Ankylosing SpondylitisNCT04751396
Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
An observational study of Ankylosing Spondylitis and Autoimmune Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis, Autoimmune Disease, Crohn Disease
- What is being tested?
- Best Practice, Educational Intervention and Interview
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2022to 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 with melanoma or pre-existing autoimmune disease and clinicians
Who may be able to join
- Diagnosis of melanoma
- Diagnosis of pre-existing autoimmune disease
- Inflammatory bowel disease
- Diagnosis of Crohn's disease or ulcerative colitis by a gastroenterologist
- For ulcerative colitis, proof of chronic changes over time (i.e., 6 months) and signs of inflammation histologically
- Treatment with aminosalicylates, corticosteroids, thiopurines, or immune modifiers (e.g., calcineurin inhibitors, methotrexate, adhesion molecule antagonists)
Show all 25Show fewer
- Rheumatoid arthritis
- Diagnosis of rheumatoid arthritis by a rheumatologist
- Treatment with traditional disease-modifying antirheumatic drugs (e.g., methotrexate, sulfasalazine, hydroxychloroquine) or targeted therapy
- Systemic lupus erythematosus
- Diagnosis of systemic lupus erythematosus by a rheumatologist
- Psoriasis
- Diagnosis of psoriasis by a dermatologist
- Treatment with corticosteroids, vitamin D analogs, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, or moisturizers; light therapy, including sunlight, ultraviolet B (UVB) phototherapy, narrowband UVB therapy, Goeckerman therapy, photochemotherapy, excimer laser, or pulsed dye laser; or systemic medications, including retinoids, methotrexate, cyclosporine, hydroxyurea, or thioguanine or targeted therapies
- Spondyloarthropathies
- Diagnosis of ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis/spondylitis by a rheumatologist
- Treatment with disease-modifying antirheumatic drugs (e.g., sulfasalazine) or targeted therapy
- Age of 18 years or older
- Patients whose physicians had recommended they begin using any of the currently available immune checkpoint inhibitors or people who are in the midst of or have already made the decision on whether or not start an immune checkpoint inhibitor
- E-mail access and computer with Internet access or telephone
- Ability to communicate in English or Spanish
- CLINICIAN
- Prescribed immune checkpoint inhibitors
- Are providing care for patients with melanoma
- In the clinics at MD Anderson
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Maria A. Lopez-Olivo, 713-792-9175
Maria A. Lopez-Olivo
About this study
Official title: Testing of an Educational Tool for Patients With Melanoma and Concomitant Autoimmune Disease Who Are Candidates for Adjuvant Therapy With Immune Checkpoint Inhibitors: Acceptability and Usability With Patients and Providers
This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the acceptability (e.g., ease of use, design, accessibility, content) of the educational tool that will be developed for patients with melanoma and pre-existing autoimmune conditions considering or undergoing treatment with immune checkpoint inhibitors.
II. To test the usability in real world-settings of the educational tool (to be developed) and evaluate feasibility of patient recruitment (i.e., ability to identify enough patients and consent at least 50% of the identified patients) in a pilot study.
OUTLINE:
PART A: Participants navigate the educational tool over 30-45 minutes then participate in an interview about their thoughts and opinions about the content, ease of use, and format of the tool over 45 minutes.
PART B: 2 group of participants will be evaluated sequentially (Participants in group II will be enrolled after all the participants in group I have been assessed).
GROUP I: Patients receive standard educational information during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months.
GROUP II: Patients navigate educational tool over 20 minutes during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months.
- Conditions
- Ankylosing Spondylitis, Autoimmune Disease, Crohn Disease, Enteropathic Arthritis, Enteropathic Spondylitis, Inflammatory Bowel Disease
- Being tested
- Best Practice, Educational Intervention, Interview, Questionnaire Administration, Survey Administration
- Medical subject headings
- Spondylitis, Ankylosing, Autoimmune Diseases, Crohn Disease, Inflammatory Bowel Diseases, Melanoma, Psoriasis, Arthritis, Psoriatic, Arthritis, Reactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard educational information
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Navigate educational tool
InterviewOther
Participate in interview
Questionnaire AdministrationOther
Complete questionnaire
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Part A (Interview) | Participants navigate the educational tool over 30-45 minutes then participate in an interview about their thoughts and opinions about the content, ease of use, and format of the tool over 45 minutes. Receives: Other: Educational Intervention; Other: Interview | |
| Part B Group I (standard information) | Patients receive standard educational information during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months. Receives: Other: Best Practice; Other: Questionnaire Administration; Other: Survey Administration | |
| Part B Group II (educational tool) | Patients navigate educational tool over 20 minutes during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months. Receives: Other: Educational Intervention; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict scale
The scale will be used to assess personal perceptions of 1) uncertainty in choosing among options; 2) modifiable factors contributing to uncertainty, such as feeling uninformed, and 3) feeling that the choice is values-based and likely to be implemented.
Measured: Up to 4 years
Secondary outcomes (9)
Knowledge
Will be assessed using a questionnaire developed by the research team covering various content areas, including general information about immune checkpoint inhibitors and the associated adverse effects and benefits of the treatments.
Measured: Up to 3 months
Acceptability
A standard assessment questionnaire will be used to obtain users' ratings of various features of the educational tool, including ease of use, presentation, usefulness and satisfaction. The items in the questionnaire come from the Ottawa Acceptability Measures.
Measured: Immediately after the clinical encounter
Usability
A standard assessment questionnaire will be used to obtain users' ratings of various features of the educational tool, including ease of use, presentation, usefulness and satisfaction. The items in the questionnaire come from the Ottawa Acceptability Measures.
