Viewing Study NCT01629069



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Study NCT ID: NCT01629069
Status: COMPLETED
Last Update Posted: 2014-10-07
First Post: 2012-06-21

Brief Title: A Transplant or Cancer Resilience Intervention
Sponsor: Mayo Clinic
Organization: Mayo Clinic

Study Overview

Official Title: A Resilience Intervention Involving Mindfulness Training for Transplant and Cancer Patients and Their Caregivers
Status: COMPLETED
Status Verified Date: 2014-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The overall aim of this protocol is to examine patient and care-giver outcomes and acceptance of a new 6 week intervention in Arizona for our transplant and cancer patients and their care-givers designed to improve quality of life decrease perceived stress and improve medical outcomes that has been approved as a pilot clinical program at Mayo Clinic in Arizona
Detailed Description: Transplant medicine and cancer are major strategic foci of Mayo Clinic At Mayo Clinic we are often challenged to respond adequately to the high levels of stress encountered by our transplant patients and their care-givers The overall aim of this project is to pilot a 6 session intervention in Arizona for our transplant and cancer patients and their care-givers designed to improve quality of life decrease perceived stress and improve medical outcomes Demonstration of a feasible and effective program will allow us to offer similar programs at all three sites This program has potential to better meet our transplant patients needs improve outcomes and set us apart from other transplant programs who do not offer this intervention for patients and caregivers Psychiatry already has a good collaboration with transplant medicine with psychiatry screening transplant patients and following a large subset of patients Many of the referrals to psychiatry post-transplant have to do with difficulty managing stress or break-down in care-giver support The proposed program would address this unmet need with a more comprehensive intervention than is currently available at the Mayo Clinic The role of this pilot program is to

Explore the feasibility of routinely offering a resilience intervention involving mindfulness based stress reduction to our solid organ and stem-cell transplant and cancer patients and their care-givers
Pilot a mindfulness-based group treatment for stress reduction to assess its impact using standardized rating tools on transplant patient stress-levels sleep quality anxiety depression medical outcomes and health-care utilization
Examine patient and care-giver acceptanceadherence and satisfaction
Understand the resources both in terms of staffing and fees required to offer this as a clinical program in the future
Explore the reimbursement options for covering the programs expenses

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None