Pilot Study of Multi-platform Assessment of Radiation Toxicity (M-PART) in Head and Neck Cancer Patients Treated With KeraStat® Cream for Acute Radiation Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants that Complete Scheduled Study Assessments to Measure for Feasibility
研究概览
简要总结
The purpose of this research study is to test the ability of a mobile device application (MyCap) to collect patient information about their radiation skin rash in patients with head and neck cancer being treated with radiation therapy.
详细描述
Primary Objective: To determine the feasibility of M-PART for the assessment of acute radiation dermatitis in patients treated with radiotherapy for head and neck cancer via MyCap.
Secondary Objectives:
- To assess agreement between site clinician-rated CTCAE G2+ radiation dermatitis with moist desquamation and patient-reported moist desquamation (a and b above).
- To assess the proportion of patient-submitted photographs of skin in the irradiated area that are evaluable for radiation dermatitis assessments by central review.
- To assess agreement between clinician-rated radiation dermatitis grading, central review of patient-submitted photographs, and central review of standardized clinic photographs (methods a, c, and d above).
- To measure the level of interval (i.e., optional engagement in between scheduled collection) patient engagement in the collection of radiation toxicity outcomes using the M-PART methodology.
- To measure patient and research staff satisfaction, perceptions, and preferences with regard to the M-PART data collection framework.
OUTLINE:
Patients apply KeraStat topically at least twice daily (BID) or more as needed and complete MyCap patient reported dermatitis assessments and submit photographs in MyCap once a week (QW) during RT and for 1 month following treatment in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo clinician skin rash assessments and standardized in-clinic photography on study.
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
- •- Histological or cytological diagnosis of head and neck cancer (of any part of the oral cavity, pharynx, larynx, or sinuses) planned to receive conventionally fractionated radiation therapy (RT) targeting the head and neck to a total prescribed dose of at least 50 Gy. The 50 Gy radiation therapy target must include at least a part of the unilateral and/or bilateral lymph node regions of the head/neck. Planned prescribed dose will be reviewed and approved by the study principal investigator.
- •NOTE: Patients without a clear pathologic diagnosis of invasive disease (i.e., biopsy showing at least carcinoma in situ) but with clinically diagnosed head and neck cancer planned for treatment as above are also eligible.
- •Age ≥ 18 years at the time of enrollment.
- •Able and willing to complete electronic toxicity and quality of life assessments in the MyCap application using their personal mobile device.
- •Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative) in English.
排除标准
- •Early stage (Stage I-II) squamous cell carcinoma of the glottic larynx planned for treatment with limited field radiation therapy alone. These participants are excluded since they are expected to receive a more limited exposure to radiation therapy.
- •Patients planned for treatment to the primary site alone without regional lymph node targeting.
- •Previous radiation therapy to the area in the head and neck to be treated with radiation therapy.
- •Active use of topical corticosteroids in the irradiation area at the time of enrollment. Note that it is acceptable to use topical corticosteroids if study participants develop moist desquamation during radiation therapy.
- •History of scleroderma or active lupus requiring systemic medication at the time of enrollment.
- •Planned concurrent treatment with anti-EGFR biologic therapy (e.g., cetuximab) for head and neck cancer.
- •Individuals who are pregnant or plan to become pregnant. Radiotherapy is contraindicated in this patient population.
研究组 & 干预措施
M-PART Assessment via MyCap
Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream.
干预措施: M-PART Assessments via MyCap (Device)
M-PART Assessment via MyCap
Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream.
干预措施: Clinical Assessments (Other)
M-PART Assessment via MyCap
Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream.
干预措施: Feedback phone interview (Other)
M-PART Assessment via MyCap
Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream.
干预措施: KeraStat cream (Drug)
结局指标
主要结局
Number of Participants that Complete Scheduled Study Assessments to Measure for Feasibility
时间窗: 4 weeks post radiation therapy, up to 2 years
Participants to complete 75% or more of required assessments over the course of the study will be calculated in two steps. First, investigators will separate patients into two groups, those who have completed 75% or more of their scheduled assessments over all time periods, and those who have not. Investigators will then divide the former number by the total number of patients who completed the study (i.e., completed their radiation treatment) with a final anticipated analyzable number of 16, using a 95% confidence interval. Thus, if 50% or more of the patients in the sample have completed at least 75% of scheduled assessments, the study will be deemed feasible to conduct a future study using M-PART.
次要结局
- Frequency in Responses to Satisfaction with M-PART - Qualitative Interviews(4 weeks after completion of radiation therapy, up to 2 years)
- Frequency in Responses to Satisfaction with M-PART - Semi-Quantitative Survey(4 weeks after completion of radiation therapy, up to 2 years)
- Number of Participants to Self-Report Presence of Radiation Dermatitis Compared to Site Clinician Reported Radiation Dermatitis.(At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years)
- Percentage of Participant-Submitted Photographs Evaluable for Radiation Dermatitis Grading(At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years)
- Proportion of Agreement in Grading Methods for Radiation Dermatitis(At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years)
- Number of Skin Assessments Provided Through MyCap - Patient Engagement(At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years)