NCT05098002

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2023

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

October 18, 2021

Last Update Submit

February 15, 2024

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility - Enrollment rates

    Number of participants enrolled in virtual classes vs in person classes

    6 weeks

Secondary Outcomes (1)

  • Acceptability

    6 weeks

Study Arms (1)

Mindful based stress classes

EXPERIMENTAL

6 week mindfulness program

Behavioral: Mindfulness program

Interventions

Mindfulness programBEHAVIORAL

6 week class designed to improve psychological well-being

Mindful based stress classes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old
  • Cancer survivor or a caregiver of cancer patient/survivor.

You may not qualify if:

  • 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):
  • Drug addiction (or recent recovery)
  • Bereavement (recent loss)
  • Mental health inpatient (recently discharged)
  • Current depression or other major psychiatric diagnoses (including suicidality or suicidal ideation) that would interfere with participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Elizabeth Bouchard, MD

    Roswell Park Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 28, 2021

Study Start

January 2, 2022

Primary Completion

February 28, 2023

Study Completion

November 28, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

US(1)