NCT04270266

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable lymphoma

Timeline
8mo left

Started Sep 2019

Longer than P75 for not_applicable lymphoma

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Sep 2019Dec 2026

Study Start

First participant enrolled

September 6, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

7.3 years

First QC Date

September 12, 2019

Last Update Submit

March 3, 2026

Conditions

Lymphoma

Keywords

All types of lymphoma

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (1)

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

    Up to 12 weeks

Study Arms (2)

Group I (meditation)

EXPERIMENTAL

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

Other: Meditation TherapyOther: Questionnaire Administration

Group II (educational)

ACTIVE COMPARATOR

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

Other: Educational InterventionOther: Questionnaire Administration

Interventions

Educational InterventionOTHER

Attend educational sessions

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Group II (educational)
Meditation TherapyOTHER

Attend meditation sessions

Also known as: Meditation
Group I (meditation)
Questionnaire AdministrationOTHER

Ancillary studies

Group I (meditation)Group II (educational)

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Cho D, Ahmed S, Snyder S, Kroll J, Chen M, Roth M, Milbury K. Group-Based Support Interventions for Adolescents and Young Adults With Lymphoma: A Pilot Randomized Controlled Trial. Psychooncology. 2025 Dec;34(12):e70343. doi: 10.1002/pon.70343.

    PMID: 41298073DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

Early Intervention, EducationalEducational StatusMethodsMeditation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative TechniquesMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kathrin Milbury

    M.D. Anderson Cancer Center

    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
SPONSOR

Study Record Dates

First Submitted

September 12, 2019

First Posted

February 17, 2020

Study Start

September 6, 2019

Primary Completion (Estimated)

December 21, 2026

Study Completion (Estimated)

December 21, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(1)