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

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ClinicalTrials.gov Identifier: NCT02057991
Recruitment Status : Terminated (Insufficient Accrual)
First Posted : February 7, 2014
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date  ICMJE February 5, 2014
First Posted Date  ICMJE February 7, 2014
Last Update Posted Date November 29, 2017
Actual Study Start Date  ICMJE January 7, 2014
Actual Primary Completion Date November 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
  • Change in self-reported stress levels assessed using pre- and post-test assessments [ Time Frame: Baseline to up to 60 minutes ]
    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 [ Time Frame: Baseline to up to 60 minutes ]
    The intervention effects will be examined using multi-level modeling (MLM). These analyses will include chi-square, t-tests, and one way ANOVAs.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
Changes in salivary cortisol levels using chemiluminescence immunoassay [ Time Frame: Baseline to up 60 minutes ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers
Official Title  ICMJE A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anxiety Disorder
  • Colon Cancer
  • Depression
  • Fatigue
  • Rectal Cancer
Intervention  ICMJE
  • Other: educational intervention
    Watch an educational video
    Other Name: intervention, educational
  • Procedure: CAM exercise therapy
    Watch a mindfulness exercise video
    Other Name: Exercise Therapy
  • Other: caregiver-related intervention or procedure
    Watch mindfulness exercise video and/or educational video
  • Other: questionnaire administration
    Ancillary studies
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE
  • No Intervention: Group I (standard of care)
    Patients and caregivers receive standard of care.
  • Experimental: Group II (educational video)
    Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
    Interventions:
    • Other: educational intervention
    • Other: caregiver-related intervention or procedure
    • Other: questionnaire administration
    • Other: laboratory biomarker analysis
  • Experimental: Group III (educational video, mindfulness exercise video)
    Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
    Interventions:
    • Other: educational intervention
    • Procedure: CAM exercise therapy
    • Other: caregiver-related intervention or procedure
    • Other: questionnaire administration
    • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 28, 2016)
94
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2014)
300
Actual Study Completion Date  ICMJE November 9, 2017
Actual Primary Completion Date November 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02057991
Other Study ID Numbers  ICMJE 3C-13-6
NCI-2014-00164 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
3C-13-6 ( Other Identifier: USC Norris Comprehensive Cancer Center )
R01CA155101 ( U.S. NIH Grant/Contract )
P30CA014089 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jane Figueiredo University of Southern California
PRS Account University of Southern California
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP