Efficacy of an Adapted Multicomponent Physical Activity Intervention to Reduce Psychosocial Distress in Rural Adults Following Cancer Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To establish a multicomponent intervention that assesses the perspective of health care provider
研究概览
简要总结
This study adapts and assesses the effect of a multicomponent physical activity intervention in reducing psychosocial distress in cancer patients. This study aims to develop a program to help increase physical activity and reduce stress in cancer survivors who live in rural areas.
详细描述
PRIMARY OBJECTIVES:
I. To adapt a multicomponent intervention (HH+AIM) that assesses the perspective of health care provider and cancer survivors about:
Ia. Needs related to psychosocial distress and health behaviors in rural patients with cancer.
Ib. Needs related to implementing interventions within the treatment setting. Ic. Barriers to intervention delivery/participate. Id. Preferred means/methods for referring participants and receiving information related to the intervention.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •PROVIDERS: Work with cancer survivors (e.g., radiation and medical oncologists, oncology nurses, oncology patient navigators, and clinical research coordinators)
- •PROVIDERS: Place of engagement falls within a rural county in Texas
- •PROVIDERS: Able to read, speak, and write in English
- •PROVIDERS: At least 18 years old
- •PROVIDERS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions
- •INTERVIEW SURVIVORS: Men and women >= 18 years of age
- •INTERVIEW SURVIVORS: History of cancer
- •INTERVIEW SURVIVORS: Currently receiving treatment or have recently completed treatment but are still attending appointments at UTHealth North Campus Tyler (=< 1 year)
- •INTERVIEW SURVIVORS: Able to read, speak, and write in English
- •INTERVIEW SURVIVORS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions
- •INTERVENTION SURVIVORS: Men and women >= 18 years of age
- •INTERVENTION SURVIVORS: Received a solid tumor cancer diagnosis stage I-III
- •INTERVENTION SURVIVORS: Receiving radiation therapy or planning to receive radiation therapy for a solid tumor diagnosis for at least 4 weeks
- •INTERVENTION SURVIVORS: Able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner)
- •INTERVENTION SURVIVORS: Physician clearance to participate in the study
- •INTERVENTION SURVIVORS: Physically inactive (=< 60 minutes of moderate or greater physical activity [PA] per week during the past 6 months)
- •INTERVENTION SURVIVORS: Live within MD Anderson's rural catchment area
- •INTERVENTION SURVIVORS: Have a home address where information can be mailed and a working telephone
- •INTERVENTION SURVIVORS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions
- •INTERVENTION SURVIVORS: Able to read, speak, and write in English
- •INTERVENTION SURVIVORS: Able to receive text messages on their smartphone (via cellular data or wireless internet)
排除标准
- •PROVIDERS: Does not work with cancer survivors
- •PROVIDERS: Place of work or engagement falls within an urban/metropolitan county in Texas
- •PROVIDERS: Does not read, speak, or write in English
- •PROVIDERS: Below the age of 18 years
- •INTERVIEW SURVIVORS: No history of cancer
- •INTERVIEW SURVIVORS: Does not read, speak, or write in English
- •INTERVIEW SURVIVORS: Below the age of 18
- •INTERVENTION SURVIVORS: No history of cancer
- •INTERVENTION SURVIVORS: Have absolute contraindications to unassisted physical activity (e.g., acute myocardial infarction, severe orthopedic or musculoskeletal limitations)
- •INTERVENTION SURVIVORS: Currently participating in another intervention to increase physical activity or reduce sedentary behavior
- •INTERVENTION SURVIVORS: Self-report meeting physical activity recommendations (>= 60 minutes of moderate or greater PA per week during the past 6 months)
- •INTERVENTION SURVIVORS: Physical limitations that might be aggravated by participation in moderate-intensity physical activity as measured using the Physical Activity Readiness Questionnaire (PAR-Q), and any physical limitation that prevents engaging in moderate intensity exercise
- •INTERVENTION SURVIVORS: Primary address falls within an urban/metropolitan county in Texas
- •INTERVENTION SURVIVORS: Plan to move from the area or discontinue their treatment at UTHealth North Campus Tyler during the 14-week study period
- •INTERVETION SURVIVORS: Does not read, speak, or write in English
- •INTERVENTION SURVIVORS: Below the age of 18
- •INTERVENTION SURVIVORS: Pregnant or planning to become pregnant during the 14 week study period
研究组 & 干预措施
Group I (physical activity intervention)
Patients attend face-to-face mind-body sessions focused on stretching, breathing, and relaxation twice a week and receive targeted text messages daily on their smartphone for 8 weeks.
干预措施: Behavioral Intervention (Behavioral)
Group I (physical activity intervention)
Patients attend face-to-face mind-body sessions focused on stretching, breathing, and relaxation twice a week and receive targeted text messages daily on their smartphone for 8 weeks.
干预措施: Informational Intervention (Other)
Group I (physical activity intervention)
Patients attend face-to-face mind-body sessions focused on stretching, breathing, and relaxation twice a week and receive targeted text messages daily on their smartphone for 8 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group I (physical activity intervention)
Patients attend face-to-face mind-body sessions focused on stretching, breathing, and relaxation twice a week and receive targeted text messages daily on their smartphone for 8 weeks.
干预措施: Questionnaire Administration (Other)
Group II (usual care)
Patients receive usual care.
干预措施: Best Practice (Other)
Group II (usual care)
Patients receive usual care.
干预措施: Quality-of-Life Assessment (Other)
Group II (usual care)
Patients receive usual care.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
To establish a multicomponent intervention that assesses the perspective of health care provider
时间窗: Through study completion, an average of 1 year
To establish a multicomponent intervention that assesses the perspective of cancer survivors
时间窗: Through study completion, an average of 1 year
次要结局
未报告次要终点