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Active, Not Recruiting

NCT Number: NCT04875286

Patient Reported Symptom Control With THC or CBD Use

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer-Associated Pain Cancer Pain Hematologic Diseases Hematologic Neoplasms Hematopoietic and Lymphoid Cell Neoplasm Hemic and Lymphatic Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Health Record Review

Other

Medical records reviewed

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
May 6, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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