Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology

NCT ID: NCT02495376

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-12-31

Brief Summary

We propose to examine the effects of mindfulness based stress reduction (MBSR) on outcomes of health related quality of life, disease symptoms, and biological correlates of stress in a sample of young adults with cancer. The proposed work will serve as an essential foundation for launching a program of clinical stress reduction research with this traditionally underserved population and has the potential to lead to the discovery of specific, modifiable psychosocial, behavioral, and biological mechanisms from which to address the problem of health disparities with this group.

Detailed Description

Primary Objective Examine the feasibility and acceptability of MBSR with YACs. We hypothesize that MBSR will be feasible and acceptable with this population, which will be assessed through examination of response rate and study attrition variables.

Secondary Objectives

1. Evaluate the effects of MBSR on outcomes of health related quality of life and disease symptoms among YACs.

2. Explore the impact of different forms of eHealth maintenance support following the MBSR intervention (instructor-delivered, peer-delivered, no message) to help uphold intervention effects over time.

3. Compare intervention and control groups on changes in biologic measures of stress (blood pressure, pulse, salivary cortisol, CRP and IL-6 biomarkers) over a 32-week period.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group A

Group A participates in the first available MBSR course.

Group Type: ACTIVE_COMPARATOR

MBSR

Intervention Type: BEHAVIORAL

Based primarily on the instruction of mindfulness meditation and yoga, MBSR is a group-based, 8-week program that was developed at the University of Massachusetts Stress Reduction Clinic under the direction of Jon Kabat-Zinn. MBSR is comprised of a structured, developmentally sequenced curriculum that uses a group format to experientially instruct participants in the practice of mindfulness meditation and mindful Hatha yoga. Each session includes different forms of meditation practice, such as cultivating awareness of thoughts, feelings and bodily sensations, and learning to incorporate this awareness during stressful emotional and/or physical life situations.

Group B

Group B waits 16 weeks before participating in the MBSR course.

Group Type: ACTIVE_COMPARATOR

MBSR

Intervention Type: BEHAVIORAL

Based primarily on the instruction of mindfulness meditation and yoga, MBSR is a group-based, 8-week program that was developed at the University of Massachusetts Stress Reduction Clinic under the direction of Jon Kabat-Zinn. MBSR is comprised of a structured, developmentally sequenced curriculum that uses a group format to experientially instruct participants in the practice of mindfulness meditation and mindful Hatha yoga. Each session includes different forms of meditation practice, such as cultivating awareness of thoughts, feelings and bodily sensations, and learning to incorporate this awareness during stressful emotional and/or physical life situations.

Interventions

MBSR

Based primarily on the instruction of mindfulness meditation and yoga, MBSR is a group-based, 8-week program that was developed at the University of Massachusetts Stress Reduction Clinic under the direction of Jon Kabat-Zinn. MBSR is comprised of a structured, developmentally sequenced curriculum that uses a group format to experientially instruct participants in the practice of mindfulness meditation and mindful Hatha yoga. Each session includes different forms of meditation practice, such as cultivating awareness of thoughts, feelings and bodily sensations, and learning to incorporate this awareness during stressful emotional and/or physical life situations.

Intervention Type: BEHAVIORAL

Other Intervention Names

mindfulness based stress reduction

Eligibility Criteria

Inclusion Criteria

• Must have a diagnosis of any cancer between ages 18-39
• Must have signed and dated informed consent form, which includes agreeing to study procedures
• Must be currently between 18-39 years of age
• Must be able to read, write, speak and understand English
• Must be able to perform basic activities of daily living
• Must be cognitively intact and free of serious psychiatric illness
• Must have the ability to use a touchscreen keypad on a tablet device
• Must be willing to commit to either the MBSR course or waitlist control condition
• Must be willing to commit to eHealth intervention maintenance conditions
• Must be willing to complete all assessments

Exclusion Criteria

• Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship
• History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians
• Regular user of mindfulness-based stress reduction or a similar mind-body therapy (e.g., yoga, meditation), which is defined as ≥ 3 times a week for the past 2 weeks

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Robert H. Lurie Cancer Center

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

David Victorson

Associate Professor of Medical Social Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David E Victorson, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Countries

United States

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Related Links

http://acspressroom.wordpress.com/2012/01/06/cancer-in-teens-and-young-adults-not-much-improvement/

American Cancer Society I. Cancer in Teens and Young Adults: Not Much Improvement? Accessed on February 24, 2013.

Other Identifiers

STU00093614

Identifier Type: -

Identifier Source: org_study_id