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Clinical Trials/NCT05056831
NCT05056831
Terminated
Not Applicable

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

M.D. Anderson Cancer Center1 site in 1 country76 target enrollmentJune 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety Disorder
Sponsor
M.D. Anderson Cancer Center
Enrollment
76
Locations
1
Primary Endpoint
To establish a multicomponent intervention that assesses the perspective of health care provider
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 21, 2021
End Date
October 7, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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

Outcomes

Primary Outcomes

To establish a multicomponent intervention that assesses the perspective of health care provider

Time Frame: Through study completion, an average of 1 year

To establish a multicomponent intervention that assesses the perspective of cancer survivors

Time Frame: Through study completion, an average of 1 year

Study Sites (1)

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