Hematopoietic and Lymphatic System NeoplasmNCT06582030
Stop Addiction Stigma
A study testing Assessment, Educational Activity and Training in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates the impact of a Stop Addiction Stigma (SAS) training workshop with a short description of the conditions related to addiction (vignettes) on stigmatizing attitudes toward individuals with substance abuse disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Assessment, Educational Activity and Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 31 Dec 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employee of Ohio State University Wexner Medical Center (OSUWMC)
- Age ≥ 18 years
- Participants must be able to read and comprehend survey items
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Stop Addiction Stigma Training Workshop With Case Vignettes to Decrease Stigmatizing Attitudes Toward People With Substance Abuse Disorders
This clinical trial evaluates the impact of a Stop Addiction Stigma (SAS) training workshop with a short description of the conditions related to addiction (vignettes) on stigmatizing attitudes toward individuals with substance abuse disorders. Reviews have shown that patients with substance abuse disorders have experienced negative attitudes from their health care providers. Negative attitudes may lead to less involvement from the provider and the patient and may lead to less effective care. Using case vignettes with a SAS workshop may be an effective method to help people learn about addiction, reduce the stigma toward addiction and improve the quality of health care.
Read the detailed description
PRIMARY OBJECTIVE:
- To describe the impact of SAS training on participants' responses to people with a substance impairment.
SECONDARY OBJECTIVES:
- To evaluate the feasibility of stigma training workshops on stigmatizing attitudes health care personnel.
II. To explore the maintainability of responses over time. III. To explore relationships between language and stigmatizing attitudes.
OUTLINE: Participants are randomized to 1 of 6 group case vignettes.
GROUP A (CHRONICALLY RELAPSING BRAIN DISEASE): Participants view the chronically relapsing brain disease vignette and attend a SAS workshop on study.
GROUP B (BRAIN DISEASE): Participants view the brain disease vignette and attend a SAS workshop on study.
GROUP C (DISEASE): Participants view the disease vignette and attend a SAS workshop on study.
GROUP D (ILLNESS): Participants view the illness vignette and attend a SAS workshop on study.
GROUP E (DISORDER): Participants view the disorder vignette and attend a SAS workshop on study.
GROUP F (PROBLEM): Participants view the problem vignette and attend a SAS workshop on study.
- Being tested
- Assessment, Educational Activity, Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentBehavioural
Also called Assess, Study Assessment, Study Observation
Ancillary studies
Educational ActivityOther
View the chronically relapsing brain disease vignette
Educational ActivityOther
View the brain disease vignette
Educational ActivityOther
View the disease vignette
Educational ActivityOther
View the illness vignette
Educational ActivityOther
View the disorder vignette
Educational ActivityOther
View the problem vignette
TrainingOther
Also called Training Programs
Attend a SAS workshop
| Study group | Role | What they receive |
|---|---|---|
| Group A (chronically relapsing brain disease vignette, SAS) | Experimental | Participants view the chronically relapsing brain disease vignette and attend a SAS workshop on study. Receives: Behavioral: Assessment; Other: Educational Activity |
| Group B (brain disease vignette, SAS) | Experimental | Participants view the brain disease vignette and attend a SAS workshop on study. Receives: Behavioral: Assessment; Other: Educational Activity; Other: Training |
| Group C (disease vignette, SAS) | Experimental | Participants view the disease vignette and attend a SAS workshop on study. Receives: Behavioral: Assessment; Other: Educational Activity; Other: Training |
| Group D (illness vignette, SAS) | Experimental | Participants view the illness vignette and attend a SAS workshop on study. Receives: Behavioral: Assessment; Other: Educational Activity; Other: Training |
| Group E (disorder vignette, SAS) | Experimental | Participants view the disorder vignette and attend a SAS workshop on study. Receives: Behavioral: Assessment; Other: Educational Activity; Other: Training |
| Group F (problem vignette, SAS) | Experimental | Participants view the problem vignette and attend a SAS workshop on study. Receives: Behavioral: Assessment; Other: Educational Activity; Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stigmatizing attitudes
Stigmatizing attitudes will be measured with the Stigma and Attribution Assessment. The assessment score will be compared both between and within participants for each case vignette. Results will be reported with descriptive statistics, including means and standard deviations or medians and first-third quartiles for continuous variables, and frequencies and percentages for discrete variables.The linear mixed effect model will be used to study the repeated stigma and attribution measures over time (pre-workshop, immediately post-workshop, and 8 weeks post-workshop) within 6 vignettes as well as the effects between the vignettes, while controlling for the potential confounding factors (e.g., sex).
Measured: Before, immediately after and 8 weeks after the session
Secondary outcomes (2)
Attendance rate
The proportion of participants attending the workshop will be summarized with 95% confidence interval.
Measured: At 90 minute session.
Response to post-workshop evaluations
The proportion of participants who respond to the post-workshop evaluations will be summarized with 95% confidence interval.
