Adult Hematopoietic Cell Transplant (HCT) Survivors 1-2 Yrs Post Most Recent HCTNCT02200133
Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors
A study testing Individualized Survivorship Care Plan (SCP) in people with Adult Hematopoietic Cell Transplant (HCT) Survivors 1-2 Yrs Post Most Recent HCT, run by Center for International Blood and Marrow Transplant Research at 17 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Hematopoietic Cell Transplant (HCT) Survivors 1-2 Yrs Post Most Recent HCT
- What is being tested?
- Individualized Survivorship Care Plan (SCP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- Patients who have received their transplant at a different transplant center will not be eligible for the study
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Baylor University Medical Center
Dallas, Texas, 75246
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Florida, Shands Hospital
Gainesville, Florida, 32608
Loyola Medical Center
Maywood, Illinois, 60153
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 85259-5499
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
University of Kansas Cancer Center
Westwood, Kansas, 66205
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Being tested
- Individualized Survivorship Care Plan (SCP)
- Keywords
- Hematopoietic cell transplant (HCT) survivors, Survivorship Care Plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Survivorship Care Plan (SCP)Other
The individualized SCP incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Survivorship Care Plan (SCP) | Experimental | * Participant information sheet and instructions on how to use the SCP
* Patient version of individualized SCP that includes but is not limited to: (1) a treatment summary that consists of disease characteristics and treatment details (including HCT), and (2) recommendations for preventive care and screening for late complications based on patient treatment exposures (age, type of transplant, use of TBI, corticosteroid exposure as part of HCT, and history of GVHD)
* Newest Vital Sign nutrition label to measure health literacy and its instructions
* Participants may receive other materials their transplant center routinely provides to patients for follow-up care (e.g., discharge summary or clinic note) Receives: Other: Individualized Survivorship Care Plan (SCP) |
| Usual care (no SCP) | No intervention | * Materials that their transplant center routinely provides to patients for follow-up care * Newest Vital Sign nutrition label to measure health literacy and its instructions * Participants randomized to the usual care arm who complete the 6 month study assessments will receive their individualized SCP upon completion of the patient's participation. Participants who withdraw from the study or who do not complete the 6 month assessment will not receive the individualized SCP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Confidence in Survivorship Information instrument score
Measured: baseline to 6 months after the study intervention
Secondary outcomes (6)
Change in HCT treatment distress instrument score
Measured: baseline to 6 months after the study intervention
Change in Health behaviors instrument score
Measured: baseline to 6 months after the study intervention
Changes in Healthcare utilization instrument score
Measured: baseline to 6 months after the study intervention
Change in Knowledge about transplant exposures instrument score
Measured: baseline to 6 months after the study intervention
Change in Quality of life instrument score
Measured: baseline to 6 months after the study intervention
Change in Self-efficacy instrument score
Measured: baseline to 6 months after the study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startApr 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Hematopoietic Cell Transplant (HCT) Survivors 1-2 Yrs Post Most Recent HCTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Collaborators
- Patient-Centered Outcomes Research Institute, National Marrow Donor Program
- Responsible party
- Sponsor
- Investigators
- Elizabeth Murphy, EdD, RN, Study chair, National Marrow Donor ProgramNavneet Majhail, MD, MS, Study chair, Cleveland Clinic Foundation; National Marrow Donor ProgramK Scott Baker, MD, MS, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200133
- Sponsor's protocol ID
- 13-SCP
- Status last verified
- Sep 2017
- First submitted
- 21 Jul 2014
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors
- ClinicalTrials.gov ID
- NCT02200133
- Acronym / sponsor ID
- 13-SCP
- Keywords
- Hematopoietic cell transplant (HCT) survivors, Survivorship Care Plan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Collaborators
- Patient-Centered Outcomes Research Institute, National Marrow Donor Program
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Survivorship Care Plan (SCP) | Experimental | Other: Individualized Survivorship Care Plan (SCP)* Participant information sheet and instructions on how to use the SCP * Patient version of individualized SCP that includes but is not limited to: (1) a treatment summary that consists of disease characteristics and treatment details (including HCT), and (2) recommendations for preventive care and screening for late complications based on patient treatment exposures (age, type of transplant, use of TBI, corticosteroid exposure as part of HCT, and history of GVHD) * Newest Vital Sign nutrition label to measure health literacy and its instructions * Participants may receive other materials their transplant center routinely provides to patients for follow-up care (e.g., discharge summary or clinic note) |
| Usual care (no SCP) | No intervention | –* Materials that their transplant center routinely provides to patients for follow-up care * Newest Vital Sign nutrition label to measure health literacy and its instructions * Participants randomized to the usual care arm who complete the 6 month study assessments will receive their individualized SCP upon completion of the patient's participation. Participants who withdraw from the study or who do not complete the 6 month assessment will not receive the individualized SCP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients who have received their transplant at a different transplant center will not be eligible for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Survivorship Care Plan (SCP)The individualized SCP incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications. | Other | Individualized Survivorship Care Plan (SCP) |
Primary outcome
Change in Confidence in Survivorship Information instrument score
Time frame: baseline to 6 months after the study intervention
6 secondary outcomes
Change in HCT treatment distress instrument score
Time frame: baseline to 6 months after the study intervention
Change in Health behaviors instrument score
Time frame: baseline to 6 months after the study intervention
Changes in Healthcare utilization instrument score
Time frame: baseline to 6 months after the study intervention
Change in Knowledge about transplant exposures instrument score
Time frame: baseline to 6 months after the study intervention
Change in Quality of life instrument score
Time frame: baseline to 6 months after the study intervention
Change in Self-efficacy instrument score
Time frame: baseline to 6 months after the study intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Murphy, EdD, RN study chair
National Marrow Donor Program
Navneet Majhail, MD, MS study chair
Cleveland Clinic Foundation; National Marrow Donor Program
K Scott Baker, MD, MS study chair
Fred Hutchinson Cancer Center
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Survivorship Care Plan (SCP) in people with Adult Hematopoietic Cell Transplant (HCT) Survivors 1-2 Yrs Post Most Recent HCT, run by Center for International Blood and Marrow Transplant Research at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Confidence in Survivorship Information instrument score (time frame: baseline to 6 months after the study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.