Cancer SurvivorNCT04215029
Lifestyle Intervention for the Reduction of Prostate Cancer Disparities Among African Americans
A study testing Exercise Intervention, Informational Intervention and Interview in people with Cancer Survivor and Partner, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well a lifestyle intervention works in reducing prostate cancer disparities among African American prostate cancer patients and their spouses or romantic partners. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivor, Partner, Spouse
- What is being tested?
- Exercise Intervention, Informational Intervention and Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2019to 31 Jul 2026
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible, prostate cancer survivors must self-identify as black or African American
- Prostate cancer survivors must have 0-III stage prostate cancer
- Prostate cancer survivors must have completed therapy (e.g., surgery, chemotherapy [chemo] and/or radiation)
- Prostate cancer survivors must enroll with a spouse or a romantic partner
- Prostate cancer survivors must not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week)
- Prostate cancer survivors must be willing and able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q)
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- Prostate cancer survivors must not participate in another physical activity, diet, or lifestyle program
- Prostate cancer survivors must have a valid home address and telephone number
- Prostate cancer survivors must be able to access internet over a smartphone or a computer at home or other location (e.g., work, church, library, community center, etc.)
- To be eligible, spouses or romantic partners must be >=18 years of age
- Spouses or romantic partners must enroll with a spouse or a romantic partner with prostate cancer
- Spouses or romantic partners must live together with the survivors
- Spouses or romantic partners must not have major health problems (e.g., cancer, dementia, stroke, and heart and lung diseases)
- Spouses or romantic partners must be willing and able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q)
- To be eligible, healthcare providers must be currently providing care with individuals diagnosed with prostate cancer
- Any professionals such as surgical and medical oncologists, fellows, nurse practitioners, physical assistants, and primary care physicians will be eligible
Who cannot join
- Prostate cancer survivors will be excluded if they are not married or partnered
- Prostate cancer survivors will be excluded if they have an active noncutaneous malignancy at any site
- Prostate cancer survivors will be excluded if they had a prior history of other cancer or have metastatic cancer
- Prostate cancer survivors will be excluded if they have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period
- Prostate cancer survivors will be excluded if they are on active surveillance
- Prostate cancer survivors will be excluded if they enrolled in a protocol #: 2017-0556
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- Prostate cancer survivors will be excluded if they are not able to understand and speak English
- Spouses or romantic partners who are not able to understand and speak English will be excluded
- Also, spouses or romantic partners who enrolled in a protocol (#2017-0556) will be excluded
- There are no exclusion criteria for healthcare providers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Prostate Cancer Disparities Among African Americans
This trial studies how well a lifestyle intervention works in reducing prostate cancer disparities among African American prostate cancer patients and their spouses or romantic partners. A lifestyle intervention may help researchers learn if social support can help African American prostate cancer patients and their partners improve their quality of life, support from their partner, physical activity, diet, and inflammation.
Read the detailed description
PRIMARY OBJECTIVE:
- To expand an existing couple-based behavioral intervention developed for African American (AA) or Hispanic men on active surveillance (Watchful Living; protocol #: 2017-0556) to AA prostate cancer (PCa) survivors who underwent active treatments to examine its feasibility of recruiting AA PCa survivor-partner dyads (N = 40 dyads) and implementing a lifestyle intervention.
SECONDARY OBJECTIVES:
- Evaluate a preliminary efficacy of the intervention in improving quality of life, physical activity, nutrient intake, and inflammation.
II. Explore psychosocial mediators and moderators of the intervention. III. Conduct a process evaluation. IV. Assess healthcare-provider level factors (with N=15 providers) that influence both survivors' and partners' healthy lifestyle behaviors.
OUTLINE: Patients and their partners are randomized to 1 of 2 groups.
GROUP I: Patients and their partners receive an exercise plan and printed materials that includes instructions for walking or other moderate-intensity activities. Patients and their partners also receive coaching calls discussing physical activity and diet related questions, each lasting 45-60 minutes and occurring every 2 weeks for 6 months. In addition, patients and their partners complete 2 nutrition counseling sessions over 1 hour each at baseline and before month 3 with an MD Anderson registered dietitian.
GROUP II: Patients and their partners receive information/materials regarding physical activity and healthy eating.
PROVIDER INTERVIEWS: Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.
- Conditions
- Cancer Survivor, Partner, Spouse, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8
- Being tested
- Exercise Intervention, Informational Intervention, Interview, Nutritional Assessment, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Receive exercise plan
Informational InterventionOther
Receive printed exercise materials
Informational InterventionOther
Receive physical activity and healthy eating information/materials
InterviewOther
Participate in interview
Nutritional AssessmentOther
Also called Dietary Assessment, dietary counseling, nutritional counseling
Complete nutrition counseling sessions
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive coaching calls
| Study group | Role | What they receive |
|---|---|---|
| Group I (exercise plan, coaching calls, nutrition counseling) | Experimental | Patients and their partners receive an exercise plan and printed materials that includes instructions for walking or other moderate-intensity activities. Patients and their partners also receive coaching calls discussing physical activity and diet related questions, each lasting 45-60 minutes and occurring every 2 weeks for 6 months. In addition, patients and their partners complete 2 nutrition counseling sessions over 1 hour each at baseline and before month 3 with an MD Anderson registered dietitian. Receives: Behavioral: Exercise Intervention; Other: Informational Intervention; Other: Nutritional Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention |
| Group II (physical activity/healthy eating information) | Active comparator | Patients and their partners receive information/materials regarding physical activity and healthy eating. Receives: Other: Informational Intervention; Other: Questionnaire Administration |
| Provider Interviews (interviews) | Experimental | Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementing a lifestyle intervention and active surveillance on couple-based behavioral intervention developed for African American (AA) or Hispanic men
We will calculate rates of recruitment and retention, along with 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations (SDs)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start27 Aug 2019
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brander Beacons Cancer Research, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dalnim Cho, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215029
- Sponsor's protocol ID
- 2019-0361
- Other IDs
- NCI-2019-05912, 2019-0361
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2019
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Prostate Cancer Disparities Among African Americans
- ClinicalTrials.gov ID
- NCT04215029
- Acronym / sponsor ID
- 2019-0361
- Conditions
- Cancer Survivor, Partner, Spouse, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Brander Beacons Cancer Research, National Cancer Institute (NCI)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 2 Jan 2020 (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.
