A Multicenter Prospective Observational Cohort Study Evaluating the Impact of Cancer-Directed Treatment and Medication Use, Including Cannabis Use, in Multiple Myeloma Patients
Purpose
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.
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- * Documented informed consent of the participant - Age: ≥ 18 years - ECOG ≤ 3 - Ability to read and understand English - Patient must be newly diagnosed with a histologically confirmed multiple myeloma - Patients may have started first line therapies and received up to four cycles - HCP SURVEY: Documented informed consent of the participant - HCP SURVEY: Age: ≥ 18 years - HCP SURVEY: Licensed physician, physician assistant, nurse practitioner, or registered nurse - HCP SURVEY: Currently practicing in oncology or providing direct care to oncology patients - HCP SURVEY: Able to read and understand English - HCP SURVEY: Affiliation with City of Hope
Exclusion Criteria
- * Patients may not have completed five cycles of first line therapy or undergone any second line therapy - Other active malignancy - Patients may not have undergone autologous hematopoietic stem cell transplantation - Unable to comply with the study assessments - HCP SURVEY: Reports directly to study PI (Dr. Richard Lee) - HCP SURVEY: Member of the study team or involved in survey design or analysis - HCP SURVEY: Individuals with a real or perceived conflict of interest that could bias survey responses
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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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Recruiting Locations
Duarte 5344147, California 5332921 91010
Irvine 5359777, California 5332921 92618
More Details
- Status
- Recruiting
- Sponsor
- City of Hope Medical Center
Study Contact
Detailed Description
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.