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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056831
• Other study ID #: 2020-1278
• Secondary ID: NCI-2021-0957220
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: Scherezade Mama, MD
• Phone: (713) 563-7546
• Email: SKMama[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Behavioral:
• Behavioral Intervention
Attend face-to-face mind-body sessions

Other:
• Best Practice
Receive usual care
• Informational Intervention
Receive targeted text messages
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish a multicomponent intervention that assesses the perspective of health care provider		Through study completion, an average of 1 year
Primary	To establish a multicomponent intervention that assesses the perspective of cancer survivors		Through study completion, an average of 1 year

External Links

•   M D Anderson Cancer Center