Watchful Living: A Lifestyle Intervention for Black and Hispanic Prostate Cancer Patients and Their Partners
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Intervention adherence
研究概览
简要总结
This pilot trial studies how well Watchful Living works in improving quality of life in participants with prostate cancer that has not spread to other parts of the body who are on active surveillance and their partners. A social support lifestyle intervention (called Watchful Living) may help African American prostate cancer participants and their partners improve their quality of life, physical activity, diet, and inflammation.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of recruiting and implementing a lifestyle intervention for prostate cancer patients and their partners.
SECONDARY OBJECTIVES:
I. To evaluate the preliminary efficacy of a lifestyle intervention in improving diet, physical activity, physical fitness, partner's support, quality of life, and inflammation at the end of the study (month 6).
II. To conduct a process evaluation of the lifestyle intervention. III. Explore participants' satisfaction, likes/dislikes, strengths, weaknesses, and areas of improvement regarding the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identify as black or African American or Hispanic (patient)
- •Be greater than 18 years of age (patient and spouse or intimate partner)
- •Have 0-III stage prostate cancer (patient)
- •If treated, have completed therapy (e.g., surgery, chemo and/or radiation) (patient)
- •Enroll with a spouse or intimate partner (patient)
- •Do not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week) (patient and spouse or intimate partner)
- •Be ready and able to be physically active, as determined by a physician (letter from a physician or nurse practitioner) (patient and spouse or intimate partner)
- •Not participate in another physical activity, diet, or lifestyle program (patient)
- •Have a valid home address and telephone number (patient)
- •Internet access at home or other location (e.g., work, church, library, community center, etc.) (spouse or intimate partner)
- •Patients on active surveillance will be included
排除标准
- •They have an active noncutaneous malignancy at any site (patient)
- •Had prior radiation therapy for treatment of the primary tumor (patient)
- •Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period (patient)
- •Are enrolled in another active surveillance protocol (patient)
- •Participated in formative focus groups for this study (patient and spouse or intimate partner)
研究组 & 干预措施
Supportive care (exercise, nutrition counseling)
Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.
干预措施: Counseling (Other)
Supportive care (exercise, nutrition counseling)
Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.
干预措施: Informational Intervention (Other)
Supportive care (exercise, nutrition counseling)
Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.
干预措施: Quality-of-Life Assessment (Other)
Supportive care (exercise, nutrition counseling)
Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.
干预措施: Questionnaire Administration (Other)
Supportive care (exercise, nutrition counseling)
Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.
干预措施: Telephone-Based Intervention (Behavioral)
结局指标
主要结局
Intervention adherence
时间窗: Up to 8 months
The intervention adherence rate for each dyad is defined as the proportion of intervention sessions completed by both the patient and partner. Will also look at percentage of both patient and partner completing a minimum of 7 out of 10 coaching calls and both nutrition counseling sessions.
Recruitment and retention
时间窗: Up to 8 months
Rates of study eligibility, recruitment, and retention will be assessed. Will maintain detailed information during the recruitment process regarding numbers of patients and their partners interested, eligible, ineligible (and reasons for ineligibility), and enrolled (and reasons for choosing not to enroll if deemed eligible). Will calculate rates of study eligibility, recruitment, and retention, along with 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations (SDs), along with graphical display (e.g., box plots). Will also assess reasons for withdrawal from study among those that chose to withdraw. Will examine the differences between dropout and non-dropout group at each time point by demographic factors such as age, gender, marital status, education, and income.
次要结局
- Elements of the intervention that were successful and/or need improvements(Up to 8 months)
- Surveillance lifestyle(Up to 8 months)