Patient Reported Symptom Control With THC or CBD Use

Recruiting

• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Cancer-Associated Pain
• Interventions: Other: Electronic Health Record Review; Other: Questionnaire Administration

• Registration Number: NCT04875286
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-02-03
• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-05-01
• Study First Posted: 2021-05-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2027-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (medical record review, questionnaires))	Electronic Health Record Review	Patients' medical records are reviewed and then complete questionnaires over 27 minutes.
Observational (medical record review, questionnaires))	Questionnaire Administration	Patients' medical records are reviewed and then complete questionnaires over 27 minutes.

Primary Outcome Measures

Name	Time	Method
Proportion of patients who prefer opioids with THC-marijuana and/or opioids with cannabidiol (CBD) to opioids alone for their cancer pain relief	through study completion, an average of 1 year	Will be calculated and reported along with a 95% confidence interval.

Secondary Outcome Measures

Name	Time	Method
Perception of cancer-related symptom relief	through study completion, an average of 1 year	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.
To evaluate patient report of adverse effects experienced while using THC-marijuana and/or CBD	through study completion, an average of 1 year	Patient reported outcomes will be summarized by frequency and proportion.
To evaluate patient reported concerns while using THC-marijuana and/or CBD	through study completion, an average of 1 year	Patient reported outcomes will be summarized by frequency and proportion.
To explore the difference of patient perception of THC-marijuana and CBD in cancer centers in a legalized vs. a non-legalized state.	through study completion, an average of 1 year	Differences will be explored.
Patient perception of THC-marijuana and/or CBD	through study completion, an average of 1 year	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.
Patient attitude of dosing, forms and use of THC-marijuana and/or CBD	through study completion, an average of 1 year	Patient reported outcomes will be summarized by frequency and proportion.
Demographic, physical and psychosocial factors that influence patient perception and attitudes of THC-marijuana and/or CBD	through study completion, an average of 1 year	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.
Patient reported preference of THC-Marijuana and CBD for cancer pain and symptom relief of patients	through study completion, an average of 1 year	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.

Trial Locations

Locations (2)

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States