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

Primary Purpose

Lymphoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Meditation Therapy
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma focused on measuring All types of lymphoma

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (meditation)

Group II (educational)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2019
Last Updated
September 1, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04270266
Brief Title
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
Official Title
Mind-Body Medicine for Adolescents and Young Adults (AYA) Coping With Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 6, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
All types of lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (meditation)
Arm Type
Experimental
Arm Description
Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks.
Arm Title
Group II (educational)
Arm Type
Active Comparator
Arm Description
Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Attend educational sessions
Intervention Type
Other
Intervention Name(s)
Meditation Therapy
Other Intervention Name(s)
Meditation
Intervention Description
Attend meditation sessions
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Mind-body intervention in (AYAs) Adolescents and Young Adults with Lymphoma Questionnaire
Description
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
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Psychological distress and cancer symptoms (tertiary objective) relative to an attention control (AC) group Questionnaire
Description
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
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathrin Milbury
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center

Learn more about this trial

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

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