NCT02057991

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

February 5, 2014

Last Update Submit

November 27, 2017

Conditions

Anxiety DisorderColon CancerDepressionFatigueRectal Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Changes in salivary cortisol levels using chemiluminescence immunoassay

    Baseline to up 60 minutes

Study Arms (3)

Group I (standard of care)

NO INTERVENTION

Patients and caregivers receive standard of care.

Group II (educational video)

EXPERIMENTAL

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

Other: educational interventionOther: caregiver-related intervention or procedureOther: questionnaire administrationOther: laboratory biomarker analysis

Group III (educational video, mindfulness exercise video)

EXPERIMENTAL

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

Other: educational interventionProcedure: CAM exercise therapyOther: caregiver-related intervention or procedureOther: questionnaire administrationOther: laboratory biomarker analysis

Interventions

educational interventionOTHER

Watch an educational video

Also known as: intervention, educational
Group II (educational video)Group III (educational video, mindfulness exercise video)
CAM exercise therapyPROCEDURE

Watch a mindfulness exercise video

Also known as: Exercise Therapy
Group III (educational video, mindfulness exercise video)
caregiver-related intervention or procedureOTHER

Watch mindfulness exercise video and/or educational video

Group II (educational video)Group III (educational video, mindfulness exercise video)
questionnaire administrationOTHER

Ancillary studies

Group II (educational video)Group III (educational video, mindfulness exercise video)
laboratory biomarker analysisOTHER

Correlative studies

Group II (educational video)Group III (educational video, mindfulness exercise video)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Illiterate participants
  • Deaf participants
  • Participants that do not read speak or understand either Spanish or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Anxiety DisordersColonic NeoplasmsDepressionFatigueRectal Neoplasms

Interventions

Early Intervention, EducationalMethodsExercise Therapy

Condition Hierarchy (Ancestors)

Mental DisordersColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsRectal Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative TechniquesRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Jane Figueiredo

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 7, 2014

Study Start

January 7, 2014

Primary Completion

November 9, 2016

Study Completion

November 9, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

US(1)