Ignite Creation Date:
2025-12-24 @ 4:00 PM
Ignite Modification Date:
2026-02-20 @ 8:09 PM
Study NCT ID:
NCT04270266
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2019-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Mind-Body Medicine for Adolescents and Young Adults (AYA) Coping With Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: