Mindfulness Meditation | NCT05098002

Studies
Mindfulness Meditation

NCT05098002

Sponsor

Roswell Park Cancer Institute

Status

Completed

Last Update Posted

Feb 16, 2024Actual

Enrollment

57Actual

Phase

Not Applicable

Conditions

Cancer

Interventions

Mindfulness program

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2022Actual

Primary Completion Date

Feb 28, 2023Actual

Completion Date

Nov 28, 2023Actual

First Submitted Date

Oct 18, 2021

First Submission Date that Met QC Criteria

Oct 18, 2021

First Posted Date

Oct 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2024

Last Update Posted Date

Feb 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindful based stress classes	Experimental	6 week mindfulness program	Behavioral: Mindfulness program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness program	Behavioral	6 week class designed to improve psychological well-being	Mindful based stress classes

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth Bouchard, MD	Roswell Park Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Roswell Park Comprehensive Cancer Center		Buffalo	New York	14263	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided