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

NCT02495376 | Completed

• 1 other identifier: STU00093614
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

YACS; cancer; MBSR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  weekly, for the 8 consecutive weeks after the MBSR course

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

  baseline and study weeks 16 and 32

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A participates in the first available MBSR course.

Behavioral: MBSR

Group B

ACTIVE COMPARATOR

Group B waits 16 weeks before participating in the MBSR course.

Behavioral: MBSR

Interventions

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.

Also known as: mindfulness based stress reduction

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• American Cancer Society, Inc.: collaborator
• Robert H. Lurie Cancer Center: collaborator

Study Sites (2)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (90)

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  RESULT

Related Links

• American Cancer Society I. Cancer in Teens and Young Adults: Not Much Improvement? Accessed on February 24, 2013.

MeSH Terms

Conditions

Neoplasms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David E Victorson, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medical Social Sciences

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 13, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)