NCT03530969

Brief Summary

The purpose of this study is to learn more about the effects of a training program designed to help doctors communicate better with older patients and their caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 7, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

5.8 years

First QC Date

May 8, 2018

Last Update Submit

February 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Feasibility of Health Care Provider (HCP) training

    Measured by number of HCP successfully recruited for the training

    8 weeks

  • Participants satisfaction with Health Care Provider (HCP) training

    Self-reported measure of satisfaction

    1 week

Study Arms (3)

GI/GU/Lymphoma Oncologists

EXPERIMENTAL

Doctors specializing in treating gastrointestinal cancer (cancer of the stomach, pancreas, colon, etc.), genitourinary cancer (cancer of the genitals and urinary tract), and lymphoma (cancer affecting the blood and lymph nodes)

Behavioral: Self-Efficacy AssessmentBehavioral: UCLA Geriatrics Attitudes ScaleBehavioral: Course Evaluations

Participants with GI/GU/Lymphoma Cancer

ACTIVE COMPARATOR

Patients of the physicians in group 1

Behavioral: The Consultation and Relational Empathy (CARE) questionnaireBehavioral: Consumer Assessment of Health Care Providers and Systems Program (CAHPS)Behavioral: Patient activation measure (PAM) scale

Caregivers of Participants with GI/GU/Lymphoma Cancer

ACTIVE COMPARATOR

Family members or caregivers of the patients in group 2

Behavioral: The Consultation and Relational Empathy (CARE) questionnaireBehavioral: Consumer Assessment of Health Care Providers and Systems Program (CAHPS)

Interventions

Health Care Professional's self-efficacy will be assessed by 12 ratings of self-reported confidence from (1) "strongly disagree" to (5) "strongly agree" in module-specific topics both before and after the training.

GI/GU/Lymphoma Oncologists

The UCLA Geriatrics Attitudes Scale is a 14-item scale developed to assess health care providers' attitudes toward older persons and caring for older patients.

Also known as: Perceived Ageism
GI/GU/Lymphoma Oncologists

The evaluation surveys for each of the three modules will contain fifteen statements assessing post-training attitudes regarding the skills learned and application of skills in oncology clinical practice, measured on a 5-point Likert scale.

GI/GU/Lymphoma Oncologists

The Consultation and Relational Empathy (CARE) questionnaire is a 10-item self-report scale that measures a patient's satisfaction with how empathic their health care providers (HCP) was within a specific consultation.

Also known as: Perceived Empathy
Caregivers of Participants with GI/GU/Lymphoma CancerParticipants with GI/GU/Lymphoma Cancer

Patients" perceptions of the quality of their interactions with their clinicians will be rated with 6 items from the Consumer Assessment of Health Care Providers and Systems Program (CAHPS)

Also known as: Satisfaction with communication
Caregivers of Participants with GI/GU/Lymphoma CancerParticipants with GI/GU/Lymphoma Cancer

The PAM scale contains 22 items that assess patient engagement in their care process.

Also known as: Patient Activation.
Participants with GI/GU/Lymphoma Cancer

Eligibility Criteria

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

You may qualify if:

  • Clinician Eligibility
  • MSK medical oncology Health Care Professionals (HCP) - specifically identified as Attendings, fellows, or Advance Practice Professional (APP) - either a Nurse Practitioner (NP) or Physician Assistant (PA) from GI, GU Oncology, Lymphoma, Bone Marrow Transplant or Geriatrics Service (five services with a large number of geriatric patients)
  • Willingness to be audio-recorded as per self-report
  • Clinician has individual clinic consultations with patients in the target population: 65 years of age and over, English speaking, and patients who have had a new visit within the last 6 months.
  • Patient Eligibility
  • MSK patients 65 years of age and over as per EMR
  • English speaking as per EMR
  • Being seen by one of the consented HCPs as per the HCP and/or electronic medical record (EMR)
  • Willingness to be audio-recorded as per self-report
  • Patient had their first visit with the clinician within the last 6 months
  • Caregiver Eligibility
  • English speaking as per EMR
  • Accompanying an MSK patient being seen by one of the consented HCPs as per the HCP and/or EMR

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal NeoplasmsLymphoma

Interventions

Surveys and QuestionnairesWeights and Measures

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Smita Banerjee, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 21, 2018

Study Start

May 7, 2018

Primary Completion

February 16, 2024

Study Completion

February 16, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations