolescents. Youth experiencing parental cancer are at increased risk for anxiety, depression, stress, communication difficulties, and impaired coping. Despite these challenges, relatively few evidence-based psychosocial interventions have been developed specifically for this population, and many existing interventions have not incorporated input from adolescents and families during development.
The SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences) study is a mixed-methods investigation designed to develop and pilot-test a family-centered psychosocial intervention for adolescents ages 10-17 whose parent has been diagnosed with Stage I-IV cancer.
The study consists of two sequential phases.
Aim 1 uses qualitative focus groups with parents and individual interviews with adolescents to identify priority psychosocial needs related to parental cancer, including age-appropriate information, family communication, coping strategies, peer support, emotional expression, and ongoing supportive care. Findings from these interviews will be used to refine the SHINE intervention, and a subset of families will participate in additional feedback sessions to finalize intervention materials.
Aim 2 is a pilot randomized controlled trial enrolling approximately 40 families (one parent with cancer and one adolescent child per family). Following completion of baseline assessments, families will be randomized in a 1:1 ratio to either the SHINE intervention or usual supportive care. The SHINE intervention is a modular psychosocial program delivered over approximately 8 weeks through approximately four sessions that may be conducted in person or virtually using HIPAA-compliant platforms.
Primary objectives are to evaluate the feasibility of recruitment, retention, and intervention adherence, as well as participant acceptability and satisfaction. Secondary objectives are to estimate the preliminary effects of SHINE on adolescent psychosocial outcomes, including illness perceptions, coping, resilience, stress, depression, anxiety, peer relationships, family functioning, and communication. Outcomes will be assessed at baseline, immediately following the intervention, and at 3-month follow-up using validated patient-reported outcome measures.
The results of this pilot study will provide feasibility data and preliminary effect size estimates to support future fully powered clinical trials evaluating psychosocial interventions for families affected by parental cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either the SHINE intervention or usual supportive care. The SHINE intervention consists of approximately four family-centered psychosocial sessions delivered over an 8-week period. The control group will receive usual supportive care available through the cancer center. Participants will complete assessments at baseline, post-intervention (8 weeks), and 3-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| SHINE Intervention | Experimental | Behavioral: SHINE Psychosocial InterventionParticipants randomized to this arm will receive the SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences) intervention in addition to usual supportive care. SHINE is a family-centered, modular psychosocial intervention consisting of approximately four sessions delivered over an 8-week period. Sessions focus on age-appropriate cancer education, family communication, coping skills, resilience, emotional support, and peer support. Intervention sessions may be delivered in person at UT Southwestern Simmons Cancer Center or remotely using HIPAA-compliant virtual platforms. |
| Usual Supportive Care | Active comparator | Behavioral: Usual Supportive CareParticipants randomized to this arm will receive the usual supportive care available through UT Southwestern Simmons Cancer Center. Usual supportive care may include access to oncology social work services, counseling, community resources, and other supportive services routinely available to families affected by cancer. Participants in this arm will complete the same study assessments as the intervention group but will not receive the SHINE intervention during the study period. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parent or caregiver aged 18 years or older with a documented diagnosis of Stage I-IV (or equivalent) cancer.
- Parent or caregiver has at least one adolescent child between the ages of 10 and 17 years living in the household.
- Parent/caregiver and adolescent are able to communicate in English or Spanish. Parent or caregiver is willing and able to provide informed consent, and the adolescent is willing and able to provide assent.
- Family is willing and able to participate in study procedures, including intervention sessions and study assessments.
Key exclusion criteria (3 listed)
- Adolescent younger than 10 years or older than 17 years. Parent/caregiver or adolescent unable to communicate in English or Spanish. Parent/caregiver or adolescent with significant cognitive impairment or developmental delay that would prevent meaningful participation in study procedures.
- Family unable or unwilling to complete study procedures or follow-up assessments.
- Parent/caregiver unwilling or unable to provide informed consent, or adolescent unwilling or unable to provide assent.
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 |
|---|---|---|
| SHINE Psychosocial InterventionThe SHINE (Support and Healing Intervention for Navigating Parental Cancer Experiences) intervention is a family-centered, modular behavioral intervention designed to improve psychosocial outcomes among adolescents with a parent diagnosed with cancer. The intervention consists of approximately four sessions delivered over an 8-week period, either in person or remotely using HIPAA-compliant platforms. Intervention modules address age-appropriate cancer education, family communication, coping skills, resilience, peer support, and emotional well-being. Content is informed by qualitative input from adolescents, parents, and clinical providers and may be tailored to family needs while maintaining a standardized intervention framework. | Behavioural | SHINE Intervention |
| Usual Supportive CareParticipants assigned to this group will receive the standard supportive care services routinely available through UT Southwestern Simmons Comprehensive Cancer Center. These services may include access to oncology social work, counseling, patient navigation, educational resources, and community support programs as clinically indicated. Participants will not receive the SHINE intervention during the study period but will complete the same study assessments as the intervention group. | Behavioural | Usual Supportive Care |
Primary outcome
Recruitment Rate
Time frame: From study initiation through completion of participant enrollment (approximately 36 months).
Recruitment rate will be defined as the percentage of eligible families who enroll in the study.
Retention Rate
Time frame: Baseline through 3-month follow-up.
Retention rate will be defined as the percentage of enrolled families who complete all planned study assessments through the 3-month follow-up.
Intervention Adherence Rate
Time frame: Baseline through completion of the 8-week intervention.
Intervention adherence will be defined as the percentage of participants randomized to the SHINE intervention who complete all planned intervention sessions (approximately four sessions over 8 weeks).
Participant Satisfaction and Acceptability Questionnaire Total Score
Time frame: Immediately following the 8-week intervention
Acceptability will be assessed using a study-specific Participant Satisfaction and Acceptability Questionnaire administered immediately following completion of the SHINE intervention. The questionnaire consists of Likert-scale items assessing satisfaction, perceived usefulness, and willingness to recommend the intervention. Total scores range from 1 to 5, with higher scores indicating greater acceptability and satisfaction.
8 secondary outcomes
Perceptions of Parental Illness Questionnaire for Cancer (PPIQ-C)
Time frame: Baseline, 8 weeks, and 3 months
Communication Self-Efficacy Scale
Time frame: Baseline, 8 weeks, and 3 months
Connor-Davidson Resilience Scale (CD-RISC-25) Total Score
Time frame: Baseline, 8 weeks, and 3 months
Perceived Stress Scale (PSS-10)
Time frame: Baseline, 8 weeks, and 3 months
Patient Health Questionnaire for Adolescents (PHQ-A)
Time frame: Baseline, 8 weeks, and 3 months
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: Baseline, 8 weeks, and 3 months
PROMIS Pediatric Peer Relationships Short Form
Time frame: Baseline, 8 weeks, and 3 months
McMaster Family Assessment Device - General Functioning Subscale
Time frame: Baseline, 8 weeks, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications, including participant-level survey data and associated data dictionaries, may be shared with qualified researchers following publication of the primary study results. Qualitative interview transcripts will not be shared in their original form due to the potential risk of participant re-identification; however, de-identified qualitative data or coded thematic datasets may be shared when appropriate and consistent with participant consent and institutional policies.
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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.
Sarah E Messiah, MPH, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHINE Psychosocial Intervention and Usual Supportive Care in people with Cancer and Psychological Distress, run by University of Texas Southwestern Medical Center 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 4 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: opening soon, as of the sponsor's last update on 7 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophia Ngenge, BS, MPH (214-645-8226, Sophia.Ngenge@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From study initiation through completion of participant enrollment (approximately 36 months).). The study lists 4 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 7 Aug 2026.