Communication Skills Intervention to Promote Transition Into Survivorship

NCT ID: NCT01483664

Last Updated: 2025-12-18

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2026-11-30

Brief Summary

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The purpose of this study is to improve the communication skills of physicians who transition lymphoma cancer patients from the end of treatment to survivorship.

Detailed Description

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Conditions

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Hodgkin's Lymphoma Diffuse Large B-cell Lymphoma

Keywords

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patient outcomes Survivorship Communication Skills Communication strategies Physicians communication 11-180

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Physicians:

* 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

Physicians:

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Maimonides Medical Center

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role collaborator

Rutgers University

OTHER

Sponsor Role collaborator

Tampa General Hospital

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role collaborator

Weill Cornell Medical College in Qatar

OTHER

Sponsor Role collaborator

New York Presbyterian Brooklyn Methodist Hospital

OTHER

Sponsor Role collaborator

San Francisco State University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, United States

Site Status

Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center at Commack

Commack, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center at Mercy

Rockville Centre, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center at Phelps

Sleepy Hollow, New York, United States

Site Status

Md Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 27354079 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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11-180

Identifier Type: -

Identifier Source: org_study_id