Communication Skills Intervention to Promote Transition Into Survivorship
NCT ID: NCT01483664
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
314 participants
OBSERVATIONAL
2011-11-30
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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initial survivorship planning consultation
The overall design follows a cluster-randomized, clinical trial design. Although an apparently statistically-efficient design would have us randomize patients, the CST intervention must be delivered to physicians at four participating sites (MSKCC, Maimonides, MD Anderson, and Moffitt/TGH). Therefore, participating sites will be stratified by size and randomized to either experimental (initial survivorship planning consultation) or control (initial wellness rehabilitation consultation) in a multiple-level, cluster-randomized design, which protects against physician contamination of the experimental intervention within any site.
No interventions assigned to this group
initial wellness rehabilitation consultation
The overall design follows a cluster-randomized, clinical trial design. Although an apparently statistically-efficient design would have us randomize patients, the CST intervention must be delivered to physicians at four participating sites (MSKCC, Maimonides, MD Anderson, and Moffitt/TGH). Therefore, participating sites will be stratified by size and randomized to either experimental (initial survivorship planning consultation) or control (initial wellness rehabilitation consultation) in a multiple-level, cluster-randomized design, which protects against physician contamination of the experimental intervention within any site.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* who treat patients with DLBCL and HD as per self report
Patients of Physicians:
* have a new diagnosis of Hodgkin's or Diffuse Large B-cell Lymphoma as per pathology report or physician assessment in medical record and/or clinical judgment of the treating physician treated with curative intent.
For part 1 - have scans indicating remission and completing planned chemotherapy and/or radiation therapy. The treating physician will determine that clinical remission has been achieved based on their best judgment.
For part 2 (longitudinal phase): - have new scans indicating remission and completing planned chemotherapy and/or radiation therapy. The treating physician will determine that clinical remission has been achieved based on their best judgment.
* be at least 18 years old
* speak English well enough, in the judgment of the consenting professional, to be able to understand all aspects of the study, provide informed consent, and be able to complete all study measures.
Exclusion Criteria
* who do not have adequate patients in their clinical practice to meet the 8 patient enrollment requirement for patients with either DLBCL or HD as per self report
Patients of Physicians:
* show evidence of cognitive impairment severe enough to preclude giving permission to the study staff, or completing the survey instruments of the study.
* as per physician judgment, patient's prognosis and/or co-morbidities make them inappropriate for participation in a survivorship study.
For Part 2 ONLY (longitudinal phase):
* those who consented to part 1, consult recording, of the study.
18 Years
ALL
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
Maimonides Medical Center
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Rutgers University
OTHER
Tampa General Hospital
OTHER
University of California, Los Angeles
OTHER
National Cancer Institute (NCI)
NIH
Monash University
OTHER
Weill Cornell Medical College in Qatar
OTHER
New York Presbyterian Brooklyn Methodist Hospital
OTHER
San Francisco State University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Steven Horwitz, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Tampa General Hospital
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Maimonides Medical Center
Brooklyn, New York, United States
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center at Mercy
Rockville Centre, New York, United States
Memorial Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York, United States
Md Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Parker PA, Banerjee SC, Matasar MJ, Bylund CL, Franco K, Li Y, Levin TT, Jacobsen PB, Astrow AB, Leventhal H, Horwitz S, Kissane DW. Protocol for a cluster randomised trial of a communication skills intervention for physicians to facilitate survivorship transition in patients with lymphoma. BMJ Open. 2016 Jun 28;6(6):e011581. doi: 10.1136/bmjopen-2016-011581.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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11-180
Identifier Type: -
Identifier Source: org_study_id