NCT01483664

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Nov 2011Nov 2026

Study Start

First participant enrolled

November 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

15 years

First QC Date

November 29, 2011

Last Update Submit

January 16, 2026

Conditions

Hodgkin's LymphomaDiffuse Large B-cell Lymphoma

Keywords

patient outcomesSurvivorshipCommunication SkillsCommunication strategiesPhysicians communication11-180

Outcome Measures

Primary Outcomes (1)

  • impact on patient outcomes of targeted physician communication skills training

    3 years

Secondary Outcomes (2)

  • impact of a targeted CST intervention on the physicians

    3 years

  • describe communication during doctor-patient visits during the patients' first three years of survivorship

    3 years

Study Arms (2)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11220, United States

Location

Memorial Sloan Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center at Mercy

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Cancer Center at Phelps

Sleepy Hollow, New York, 10591, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 27354079DERIVED

Related Links

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-Hodgkin

Study Officials

  • Patricia Parker, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

November 1, 2011

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

US(9)