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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02057991
• Other study ID #: 3C-13-6
• Secondary ID: NCI-2014-001643C
• Status: Terminated
• Phase: N/A
• First received: February 5, 2014
• Last updated: November 27, 2017
• Start date: January 7, 2014
• Est. completion date: November 9, 2017

Study information

• Verified date: November 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 94
• Est. completion date: November 9, 2017
• Est. primary completion date: November 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Colon Cancer
• Colorectal Neoplasms
• Depression
• Fatigue
• Rectal Cancer

Intervention

Other:
• educational intervention
Watch an educational video

Procedure:
• CAM exercise therapy
Watch a mindfulness exercise video

Other:
• caregiver-related intervention or procedure
Watch mindfulness exercise video and/or educational video
• questionnaire administration
Ancillary studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline to up to 60 minutes
Primary	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.	Baseline to up to 60 minutes
Secondary	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.	Baseline to up 60 minutes