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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Lymphoma

Treatments: Other: Meditation Therapy; Other: Educational Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04270266

2019-0282 (Other Identifier)

NCI-2019-05846 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Group I (meditation)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Meditation Therapy

Group II (educational)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Educational Intervention