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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-07334 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 25077 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| U01CA286808 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study assesses the impact of cannabis (also commonly called marijuana, weed, or THC) use on quality of life among patients with multiple myeloma who are receiving chemotherapy. It also evaluates the potential benefits and harms of cannabis use.
PRIMARY OBJECTIVES:
I. Characterize and compare longitudinal patterns in quality of life, as assessed by the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) instrument, among cannabis users and non-users.
II. Estimate and characterize the potential therapeutic benefit and adverse effects associated with cannabis use as assessed by longitudinal patterns of patient reported symptoms (Edmonton Symptoms Assessment Scale-ESAS) and medical assessments (Common Terminology Criteria for Adverse Events-CTCAE v5.0) through a comparative analysis of users and non-users.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: Patients complete surveys and undergo blood sample collection throughout the study.
GROUP II: Healthcare providers complete a survey on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational group I | Patients complete surveys and undergo blood sample collection throughout the study. |
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| Observational group II | Healthcare providers complete a survey on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
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| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal patterns in quality of life | Will characterize and compare longitudinal patterns in quality of life, as assessed by the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) instrument, among cannabis users and non-users. The analysis will compare difference scores from the FACT-MM between these groups using ANOVA at the end of treatment. For comparisons between groups at four specific assessment points (baseline, C1, C2, C3, and C4), a repeated measures analysis of variance analysis will be performed. Multivariable mixed-effects regression model, which takes possible dependence of longitudinal measurements within each subject into account, will be used. The possible within-subject dependence will also be taken into account using the robust standard error (generalized estimating equation method) when statistical inferences are made with regards to the treatment effect and interaction between treatment and time period. | Up to one year |
| Potential therapeutic benefit and adverse effects associated with cannabis use | Will estimate and characterize the potential therapeutic benefit and adverse effects associated with cannabis use as assessed by longitudinal patterns of patient reported symptoms (Edmonton Symptoms Assessment Scale-ESAS) through a comparative analysis of users and non-users. Descriptive statistics will be computed regarding reported benefits and harms of cannabis, and associations will be explored with the different type of cannabis utilized. | Up to one year |
| Potential therapeutic benefit and adverse effects associated with cannabis use | Will estimate and characterize the potential therapeutic benefit and adverse effects associated with cannabis use as assessed by medical assessments (Common Terminology Criteria for Adverse Events-CTCAE v5.0) through a comparative analysis of users and non-users. Descriptive statistics will be computed regarding reported benefits and harms of cannabis, and associations will be explored with the different type of cannabis utilized. | Up to one year |
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Inclusion Criteria:
* Documented informed consent of the participant
Exclusion Criteria:
* Patients may not have completed five cycles of first line therapy or undergone any second line therapy
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Newly diagnosed multiple myeloma patients who have received up to four cycles of first line therapy and City of Hope affiliated health care providers currently practicing in oncology or providing direct care to oncology patients.
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| Name | Affiliation | Role |
|---|---|---|
| Richard T Lee | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTCA at Western Regional Medical Center | Not yet recruiting | Goodyear | Arizona | 85338 | United States |
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| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| City of Hope Seacliff | Not yet recruiting | Huntington Beach | California | 92648 | United States |
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| City of Hope at Irvine Lennar | Recruiting | Irvine | California | 92618 | United States |
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| City of Hope at Long Beach Elm | Not yet recruiting | Long Beach | California | 90813 | United States |
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| City of Hope at Newport Beach Fashion Island | Not yet recruiting | Newport Beach | California | 92660 | United States |
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| City of Hope South Pasadena | Not yet recruiting | South Pasadena | California | 91030 | United States |
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| City of Hope Upland | Not yet recruiting | Upland | California | 91786 | United States |
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| City of Hope West Covina | Not yet recruiting | West Covina | California | 91790 | United States |
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| City of Hope Atlanta Cancer Center | Not yet recruiting | Newnan | Georgia | 30265 | United States |
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| City of Hope at Chicago | Not yet recruiting | Zion | Illinois | 60099 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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