A Transplant or Cancer Resilience Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia M. Stonnington, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01629069
First received: June 21, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Behavior
Emotions
Behavioral: Mindfulness based Resilience Training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Resilience Intervention Involving Mindfulness Training for Transplant and Cancer Patients and Their Caregivers

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Patient questionaire [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Participant in MBRT
6 sessions of Mindfulness Based Resilience Training
Behavioral: Mindfulness based Resilience Training
6 weekly group sessions

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 acceptance/adherence 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 program's expenses.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient listed for liver, heart, kidney, or bone marrow transplant
  • Patient who has received a liver, heart, kidney, or bone marrow transplant
  • Caregiver of transplant patient
  • patient with diagnosis of cancer, either active or in remission
  • supportive care partner of cancer patient

Exclusion Criteria

  • Suicidal
  • Severe cognitive impairment
  • psychotic
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629069

Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Cynthia Stonnington, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Cynthia M. Stonnington, M.D., Chair, Department of Psychiatry & Psychology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01629069     History of Changes
Other Study ID Numbers: 12-004988
Study First Received: June 21, 2012
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
stress
mindfulness
coping

ClinicalTrials.gov processed this record on October 21, 2014