- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05095948
Improving Processes of Cancer Care Delivery at a Comprehensive Cancer Center
Mapping the Processes of Cancer Care Delivery at a Comprehensive Cancer Center
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To compare the total amount of follow-up clinic time spent on discussing supportive/palliative care issues between primary palliative care provided by the oncology team and specialist palliative care.
SECONDARY OBJECTIVES:
I. To compare between the specialist palliative care team and the oncology team the following aspects of supportive/palliative care delivery: Ia. The number of supportive/palliative care needs the patient reported before the clinic visit (SPARC).
Ib. The number of supportive/palliative care needs the patient wanted to discuss with the clinical team before the clinic visit (SPARC).
Ic. The number of supportive/palliative care needs that were actually raised by the patient during the clinic visit (audiotape).
Id. The number of supportive/palliative care needs that were actually discussed by the clinical team during clinic visit (audiotape).
Ie. The number of supportive/palliative care needs that were documented in progress note by the clinical team after each visit (electronic health record).
If. The number of supportive/palliative care needs that the patient reported had been adequate addressed after the clinic visit (SPARC).
II. To compare the amount of clinic time (both absolute and proportion) spent on discussing supportive/palliative care issues by individual disciplines (e.g. medical doctor, registered nurse, counselor, pharmacist, psychologist, social worker, and priest) between the specialist palliative care team and the oncology team.
III. To examine the nature of topics discussed by the specialist palliative care team and the oncology team and compare the amount of clinic time (both absolute and proportion) spent on each supportive/palliative care issue.
IV. To compare the number of empathic statements between the specialist palliative care team and the oncology team.
V. To compare the processes of supportive/palliative care delivery between patients seeing the oncology team without specialist palliative care (Cohort A) and patients seeing the oncology team when specialist palliative care team is involved (Cohort B).
OUTLINE:
Patients complete questionnaires over 15-20 minutes and undergo audio recording of clinic conversations between the oncology team or the specialist palliative care team. Patients' medical records are also reviewed.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: David Hui, MD
- Phone Number: (713) 792-6258
- Email: dhui@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
Contact:
- David Hui, MD
- Phone Number: 713-792-6258
- Email: dhui@mdanderson.org
-
Principal Investigator:
- David Hui, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Within 6 months of diagnosis of metastatic (or stage IV) solid malignancies
- Age 18 or greater
- English speaking
- Follow-up clinic visit (Supportive Care and Medical Oncology Outpatient Clinics at MD Anderson Cancer Center)
- Medical oncologist listed as the attending physician
- COHORT A (Oncology team only cohort): Patients should not have been referred to palliative care services at MD Anderson Cancer Center
- COHORT B (Oncology team and specialist palliative care cohort): Patients should have an upcoming specialist palliative care follow-up visit within 1 week of a medical oncology visit
Exclusion Criteria:
- Delirium (Memorial Delirium Assessment Scale [MDAS] >= 13/30)
- Significant hearing impairment requiring multiple repetitions during the screening process (that may prolong clinic time)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Supportive Care (questionnaire, clinic conversation)
Patients complete questionnaires over 15-20 minutes and undergo audio recording of clinic conversations between the oncology team or the specialist palliative care team.
Patients' medical records are also reviewed.
|
Complete questionnaires
Review of medical records
Undergo audio recording of clinic conversations
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minutes spent in discussion
Time Frame: through study completion, an average of 1 year
|
Will be examined using linear mixed models (LMMs) with physician as the unit of analysis.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Hui, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0246 (Other Identifier: M D Anderson Cancer Center)
- NCI-2021-10266 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Malignant Solid Neoplasm
-
National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Unresectable Solid NeoplasmUnited States, Canada
-
M.D. Anderson Cancer CenterTerminatedLocally Advanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterWithdrawnLocally Advanced Malignant Solid Neoplasm | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Bone
-
University of California, San FranciscoCompletedIntegrative Palliative Care/Psycho-Oncology Telehealth Intervention in Patients With Advanced CancerAdvanced Malignant Solid Neoplasm | Locally Advanced Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
Ronald LevyBristol-Myers SquibbCompletedAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Extracranial Solid NeoplasmUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Metastatic Malignant Neoplasm in the LungUnited States
-
M.D. Anderson Cancer CenterTerminatedAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
Mayo ClinicRecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphoid System Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
Clinical Trials on Questionnaire Administration
-
Fondazione Don Carlo Gnocchi OnlusCompleted
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
Istanbul Aydın UniversityCompleted
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBreast Carcinoma | Fallopian Tube Carcinoma | Endometrial Carcinoma | Ovarian Carcinoma | Primary Peritoneal Carcinoma | Deleterious CDH1 Gene Mutation | Deleterious DICER1 Gene Mutation | Deleterious SMARCA4 Gene Mutation | Deleterious STK11 Gene MutationUnited States
-
Université Catholique de LouvainRecruiting
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingCOVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingEndometrial Carcinoma | Malignant Uterine Neoplasm | Uterine Corpus Cancer | Uterine Corpus SarcomaUnited States
-
Ohio State University Comprehensive Cancer CenterNational Center for Complementary and Integrative Health (NCCIH)CompletedBreast Cancer | Prostate CancerUnited States