Clinical trial NCT02057991: Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers
Official title: A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety Disorder
Colon Cancer
Depression
Fatigue
Rectal Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-07
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in self-reported stress levels assessed using pre- and post-test assessments
timeFrame: Baseline to up to 60 minutes
measure: Change in colorectal cancer knowledge assessed using pre- and post-test assessments
timeFrame: Baseline to up to 60 minutes
Secondary outcomes:
measure: Changes in salivary cortisol levels using chemiluminescence immunoassay
timeFrame: Baseline to up 60 minutes
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Jane Figueiredo
role: PRINCIPAL_INVESTIGATOR
References: