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

Northwestern University

Status: Completed

Conditions: Cancer

Treatments: Behavioral: MBSR

Study type: Interventional

Funder types: Other

Identifiers

NCT02495376

STU00093614

Details and patient eligibility

About

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.

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups

Group A

Active Comparator group

Description:

Group A participates in the first available MBSR course.

Treatment:

Behavioral: MBSR

Group B

Active Comparator group

Description:

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

Treatment:

Behavioral: MBSR