This trial studies how well a lifestyle intervention works in reducing prostate cancer disparities among African American prostate cancer patients and their spouses or romantic partners. A lifestyle intervention may help researchers learn if social support can help African American prostate cancer patients and their partners improve their quality of life, support from their partner, physical activity, diet, and inflammation.
Detailed description
PRIMARY OBJECTIVE:
- To expand an existing couple-based behavioral intervention developed for African American (AA) or Hispanic men on active surveillance (Watchful Living; protocol #: 2017-0556) to AA prostate cancer (PCa) survivors who underwent active treatments to examine its feasibility of recruiting AA PCa survivor-partner dyads (N = 40 dyads) and implementing a lifestyle intervention.
SECONDARY OBJECTIVES:
- Evaluate a preliminary efficacy of the intervention in improving quality of life, physical activity, nutrient intake, and inflammation.
II. Explore psychosocial mediators and moderators of the intervention. III. Conduct a process evaluation. IV. Assess healthcare-provider level factors (with N=15 providers) that influence both survivors' and partners' healthy lifestyle behaviors.
OUTLINE: Patients and their partners are randomized to 1 of 2 groups.
GROUP I: Patients and their partners receive an exercise plan and printed materials that includes instructions for walking or other moderate-intensity activities. Patients and their partners also receive coaching calls discussing physical activity and diet related questions, each lasting 45-60 minutes and occurring every 2 weeks for 6 months. In addition, patients and their partners complete 2 nutrition counseling sessions over 1 hour each at baseline and before month 3 with an MD Anderson registered dietitian.
GROUP II: Patients and their partners receive information/materials regarding physical activity and healthy eating.
PROVIDER INTERVIEWS: Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (exercise plan, coaching calls, nutrition counseling) | Experimental | Behavioral: Exercise Intervention, Other: Informational Intervention, Other: Nutritional Assessment, Other: Questionnaire Administration, Behavioral: Telephone-Based InterventionPatients and their partners receive an exercise plan and printed materials that includes instructions for walking or other moderate-intensity activities. Patients and their partners also receive coaching calls discussing physical activity and diet related questions, each lasting 45-60 minutes and occurring every 2 weeks for 6 months. In addition, patients and their partners complete 2 nutrition counseling sessions over 1 hour each at baseline and before month 3 with an MD Anderson registered dietitian. |
| Group II (physical activity/healthy eating information) | Active comparator | Other: Informational Intervention, Other: Questionnaire AdministrationPatients and their partners receive information/materials regarding physical activity and healthy eating. |
| Provider Interviews (interviews) | Experimental | Other: InterviewHealthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- To be eligible, prostate cancer survivors must self-identify as black or African American
- Prostate cancer survivors must have 0-III stage prostate cancer
- Prostate cancer survivors must have completed therapy (e.g., surgery, chemotherapy [chemo] and/or radiation)
- Prostate cancer survivors must enroll with a spouse or a romantic partner
- Prostate cancer survivors must not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week)
Key exclusion criteria (10 listed)
- Prostate cancer survivors will be excluded if they are not married or partnered
- Prostate cancer survivors will be excluded if they have an active noncutaneous malignancy at any site
- Prostate cancer survivors will be excluded if they had a prior history of other cancer or have metastatic cancer
- Prostate cancer survivors will be excluded if they have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period
- Prostate cancer survivors will be excluded if they are on active surveillance
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 |
|---|---|---|
| Exercise InterventionReceive exercise plan | Behavioural | Group I (exercise plan, coaching calls, nutrition counseling) |
| Informational InterventionReceive printed exercise materials | Other | Group I (exercise plan, coaching calls, nutrition counseling) |
| Informational InterventionReceive physical activity and healthy eating information/materials | Other | Group II (physical activity/healthy eating information) |
| InterviewParticipate in interview | Other | Provider Interviews (interviews) |
| Nutritional AssessmentAlso: Dietary Assessment, dietary counseling, nutritional counselingComplete nutrition counseling sessions | Other | Group I (exercise plan, coaching calls, nutrition counseling) |
| Questionnaire AdministrationAncillary studies | Other | Group I (exercise plan, coaching calls, nutrition counseling), Group II (physical activity/healthy eating information) |
| Telephone-Based InterventionReceive coaching calls | Behavioural | Group I (exercise plan, coaching calls, nutrition counseling) |
Primary outcome
Implementing a lifestyle intervention and active surveillance on couple-based behavioral intervention developed for African American (AA) or Hispanic men
Time frame: up to 6 months
We will calculate rates of recruitment and retention, along with 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations (SDs)
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 15 Apr 2026.
- MD Anderson Cancer Center WebsiteLink 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. This study is not recruiting at the moment.
Dalnim Cho principal investigator
M.D. Anderson 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 Exercise Intervention, Informational Intervention and Interview in people with Cancer Survivor and Partner, 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 16 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 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?
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?
Implementing a lifestyle intervention and active surveillance on couple-based behavioral intervention developed for African American (AA) or Hispanic men (time frame: up to 6 months). 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 15 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.