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

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

Tracking Information

• First Submitted Date: February 5, 2014
• First Posted Date: February 7, 2014
• Last Update Posted Date: November 29, 2017
• Actual Study Start Date: January 7, 2014
• Actual Primary Completion Date: November 9, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Anxiety Disorder
• Colon Cancer
• Depression
• Fatigue
• Rectal Cancer

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 28, 2016): 94
• Original Estimated Enrollment (submitted: February 5, 2014): 300
• Actual Study Completion Date: November 9, 2017
• Actual Primary Completion Date: November 9, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02057991
• 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 )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Southern California
• Study Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jane Figueiredo; University of Southern California

• PRS Account: University of Southern California
• Verification Date: November 2017