Mindfulness Meditation

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05098002
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.1
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

To offer Roswell Park patients and caregivers a variety of options to reduce their stress and improve their psychological well-being amidst the difficulty of cancer

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Mindfulness program	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Mindfulness Meditation
• Actual Study Start Date: Oct 29, 2021
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindful based stress classes 6 week mindfulness program	Behavioral: Mindfulness program; 6 week class designed to improve psychological well-being

Outcome Measures

Primary Outcome Measures

1. Feasibility - Enrollment rates [6 weeks]

   Number of participants enrolled in virtual classes vs in person classes

Secondary Outcome Measures

1. Acceptability [6 weeks]

   Percentage of participants who choose in person classes vs. virtual classess

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Being over 18 years old

• Cancer survivor or a caregiver of cancer patient/survivor.

Exclusion Criteria:

• Unwilling or unable to complete the assessment in English.

• Are unwilling or unable to follow protocol requirements.

• Have any condition which in the Investigator's opinion deems the subject an unsuitable candidate to participate in this study including (based on criteria from the

Mindfulness-based stress reduction (MBSR) authorized curriculum guide):

1. Drug addiction (or recent recovery)

2. Bereavement (recent loss)

3. Mental health inpatient (recently discharged)

4. Current depression or other major psychiatric diagnoses (including suicidality or suicidal ideation) that would interfere with participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Comprehensive Cancer Center	Buffalo	New York	United States	14263

Sponsors and Collaborators

• Roswell Park Cancer Institute

Investigators

• Principal Investigator: Elizabeth Bouchard, MD, Roswell Park Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT05098002
• Other Study ID Numbers: I 1946021
• First Posted: Oct 28, 2021
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 4, 2022