Investigating Active Surveillance for Management of Low-Risk Basal Cell Carcinoma in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Enrollment in part B (Part A)
研究概览
简要总结
This clinical trial evaluates whether active surveillance (AS) is a safe and comfortable alternative to standard of care (SOC) treatment for elderly patients with low-risk basal cell carcinoma (LR-BCC). Basal cell carcinoma is a type of slow-growing skin cancer that has a very low risk of spreading inside the body (metastasis) or death. Basal cell skin cancers that are smaller across than a nickel in size and located on the trunk or limbs are particularly low risk to overall health. Active surveillance - watching and not treating unless the cancer worsens - has been shown to be a generally safe way to manage LR-BCC. Despite this, many doctors do not feel comfortable discussing this option with patients due to a lack of studies comparing it to standard of care treatment. Standard of care treatment for LR-BCC can include "scrape and burn" (electrodesiccation and curettage), surgical resection, Mohs surgery, and other approaches. These treatments can carry risks like post-operative bleeding and wound infection, and they do not always improve tumor-related quality of life. Active surveillance may be a safe and comfortable alternative to SOC treatment for elderly patients with LR-BCC.
详细描述
PRIMARY OBJECTIVES:
I. To identify the baseline characteristics of patients who are willing and able to enroll in an randomized controlled trial (RCT) examining acceptability of AS versus (vs.) SOC. (Part A) II. To determine if satisfaction of patients randomized to AS is noninferior to satisfaction of those randomized to SOC at one-year follow-up. (Part B)
EXPLORATORY OBJECTIVES:
I. To collect additional pilot data on acceptability of AS for asymptomatic LR-BCC among the elderly.
II. To determine the feasibility and optimal design of a future fully powered multi-institution RCT examining the hypothesis that active surveillance of biopsy-proven low-risk BCC is an acceptable alternative to standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject of any gender aged ≥ 65 years at the time of enrollment
- •Patient at University of Michigan Department of Dermatology (UMichDD)
- •Willing and able to provide informed consent
- •Willing and able to comply with the protocol requirements
- •Histopathologic diagnosis of one or more LR-BCC(s) within 2 months of enrollment. LR-BCC is defined here as biopsy proven primary (not recurrent) BCC of any morphologic subtype; < 2cm in size; with or without marginal involvement on histopathology; and located on the trunk or extremities excluding pretibial surface, hands, feet, nail units, and ankles (corresponding to area L in the Mohs Appropriate Use Criteria, representing the lowest risk areas)
排除标准
- •Individuals who are immunocompromised per judgement of investigator (examples include but are not limited to patients on immunosuppressive medications such as prednisone > 10 mg daily, uncontrolled HIV, and organ transplant recipients on immunosuppressive therapy)
- •Individuals who expect to relocate and will be unable to return to UMichDD for clinical follow-up visit(s)
- •Individuals with a genetic syndrome predisposing to development of basal cell carcinoma
研究组 & 干预措施
Part A (educational activity, survey administration)
Patients watch an educational video on AS for LR-BCC and complete a survey about comfort with AS for LR-BCC on study.
干预措施: Survey Administration (Other)
Part B arm 1 (active surveillance)
Patients receive no treatment and undergo active surveillance over 1 year in the absence of disease progression. Patients may choose to undergo treatment at any point on study. Patients complete a standard 1-year follow-up total body skin examination followed by a second survey.
干预措施: Patient Observation (Other)
Part B arm 1 (active surveillance)
Patients receive no treatment and undergo active surveillance over 1 year in the absence of disease progression. Patients may choose to undergo treatment at any point on study. Patients complete a standard 1-year follow-up total body skin examination followed by a second survey.
干预措施: Survey Administration (Other)
Part B arm 2 (SOC)
Patients receive SOC treatment which typically includes either electrodesiccation and curettage, surgical resection, or Mohs surgery as agreed upon by patient and provider in the absence of disease progression. Patients complete a standard 1-year follow-up total body skin examination followed by a second survey.
干预措施: Best Practice (Other)
Part B arm 2 (SOC)
Patients receive SOC treatment which typically includes either electrodesiccation and curettage, surgical resection, or Mohs surgery as agreed upon by patient and provider in the absence of disease progression. Patients complete a standard 1-year follow-up total body skin examination followed by a second survey.
干预措施: Survey Administration (Other)
Part A (educational activity, survey administration)
Patients watch an educational video on AS for LR-BCC and complete a survey about comfort with AS for LR-BCC on study.
干预措施: Educational Activity (Other)
结局指标
主要结局
Enrollment in part B (Part A)
时间窗: 6 months
Will evaluate the associations between baseline characteristics and the primary outcome of enrollment in part B (up to accrual target for 100 subjects) by logistic regression. Baseline characteristics include demographics, clinical data, patient-reported measures, baseline comfort with active surveillance (AS), and interest in enrollment in part B. The clinical research coordinator will assign each participant in part A a value of 1 if enrolled in part B or 0 if not enrolled (up to accrual target of 100 subjects for part B).
Satisfaction with AS/standard of care (SOC) (Part B)
时间窗: At week 52
Will compare the satisfaction of participants randomized to AS versus SOC as measured by five-point Likert scale.
次要结局
未报告次要终点