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

• ClinicalTrials.gov Identifier: NCT02057991
• Recruitment Status: Terminated
• First Posted: February 7, 2014
• Last Update Posted: November 29, 2017
• Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Southern California

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anxiety Disorder; Colon Cancer; Depression; Fatigue; Rectal Cancer	Other: educational intervention; Procedure: CAM exercise therapy; Other: caregiver-related intervention or procedure; Other: questionnaire administration; Other: laboratory biomarker analysis	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
• Actual Study Start Date: January 7, 2014
• Actual Primary Completion Date: November 9, 2016
• Actual Study Completion Date: November 9, 2017

Arms and Interventions

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: educational intervention; Watch an educational video; Other Name: intervention, educational; 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
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: educational intervention; Watch an educational video; Other Name: intervention, educational; Procedure: CAM exercise therapy; Watch a mindfulness exercise video; Other Name: Exercise Therapy; 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

Outcome Measures

Primary Outcome Measures :

1. Change in self-reported stress levels assessed using pre- and post-test assessments [ Time Frame: 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).
2. Change in colorectal cancer knowledge assessed using pre- and post-test assessments [ Time Frame: 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 :

1. Changes in salivary cortisol levels using chemiluminescence immunoassay [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Sponsors and Collaborators

University of Southern California

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jane Figueiredo; University of Southern California

More Information

• Responsible Party: University of Southern California
• ClinicalTrials.gov Identifier: NCT02057991
• Other Study ID Numbers: 3C-13-6; NCI-2014-00164 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 3C-13-6 ( Other Identifier: USC Norris Comprehensive Cancer Center ); R01CA155101 ( U.S. NIH Grant/Contract ); P30CA014089 ( U.S. NIH Grant/Contract )
• First Posted: February 7, 2014
• Last Update Posted: November 29, 2017
• Last Verified: November 2017

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders