Family CenteredNCT07164456
Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors and Their Caregivers
A study testing Education sessions and Questionnaire in people with Family Centered and Black Ethnicity, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To establish the efficacy of the family-centered intervention in improving healthy lifestyle behaviors (MVPA and overall diet quality), as well as physical functioning, QoL, and family health climate, compared to survivor-only and control groups. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Family Centered, Black Ethnicity, Prostate Cancer Survivors
- What is being tested?
- Education sessions and Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to 30 Jun 2033
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Survivors are excluded if they:
- Have a prior history of other cancer or have metastatic cancer.
- Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period.
- Meet physical activity recommendations (i.e., 150 min of moderate intensity physical activity per week); and (4) are currently participating in a lifestyle or weight management program.
- Caregivers are excluded if they:
- Have serious medical conditions (e.g., cancer, congestive heart failure, stroke, and dementia)
- Are currently participating in a lifestyle or weight management program.
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, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Dalnim Cho, MD, 713-745-8476, dcho1@mdanderson.org
Dalnim Cho, MD
About this study
To establish the efficacy of the family-centered intervention in improving healthy lifestyle behaviors (MVPA and overall diet quality), as well as physical functioning, QoL, and family health climate, compared to survivor-only and control groups.
Read the detailed description
Primary Objectives
- Determine the extent to which MVPA and overall diet quality have improved in Black PCa survivors and their caregivers in the family-centered intervention group, compared to those in the survivor-only and control groups at post-intervention.
Secondary Objectives
- Determine the extent to which, compared to those in the survivor-only and control groups, both survivors and caregivers in the family-centered group maintain the MVPA and high diet quality at the 6-month follow-up, and experience improved 6MWT, QoL, and family health climate at both post-intervention and 6-month follow-up.
- Identify mediators and moderators of the family-centered intervention.
- Conditions
- Family Centered, Black Ethnicity, Prostate Cancer Survivors
- Being tested
- Education sessions, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education sessionsOther
Remote and In person sessions
QuestionnaireOther
Questionnaires given a 3,6,12 mouth follow ups
| Study group | Role | What they receive |
|---|---|---|
| Family-centered intervention | Experimental | Includes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone. Receives: Other: Education sessions; Other: Questionnaire |
| survivor-only intervention | Experimental | Includes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone. Receives: Other: Education sessions; Other: Questionnaire |
| Health education control | Experimental | Will focus on enhancing participants' intrinsic motivation and problem-solving skills related to improving diet quality and engaging in PA. A total of 12 sessions will be provided, with approximately 2 sessions per month Receives: Other: Education sessions; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Readiness Questionnaire
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start13 Jan 2026
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family CenteredStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Single group
- Masking
- None (open label)
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dalnim Cho, MD, Principal investigator, MD Andersson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164456
- Sponsor's protocol ID
- 2025-0868
- Other IDs
- NCI-2025-06570
- Status last verified
- Mar 2026
- First submitted
- 4 Sep 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors and Their Caregivers
- ClinicalTrials.gov ID
- NCT07164456
- Acronym / sponsor ID
- 2025-0868
- Conditions
- Family Centered, Black Ethnicity, Prostate Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 10 Sep 2025 (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.
To establish the efficacy of the family-centered intervention in improving healthy lifestyle behaviors (MVPA and overall diet quality), as well as physical functioning, QoL, and family health climate, compared to survivor-only and control groups.
Detailed description
Primary Objectives
- Determine the extent to which MVPA and overall diet quality have improved in Black PCa survivors and their caregivers in the family-centered intervention group, compared to those in the survivor-only and control groups at post-intervention.
Secondary Objectives
- Determine the extent to which, compared to those in the survivor-only and control groups, both survivors and caregivers in the family-centered group maintain the MVPA and high diet quality at the 6-month follow-up, and experience improved 6MWT, QoL, and family health climate at both post-intervention and 6-month follow-up.
- Identify mediators and moderators of the family-centered intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Family-centered intervention | Experimental | Other: Education sessions, Other: QuestionnaireIncludes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone. |
| survivor-only intervention | Experimental | Other: Education sessions, Other: QuestionnaireIncludes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone. |
| Health education control | Experimental | Other: Education sessions, Other: QuestionnaireWill focus on enhancing participants' intrinsic motivation and problem-solving skills related to improving diet quality and engaging in PA. A total of 12 sessions will be provided, with approximately 2 sessions per month |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Have a prior history of other cancer or have metastatic cancer.
- Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period.
- Meet physical activity recommendations (i.e., 150 min of moderate intensity physical activity per week); and (4) are currently participating in a lifestyle or weight management program.
- Have serious medical conditions (e.g., cancer, congestive heart failure, stroke, and dementia)
- Are currently participating in a lifestyle or weight management program.
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 |
|---|---|---|
| Education sessionsRemote and In person sessions | Other | Family-centered intervention, Health education control, survivor-only intervention |
| QuestionnaireQuestionnaires given a 3,6,12 mouth follow ups | Other | Family-centered intervention, Health education control, survivor-only intervention |
Primary outcome
Physical Activity Readiness Questionnaire
Time frame: Through study completion; an average of 1 year
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 9 Mar 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Dalnim Cho, MD principal investigator
MD Andersson Cancer 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 Education sessions and Questionnaire in people with Family Centered and Black Ethnicity, run by M.D. Anderson Cancer 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 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 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 Dalnim Cho, MD (713-745-8476, dcho1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Readiness Questionnaire (time frame: Through study completion; an average of 1 year). 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 9 Mar 2026.