Efficacy of an Adapted Multicomponent Physical Activity Intervention to Reduce Psychosocial Distress in Rural Adults Following Cancer Diagnosis
Study Details
Study Description
Brief Summary
This study is to adapt and evaluate a multicomponent intervention to reduce sedentary behavior and improve psychosocial distress and quality of life in rural cancer survivors currently receiving treatment. The multicomponent intervention combines Harmony & Health (HH),40,41 a face-to-face light-intensity physical activity intervention to reduce sedentary behavior and psychosocial distress, with AIM,42 a smartphonebased personalized messaging intervention, to motivate participants to move more and sit less.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Primary Objective
To adapt a multicomponent intervention (HH+AIM) that assesses the perspective of health care provider and cancer survivors about: 1) needs related to psychosocial distress and health behaviors in rural patients with cancer, 2) needs related to implementing interventions within the treatment setting, 3) barriers to intervention delivery/participate, and 4) preferred means/methods for referring participants and receiving information related to the intervention.
Secondary Objectives
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To assess time spent sitting in prolonged bouts of 20 consecutive minutes or more (minutes/day)
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To assess daily number of steps (collected using the activPALTM over 7 days at week 8, data will be averaging over 7 days to get minutes per day)
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To assess psychosocial distress measured using the NCCN Distress Thermometer scores
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To assess health-related quality of life measured using the SF-36 short form
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: In-Depth Interviews-First The first interviews with health care providers and clinical stakeholders |
Other: First Interview
1) needs related to psychosocial distress and health behaviors in rural patients with cancer, 2) needs related to implementing interventions within the treatment setting, 3) barriers to intervention delivery at UTHealth North Campus Tyler, and 4) preferred means/methods for referring participants and receiving information related to the intervention.
|
| Other: In Depth Interviews-Second The second interview guide for interviews with rural cancer survivors |
Other: Second Interview
1) needs related to psychosocial distress and health behaviors, 2) barriers and facilitators to participating in a multicomponent intervention during treatment (e.g., barriers related face-to-face vs.
videoconference delivery, text messaging, dose, etc.), 3) preferred methods for receiving health information and the intervention (e.g., mode, delivery agent), 4) additional cultural adaptations needed for rural cancer patients and survivors, and 5) availability of support and resources that will aid participation
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| Other: 8-week multicomponent intervention Participants randomized to the multicomponent intervention group will attend mind-body sessions focused on stretching, breathing, and relaxation twice a week for eight weeks (16 sessions total). |
Other: 8-week multicomponent intervention
Participants will be attending the Mind-body sessions that are 45 minutes in length, consisting of a 5-minute introduction, 30 minutes of gentle yoga-like poses, and 10 minutes of breathing and guided relaxation.
|
| Other: Usual Care Participants randomized to the usual care group will be given educational materials at one time point (following baseline) on the benefits of physical activity while receiving cancer treatment. |
Other: Usual Care
Participants will be given educational materials at one time point (following baseline) on the benefits of physical activity while receiving cancer treatment
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- To establish time spent sitting in prolonged bouts of 20 consecutive minutes or more (minutes/day) [through study completion, an average of 1 year]
- To establish the daily number of steps (collected using the activPAL over 7 days at week 8; data will be averaged over 7 days to get minutes per day) [Up to 8 weeks]
- To establish the psychosocial distress measured using the NCCN Distress Thermometer scores. [through study completion, an average of 1 year]
Score Scales ranges (0-10) with 10 indicating extreme distress
- To establish the health-related quality of life measured using the SF-36 short form [through study completion, an average of 1 year]
Score Scale ranges (0-100) for scales measuring physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Higher average scores for each scale indicate better quality of life for that area.
Eligibility Criteria
Criteria
In-depth Interviews - Health Care Providers
Inclusion Criteria:
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Work with cancer survivors (e.g., radiation and medical oncologists, oncology nurses, oncology patient navigators, and clinical research coordinators)
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Place of engagement falls within a rural county in Texas
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Able to read, speak, and write in English
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At least 18 years old
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Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions
Exclusion Criteria:
- Does not work with cancer survivors 2) Place of work or engagement falls within an urban/metropolitan county in Texas 3) Does not read, speak, or write in English 4) Below the age of 18 years In-depth Interviews - Rural Cancer Survivors Inclusion Criteria.
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Men and Women ≥18 years of age
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History of cancer 2020-1278 PI: Mama February 8, 2021 Protocol - Page 4 of 22
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Currently receiving treatment or have recently completed treatment but are still attending appointments at UTHealth North Campus Tyler (≤ 1 year)
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Able to read, speak, and write in English
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Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions
Exclusion Criteria:
- No history of cancer 2) Does not read, speak, or write in English 3) Below the age of 18 Multicomponent Intervention in Rural Cancer Survivors Inclusion Criteria.
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Men and Women ≥18 years of age
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Received a solid tumor cancer diagnosis stage I-III
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Receiving radiation therapy or planning to receive radiation therapy for a solid tumor diagnosis for at least 4 weeks
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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).
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Physician clearance to participate in the study
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Physically inactive (≤60 minutes of moderate or greater PA per week during the past 6 months)
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Live within MD Anderson's rural catchment area
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Have a home address where information can be mailed and a working telephone
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Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions
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Able to read, speak, and write in English
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Able to receive text messages on their smartphone (via cellular data or wireless internet)
Exclusion Criteria:
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No history of cancer
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Have absolute contraindications to unassisted physical activity (e.g., acute myocardial infarction, severe orthopedic or musculoskeletal limitations)
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Currently participating in another intervention to increase physical activity or reduce sedentary behavior
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Self-report meeting physical activity recommendations (>60 minutes of moderate or greater PA per week during the past 6 months)
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Physical limitations that might be aggravated by participation in moderate-intensity physical activity as measured using the PAR-Q, and any physical limitation that prevents engaging in moderate intensity exercise.
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Primary address falls within an urban/metropolitan county in Texas
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Plan to move from the area or discontinue their treatment at UTHealth North Campus Tyler during the 14-week study period
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Does not read, speak, or write in English
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Below the age of 18
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Pregnant or planning to become pregnant during the 14 week study period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- American Institute for Cancer Research
Investigators
- Principal Investigator: Scherezade K Mama, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2020-1278
- NCI-2021-09572