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NCT05095948 Clinical Trial

Improving Processes of Cancer Care Delivery at a Comprehensive Cancer Center

Metastatic Malignant Solid Neoplasm Clinical Trial

Official title:
Mapping the Processes of Cancer Care Delivery at a Comprehensive Cancer Center

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05095948
Other study ID # 2020-0246
Secondary ID NCI-2021-1026620
Status Not yet recruiting
Phase
First received
Last updated
Start date September 30, 2024
Est. completion date September 30, 2026

Study information
Verified date March 2024
Source M.D. Anderson Cancer Center
Contact David Hui, MD
Phone (713) 792-6258
Email dhui@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study examines how cancer care is delivered in oncology and supportive care clinics. Collecting patient feedback may help doctors better understand the processes of cancer care in oncology and supportive care clinics.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

  • Metastatic Malignant Solid Neoplasm

Intervention

Procedure:
• Discussion
Undergo audio recording of clinic conversations
Other:
• Electronic Health Record Review
Review of medical records
• Questionnaire Administration
Complete questionnaires

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Minutes spent in discussion Will be examined using linear mixed models (LMMs) with physician as the unit of analysis. through study completion, an average of 1 year
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