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Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors

Information source: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adult Hematopoietic Cell Transplant (HCT) Survivors 1-2 Yrs Post Most Recent HCT

Intervention: Individualized Survivorship Care Plan (SCP) (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Center for International Blood and Marrow Transplant Research

Official(s) and/or principal investigator(s):
Elizabeth Murphy, EdD, RN, Study Chair, Affiliation: National Marrow Donor Program
Navneet Majhail, MD, MS, Study Chair, Affiliation: Cleveland Clinic Foundation; National Marrow Donor Program
K Scott Baker, MD, MS, Study Chair, Affiliation: Fred Hutchinson Cancer Research Center

Overall contact:
Lexi Adams, BA, CCRP, Phone: 612-884-8735, Email: aadams@nmdp.org

Summary

This randomized study will compare a personalized Survivorship Care Plan (SCP) template with usual care (no SCP). The investigators hypothesize that the personalized SCP that incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications will enhance patient survivorship confidence in knowledge, increase adherence to recommended healthcare, improve health behaviors and reduce HCT-related emotional distress.

Clinical Details

Official title: Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Change in Confidence in Survivorship Information instrument score

Secondary outcome:

Change in HCT treatment distress instrument score

Change in Health behaviors instrument score

Changes in Healthcare utilization instrument score

Change in Knowledge about transplant exposures instrument score

Change in Quality of life instrument score

Change in Self-efficacy instrument score

Detailed description: This randomized study will compare a personalized Survivorship Care Plan (SCP) template with usual care (no SCP). The investigators hypothesize that the personalized SCP that incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications will enhance patient survivorship confidence in knowledge, increase adherence to recommended healthcare,

improve health behaviors and reduce hematopoietic cell transplant (HCT) - related emotional

distress. The randomized study design will be able to evaluate the efficacy of individualized SCP in enhancing transplant survivor knowledge, health behaviors and health care utilization for recommended preventive care. Most transplant centers do not use a standardized SCP for their HCT recipients, and hence, the control arm would represent prevalent standard of care (e. g., discharge summary, provider-to-provider communication). Transplant centers that will participate in this study will represent a spectrum of center types (e. g., geographic location, center volume, resources and infrastructure) and patient populations (e. g., healthcare disparities, urban/rural population, distance from transplant center). Usual care for each center will be documented at the time of determining center eligibility. The study principal investigators, in consultation with the protocol team, will make the determination about center eligibility after reviewing the centers "usual care" procedures. In order to avoid contamination of the study intervention, centers will be asked not to change their follow-up practices for the period they are enrolling patients on the study. The primary objective of the investigators study is to evaluate the impact of an individualized SCP on survivor knowledge about past diagnostic and treatment details, confidence in knowledge about prevention and treatment of late-effects, access to resources and familial risk of cancer. For this objective, the investigators will compare the change in score on the Confidence in Survivorship Information instrument from baseline to 6 months after the study intervention. Secondary objectives will investigate the influence of individualized SCP on standardized measures of HCT related distress, knowledge of recommended care, health behaviors, self-efficacy, and health care utilization.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult (≥ 18 years at time of allogeneic HCT recipient at participating transplant

centers)

- Survival 1-2 years after most recent HCT with no evidence of relapse, disease

progression, or secondary cancer on last follow-up

- All diagnoses will be eligible

- All transplant types will be eligible (autologous or allogeneic related or unrelated)

- All graft sources will be eligible (bone marrow, peripheral blood or umbilical cord

blood)

- All conditioning regimens will be eligible (in case of allogeneic HCT, patient could

have received myeloablative or non-myeloablative/reduced-intensity conditioning)

- Patient may have received more than one HCT

- Patient must be proficient in English (written and spoken) to complete study

assessments

- Patient must have a valid mailing address within the United States to receive study

materials

- Signed informed consent form from patient

Exclusion Criteria:

- Patients who have received their transplant at a different transplant center will not be

eligible for the study

Locations and Contacts

Lexi Adams, BA, CCRP, Phone: 612-884-8735, Email: aadams@nmdp.org

Mayo Clinic, Scottsdale, Arizona 85259-5499, United States; Recruiting
Clinical Trials Office, Phone: 855-776-0015
Meline Arzumanyan, Phone: 480-342-2082, Email: Arzumanyan.Meline@mayo.edu
Nandita Khera, MD, Principal Investigator

