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

Study Overview
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Brief Summary
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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
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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 Evaluate the effects of MBSR on outcomes of health related quality of life and disease symptoms among YACs. 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. 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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: MBSR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Group A participates in the first available MBSR course. | Behavioral: MBSR<br>* 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.<br>* Other names: mindfulness based stress reduction;|
| Active Comparator: Group B<br>Group B waits 16 weeks before participating in the MBSR course. | Behavioral: MBSR<br>* 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.<br>* Other names: mindfulness based stress reduction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility assessed through examination of response rate and study attrition variables | feasibility assessed through examination of response rate and study attrition variables | week 33 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects on health related quality of life accessed through online questionnaires | effects on health related quality of life accessed through online questionnaires | baseline and study weeks 8, 16, 24, and 32 | 
| the impact of eHealth maintenance support accessed through text message response | the impact of eHealth maintenance support accessed through text message response | weekly, for the 8 consecutive weeks after the MBSR course | 
| compare between-group changes in biologic measures of stress accessed through biomarkers | compare between-group changes in biologic measures of stress accessed through | baseline and study weeks 16 and 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YACS, cancer, MBSR