Communication Skills Intervention to Promote Transition Into Survivorship

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01483664

Collaborator

M.D. Anderson Cancer Center (Other), Maimonides Medical Center (Other), H. Lee Moffitt Cancer Center and Research Institute (Other), Rutgers University (Other), Tampa General Hospital (Other), University of California, Los Angeles (Other), National Cancer Institute (NCI) (NIH), Monash University (Other), Weill Cornell Medical College in Qatar (Other), New York Presbyterian Brooklyn Methodist Hospital (Other), San Francisco State University (Other)

314

Enrollment

Locations

132

Duration (Months)

34.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Lymphoma Diffuse Large B-cell Lymphoma

Study Design

Study Type:

Observational

Actual Enrollment :

314 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Communication Skills Intervention to Promote Transition Into Survivorship

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

impact on patient outcomes of targeted physician communication skills training [3 years]

Secondary Outcome Measures

impact of a targeted CST intervention on the physicians [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampa General Hospital	Tampa	Florida	United States	33606
2	Moffitt Cancer Center	Tampa	Florida	United States	33612
3	Memorial Sloan Kettering at Basking Ridge	Basking Ridge	New Jersey	United States	07920
4	Maimonides Medical Center	Brooklyn	New York	United States	11220
5	Memorial Sloan Kettering Cancer Center at Commack	Commack	New York	United States	11725
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Cancer Center at Mercy	Rockville Centre	New York	United States	11570
8	Memoral Sloan Kettering Cancer Center at Phelps	Sleepy Hollow	New York	United States	10591
9	Md Anderson Cancer Center	Houston	Texas	United States	77030