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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers

Conditions
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Anxiety Disorder, Colon Cancer, Depression, Fatigue, Rectal Cancer

Intervention / Treatment
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* Other: educational intervention
* Procedure: CAM exercise therapy
* Other: caregiver-related intervention or procedure
* Other: questionnaire administration
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |