Multicomponent Physical Activity Intervention for the Reduction of Psychosocial Distress in Cancer Patients
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About
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.
Full description
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:
I. To assess time spent sitting in prolonged bouts of 20 consecutive minutes or more (minutes/day).
II. To assess daily number of steps (collected using the activPAL over 7 days at week 8, data will be averaging over 7 days to get minutes per day).
III. To assess psychosocial distress measured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer scores.
IV. To assess health-related quality of life measured using the SF-36 short form.
OUTLINE:
PART I: Patients and providers complete a questionnaire and attend an interview over 1 hour.
PART II: Patients are randomized to 1 of 2 groups.
GROUP I: 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.
GROUP II: Patients receive usual care.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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)
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
2 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Scherezade Mama, MD
Data sourced from clinicaltrials.gov
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