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



Status:Terminated
Conditions:Anxiety, Colorectal Cancer, Colorectal Cancer, Colorectal Cancer, Cancer, Cancer, Depression, Depression, Other Indications
Therapuetic Areas:Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 65
Updated:12/1/2017
Start Date:January 7, 2014
End Date:November 9, 2017

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

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.

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.

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
We found this trial at
1
site
1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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mi
from
Los Angeles, CA
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