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Communication Skills Intervention to Promote Transition Into Survivorship

This study is ongoing, but not recruiting participants.
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
National Cancer Institute (NCI)
Monash University
Weill Cornell Medical College in Qatar
New York Methodist Hospital
San Francisco State University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01483664
First received: November 29, 2011
Last updated: October 25, 2016
Last verified: October 2016

November 29, 2011
October 25, 2016
November 2011
November 2017   (Final data collection date for primary outcome measure)
impact on patient outcomes of targeted physician communication skills training [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT01483664 on ClinicalTrials.gov Archive Site
  • impact of a targeted CST intervention on the physicians [ Time Frame: 3 years ]
    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 ]
    (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.
impact of a targeted CST intervention on the physicians [ Time Frame: 3 years ]
use of strategies, tasks and skills about transitioning lymphoma patients from the end of primary treatment to survivorship.
Not Provided
Not Provided
 
Communication Skills Intervention to Promote Transition Into Survivorship
Communication Skills Intervention to Promote Transition Into Survivorship
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

  • Hodgkin's Lymphoma
  • Diffuse Large B-cell Lymphoma
Not Provided
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
314
November 2017
November 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01483664
11-180
Yes
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
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
  • National Cancer Institute (NCI)
  • Monash University
  • Weill Cornell Medical College in Qatar
  • New York Methodist Hospital
  • San Francisco State University
Principal Investigator: Steven Horwitz, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP