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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 39
Updated:4/21/2016
Start Date:June 2014
End Date:December 2016
Contact:Sandra Gutierrez, MEd
Email:sandra.gutierrez@northwestern.edu
Phone:312-503-3465

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

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.

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 a semi-structured debriefing survey at the end of the study and 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, IL-6, and IL-1b biomarkers) over a
32-week period.

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
We found this trial at
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303 East Superior Street
Chicago, Illinois 60611
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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