A Transplant or Cancer Resilience Intervention

Status Completed

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01629069
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	N/A
Start date	September 2012
Completion date	May 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.