NCT05056831

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Intervention	Attend face-to-face mind-body sessions
OTHER	Best Practice	Receive usual care
OTHER	Informational Intervention	Receive targeted text messages
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2021-06-21
• Primary completion: 2024-10-07
• Completion: 2024-10-07
• First posted: 2021-09-27
• Last updated: 2024-10-23

Locations

1 site across 1 country: United States