Mindfulness Meditation

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Mindfulness program

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Enrollment rates	Number of participants enrolled in virtual classes vs in person classes	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Percentage of participants who choose in person classes vs. virtual classess	6 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: I 1946021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No