Clinical trial NCT01629069: A Transplant or Cancer Resilience Intervention
Official title: A Resilience Intervention Involving Mindfulness Training for Transplant and Cancer Patients and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Emotions
Keywords: stress
mindfulness
coping
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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 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

Primary outcomes:
measure: Patient questionaire
timeFrame: baseline to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Cynthia Stonnington, MD
role: PRINCIPAL_INVESTIGATOR
References: