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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Watch an educational video
Watch a mindfulness exercise video
Watch mindfulness exercise video and/or educational video
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
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).
Time frame: 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.
Time frame: Baseline to up to 60 minutes
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.
Time frame: Baseline to up 60 minutes
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Enrollment
94
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