GI CancerNCT03530969
Geriatric Communication Skills Training Program for Oncology Clinicians
A study testing Self-Efficacy Assessment, UCLA Geriatrics Attitudes Scale and Course Evaluations in people with GI Cancer and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Self-Efficacy Assessment, UCLA Geriatrics Attitudes Scale and Course Evaluations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Geriatric Communication Skills Training Program for Oncology Clinicians to Improve Management of Care for Geriatrics Cancer Patients
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.
- Conditions
- GI Cancer, Lymphoma, GU Cancer, Bone Marrow Transplant
- Being tested
- Self-Efficacy Assessment, UCLA Geriatrics Attitudes Scale, Course Evaluations, The Consultation and Relational Empathy (CARE) questionnaire, Consumer Assessment of Health Care Providers and Systems Program (CAHPS)
- Medical subject headings
- Gastrointestinal Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Efficacy AssessmentBehavioural
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.
UCLA Geriatrics Attitudes ScaleBehavioural
Also called Perceived Ageism
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.
Course EvaluationsBehavioural
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.
The Consultation and Relational Empathy (CARE) questionnaireBehavioural
Also called Perceived Empathy
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.
Consumer Assessment of Health Care Providers and Systems Program (CAHPS)Behavioural
Also called Satisfaction with communication
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)
Patient activation measure (PAM) scaleBehavioural
Also called Patient Activation.
The PAM scale contains 22 items that assess patient engagement in their care process.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Self-Efficacy Assessment; Behavioral: UCLA Geriatrics Attitudes Scale; Behavioral: Course Evaluations |
| Participants with GI/GU/Lymphoma Cancer | Active comparator | Patients of the physicians in group 1 Receives: Behavioral: The Consultation and Relational Empathy (CARE) questionnaire; Behavioral: 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 Receives: Behavioral: The Consultation and Relational Empathy (CARE) questionnaire; Behavioral: Consumer Assessment of Health Care Providers and Systems Program (CAHPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Health Care Provider (HCP) training
Measured by number of HCP successfully recruited for the training
Measured: 8 weeks
Participants satisfaction with Health Care Provider (HCP) training
Self-reported measure of satisfaction
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start7 May 2018
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Smita Banerjee, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530969
- Sponsor's protocol ID
- 18-183
- Status last verified
- Feb 2024
- First submitted
- 8 May 2018
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Communication Skills Training Program for Oncology Clinicians to Improve Management of Care for Geriatrics Cancer Patients
- ClinicalTrials.gov ID
- NCT03530969
- Acronym / sponsor ID
- 18-183
- Conditions
- GI Cancer, Lymphoma, GU Cancer, Bone Marrow Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GI/GU/Lymphoma Oncologists | Experimental | Behavioral: Self-Efficacy Assessment, Behavioral: UCLA Geriatrics Attitudes Scale, Behavioral: Course EvaluationsDoctors 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) |
| Participants with GI/GU/Lymphoma Cancer | Active comparator | Behavioral: The Consultation and Relational Empathy (CARE) questionnaire, Behavioral: Consumer Assessment of Health Care Providers and Systems Program (CAHPS), Behavioral: Patient activation measure (PAM) scalePatients of the physicians in group 1 |
| Caregivers of Participants with GI/GU/Lymphoma Cancer | Active comparator | Behavioral: The Consultation and Relational Empathy (CARE) questionnaire, Behavioral: Consumer Assessment of Health Care Providers and Systems Program (CAHPS)Family members or caregivers of the patients in group 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Efficacy AssessmentHealth 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. | Behavioural | GI/GU/Lymphoma Oncologists |
| UCLA Geriatrics Attitudes ScaleAlso: Perceived AgeismThe UCLA Geriatrics Attitudes Scale is a 14-item scale developed to assess health care providers' attitudes toward older persons and caring for older patients. | Behavioural | GI/GU/Lymphoma Oncologists |
| Course EvaluationsThe 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. | Behavioural | GI/GU/Lymphoma Oncologists |
| The Consultation and Relational Empathy (CARE) questionnaireAlso: Perceived EmpathyThe 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. | Behavioural | Caregivers of Participants with GI/GU/Lymphoma Cancer, Participants with GI/GU/Lymphoma Cancer |
| Consumer Assessment of Health Care Providers and Systems Program (CAHPS)Also: Satisfaction with communicationPatients" 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) | Behavioural | Caregivers of Participants with GI/GU/Lymphoma Cancer, Participants with GI/GU/Lymphoma Cancer |
| Patient activation measure (PAM) scaleAlso: Patient Activation.The PAM scale contains 22 items that assess patient engagement in their care process. | Behavioural | Participants with GI/GU/Lymphoma Cancer |
Primary outcome
Feasibility of Health Care Provider (HCP) training
Time frame: 8 weeks
Measured by number of HCP successfully recruited for the training
Participants satisfaction with Health Care Provider (HCP) training
Time frame: 1 week
Self-reported measure of satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Smita Banerjee, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Efficacy Assessment, UCLA Geriatrics Attitudes Scale and Course Evaluations in people with GI Cancer and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Health Care Provider (HCP) training (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.