Malignant NeoplasmNCT03360799
Questionnaires in Assessing Attitudes About Legalization of Marijuana Use in Participants With Cancer
An observational study of Malignant Neoplasm, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
This trial studies attitudes about legalization of marijuana use in participants with cancer. Questionnaires may help doctors to learn about and compare the attitudes that patients in non-legalized and legalized states have towards the legalization of medical marijuana. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Questionnaire Administration
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Nov 2017to 26 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Participants with cancer seen by the Palliative Care team at Banner MD Anderson or University of Texas (UT) MD Anderson
Who may be able to join
- Patients (inpatient or outpatient) seen by the Palliative Care team at Banner MD Anderson or UT MD Anderson
- Patients able to speak and read English
- Patients enrolled in each site must be a resident of the state where that site is located (e.g. if a patient is enrolled at UT MD Anderson Cancer Center [MDACC], they should be resident of the state of Texas)
- Patients should have a cancer diagnosis
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
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
About this study
Official title: A Comparison of the Attitudes About Legalization of Marijuana Use for Medical Purposes by Cancer Patients in Two Cancer Centers Located in a Legalized and a Non-Legalized State
This trial studies attitudes about legalization of marijuana use in participants with cancer. Questionnaires may help doctors to learn about and compare the attitudes that patients in non-legalized and legalized states have towards the legalization of medical marijuana.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the proportion of cancer patients' who have a positive attitude about legalizing marijuana for medical purposes between those in a legalized versus (vs.) a non-legalized state.
SECONDARY OBJECTIVES:
- To evaluate the association of cancer patients' belief in the usefulness of medical marijuana in their state of residency (Texas versus Arizona).
II. To examine the association of demographic, physical and psychosocial characteristics of patients and their perception of medical marijuana.
III. To examine the preference of patients for treatment of pain, anxiety and depression between medical marijuana vs. opioids, anti-anxiety and anti-depressant medications.
IV. To examine the association of media to perception of use of medical marijuana.
- To evaluate the association of cancer patients' attitude about legalizing marijuana for medical purposes vs. recreational purposes.
VI. To examine the association of patients who have used marijuana for certain medical conditions/symptoms and their belief of how it has affected that condition/symptom.
VII. To compare demographic, physical and psychosocial characteristics of patients who have used marijuana for medical purposes.
VIII. To compare demographic, physical and psychosocial characteristics of patients who have used marijuana for non-medical purposes. IX. To compare demographic, physical and psychosocial characteristics of patients who believe marijuana is useful for medical reasons.
OUTLINE:
Participants complete 5 questionnaires.
- Conditions
- Malignant Neoplasm
- Being tested
- Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaire) | Participants complete 5 questionnaires. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive attitude regarding the legalization of medical marijuana for medical purposes
Will be defined as answering "Completely Agree" or "Slightly Agree" to the question 1 in Marijuana Survey for Patients. The number of subjects with positive attitude towards legalizing medical marijuana will be compared between patients from Texas and Arizona States using one-sided Fisher's exact test or chi-squared test, whichever appropriate. A logistic model will be used to assess the effect of state of residency, adjusting for other covariates such as gender, age, race, etc. Will employ inverse probability of state weighting using the propensity score on all patients to estimate the difference in attitudes of marijuana use between the states. In the weighted sample, will also compute the standardized differences to evaluate the balance of baseline covariates between the two states. The propensity score model may be adjusted to further minimize some of the residual difference in the distribution of the baseline covariates between the two states.
Measured: Up to 1 year
Secondary outcomes (2)
Participants' belief in the usefulness of medical marijuana between those who are residents of Texas versus Arizona
The proportion of patients with positive belief will be reported with a 95% confidence interval. Fisher's exact test will be applied to compare the proportion between residents of two states.