Measured: Immediately after the clinical encounter
Depression
Will be assessed using the Depression and Anxiety Stress Scale (DASS). The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia
Measured: Up to 3 months
Anxiety
Will be assessed using the DASS. The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect.
Measured: Up to 3 months
Stress
Will be assessed using the DASS. The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient.
Measured: Up to 3 months
CollaboRATE measure
The CollaboRATE questions ask about the effort made to help patients understand their health issues, listen to what matters most to them, and include what matters most to them in choosing what to do next.
Measured: Immediately after the clinical encounter
Shared decision-making process survey
This instrument measures the extent to which health care providers engage patients in shared decision making. Items are focused on four specific behaviors that are critical for shared decision making -discussion of options, pros, cons and preferences.
Measured: Immediately after the clinical encounter
Patient's perception of usefulness of the tool
Will use the Preparation for Decision Making Scale (Prep-DM) to assess the patients' perception of how useful the educational tool is in preparing them to communicate with their practitioner at a consultation. It is a 10-item scale developed to evaluate decision processes relating to the preparation of patients for decision making and dialoguing with their practitioners.
Measured: Immediately after the clinical encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start20 Apr 2022
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- 125 participants (estimated)
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
- Angeles Lopez-Olivo, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751396
- Sponsor's protocol ID
- 2020-0843
- Other IDs
- NCI-2021-00565, 2020-0843, K08CA237619
- Status last verified
- May 2026
- First submitted
- 8 Feb 2021
- Last updated
- 20 May 2026
- 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of an Educational Tool for Patients With Melanoma and Concomitant Autoimmune Disease Who Are Candidates for Adjuvant Therapy With Immune Checkpoint Inhibitors: Acceptability and Usability With Patients and Providers
- ClinicalTrials.gov ID
- NCT04751396
- Acronym / sponsor ID
- 2020-0843
- Conditions
- Ankylosing Spondylitis, Autoimmune Disease, Crohn Disease, Enteropathic Arthritis, Enteropathic Spondylitis, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 12 Feb 2021 (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 study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the acceptability (e.g., ease of use, design, accessibility, content) of the educational tool that will be developed for patients with melanoma and pre-existing autoimmune conditions considering or undergoing treatment with immune checkpoint inhibitors.
II. To test the usability in real world-settings of the educational tool (to be developed) and evaluate feasibility of patient recruitment (i.e., ability to identify enough patients and consent at least 50% of the identified patients) in a pilot study.
OUTLINE:
PART A: Participants navigate the educational tool over 30-45 minutes then participate in an interview about their thoughts and opinions about the content, ease of use, and format of the tool over 45 minutes.
PART B: 2 group of participants will be evaluated sequentially (Participants in group II will be enrolled after all the participants in group I have been assessed).
GROUP I: Patients receive standard educational information during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months.
GROUP II: Patients navigate educational tool over 20 minutes during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A (Interview) | – | Other: Educational Intervention, Other: InterviewParticipants navigate the educational tool over 30-45 minutes then participate in an interview about their thoughts and opinions about the content, ease of use, and format of the tool over 45 minutes. |
| Part B Group I (standard information) | – | Other: Best Practice, Other: Questionnaire Administration, Other: Survey AdministrationPatients receive standard educational information during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months. |
| Part B Group II (educational tool) | – | Other: Educational Intervention, Other: Questionnaire Administration, Other: Survey AdministrationPatients navigate educational tool over 20 minutes during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with melanoma or pre-existing autoimmune disease and clinicians
Key inclusion criteria (25 listed)
- Diagnosis of melanoma
- Diagnosis of pre-existing autoimmune disease
- Age of 18 years or older
- Patients whose physicians had recommended they begin using any of the currently available immune checkpoint inhibitors or people who are in the midst of or have already made the decision on whether or not start an immune checkpoint inhibitor
- E-mail access and computer with Internet access or telephone
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard educational information | Other | Part B Group I (standard information) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalNavigate educational tool | Other | Part A (Interview), Part B Group II (educational tool) |
| InterviewParticipate in interview | Other | Part A (Interview) |
| Questionnaire AdministrationComplete questionnaire | Other | Part B Group I (standard information), Part B Group II (educational tool) |
| Survey AdministrationComplete surveys | Other | Part B Group I (standard information), Part B Group II (educational tool) |
Primary outcome
Decisional conflict scale
Time frame: Up to 4 years
The scale will be used to assess personal perceptions of 1) uncertainty in choosing among options; 2) modifiable factors contributing to uncertainty, such as feeling uninformed, and 3) feeling that the choice is values-based and likely to be implemented.
9 secondary outcomes
Knowledge
Time frame: Up to 3 months
Acceptability
Time frame: Immediately after the clinical encounter
Usability
Time frame: Immediately after the clinical encounter
Depression
Time frame: Up to 3 months
Anxiety
Time frame: Up to 3 months
Stress
Time frame: Up to 3 months
CollaboRATE measure
Time frame: Immediately after the clinical encounter
Shared decision-making process survey
Time frame: Immediately after the clinical encounter
Patient's perception of usefulness of the tool
Time frame: Immediately after the clinical encounter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- MD Anderson Cancer CenterLink 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.
Angeles Lopez-Olivo principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Autoimmune Disease, run by M.D. Anderson 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 25 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: looking for participants now, as of the sponsor's last update on 20 May 2026. 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?
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?
Contact Angeles Lopez-Olivo (713-792-9175, amlopezo@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict scale (time frame: Up to 4 years). 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 20 May 2026.