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

Not Applicable

Terminated

• Conditions: Fatigue; Rectal Cancer; Anxiety Disorder; Depression; Colon Cancer
• Interventions: Other: educational intervention; Procedure: CAM exercise therapy; Other: caregiver-related intervention or procedure; Other: questionnaire administration; Other: laboratory biomarker analysis

• Registration Number: NCT02057991
• Lead Sponsor: University of Southern California

Brief 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.

Study Timeline

• Study Start: 2014-01-07
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-07
• Primary Completion: 2016-11-09
• Status Verified: 2017-11
• Study Completion: 2017-11-09
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Patient diagnosed with colorectal cancer
• Patients with at least one more chemotherapy appointment at the time of enrollment
• if patients have a caregiver, patients should agree to bring a caregiver to one of their hospital visits or have the caregiver schedule a separate study visit
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

• Illiterate participants
• Deaf participants
• Participants that do not read speak or understand either Spanish or English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (educational video)	educational intervention	Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
Group II (educational video)	questionnaire administration	Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
Group III (educational video, mindfulness exercise video)	questionnaire administration	Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
Group III (educational video, mindfulness exercise video)	CAM exercise therapy	Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
Group II (educational video)	caregiver-related intervention or procedure	Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
Group II (educational video)	laboratory biomarker analysis	Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
Group III (educational video, mindfulness exercise video)	educational intervention	Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
Group III (educational video, mindfulness exercise video)	caregiver-related intervention or procedure	Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
Group III (educational video, mindfulness exercise video)	laboratory biomarker analysis	Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.

Primary Outcome Measures

Name	Time	Method
Change in self-reported stress levels assessed using pre- and post-test assessments	Baseline to up to 60 minutes	The intervention effects will be examined using multi-level modeling (MLM). These analyses will include chi-square, t-tests, and one way analyses of variance (ANOVAs).
Change in colorectal cancer knowledge assessed using pre- and post-test assessments	Baseline to up to 60 minutes	The intervention effects will be examined using multi-level modeling (MLM). These analyses will include chi-square, t-tests, and one way ANOVAs.

Secondary Outcome Measures

Name	Time	Method
Changes in salivary cortisol levels using chemiluminescence immunoassay	Baseline to up 60 minutes	Cortisol slopes will be calculated with two distinct areas under the curve analyses using the trapezoid formula as outlined by Pruessner 2003. Data values will be entered into a two factor (group by time) multilevel MIXED linear regression model to calculate differences between the three groups. A Scheffe post hoc test will be employed to determine the direction of the differences between the groups.

Trial Locations

Locations (1)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States