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

Primary Purpose

Anxiety Disorder, Colon Cancer, Depression

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
CAM exercise therapy
caregiver-related intervention or procedure
questionnaire administration
laboratory biomarker analysis
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Group I (standard of care)

Group II (educational video)

Group III (educational video, mindfulness exercise video)

Arm Description

Patients and caregivers receive standard of care.

Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.

Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 5, 2014
Last Updated
November 27, 2017
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02057991
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Accrual
Study Start Date
January 7, 2014 (Actual)
Primary Completion Date
November 9, 2016 (Actual)
Study Completion Date
November 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Colon Cancer, Depression, Fatigue, Rectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (standard of care)
Arm Type
No Intervention
Arm Description
Patients and caregivers receive standard of care.
Arm Title
Group II (educational video)
Arm Type
Experimental
Arm Description
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
Arm Title
Group III (educational video, mindfulness exercise video)
Arm Type
Experimental
Arm Description
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Watch an educational video
Intervention Type
Procedure
Intervention Name(s)
CAM exercise therapy
Other Intervention Name(s)
Exercise Therapy
Intervention Description
Watch a mindfulness exercise video
Intervention Type
Other
Intervention Name(s)
caregiver-related intervention or procedure
Intervention Description
Watch mindfulness exercise video and/or educational video
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Change in self-reported stress levels assessed using pre- and post-test assessments
Description
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
Title
Change in colorectal cancer knowledge assessed using pre- and post-test assessments
Description
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
Secondary Outcome Measure Information:
Title
Changes in salivary cortisol levels using chemiluminescence immunoassay
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Figueiredo
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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

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