Breast CarcinomaColorectal CarcinomaLung Non-Small Cell CarcinomaMelanomaNon-Hodgkin Lymphoma
Investigational drug(s) / intervention(s)
Non-interventional Study
Non-interventional Study: Non-interventional study
Study summary
This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer (e.g. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous cell carcinoma, and not otherwise specified).
* Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and/or immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment.
* Participants must be able to comprehend English or Spanish (for survey completion).
* Participants must have a working email address and be must be willing to complete surveys online. This can be completed at home, in the clinic or other location.
* Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment.
* Participant must reside in the United States, officially determined per patient report on Self-reported Screening Survey
* In the treating provider's opinion, the participant should have a life expectancy of \>=6 months. Participants in hospice are not eligible.
Optional Sub-study (available at select sites only):
* Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU).
* Must be receiving treatment at the WF CCC and VCU.
* Must be diagnosed with non-small cell lung cancer.
* Must be planning to receive paclitaxel as part of their chemotherapy in conjunction with Immune Checkpoint Inhibitor (ICIs) PD-1, PD-L1 or CTLA-4.
Exclusion Criteria:
* Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.
* Participants with known pregnancy.
* Participant received systemic therapy treatment for prior cancer(s) including chemotherapy, immunotherapy, targeted therapy, and hormonal therapy.
* Participants enrolled in hospice.
Optional Substudy (available at select sites only):
* Participants with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). The use of glucocorticoids as pre-medications for chemotherapy treatment is allowed.
* Participants with a history of HIV, hepatitis B or hepatitis C.
Primary outcome measure(s)
Cancer-related symptoms — Baseline and re-assessed monthly up to 12 months post-enrollment Will use the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events to measure cancer-related symptoms. Will examine the longitudinal relationship between cannabis and/or cannabinoid use and the likelihood of exhibiting individual symptoms using three-level GLMMs to account for the nested data. The investigators will model continuous measures (e.g., symptom severity) using a linear generalized linear mixed-effects models (GLMM) and the prevalence of symptoms or moderate to severe symptoms using a logistic GLMM. Cannabis and/or cannabinoid use at each monthly assessment will be included as a time-varying covariate and an interaction with time will be included to assess its impact on symptoms over time. Analyses will consider dichotomous definitions of use (yes/no past month), frequency of use (# days in the past month) as well as mode of administration, dose/potency, and cannabinoid type.
Trial sites (467)
Facility
City
Region
Status
Fairbanks Memorial Hospital
Fairbanks
Alaska
Recruiting
Kingman Regional Medical Center
Kingman
Arizona
Recruiting
Cancer Center at Saint Joseph's
Phoenix
Arizona
Recruiting
Mercy Hospital Fort Smith
Fort Smith
Arkansas
Recruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arkansas
Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch
California
Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande
California
Recruiting
PCR Oncology
Arroyo Grande
California
Recruiting
Mercy Cancer Center - Carmichael
Carmichael
California
Recruiting
Mercy San Juan Medical Center
Carmichael
California
Recruiting
Kaiser Permanente Dublin
Dublin
California
Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove
California
Recruiting
Kaiser Permanente-Fremont
Fremont
California
Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno
California
Recruiting
Kaiser Permanente-Fresno
Fresno
California
Recruiting
Saint Agnes Medical Center
Fresno
California
Recruiting
Saint Helena Hospital
Fresno
California
Recruiting
Contra Costa Regional Medical Center
Martinez
California
Recruiting
Contra Costa Regional Medical Center
Martinez
California
Recruiting
Kaiser Permanente- Modesto MOB II
Modesto
California
Recruiting
Kaiser Permanente-Modesto
Modesto
California
Recruiting
Kaiser Permanente-Oakland
Oakland
California
Recruiting
Kaiser Permanente- Marshall Medical Offices
Redwood City
California
Recruiting
Kaiser Permanente-Richmond
Richmond
California
Recruiting
Mercy Cancer Center - Rocklin
Rocklin
California
Recruiting
Kaiser Permanente-Roseville
Roseville
California
Recruiting
Kaiser Permanente Downtown Commons
Sacramento
California
Recruiting
Mercy Cancer Center - Sacramento
Sacramento
California
Recruiting
Kaiser Permanente-South Sacramento
Sacramento
California
Recruiting
Kaiser Permanente-San Francisco
San Francisco
California
Recruiting
Kaiser Permanente-Santa Teresa-San Jose
San Jose
California
Recruiting
Kaiser Permanente San Leandro
San Leandro
California
Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo
California
Recruiting
Kaiser San Rafael-Gallinas
San Rafael
California
Recruiting
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
California
Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria
California
Recruiting
Kaiser Permanente-Santa Rosa
Santa Rosa
California
Recruiting
Providence Medical Foundation - Santa Rosa
Santa Rosa
California
Recruiting
Kaiser Permanente-South San Francisco
South San Francisco
California
Recruiting
Saint Helena Hospital
St. Helena
California
Recruiting
+ 427 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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