Clinical trial NCT02495376: Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology
Official title: REDEFINE AYAO: Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: YACS
cancer
MBSR
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Robert H. Lurie Cancer Center
First posted: 2015-07-13
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: feasibility assessed through examination of response rate and study attrition variables
timeFrame: week 33
Secondary outcomes:
measure: effects on health related quality of life accessed through online questionnaires
timeFrame: baseline and study weeks 8, 16, 24, and 32
measure: the impact of eHealth maintenance support accessed through text message response
timeFrame: weekly, for the 8 consecutive weeks after the MBSR course
measure: compare between-group changes in biologic measures of stress accessed through biomarkers
timeFrame: baseline and study weeks 16 and 32
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: David E Victorson, PhD
role: PRINCIPAL_INVESTIGATOR
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