Clinical trial NCT05056831: Multicomponent Physical Activity Intervention for the Reduction of Psychosocial Distress in Cancer Patients
Official title: Efficacy of an Adapted Multicomponent Physical Activity Intervention to Reduce Psychosocial Distress in Rural Adults Following Cancer Diagnosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety Disorder
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Kawut, Steven, MD
First posted: 2021-09-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: To establish a multicomponent intervention that assesses the perspective of health care provider
timeFrame: Through study completion, an average of 1 year
measure: To establish a multicomponent intervention that assesses the perspective of cancer survivors
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Scherezade Mama, MD
role: PRINCIPAL_INVESTIGATOR
References: