跳至主要内容
临床试验/NCT04189770
NCT04189770进行中(未招募)不适用

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

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
2
主要终点
Physical activity in both patients and partners

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Survivors are eligible if they self-identify as African American adults
  • Had stage 0-III prostate cancer (no restriction on time elapsed since diagnosis)
  • Completed adjuvant therapy (i.e., chemo and/or radiation therapy)
  • Live together with a current partner/spouse who is eligible for the study
  • Do not need physical assistance (e.g., wheelchair, cane)
  • Have a smartphone
  • Can read and speak English
  • Currently are not participating in a health behavior or weight management program
  • Men on active surveillance will be included
  • Partners are eligible if they are adults
  • Partners are eligible if they do not have serious medical conditions (e.g., cancer, congestive heart failure, stroke, and dementia)
  • Partners are eligible if they have a smartphone
  • Partners are eligible if they can read and speak English
  • Partners are eligible if they currently are not participating in a health behavior or weight management program
  • The dyad can be either married or unmarried and same-sex or heterosexual

排除标准

  • Survivors will be excluded if they had a prior history of other cancer or have metastatic cancer

研究组 & 干预措施

Observational (questionnaire, accelerometer, EMA, survey)

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.

干预措施: Accelerometer (Device)

Observational (questionnaire, accelerometer, EMA, survey)

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.

干预措施: Ecological Momentary Assessment (Other)

Observational (questionnaire, accelerometer, EMA, survey)

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.

干预措施: Questionnaire Administration (Other)

Observational (questionnaire, accelerometer, EMA, survey)

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.

干预措施: Survey Administration (Other)

结局指标

主要结局

Physical activity in both patients and partners

时间窗: Up to 14 days

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.

Nutrition in both patients and partners

时间窗: Up to 14 days

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.

Stress in both patients and partners

时间窗: Up to 14 days

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.

Social and physical contexts where health behaviors occur/co-occur among survivors and partners

时间窗: Up to 14 days

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验