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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02495376
Recruitment Status : Completed
First Posted : July 13, 2015
Last Update Posted : December 4, 2019
Sponsor:
Collaborators:
American Cancer Society, Inc.
Robert H. Lurie Cancer Center
Information provided by (Responsible Party):
David Victorson, 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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: MBSR Not Applicable

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, IL-6, and IL-1b biomarkers) over a 32-week period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: REDEFINE AYAO: Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology
Actual Study Start Date : June 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Group A
Group A participates in the first available MBSR course.
Behavioral: MBSR
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 Name: mindfulness based stress reduction

Active Comparator: Group B
Group B waits 16 weeks before participating in the MBSR course.
Behavioral: MBSR
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 Name: mindfulness based stress reduction




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495376


Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
American Cancer Society, Inc.
Robert H. Lurie Cancer Center
Investigators
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Principal Investigator: David E Victorson, PhD Northwestern University
Additional Information:
Publications of Results:
Eyberg S, Edwards D, Boggs S, Foote R. Maintaining the Treatment Effects of Parent Training: The Role of Booster Sessions and Other Maintenance Strategies. Clinical Psychology: Science and Practice. 1998 1998;5:544-554.

Other Publications:
Victorson D, Cella D, Wagner LI, Kramer L, Smith ML. Measuring quality of life in cancer survivors. In: Feuerstein M, ed. Handbook of cancer survivorship. New York, NY: Springer; 2007:79-112.
NCCAM Definition of Mind Body Medicine. 2011.
Kabat-Zinn J. Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. New York: Dell Publishing; 1990.
Bishop SR, Lau M, Shapiro S, et al. Mindfulness: A Proposed Ooperational Definition. Clinical Psychology: Science and Practice. 2004 2004;11(3):230-241.
Chang C-H, Cella D. Equating health-related quality of life instruments in applied oncology settings. Physical Medicine and Rehabilitation: States of the Art Reviews. 1997 1997;11(2):397-406.
Hambleton RK. Principles and selected applications of Item Response Theory. In: Linn R, ed. Educational Measurement: Third Edition. New York: American Council on Education; 1989:147-200.
Gershon RC. The effect of individual differences variables on the assessment of ability for computerized adaptive testing, Northwestern University; 1996.
Lai J-S, Cella D, Choi S, Teresi JA, Hays RD, Stone AA. Developing a fatigue item bank for the Patient-Reported Outcomes Measurement Information System (PROMIS FIB version 1). Presented at the Meeting of the Survey Methods in Multicultural, Multinational, and Multiregional Contexts (3MC), Berlin, Germany. 2008.
Research OoBaSS. Progress and promise in research on social and cultural dimensions of health: A research agenda. Bethesda, MD: National Institutes of Health; 2001.
Stanton AL, Bower JE, Low CA. Posttraumatic growth after cancer. In: Calhoun LG, Tedeschi RG, editors. Handbook of Posttraumatic Growth: Research and Practice. Mahwah: Lawrence Erlbaum Associates, Inc; 2006:138-175.
Victorson D, Hankin V, Polster R, McCurdy M, McGuire M, Brendler C. Reducing Symptoms of Anxiety for Men with Prostate Cancer on Active Surveillance and their Spouses: Initial Findings from a Randomized Clinical Trial. The Journal of Urology. 2010 2010;138(4):e180-e181.
Hankin V. Mindfulness Based Stress Reduction in Couples Battling Multiple Sclerosis. Midwestern Psychological Association. 2008 2008;18th Annual Meeting:12.

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Responsible Party: David Victorson, Associate Professor of Medical Social Sciences, Northwestern University
ClinicalTrials.gov Identifier: NCT02495376    
Other Study ID Numbers: STU00093614
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Victorson, Northwestern University:
YACS
cancer
MBSR