Overview

This trial is active, not recruiting.

Conditions hodgkin's lymphoma, diffuse large b-cell lymphoma
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator M.D. Anderson Cancer Center
Start date November 2011
End date November 2017
Trial size 314 participants
Trial identifier NCT01483664, 11-180

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
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.

Primary Outcomes

Measure
impact on patient outcomes of targeted physician communication skills training
time frame: 3 years

Secondary Outcomes

Measure
impact of a targeted CST intervention on the physicians
time frame: 3 years
describe communication during doctor-patient visits during the patients' first three years of survivorship
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Communication Skills Intervention to Promote Transition Into Survivorship
Principal investigator Steven Horwitz, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.