Measured: Before, immediately following and 8 weeks after the session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start17 Oct 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gretchen A McNally, Ohio State University Comprehensive Cancer Center
- Investigators
- Gretchen A Mcnally, PhD, APRN-CNP, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582030
- Sponsor's protocol ID
- OSU-23194
- Other IDs
- NCI-2024-04797
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2024
- Last updated
- 3 Sep 2024
- 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Addiction Stigma Training Workshop With Case Vignettes to Decrease Stigmatizing Attitudes Toward People With Substance Abuse Disorders
- ClinicalTrials.gov ID
- NCT06582030
- Acronym / sponsor ID
- OSU-23194
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Sep 2024 (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 clinical trial evaluates the impact of a Stop Addiction Stigma (SAS) training workshop with a short description of the conditions related to addiction (vignettes) on stigmatizing attitudes toward individuals with substance abuse disorders. Reviews have shown that patients with substance abuse disorders have experienced negative attitudes from their health care providers. Negative attitudes may lead to less involvement from the provider and the patient and may lead to less effective care. Using case vignettes with a SAS workshop may be an effective method to help people learn about addiction, reduce the stigma toward addiction and improve the quality of health care.
Detailed description
PRIMARY OBJECTIVE:
- To describe the impact of SAS training on participants' responses to people with a substance impairment.
SECONDARY OBJECTIVES:
- To evaluate the feasibility of stigma training workshops on stigmatizing attitudes health care personnel.
II. To explore the maintainability of responses over time. III. To explore relationships between language and stigmatizing attitudes.
OUTLINE: Participants are randomized to 1 of 6 group case vignettes.
GROUP A (CHRONICALLY RELAPSING BRAIN DISEASE): Participants view the chronically relapsing brain disease vignette and attend a SAS workshop on study.
GROUP B (BRAIN DISEASE): Participants view the brain disease vignette and attend a SAS workshop on study.
GROUP C (DISEASE): Participants view the disease vignette and attend a SAS workshop on study.
GROUP D (ILLNESS): Participants view the illness vignette and attend a SAS workshop on study.
GROUP E (DISORDER): Participants view the disorder vignette and attend a SAS workshop on study.
GROUP F (PROBLEM): Participants view the problem vignette and attend a SAS workshop on study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A (chronically relapsing brain disease vignette, SAS) | Experimental | Behavioral: Assessment, Other: Educational ActivityParticipants view the chronically relapsing brain disease vignette and attend a SAS workshop on study. |
| Group B (brain disease vignette, SAS) | Experimental | Behavioral: Assessment, Other: Educational Activity, Other: TrainingParticipants view the brain disease vignette and attend a SAS workshop on study. |
| Group C (disease vignette, SAS) | Experimental | Behavioral: Assessment, Other: Educational Activity, Other: TrainingParticipants view the disease vignette and attend a SAS workshop on study. |
| Group D (illness vignette, SAS) | Experimental | Behavioral: Assessment, Other: Educational Activity, Other: TrainingParticipants view the illness vignette and attend a SAS workshop on study. |
| Group E (disorder vignette, SAS) | Experimental | Behavioral: Assessment, Other: Educational Activity, Other: TrainingParticipants view the disorder vignette and attend a SAS workshop on study. |
| Group F (problem vignette, SAS) | Experimental | Behavioral: Assessment, Other: Educational Activity, Other: TrainingParticipants view the problem vignette and attend a SAS workshop on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employee of Ohio State University Wexner Medical Center (OSUWMC)
- Age ≥ 18 years
- Participants must be able to read and comprehend survey items
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AssessmentAlso: Assess, Study Assessment, Study ObservationAncillary studies | Behavioural | Group A (chronically relapsing brain disease vignette, SAS), Group B (brain disease vignette, SAS), Group C (disease vignette, SAS), Group D (illness vignette, SAS), Group E (disorder vignette, SAS), Group F (problem vignette, SAS) |
| Educational ActivityView the chronically relapsing brain disease vignette | Other | Group A (chronically relapsing brain disease vignette, SAS) |
| Educational ActivityView the brain disease vignette | Other | Group B (brain disease vignette, SAS) |
| Educational ActivityView the disease vignette | Other | Group C (disease vignette, SAS) |
| Educational ActivityView the illness vignette | Other | Group D (illness vignette, SAS) |
| Educational ActivityView the disorder vignette | Other | Group E (disorder vignette, SAS) |
| Educational ActivityView the problem vignette | Other | Group F (problem vignette, SAS) |
| TrainingAlso: Training ProgramsAttend a SAS workshop | Other | Group B (brain disease vignette, SAS), Group C (disease vignette, SAS), Group D (illness vignette, SAS), Group E (disorder vignette, SAS), Group F (problem vignette, SAS) |
Primary outcome
Stigmatizing attitudes
Time frame: Before, immediately after and 8 weeks after the session
Stigmatizing attitudes will be measured with the Stigma and Attribution Assessment. The assessment score will be compared both between and within participants for each case vignette. Results will be reported with descriptive statistics, including means and standard deviations or medians and first-third quartiles for continuous variables, and frequencies and percentages for discrete variables.The linear mixed effect model will be used to study the repeated stigma and attribution measures over time (pre-workshop, immediately post-workshop, and 8 weeks post-workshop) within 6 vignettes as well as the effects between the vignettes, while controlling for the potential confounding factors (e.g., sex).
2 secondary outcomes
Attendance rate
Time frame: At 90 minute session.
Response to post-workshop evaluations
Time frame: Before, immediately following and 8 weeks after the session.
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 3 Sep 2024.
- The JameslineLink 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.
Gretchen A Mcnally, PhD, APRN-CNP principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment, Educational Activity and Training in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site 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 3 inclusion and 0 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 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Stigmatizing attitudes (time frame: Before, immediately after and 8 weeks after the session). 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 3 Sep 2024.