Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
- Conditions
- Lymphoma
- Interventions
- Other: Educational InterventionOther: Meditation TherapyOther: Questionnaire Administration
- Registration Number
- NCT04270266
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 71
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I (meditation) Questionnaire Administration Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks. Group II (educational) Educational Intervention Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks. Group II (educational) Questionnaire Administration Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks. Group I (meditation) Meditation Therapy Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks.
- Primary Outcome Measures
Name Time Method Mind-body intervention in (AYAs) Adolescents and Young Adults with Lymphoma Questionnaire Up to 12 weeks 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
Name Time Method Psychological distress and cancer symptoms (tertiary objective) relative to an attention control (AC) group Questionnaire Up to 12 weeks 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
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States