Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma

March 6, 2024 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (meditation)
Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks.
Other: Questionnaire Administration
Ancillary studies
Other: Meditation Therapy
Attend meditation sessions
Other Names:
  • Meditation
Active Comparator: Group II (educational)
Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks.
Other: Questionnaire Administration
Ancillary studies
Other: Educational Intervention
Attend educational sessions
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological distress and cancer symptoms (tertiary objective) relative to an attention control (AC) group 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
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kathrin Milbury, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2019

Primary Completion (Estimated)

December 21, 2026

Study Completion (Estimated)

December 21, 2026

Study Registration Dates

First Submitted

September 12, 2019

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0282 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2019-05846 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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