Ignite Creation Date:
2024-05-06 @ 2:17 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04270266
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2019-09-12
Brief Title:
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping with Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Mind-Body Medicine for Adolescents and Young Adults AYA Coping with Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 eg mindfulness compassion social connection inflammatory processes and moderation eg 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 eg mindfulness compassion social connection inflammatory processes and moderation eg 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2019-05846 | REGISTRY | None | None |
| 2019-0282 | OTHER | M D Anderson Cancer Center | None |