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

NCT05056831 | Terminated DMC

• 4 other identifiers: 2020-1278NCI-2021-09572K07CA222335R01HL142732
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group I (physical activity intervention)

EXPERIMENTAL

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; Other: Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (usual care)

ACTIVE COMPARATOR

Patients receive usual care.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Behavioral Intervention BEHAVIORAL

Attend face-to-face mind-body sessions

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Group I (physical activity intervention)

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Group II (usual care)

Informational Intervention OTHER

Receive targeted text messages

Group I (physical activity intervention)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (physical activity intervention); Group II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Group I (physical activity intervention); Group II (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Kawut, Steven, MD: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Anxiety Disorders; Hematologic Neoplasms

Interventions

Behavior Therapy; Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Scherezade Mama, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 27, 2021
• Study Start: June 21, 2021
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

US (1)