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Trial record 29 of 579 for:    colon cancer | ( Map: California, United States )

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

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorder Colon Cancer Depression Fatigue Rectal Cancer Other: educational intervention Procedure: CAM exercise therapy Other: caregiver-related intervention or procedure Other: questionnaire administration Other: laboratory biomarker analysis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
Actual Study Start Date : January 7, 2014
Actual Primary Completion Date : November 9, 2016
Actual Study Completion Date : November 9, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: educational intervention
Watch an educational video
Other Name: intervention, educational

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

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.
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




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057991


Locations
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United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jane Figueiredo University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02057991     History of Changes
Other Study ID Numbers: 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 )
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Fatigue
Anxiety Disorders
Signs and Symptoms
Mental Disorders