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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: MBSR

• Registration Number: NCT02495376
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-13
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	MBSR	Group B waits 16 weeks before participating in the MBSR course.
Group A	MBSR	Group A participates in the first available MBSR course.

Primary Outcome Measures

Name	Time	Method
feasibility assessed through examination of response rate and study attrition variables	week 33	feasibility assessed through examination of response rate and study attrition variables

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States