Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers
NCT ID: NCT02057991
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
94 participants
INTERVENTIONAL
2014-01-07
2017-11-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (standard of care)
Patients and caregivers receive standard of care.
No interventions assigned to this group
Group II (educational video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
educational intervention
Watch an educational video
caregiver-related intervention or procedure
Watch mindfulness exercise video and/or educational video
questionnaire administration
Ancillary studies
laboratory biomarker analysis
Correlative studies
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.
educational intervention
Watch an educational video
CAM exercise therapy
Watch a mindfulness exercise video
caregiver-related intervention or procedure
Watch mindfulness exercise video and/or educational video
questionnaire administration
Ancillary studies
laboratory biomarker analysis
Correlative studies
Interventions
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educational intervention
Watch an educational video
CAM exercise therapy
Watch a mindfulness exercise video
caregiver-related intervention or procedure
Watch mindfulness exercise video and/or educational video
questionnaire administration
Ancillary studies
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Deaf participants
* Participants that do not read speak or understand either Spanish or English
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Jane Figueiredo
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2014-00164
Identifier Type: REGISTRY
Identifier Source: secondary_id
3C-13-6
Identifier Type: OTHER
Identifier Source: secondary_id
3C-13-6
Identifier Type: -
Identifier Source: org_study_id