NCT05056831TerminatedNot Applicable
Efficacy of an Adapted Multicomponent Physical Activity Intervention to Reduce Psychosocial Distress in Rural Adults Following Cancer Diagnosis
M.D. Anderson Cancer Center2 sites in 1 country76 target enrollmentStarted: June 21, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- To establish a multicomponent intervention that assesses the perspective of health care provider
Study Overview
Brief Summary
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.
Detailed 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
To establish a multicomponent intervention that assesses the perspective of health care provider
Time Frame: Through study completion, an average of 1 year
To establish a multicomponent intervention that assesses the perspective of cancer survivors
Time Frame: Through study completion, an average of 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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