NCT02057991

Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers

A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot trial studies mindfulness-based program in educating patients with colorectal cancer and their caregivers. A mindfulness-based exercise video may help reduce stress and fatigue in patients with colorectal cancer and their caregivers.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the effect of a brief educational program on colorectal cancer knowledge acquisition in a 3-arm randomized clinical trial (Control Group: standard of care; Treatment Group 1: cancer education; Treatment Group 2: mindfulness + cancer education) comparing visual/written educational material with and without mindfulness training to the standard of care. II. To determine the priming effect of a brief mindfulness training on retaining knowledge of colorectal cancer education. III. To determine the joint effect of colorectal cancer education delivered to both the patient and a caregiver on the overall colorectal cancer knowledge. SECONDARY OBJECTIVES: I. To examine the relative changes in psychobiological variables (stress, anxiety, depression, mindfulness, fatigue, life benefit) from pre (T0) to post (T1) intervention in the 3 arms of the clinical trials. II. To measure changes in salivary cortisol levels as an indicator of acute stress reactivity across 4 time points across a one-hour period (i.e., 0 min, 20 min, 40 min, 60 min) during active chemotherapy (T1). III. To determine the moderating effect of baseline peripheral levels of inflammation (interleukin-1 \[IL-1\], IL-6, c-reactive protein \[CRP\] and tumor necrosis factor alpha \[TNFa\]) on the trajectory of salivary cortisol reactivity. OUTLINE: Patients and caregivers are randomized to 1 of 3 groups. GROUP I: Patients and caregivers receive standard of care. GROUP II: Patients and caregivers receive a 20-minute self-playing interactive educational video brochure. GROUP III: Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.

Conditions

• Anxiety Disorder
• Colon Cancer
• Depression
• Fatigue
• Rectal Cancer

Interventions

Type	Name	Description
OTHER	educational intervention	Watch an educational video
PROCEDURE	CAM exercise therapy	Watch a mindfulness exercise video
OTHER	caregiver-related intervention or procedure	Watch mindfulness exercise video and/or educational video
OTHER	questionnaire administration	Ancillary studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-01-07
• Primary completion: 2016-11-09
• Completion: 2017-11-09
• First posted: 2014-02-07
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States