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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-05912 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0361 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| Brander Beacons Cancer Research | UNKNOWN |
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVE:
I. 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:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Group II (physical activity/healthy eating information) | Active Comparator | Patients and their partners receive information/materials regarding physical activity and healthy eating. |
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| Provider Interviews (interviews) | Experimental | Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Receive exercise plan |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalnim Cho | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Informational Intervention | Other | Receive printed exercise materials |
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| Informational Intervention | Other | Receive physical activity and healthy eating information/materials |
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| Interview | Other | Participate in interview |
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| Nutritional Assessment | Other | Complete nutrition counseling sessions |
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| Questionnaire Administration | Other | Ancillary studies |
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| Telephone-Based Intervention | Behavioral | Receive coaching calls |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015991 | Epidemiologic Measurements |
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