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Completed

NCT Number: NCT02495376

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBSR

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.

Other names: mindfulness based stress reduction

Primary outcomes

  1. feasibility assessed through examination of response rate and study attrition variables

    Time frame: week 33

    feasibility assessed through examination of response rate and study attrition variables

Secondary outcomes

  1. effects on health related quality of life accessed through online questionnaires

    Time frame: baseline and study weeks 8, 16, 24, and 32

    effects on health related quality of life accessed through online questionnaires

  2. the impact of eHealth maintenance support accessed through text message response

    Time frame: weekly, for the 8 consecutive weeks after the MBSR course

    the impact of eHealth maintenance support accessed through text message response

  3. compare between-group changes in biologic measures of stress accessed through biomarkers

    Time frame: baseline and study weeks 16 and 32

    compare between-group changes in biologic measures of stress accessed through

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • American Cancer Society, Inc.
  • Robert H. Lurie Cancer Center

Registry information

Official study title

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

Acronym: REDEFINEAYAO

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 13, 2015
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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