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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hodgkin's Lymphoma; Diffuse Large B-cell Lymphoma

• Study Type: Observational
• Enrollment (Actual): 314

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering at Basking Ridge
  • New York
    • Brooklyn, New York, United States, 11220
      • Maimonides Medical Center
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center at Commack
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rockville Centre, New York, United States, 11570
      • Memorial Sloan Kettering Cancer Center at Mercy
    • Sleepy Hollow, New York, United States, 10591
      • Memorial Sloan Kettering Cancer Center at Phelps
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
impact on patient outcomes of targeted physician communication skills training	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impact of a targeted CST intervention on the physicians	use of strategies, tasks and skills about transitioning lymphoma patients from the end of primary treatment to survivorship.	3 years
describe communication during doctor-patient visits during the patients' first three years of survivorship	(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.	3 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: M.D. Anderson Cancer Center; National Cancer Institute (NCI); University of California, Los Angeles; Monash University; Maimonides Medical Center; H. Lee Moffitt Cancer Center and Research Institute; Weill Cornell Medical College in Qatar; Rutgers University; Tampa General Hospital; New York Presbyterian Brooklyn Methodist Hospital; San Francisco State University
• Investigators: Principal Investigator: Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimated): December 1, 2011

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Survivorship; patient outcomes; Communication Skills; Communication strategies; Physicians communication; 11-180
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: 11-180