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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Decisional conflict scale
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVES:
I. 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Best Practice (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Survey Administration (Other)
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.
干预措施: Educational Intervention (Other)
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.
干预措施: Interview (Other)
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.
干预措施: Educational Intervention (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Survey Administration (Other)
结局指标
主要结局
Decisional conflict scale
时间窗: 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.
次要结局
- Patient's perception of usefulness of the tool(Immediately after the clinical encounter)
- Knowledge(Up to 3 months)
- Usability(Immediately after the clinical encounter)
- Anxiety(Up to 3 months)
- Stress(Up to 3 months)
- CollaboRATE measure(Immediately after the clinical encounter)
- Shared decision-making process survey(Immediately after the clinical encounter)
- Acceptability(Immediately after the clinical encounter)
- Depression(Up to 3 months)