Communication Skills Intervention to Promote Transition Into Survivorship

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Maimonides Medical Center
H. Lee Moffitt Cancer Center and Research Institute
Rutgers University
Tampa General Hospital
University of California, Los Angeles
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01483664
First received: November 29, 2011
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition
Hodgkin's Lymphoma
Diffuse Large B-cell Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Communication Skills Intervention to Promote Transition Into Survivorship

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • impact on patient outcomes of targeted physician communication skills training [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • impact of a targeted CST intervention on the physicians [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    use of strategies, tasks and skills about transitioning lymphoma patients from the end of primary treatment to survivorship.

  • describe communication during doctor-patient visits during the patients' first three years of survivorship [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    (MSKCC and MD Anderson baseline data only) The study team will look for qualitative themes to better understand the content of these conversations and the need for survivorship care planning. Half of these recordings were with MSKCC patients and physicians and half were with MD Anderson patients and physicians.


Estimated Enrollment: 143
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients:

Patients from each site will be recruited from their respective lymphoma services.

Physicians:

Physicians from each site will be recruited from their respective lymphoma services.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483664

Contacts
Contact: Steven Horwitz, MD 212-639-3045
Contact: Matthew Matasar, MD 212-639-8889

Locations
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Paul Jacobsen, PhD.         
Principal Investigator: Paul Jacobsen, PhD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Paul B. Jacobsen, PhD         
Principal Investigator: Paul B. Jacobsen, PhD         
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Steven Horwitz, MD    212-639-3045      
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11220
Contact: Allan B. Astrow, MD         
Principal Investigator: Alan B. Astrow, MD         
Memorial Sloan-Kettering Cancer Center at Commack Recruiting
Commack, New York, United States, 11725
Contact: Steven Horwitz, MD    212-639-3045      
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Steven Horwitz, MD    212-639-3045      
Contact: Matthew Matasar, MD    212-639-8889      
Principal Investigator: Steven Horwitz, MD         
Memorial Sloan-Kettering Cancer Center at Mercy Recruiting
Rockville Centre, New York, United States, 11570
Contact: Steven Horwitz, MD    212-639-3045      
Memoral Sloan-Kettering Cancer Center at Phelps Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Steven Horwitz, MD    212-639-3045      
United States, Texas
Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Patricia A. Parker, PhD         
Principal Investigator: Patricia A. Parker, PhD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
M.D. Anderson Cancer Center
Maimonides Medical Center
H. Lee Moffitt Cancer Center and Research Institute
Rutgers University
Tampa General Hospital
University of California, Los Angeles
Investigators
Principal Investigator: Steven Horwitz, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01483664     History of Changes
Other Study ID Numbers: 11-180
Study First Received: November 29, 2011
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
patient outcomes
Survivorship
Communication Skills
Communication strategies
Physicians communication
11-180

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on August 27, 2014