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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- USC Norris Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Group I (standard of care)
Patients and caregivers receive standard of care.
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Experimental: Group II (educational video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
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Correlative studies
Ancillary studies
Watch an educational video
Other Names:
Watch mindfulness exercise video and/or educational video
|
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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.
|
Correlative studies
Ancillary studies
Watch an educational video
Other Names:
Watch mindfulness exercise video and/or educational video
Watch a mindfulness exercise video
Other Names:
|
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
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).
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Baseline to up to 60 minutes
|
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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.
|
Baseline to up to 60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline to up 60 minutes
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jane Figueiredo, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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