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Clinical Trials/NCT04270266
NCT04270266
Active, not recruiting
Not Applicable

Mind-Body Medicine for Adolescents and Young Adults (AYA) Coping With Lymphoma

M.D. Anderson Cancer Center1 site in 1 country71 target enrollmentSeptember 6, 2019

Overview

Phase
Not Applicable
Intervention
Meditation Therapy
Conditions
Lymphoma
Sponsor
M.D. Anderson Cancer Center
Enrollment
71
Locations
1
Primary Endpoint
Mind-body intervention in (AYAs) Adolescents and Young Adults with Lymphoma Questionnaire
Status
Active, not recruiting
Last Updated
last month

Overview

Brief Summary

This trial studies how well a mind-body intervention works in improving overall quality of life in adolescents and young adults with lymphoma. A meditation based mind-body intervention may help lower distress, depressive symptoms, and anxiety in adolescents and young adults coping with lymphoma.

Detailed Description

PRIMARY OBJECTIVE: I. Examine the feasibility of the mind-body intervention in adolescents and young adults (AYAs) with lymphoma. SECONDARY OBJECTIVE: I. Establish the initial intervention efficacy regarding psychological distress and cancer symptoms (tertiary objective) relative to an attention control (AC) group. EXPLORATORY OBJECTIVE: I. Explore mediation (e.g., mindfulness, compassion, social connection, inflammatory processes) and moderation (e.g., demographic and medical factors) of the intervention effects. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks. GROUP II: Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks. After completion of study intervention, patients are followed at 6 and 12 weeks.

Registry
clinicaltrials.gov
Start Date
September 6, 2019
End Date
December 21, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participants between the ages of 18-39 diagnosed within 6 months with stage I-IV Lymphoma (all types)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or below
  • Having access to the internet
  • Able to read, write and speak English

Exclusion Criteria

  • Major psychiatric or cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
  • Regular (self-defined) participation in psychotherapy or a formal cancer support group

Arms & Interventions

Group I (meditation)

Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks.

Intervention: Meditation Therapy

Group I (meditation)

Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks.

Intervention: Questionnaire Administration

Group II (educational)

Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks.

Intervention: Educational Intervention

Group II (educational)

Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks.

Intervention: Questionnaire Administration

Outcomes

Primary Outcomes

Mind-body intervention in (AYAs) Adolescents and Young Adults with Lymphoma Questionnaire

Time Frame: Up to 12 weeks

We will examine preliminary evidence of intervention efficacy. Meaning and Purpose (1-5) Strongly Disagree 1- Disagree 2, Neither agree or disagree 3, Agree 4, Strongly agree 5. Day-to-Day Experiences (1-6) Almost Always-1, Very frequently-2, Somewhat Frequently -3, Somewhat Infrequently-4, Very Infrequently-5, Almost Never 6

Secondary Outcomes

  • Psychological distress and cancer symptoms (tertiary objective) relative to an attention control (AC) group Questionnaire(Up to 12 weeks)

Study Sites (1)

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