Clinical trial NCT01483664: Communication Skills Intervention to Promote Transition Into Survivorship
Official title: Communication Skills Intervention to Promote Transition Into Survivorship
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hodgkin's Lymphoma
Diffuse Large B-cell Lymphoma
Keywords: patient outcomes
Survivorship
Communication Skills
Communication strategies
Physicians communication
11-180
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: Maimonides Medical Center
name: H. Lee Moffitt Cancer Center and Research Institute
name: Rutgers University
name: Tampa General Hospital
name: University of California, Los Angeles
name: National Cancer Institute (NCI)
name: Monash University
name: Weill Cornell Medical College in Qatar
name: New York Presbyterian Brooklyn Methodist Hospital
name: San Francisco State University
First posted: 2011-12-01
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: impact on patient outcomes of targeted physician communication skills training
timeFrame: 3 years
Secondary outcomes:
measure: impact of a targeted CST intervention on the physicians
timeFrame: 3 years
measure: describe communication during doctor-patient visits during the patients' first three years of survivorship
timeFrame: 3 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center at Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Cancer Center at Mercy
state: New York
city: Sleepy Hollow
country: United States
facility: Memorial Sloan Kettering Cancer Center at Phelps
state: New York
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Steven Horwitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.