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Cancer-Associated PainNCT04875286

Patient Reported Symptom Control With THC or CBD Use

An observational study of Cancer-Associated Pain and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Electronic Health Record Review and Questionnaire Administration
How many people
200 participants
Where
2 sitesUnited States
Study dates
3 Feb 2021to 2 Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Electronic Health Record Review, Questionnaire Administration
Medical subject headings
Cancer Pain, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronic Health Record ReviewOther

    Medical records reviewed

  • Questionnaire AdministrationOther

    Complete questionnaires

Study groups in NCT04875286
Study groupRoleWhat they receive
Observational (medical record review, questionnaires))Patients' medical records are reviewed and then complete questionnaires over 27 minutes.
Receives: Other: Electronic Health Record Review; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through study completion, an average of 1 year

Secondary outcomes (8)
  1. 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.

    Measured: through study completion, an average of 1 year

  2. 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.

    Measured: through study completion, an average of 1 year

  3. 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.

    Measured: through study completion, an average of 1 year

  4. To evaluate patient reported concerns while using THC-marijuana and/or CBD

    Patient reported outcomes will be summarized by frequency and proportion.

    Measured: through study completion, an average of 1 year

  5. Patient attitude of dosing, forms and use of THC-marijuana and/or CBD

    Patient reported outcomes will be summarized by frequency and proportion.

    Measured: through study completion, an average of 1 year

  6. 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.

    Measured: through study completion, an average of 1 year

  7. 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.

    Measured: through study completion, an average of 1 year

  8. 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.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start3 Feb 2021
  3. Primary completion2 Feb 2027 (estimated)
  4. Study completion2 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875286
Sponsor's protocol ID
2019-0753
Other IDs
NCI-2021-02853, 2019-0753
Status last verified
Sep 2026
First submitted
22 Apr 2021
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer-Associated Pain and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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