Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 5
- 主要终点
- Feasibility Determined by Accrual, Adherence and Patient Retention.
研究概览
简要总结
This is a feasibility study to assess the use of a Digital Medicine Program (consisting of an FDA-approved ingestible sensor co-encapsulated with oxycodone/acetaminophen (5 mg/325 mg), a small wearable patch, and a mobile application) in cancer patients with metastatic disease experiencing uncontrolled pain.
详细描述
Given the high prevalence of cancer pain and issues with undertreatment and opioid misuse, focused efforts to improve monitoring of medication ingestion patterns are needed. This study will test the feasibility of using a Digital Medicine Program (consisting of an FDA-approved ingestible sensor co-encapsulated with oxycodone/acetaminophen (5 mg/325 mg), a small wearable patch, and a mobile application) in cancer patients with metastatic disease experiencing uncontrolled pain. Data collected from this study (such as information on patterns of DMP usage by patients and physicians and changes to medication dosage based on the reported symptoms) will inform the design of a randomized controlled trial of the DMP vs. usual care to control cancer pain and increase quality of life. If successful, this DMP could be a new way for physicians to evaluate patients' pain medication use patterns and titrate for adequate pain control while concurrently monitoring for adverse effects or abusive/addictive behavior. It will also promote improved communication between patients and their physicians and potentially address and ease some of patients' concerns and hesitancies regarding opioid medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of metastatic cancer
- •Patients must have a worst pain score of at least 3 (on a scale of 0-10) on the Brief Pain Inventory (BPI)* within 3 days prior to registration and be deemed by their physician to require initiation, continuation, or uptitration of opioid therapy with oxycodone/acetaminophen 5mg/325mg.
- •Patients currently on oxycodone/acetaminophen are eligible as long as they are on the 5 mg/325 mg dose.
- •Patients currently on another opiate, who have been prescribed or will be prescribed oxycodone/acetaminophen as an addition to their therapy are also eligible.
- •Patients must be >/= 18 years of age
- •Patients must complete the baseline PRO questionnaires prior to registration.
- •Patients must be able to read English, as the ePRO questionnaires are in English and patient instructions on the Proteus Discover mobile application are in English.
- •Patients must be willing to participate in electronic data collection and must have an iPhone, Android phone, or tablet with cellular connectivity in order to download the Patient Cloud and Proteus Discover mobile applications onto his/her device.
- •Patients must have successfully downloaded the Proteus Discover App.
- •Patients must not have a known allergy to adhesive tape, hydrogel or conductive gel, or hydrocolloid. (The adhesive strip for the Wearable Sensor Patch does not contain natural latex rubber).
- •Patients of reproductive potential must have agreed to use an effective contraceptive method. All men are considered to be of reproductive potential unless they have had a vasectomy or orchiectomy.
排除标准
- •Women must not be pregnant or nursing
研究组 & 干预措施
Oxycodone/acetaminophen (5/325 mg) DMP
The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.
干预措施: Oxycodone/acetaminophen 5/325 mg (Drug)
Oxycodone/acetaminophen (5/325 mg) DMP
The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.
干预措施: Proteus digital medicine program (Device)
结局指标
主要结局
Feasibility Determined by Accrual, Adherence and Patient Retention.
时间窗: adherence and retention - 6 weeks; accrual - 6 months
Feasibility will be determined by accrual (as confirmed by registration to the trial), adherence and patient retention (as measured and relayed by the wearable patch/sensor).
次要结局
- Pain Levels and Pain Interference With Daily Activity(2, 4, and 6 weeks.)
- ePRO Feasibility(6 weeks)
- Patient Global Quality of Life(2, 4, and 6 weeks)
- Frequency of Changes in Pain Management Regimen(6 weeks)
- Patient Psychological Distress(2, 4, and 6 weeks)
- Opioid Medication Consumption(6 weeks)
- Unplanned Hospital and Emergency Department Visits(6 weeks)
- Activity Levels(6 weeks)
- Patient Somatic Symptoms(baseline 2, 4, and 6 weeks.)
- Patient Satisfaction With the Digital Medicine Program (DMP).(6 weeks)
- Provider Satisfaction With Digital Medicine Program (DMP)(6 weeks)