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 |
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.
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.
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
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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