Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers
Study Details
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 |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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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.
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To determine the priming effect of a brief mindfulness training on retaining knowledge of colorectal cancer education.
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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:
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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.
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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).
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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
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 Names:
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 Names:
Procedure: CAM exercise therapy
Watch a mindfulness exercise video
Other Names:
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
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient diagnosed with colorectal cancer
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Patients with at least one more chemotherapy appointment at the time of enrollment
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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
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Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
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Illiterate participants
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Deaf participants
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Participants that do not read speak or understand either Spanish or English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3C-13-6
- NCI-2014-00164
- 3C-13-6
- R01CA155101
- P30CA014089