Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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.

Patients and their partners receive information/materials regarding physical activity and healthy eating.

Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.

Exercise Intervention

Informational Intervention

Receive physical activity and healthy eating information/materials

Interview

Nutritional Assessment

Questionnaire Administration

Telephone-Based Intervention

Dalnim Cho

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.

Lifestyle Intervention for the Reduction of Prostate Cancer Disparities Among African Americans

Reducing Prostate Cancer Disparities Among African Americans

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)

Brander Beacons Cancer Research

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Carcinoma

Exercise Intervention. All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment.

EXERCISING TOGETHER PROGRAM: Participants complete three exercise sessions (approximately 1 hour per session) per week over 5-8 weeks during radiation treatment. Participants also receive a DVD of a partnered strength training exercise program to continue on their own after radiation is completed.

Questionnaire Administration \& Survey Administration. All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment.

Survey Administration

Kerri Winters-Stone

This pilot clinical trial studies how well the Exercising Together program works in helping couples cope with radiation treatment for prostate cancer. Treatments for cancer can cause side effects for the patient, such as fatigue, add stress for the spousal caregiver, and put strain on the marital relationship. The Exercising Together program is designed to promote teamwork and emotional intimacy during exercise, which itself can help manage fatigue and stress for the patient and spouse, and may facilitate communication between partners about day-to-day energy, abilities, and motivation.

PRIMARY OBJECTIVE:

I. Determine the feasibility and acceptability of offering the Exercising Together program to couples during the time when men are undergoing an 8 week radiation treatment regimen.

SECONDARY OBJECTIVES:

I. Examine the efficacy of partnered strength training on objective physical function, self-report function, symptoms and intimacy in both the patient and his spouse.

OUTLINE:

All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment.

EXERCISING TOGETHER PROGRAM: Participants complete three exercise sessions (approximately 1 hour per session) per week over 5-8 weeks during radiation treatment. Participants also receive a digital video disc (DVD) of a partnered strength training exercise program to continue on their own after radiation is completed.

After completion of the supervised exercise program, participants are followed up at 8 weeks.

Exercising Together During Radiation Treatment

Exercising Together: An Intervention for Couples Coping With Prostate Cancer During Radiation Treatment

Will be determined as the number of couples who enroll out of those approached and the number of couples who opt to participate in Exercising Together versus to participate as controls. Will evaluate using descriptive statistics.

Will be measured by the Physical Performance Battery (PPB), developed for the Established Populations for Epidemiologic Studies of the Elderly study. The PPB consists of three timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4, based on quartiles of performance, then scores are summed. Higher scores indicate better physical function.

The 400m walk test is a self-paced, submaximal exercise test. Participants will be required to move as fast as they can along a 20m course, demarked by two cones, until they have completed 10 laps of the course (400m). The time taken to complete the test will be recorded.

Will be measured by the average attendance at classes over the course of his radiation therapy. This will be calculated as the total number of classes attended divided by the total possible they could attend over the course of radiation therapy. Attendance will be categorized by sessions couples attended together and those where only one partner attends. Will evaluate using descriptive statistics.

Will be measured with the Center for Epidemiological Studies-Depression (CES-D) scale. Scores range from 0-60, with higher scores indicating \> depressive symptomology.

Will be measured from the Symptom Checklist - 90 Anxiety Scale (SCL-90 ANX) which includes 10 items representing anxiety symptoms, scored on a 5 point scale ranging from 0 (not at all) to 4 (extremely).

Physical intimacy behavior of patient and spouse will be measured using the Physical intimacy behavior scale. Respondents are asked to report the frequency with which they engage in, initiate and avoid each of four affectionate and two sexual behaviors. Three scales assess the frequency, initiation and avoidance of affectionate and sexual behaviors.

Spouse strain will be measured with the role overload scale, which assesses the extent a spouse's time and energy are exhausted by demands of care for their partner.

Two types of dyadic coping will be measured. Active engagement assesses the extent to which the survivor (SVR) and spouse view their partner's active involvement and joint problem-solving. Participants respond to five items using a Likert scale from 1 (never) to 5 (very often). Higher scores indicate higher levels of perceived active engagement. Protective buffering assesses the extent to which the SVR and spouse view their partner's use of hiding concerns and denying worries. Participants respond to six items using a Likert scale from 1 (never) to 5 (very often). Higher scores indicate higher levels of perceived protective buffering.

Will measure outside activity with the Modified Godin Leisure-Time Exercise Questionnaire (GLTEQ). This survey, reported in average minutes per week over the past month, will be broken down into four categories: mild effort (minimal effort), moderate exercise (not exhausting), and strenuous exercise (heart beats rapidly), as well as resistance (weight bearing exercise). The questionnaire will be scored three different ways, to better capture different aspects of PA: 1) total activity = vigorous + moderate + mild + resistance 2) physical activity guidelines = moderate + (vigorous x 2) 3) moderate + vigorous.

