The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
研究概览
简要总结
Multiple Myeloma (MM) patients are prone to poor quality of life (QoL) as a result of the anxiety and depression they suffer due to a poor understanding of their disease. Improving patient understanding of their illness and addressing issues that induce distress impacts QoL. This prospective, interventional study is designed to see if a structured psycho-educational program called "the myeloma pack intervention" (MPI), implemented in parallel with standard cancer treatment, can improve QoL for patients with MM.
详细描述
The purpose of this research study is to see if the MPI educational program, implemented in parallel with standard of care treatment, can improve overall quality of life (QoL) for MM patients. This program will be delivered to the study participants by multiple modes of communication including written material in a boxed pack, online tutorials, telephone and text message follow up. If they do not have online access at home, the study coordinators will arrange access for the participants at the Clinic. A health advisor will work with the physicians to coordinate their participation in the program while they are on active treatment for myeloma. The Pack Health Advisors will only give them guidance about the study and they will not provide any kind of clinical advice to the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Of age ≥18 years or older.
- •Having a diagnosis of MM; newly diagnosed or relapsed/refractory disease
- •Undergoing systemic treatment through the UAB MM Clinic Pathway
- •Able to provide informed consent to be included in the intervention
- •MM patients in a prior/concurrent (non-pyscho/educational intervention), MM study will be eligible to participate
- •Have either SMS texting or email access to receive encouragement messages
排除标准
- •Patients will be ineligible for the program if they are:
- •Being treated by end-of-life or comfort care measures only
- •MM patients not treated through the UAB MM Clinic Pathway.
- •MM patients not requiring systemic therapy.
- •Patients with a diagnosis of MGUS or SMM.
- •Have a history of other malignancy within the past [3 or 5] years with the exception of:
- •Malignancies treated with curative intent and with no known active disease present for ≥ 3 (or 5) years before enrollment and felt to be at low risk for recurrence by the treating physician
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •Adequately treated breast ductal carcinoma in situ without evidence of disease
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
- •Are enrolled in a prior/concurrent MM psycho-educational study
- •Other Exclusions:
- •Patients who do not have either SMS texting or email access to receive encouragement messaging will be excluded
- •History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
研究组 & 干预措施
ARM A EARLY INTERVENTION GROUP
In Arm A, the intervention group, the participants will start on the program immediately. The participants will receive MPI educational program, implemented in parallel with standard of care treatment. The MPI is implemented at the time of enrollment x 12 weeks
干预措施: ARM A EARLY INTERVENTION GROUP (Other)
ARM B DELAYED INTERVENTION GROUP
Arm B, is a wait-list control group that will serve as the control. The wait-list control group will be observed for an initial 12 week period while receiving usual care and then have the educational intervention implemented from week 12-24 in parallel with standard of care
干预措施: ARM B DELAYED INTERVENTION GROUP (Other)
结局指标
主要结局
Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
时间窗: 24 weeks post intervention
We will measure anxiety levels in MM patients 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
时间窗: Baseline
We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
时间窗: 12 weeks post intervention
We will measure anxiety levels in MM patients 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
次要结局
- Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy(Baseline)
- Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression(Baseline)
- Assess patient self-efficacy for symptom management 24 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy(24 weeks post intervention)
- Assess patient improvement in adherence to myeloma specific medication and treatment schedules 12 weeks after educational program (MPI) in MM patients using the CASE Medication Adherence Index(12 weeks post intervention)
- Assess patient self-efficacy for symptom management 12 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy(12 weeks post intervention)
- Assess patient improvement in adherence to myeloma specific medication and treatment schedules 24 weeks after educational program (MPI) in MM patients using the CASE Medication Adherence Index(24 weeks post intervention)
- Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression(12 weeks post intervention)
- Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression(24 weeks post intervention)
- Assess baseline patient adherence to myeloma specific medication and treatment schedules in MM patients using the CASE Medication Adherence Index(Baseline)
研究者
Smith Giri
PI
University of Alabama at Birmingham