Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/2/2017 |
Start Date: | April 2015 |
End Date: | April 2017 |
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.
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.
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.
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.
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
We found this trial at
17
sites
1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Scott Baker, MD
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Theresa Hahn, PhD
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Navneet Majhail, MD, MS
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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3500 Gaston Avenue
Dallas, Texas 75246
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Jana Reynolds, MD
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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2220 Pierce Ave
Nashville, Tennessee 37232
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Bipin Savani, MD
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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CHapel Hill, North Carolina 27599
Principal Investigator: William Allen Wood, Jr., MD
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Cleveland, Ohio 44194
Principal Investigator: Ehsan Malek, MD
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281 W. Lane Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Samantha Jaglowski, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Gainesville, Florida 32608
Principal Investigator: John Wingard, MD
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Minneapolis, Minnesota 55455
Principal Investigator: Shernan Holtan, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Alison Loren, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Shahrukh Hashmi, MD
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Westwood, Kansas 66205
Principal Investigator: Joseph McGuirk, DO
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