University of Florida, Shands Hospital, Gainesville, Florida 32608, United States; Recruiting
John Wingard, MD, Email: wingajr@ufl.edu
Zachary Hudson, Email: zachary.hudson@medicine.ufl.edu
John Wingard, MD, Principal Investigator

Loyola Medical Center, Maywood, Illinois 60153, United States; Recruiting
Patrick Stiff, MD, Email: pstiff@lumc.edu
Mary Lee, Email: mlee@lumc.edu
Patrick Stiff, MD, Principal Investigator

University of Kansas Cancer Center, Westwood, Kansas 66205, United States; Recruiting
Joseph McGuirk, DO, Email: jmcguirk@kumc.edu
Hilary Dubinsky, Email: hdubinsky@kumc.edu
Joseph McGuirk, DO, Principal Investigator

University of Massachusetts Memorial Medical Center, Worchester, Massachusetts 01655, United States; Recruiting
Rajneesh Nath, MD, Email: Rajneesh.Nath@umassmemorial.org
Cara Gregoire, Email: Cara.gregoire@umassmemorial.org
Rajneesh Nath, MD, Principal Investigator

Karmanos Cancer Institute, Detroit, Michigan 48201, United States; Recruiting
Abhinav Deol, MD, Email: deola@karmanos.org
Kendra Mellert, Email: mellertk@karmanos.org
Abhinav Deol, MD, Principal Investigator

University of Minnesota Medical Center, Minneapolis, Minnesota 55455, United States; Recruiting
Shernan Holtan, MD, Email: sgholtan@umn.edu
Blair Adams, Email: jenki107@umn.edu
Shernan Holtan, MD, Principal Investigator

Mayo Clinic Rochester, Rochester, Minnesota 55905, United States; Recruiting
Shahrukh Hashmi, MD, Email: Hashmi.Shahrukh@mayo.edu
Amy Olofson, Email: Olofson.Amy@mayo.edu
Shahrukh Hashmi, MD, Principal Investigator

Roswell Park Cancer Institute, Buffalo, New York 14263, United States; Recruiting
Theresa Hahn, MD, Email: theresa.hahn@roswellpark.org
Maria Levis, Email: maria.levis@roswellpark.org
Theresa Hahn, PhD, Principal Investigator

UNC Chapel Hill, Chapel Hill, North Carolina 27599, United States; Recruiting
William Allen Wood, Jr., MD, Email: wawood@email.unc.edu
Rebekah Craver, Email: rfcraver@med.unc.edu
William Allen Wood, Jr., MD, Principal Investigator

Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Navneet Majhail, MD, MS, Email: majhain@ccf.org
Melissa Yurch, Email: yurchm@ccf.org
Navneet Majhail, MD, MS, Principal Investigator

University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Not yet recruiting
Basem William, MD, Email: Basem.William@UHhospitals.org
Basem William, MD, Principal Investigator

Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Samantha Jaglowski, MD, Email: Samantha.jaglowski@osumc.edu
Nicholas Voss, Email: Nicholas.voss@osumc.edu
Samantha Jaglowski, MD, Principal Investigator

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Alison Loren, MD, Email: Alison.Loren@uphs.upenn.edu
Lisa Crisalli, Email: Lisa.Crisalli@uphs.upenn.edu
Alison Loren, MD, Principal Investigator

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232, United States; Not yet recruiting
Bipin Savani, MD, Email: bipin.savani@Vanderbilt.Edu
Jessica Piggee, Email: jessica.piggee@vanderbilt.edu
Bipin Savani, MD, Principal Investigator

Baylor University Medical Center, Dallas, Texas 75246, United States; Not yet recruiting
Jana Reynolds, MD, Email: Jana.Reynolds@baylorhealth.edu
Jana Reynolds, MD, Principal Investigator

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States; Recruiting
Scott Baker, MD, Email: ksbaker@fhcrc.org
Sheri Ballard, Email: sballard@fhcrc.org
Scott Baker, MD, Principal Investigator

Additional Information

Starting date: April 2015
Last updated: August 12, 2015

Page last updated: August 23, 2015

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