A Transplant or Cancer Resilience Intervention

Behavior Clinical Trial

Official title:

A Resilience Intervention Involving Mindfulness Training for Transplant and Cancer Patients and Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629069
• Other study ID #: 12-004988
• Status: Completed
• Phase: N/A
• First received: June 21, 2012
• Last updated: October 6, 2014
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Behavior
• Emotions

Intervention

Behavioral:
• Mindfulness based Resilience Training
6 weekly group sessions

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient questionaire		baseline to 6 weeks	No