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Clinical Trials/NCT04270266
NCT04270266Active, not recruitingNot Applicable

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

M.D. Anderson Cancer Center1 site in 1 country71 target enrollmentStarted: September 6, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
71
Locations
1
Primary Endpoint
Mind-body intervention in (AYAs) Adolescents and Young Adults with Lymphoma Questionnaire

Study 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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 39 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Experimental

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

Intervention: Meditation Therapy (Other)

Group I (meditation)

Experimental

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

Intervention: Questionnaire Administration (Other)

Group II (educational)

Active Comparator

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

Intervention: Educational Intervention (Other)

Group II (educational)

Active Comparator

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

Intervention: Questionnaire Administration (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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