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Patient Reported Symptom Control With THC or CBD Use

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ClinicalTrials.gov Identifier: NCT04875286
Recruitment Status : Recruiting
First Posted : May 6, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Cancer-Associated Pain Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Other: Electronic Health Record Review Other: Questionnaire Administration

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 Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Patient Reported Symptom Control With THC or CBD Use
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (medical record review, questionnaires))
Patients' medical records are reviewed and then complete questionnaires over 27 minutes.
 Other: Electronic Health Record Review
Medical records reviewed

Other: Questionnaire Administration
Complete questionnaires


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


Secondary Outcome Measures :
  1. Perception of cancer-related symptom relief [ Time Frame: 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.

  2. Patient perception of THC-marijuana and/or CBD [ Time Frame: 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.

  3. To evaluate patient report of adverse effects experienced while using THC-marijuana and/or CBD [ Time Frame: through study completion, an average of 1 year ]
    Patient reported outcomes will be summarized by frequency and proportion.

  4. To evaluate patient reported concerns while using THC-marijuana and/or CBD [ Time Frame: through study completion, an average of 1 year ]
    Patient reported outcomes will be summarized by frequency and proportion.

  5. Patient attitude of dosing, forms and use of THC-marijuana and/or CBD [ Time Frame: through study completion, an average of 1 year ]
    Patient reported outcomes will be summarized by frequency and proportion.

  6. Demographic, physical and psychosocial factors that influence patient perception and attitudes of THC-marijuana and/or CBD [ Time Frame: 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.

  7. To explore the difference of patient perception of THC-marijuana and CBD in cancer centers in a legalized vs. a non-legalized state. [ Time Frame: through study completion, an average of 1 year ]
    Differences will be explored.

  8. Patient reported preference of THC-Marijuana and CBD for cancer pain and symptom relief of patients [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04875286


Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Donato G. Dumlao    480-256-6444    donato.dumlao@bannerhealth.com   
Principal Investigator: Donato G. Dumlao         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Kimberson C. Tanco    713-792-6085    kctanco@mdanderson.org   
Principal Investigator: Kimberson C. Tanco         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Kimberson C Tanco M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04875286    
Other Study ID Numbers: 2019-0753
NCI-2021-02853 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0753 ( Other Identifier: M D Anderson Cancer Center )
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Cancer Pain
Pain
Neurologic Manifestations