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NCT04875286 Clinical Trial

Patient Reported Symptom Control With THC or CBD Use

Malignant Solid Neoplasm Clinical Trial

Official title:
Patient Reported Symptom Control With THC or CBD Use

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04875286
Other study ID # 2019-0753
Secondary ID NCI-2021-0285320
Status Recruiting
Phase
First received
Last updated
Start date February 3, 2021
Est. completion date February 2, 2027

Study information
Verified date March 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study compares patients' attitudes regarding marijuana products for medical use and other treatments for cancer-related pain. This study may help researchers gain better understanding of patient's perception on their use of marijuana products in treating cancer-related pain and other common cancer-related symptoms.

Description:

PRIMARY OBJECTIVE: I. To determine the patient's reported preference for cancer pain improvement with opioids, opioids with delta-9-tetrahydrocannabinol (THC)-marijuana and/or opioids with cannabidiol (CBD). SECONDARY OBJECTIVES: I. To determine the association between perception of cancer-related symptom relief and use of THC-marijuana and/or CBD. II. To compare patient perception of THC-marijuana and/or CBD versus (vs.) cancer treatments in treatment of cancer. III. To evaluate patient report of adverse effects experienced while using THC-marijuana and/or CBD. IV. To evaluate patient reported concerns while using THC-marijuana and/or CBD. V. To evaluate patient attitude of dosing, forms and use of THC-marijuana and/or CBD. VI. To evaluate demographic, physical and psychosocial factors that influence patient perception and attitudes of THC-marijuana and/or CBD. VII. To explore the difference of patient perception of THC-marijuana and CBD in cancer centers in a legalized vs. a non-legalized state. VIII. To explore the patient reported preference of THC-marijuana and CBD for cancer pain and symptom relief of patients in a Supportive Care Center vs. Integrative Medicine Center at University of Texas (U.T.) MD Anderson. OUTLINE: Patients' medical records are reviewed and then complete questionnaires over 27 minutes.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date February 2, 2027
Est. primary completion date February 2, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients (inpatient or outpatient) seen by the Palliative Care and Integrative Medicine teams at The University of Texas MD Anderson Cancer Center (Texas) and the Palliative Care team at Banner MD Anderson Cancer Center (Arizona) - Patients must be primary residents of Texas or Arizona - Patients able to speak and read English - Patients are 18 years old and above - Patients should have a cancer diagnosis, cancer-associated pain, and taking strong opioids (morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, methadone, fentanyl) - Patients who have used in the past 3 months or are using alternative botanical pain management while under prescription opioids Exclusion Criteria: - Patients who are not able to speak or read English - Altered mental status as determined by the interviewer based on the ability to understand the nature of the study and consent process - Patients who have not used medical marijuana and/or CBD products - Patients who do not have cancer - Patients who do not have cancer-associated pain - Patients who are not taking opioids

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Electronic Health Record Review
Medical records reviewed
• Questionnaire Administration
Complete questionnaires

Locations
Country Name City State
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients who prefer opioids with THC-marijuana and/or opioids with cannabidiol (CBD) to opioids alone for their cancer pain relief Will be calculated and reported along with a 95% confidence interval. through study completion, an average of 1 year
Secondary Perception of cancer-related symptom relief Will be associated with use of THC-Marijuana and/or CBD. Will be evaluated by generalized linear mixed models to account for the dependency among those patients who have used/are using both. through study completion, an average of 1 year
Secondary Patient perception of THC-marijuana and/or CBD Compared to cancer treatments in treatment of cancer. Will be evaluated by generalized linear mixed models to account for the dependency among those patients who have used/are using both. through study completion, an average of 1 year
Secondary To evaluate patient report of adverse effects experienced while using THC-marijuana and/or CBD Patient reported outcomes will be summarized by frequency and proportion. through study completion, an average of 1 year
Secondary To evaluate patient reported concerns while using THC-marijuana and/or CBD Patient reported outcomes will be summarized by frequency and proportion. through study completion, an average of 1 year
Secondary Patient attitude of dosing, forms and use of THC-marijuana and/or CBD Patient reported outcomes will be summarized by frequency and proportion. through study completion, an average of 1 year
Secondary Demographic, physical and psychosocial factors that influence patient perception and attitudes of THC-marijuana and/or CBD Will be evaluated by Wilcoxon rank sum (Kruskal-Wallis) test or chi-square (Fisher's exact) test, when appropriate. To further evaluate these associations, univariate and multivariable logistic regression models will be fitted. Multiple comparisons will be adjusted where appropriate. through study completion, an average of 1 year
Secondary To explore the difference of patient perception of THC-marijuana and CBD in cancer centers in a legalized vs. a non-legalized state. Differences will be explored. through study completion, an average of 1 year
Secondary Patient reported preference of THC-Marijuana and CBD for cancer pain and symptom relief of patients Will be explored between a Supportive Care Center vs. Integrative Medicine Center at University of Texas (U.T.) MD Anderson. Will be evaluated by Wilcoxon rank sum (Kruskal-Wallis) test or chi-square (Fisher's exact) test, when appropriate. To further evaluate these associations, univariate and multivariable logistic regression models will be fitted. Multiple comparisons will be adjusted where appropriate. through study completion, an average of 1 year
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