Multicomponent Physical Activity Intervention for the Reduction of Psychosocial Distress in Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of an Adapted Multicomponent Physical Activity Intervention to Reduce Psychosocial Distress in Rural Adults Following Cancer Diagnosis

Conditions
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Anxiety Disorder, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Behavioral: Behavioral Intervention
* Other: Best Practice
* Other: Informational Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (physical activity intervention)<br>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. | Behavioral: Behavioral Intervention<br>* Attend face-to-face mind-body sessions<br>* Other names: Behavioral Treatments;Other: Informational Intervention<br>* Receive targeted text messages<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (usual care)<br>Patients receive usual care. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish a multicomponent intervention that assesses the perspective of health care provider |  | Through study completion, an average of 1 year | 
| To establish a multicomponent intervention that assesses the perspective of cancer survivors |  | Through study completion, an average of 1 year |