For couples who opt to participate in Exercising Together will also ask them to fill out a survey asking about their experience in the program. They will be asked to rate their overall experience in the exercise classes using a 1 to 10 likert scale with 1 being poor and 10 being exceptional as well as indicate how much they agree or disagree with perceptions of the class.

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

Patients and partners complete questionnaires over 60 minutes about demographic information, stress, coping, and lifestyle behaviors at baseline and end of study. Patients and partners also receive an accelerometer and complete EMA questionnaire on stress, coping, physical activity, and eating behaviors over 5-10 minutes QID (7:30 am, 11:30 am, 3:30 pm, and 7:30 pm) via an smartphone app for 14 days. Patients and partners also complete a survey on nutrition BIW for a total of 4 surveys.

Accelerometer

Ecological Momentary Assessment

This trial studies the day-to-day stress, social support, and health lifestyle behaviors (such as physical activity and nutrition) in African American patients with stage 0-III prostate cancer survivors and their partners. How patients cope with stress may affect their lifestyle behaviors. This study may help understand not only survivors' behaviors but also partners' behaviors and how they interact.

PRIMARY OBJECTIVES:

I. Examine temporal associations between dyadic coping and health behaviors such as physical activity and diet.

II. Identify social and physical contexts in which health behaviors occur/co-occur among survivors and their partners.

EXPLORATORY OBJECTIVE:

I. Investigate potential moderators for the associations between stress and dyadic coping.

OUTLINE:

Patients and partners complete questionnaires over 60 minutes about demographic information, stress, coping, and lifestyle behaviors at baseline and end of study. Patients and partners also receive an accelerometer and complete Ecological Momentary Assessment (EMA) questionnaire on stress, coping, physical activity, and eating behaviors over 5-10 minutes four time daily (QID; 7:30 am, 11:30 am, 3:30 pm, and 7:30 pm) via an smartphone application (app) for 14 days. Patients and partners also complete a survey on nutrition twice weekly (BIW) for a total of 4 surveys.

Lifestyle Behavior Influences Among African American Patients With Stage 0-III Prostate Cancer Survivors and Their Partners

One Plus One Can Be Greater Than Two: Ecological Momentary Assessment for Black Prostate Cancer Survivors and Partners

To assess the association between the common dyadic coping of partner or survivor and physical activity of the survivor or partner, will construct 2 new variables corresponding to each common dyadic coping variable for each individual.

To assess the association between the common dyadic coping of partner or survivor and nutrition of the survivor or partner, will construct 2 new variables corresponding to each common dyadic coping variable for each individual.

Descriptive analysis (e.g., frequency) will be conducted to examine the places (e.g., home, neighborhood) in which the health behaviors occurred and the number of health behaviors engaged alone and with others (especially with partner). Also, contexts (days of a week and times of a day and place) in which survivors and partners engaged in health behaviors together will be investigated. All analyses will be exploratory in nature.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lifestyle Intervention for the Reduction of Prostate Cancer Disparities Among African Americans	NCT04215029	Cancer Survivor Partner Spouse Stage I Prostat... Stage II Prosta... Stage IIA Prost... Stage IIB Prost... Stage IIC Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros...	Exercise Interv... Informational I... Informational I... Interview Nutritional Ass... Questionnaire A... Telephone-Based...	18 Years -	M.D. Anderson Cancer Center
Exercising Together During Radiation Treatment	NCT03418025	Domestic Partne... Prostate Carcin... Spouse	Exercise Interv... Questionnaire A... Survey Administ...	-	OHSU Knight Cancer Institute
Lifestyle Intervention for the Reduction of Prostate Cancer Disparities Among African Americans	NCT04215029	Cancer Survivor Partner Spouse Stage I Prostat... Stage II Prosta... Stage IIA Prost... Stage IIB Prost... Stage IIC Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros...	Exercise Interv... Informational I... Informational I... Interview Nutritional Ass... Questionnaire A... Telephone-Based...	18 Years -	M.D. Anderson Cancer Center
Exercising Together During Radiation Treatment	NCT03418025	Domestic Partne... Prostate Carcin... Spouse	Exercise Interv... Questionnaire A... Survey Administ...	-	OHSU Knight Cancer Institute
Lifestyle Behavior Influences Among African American Patients With Stage 0-III Prostate Cancer Survivors and Their Partners	NCT04189770	Cancer Survivor Partner Spouse Stage I Prostat... Stage II Prosta... Stage IIA Prost... Stage IIB Prost... Stage IIC Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros...	Accelerometer Ecological Mome... Questionnaire A... Survey Administ...	18 Years -	M.D. Anderson Cancer Center
Lifestyle Behavior Influences Among African American Patients With Stage 0-III Prostate Cancer Survivors and Their Partners	NCT04189770	Cancer Survivor Partner Spouse Stage I Prostat... Stage II Prosta... Stage IIA Prost... Stage IIB Prost... Stage IIC Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros...	Accelerometer Ecological Mome... Questionnaire A... Survey Administ...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for spouse

Every month we try and update this database with for spouse cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for spouse

Every month we try and update this database with for spouse cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for spouse cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.