Clinical trial NCT04875286: Patient Reported Symptom Control With THC or CBD Use
Official title: Patient Reported Symptom Control With THC or CBD Use
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer-Associated Pain
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who prefer opioids with THC-marijuana and/or opioids with cannabidiol (CBD) to opioids alone for their cancer pain relief
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Perception of cancer-related symptom relief
timeFrame: through study completion, an average of 1 year
measure: Patient perception of THC-marijuana and/or CBD
timeFrame: through study completion, an average of 1 year
measure: To evaluate patient report of adverse effects experienced while using THC-marijuana and/or CBD
timeFrame: through study completion, an average of 1 year
measure: To evaluate patient reported concerns while using THC-marijuana and/or CBD
timeFrame: through study completion, an average of 1 year
measure: Patient attitude of dosing, forms and use of THC-marijuana and/or CBD
timeFrame: through study completion, an average of 1 year
measure: Demographic, physical and psychosocial factors that influence patient perception and attitudes of THC-marijuana and/or CBD
timeFrame: through study completion, an average of 1 year
measure: To explore the difference of patient perception of THC-marijuana and CBD in cancer centers in a legalized vs. a non-legalized state.
timeFrame: through study completion, an average of 1 year
measure: Patient reported preference of THC-Marijuana and CBD for cancer pain and symptom relief of patients
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kimberson C Tanco
role: PRINCIPAL_INVESTIGATOR
References: