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

Not Applicable

Terminated

• Conditions: Anxiety Disorder; Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm

• Registration Number: NCT05056831
• Lead Sponsor: M.D. Anderson Cancer Center

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:

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.

Study Timeline

• Study Start: 2021-06-21
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Status Verified: 2024-10
• Primary Completion: 2024-10-07
• Study Completion: 2024-10-07
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States