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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group I (standard of care); Patients and caregivers receive standard of care.
Experimental: Group II (educational video); Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies; Other: educational intervention; Watch an educational video; Other Names: intervention, educational; Other: caregiver-related intervention or procedure; Watch mindfulness exercise video and/or educational video
Experimental: Group III (educational video, mindfulness exercise video); Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies; Other: educational intervention; Watch an educational video; Other Names: intervention, educational; Other: caregiver-related intervention or procedure; Watch mindfulness exercise video and/or educational video; Procedure: CAM exercise therapy; Watch a mindfulness exercise video; Other Names: Exercise Therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in salivary cortisol levels using chemiluminescence immunoassay	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.	Baseline to up 60 minutes

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jane Figueiredo, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2014
• Primary Completion (Actual): November 9, 2016
• Study Completion (Actual): November 9, 2017

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: February 5, 2014
• First Posted (Estimate): February 7, 2014

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 3C-13-6 (Other Identifier: USC Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2014-00164 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA155101 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No