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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04270266
• Other study ID #: 2019-0282
• Secondary ID: NCI-2019-0584620
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 6, 2019
• Est. completion date: December 21, 2026

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: December 21, 2026
• Est. primary completion date: December 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Other:
• Educational Intervention
Attend educational sessions
• Meditation Therapy
Attend meditation sessions
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Psychological distress and cancer symptoms (tertiary objective) relative to an attention control (AC) group 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

External Links

•   University of Texas MD Anderson Cancer Center