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

University of Southern California

Status: Terminated

Conditions: Colon Cancer; Anxiety Disorder; Depression; Fatigue; Rectal Cancer

Treatments: Other: caregiver-related intervention or procedure; Procedure: CAM exercise therapy; Other: questionnaire administration; Other: laboratory biomarker analysis; Other: educational intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02057991

P30CA014089 (U.S. NIH Grant/Contract)

R01CA155101 (U.S. NIH Grant/Contract)

3C-13-6 (Other Identifier)

NCI-2014-00164 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 3 patient groups

Group I (standard of care)

No Intervention group

Description:

Patients and caregivers receive standard of care.

Group II (educational video)

Experimental group

Description:

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

Treatment:

Other: educational intervention

Other: questionnaire administration

Other: laboratory biomarker analysis

Other: caregiver-related intervention or procedure

Group III (educational video, mindfulness exercise video)

Experimental group

Description:

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

Treatment:

Other: educational intervention

Other: questionnaire administration

Other: laboratory biomarker analysis

Other: caregiver-related intervention or procedure

Procedure: CAM exercise therapy