Measured: Up to 1 year
Perception of medical marijuana
Will evaluate the association of demographical, physical, and psychosocial characteristics of patients and their perception of medical marijuana. In order to address this objective, all the specified characteristics will be summarized by descriptive statistics based on patients' perception of medical marijuana (positive or negative attitude); chi-square (or Fisher's exact) test and Wilcoxon rank sum test may be applied to test the associations for categorical and continuous variables, respectively. Logistic regression model may be utilized to evaluate the association of patients' characteristics with their perception of medical marijuana. Summarized reports of all other questions regarding the preference of patients for treatment of pain, anxiety and depression between medical marijuana versus opioids, anti-anxiety, anti-depressant medications, as well as the perception of impact of media on patient's preference in the Marijuana Survey for Patients will be provided.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start17 Nov 2017
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimberson C Tanco, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360799
- Sponsor's protocol ID
- 2017-0568
- Other IDs
- NCI-2018-01026, 2017-0568, P30CA016672
- Status last verified
- Aug 2019
- First submitted
- 28 Nov 2017
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Attitudes About Legalization of Marijuana Use for Medical Purposes by Cancer Patients in Two Cancer Centers Located in a Legalized and a Non-Legalized State
- ClinicalTrials.gov ID
- NCT03360799
- Acronym / sponsor ID
- 2017-0568
- Conditions
- Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies attitudes about legalization of marijuana use in participants with cancer. Questionnaires may help doctors to learn about and compare the attitudes that patients in non-legalized and legalized states have towards the legalization of medical marijuana.
Detailed description
PRIMARY OBJECTIVES:
- To compare the proportion of cancer patients' who have a positive attitude about legalizing marijuana for medical purposes between those in a legalized versus (vs.) a non-legalized state.
SECONDARY OBJECTIVES:
- To evaluate the association of cancer patients' belief in the usefulness of medical marijuana in their state of residency (Texas versus Arizona).
II. To examine the association of demographic, physical and psychosocial characteristics of patients and their perception of medical marijuana.
III. To examine the preference of patients for treatment of pain, anxiety and depression between medical marijuana vs. opioids, anti-anxiety and anti-depressant medications.
IV. To examine the association of media to perception of use of medical marijuana.
- To evaluate the association of cancer patients' attitude about legalizing marijuana for medical purposes vs. recreational purposes.
VI. To examine the association of patients who have used marijuana for certain medical conditions/symptoms and their belief of how it has affected that condition/symptom.
VII. To compare demographic, physical and psychosocial characteristics of patients who have used marijuana for medical purposes.
VIII. To compare demographic, physical and psychosocial characteristics of patients who have used marijuana for non-medical purposes. IX. To compare demographic, physical and psychosocial characteristics of patients who believe marijuana is useful for medical reasons.
OUTLINE:
Participants complete 5 questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire) | – | Other: Questionnaire AdministrationParticipants complete 5 questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with cancer seen by the Palliative Care team at Banner MD Anderson or University of Texas (UT) MD Anderson
Key inclusion criteria (4 listed)
- Patients (inpatient or outpatient) seen by the Palliative Care team at Banner MD Anderson or UT MD Anderson
- Patients able to speak and read English
- Patients enrolled in each site must be a resident of the state where that site is located (e.g. if a patient is enrolled at UT MD Anderson Cancer Center [MDACC], they should be resident of the state of Texas)
- Patients should have a cancer diagnosis
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaire) |
Primary outcome
Positive attitude regarding the legalization of medical marijuana for medical purposes
Time frame: Up to 1 year
Will be defined as answering "Completely Agree" or "Slightly Agree" to the question 1 in Marijuana Survey for Patients. The number of subjects with positive attitude towards legalizing medical marijuana will be compared between patients from Texas and Arizona States using one-sided Fisher's exact test or chi-squared test, whichever appropriate. A logistic model will be used to assess the effect of state of residency, adjusting for other covariates such as gender, age, race, etc. Will employ inverse probability of state weighting using the propensity score on all patients to estimate the difference in attitudes of marijuana use between the states. In the weighted sample, will also compute the standardized differences to evaluate the balance of baseline covariates between the two states. The propensity score model may be adjusted to further minimize some of the residual difference in the distribution of the baseline covariates between the two states.
2 secondary outcomes
Participants' belief in the usefulness of medical marijuana between those who are residents of Texas versus Arizona
Time frame: Up to 1 year
Perception of medical marijuana
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberson C Tanco principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 30 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive attitude regarding the legalization of medical marijuana for medical purposes (time frame: Up to 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 30 Aug 2019.