Tailored Intervention for Melanoma Patient's Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 553
- 试验地点
- 3
- 主要终点
- Impact of generic print and phone counseling vs. tailored print and phone counseling interventions on the engagement in total cutaneous examination (TCE) and self-skin examination (SSE) among first degree relatives (FDRs) at increased risk for CMM.
研究概览
简要总结
The purpose of the investigators' study is to find the best way to provide information about sun protection and skin cancer detection. The investigators want to see which of two methods most improves sun protection and screening attitudes and practices. The investigators hope to improve these attitudes and practices among people who are at higher risk for melanoma. People at higher risk for melanoma are first degree relatives (mother, father, sibling or child) of people diagnosed with melanoma.
详细描述
Eligible patients will be contacted to find out whether they have any living first degree relatives that we may contact to discuss their participation in our study.
Eligible first degree relatives (FDRs) will participate in our study as outlined under Interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients (for referral of FDRs):
- •Newly diagnosed with cutaneous malignant melanoma (CMM) within the past 2 years but more than 3 months prior to being approached
- •Seen at FCCC, FCCC Network, Temple, MCC, or HUP patient clinics
- •Greater than 18 years of age
- •English speaking
- •Able to give meaningful informed consent
- •Does NOT have a first-degree relative with CMM
- •Inclusion Criteria - FDR (First Degree Relative):
- •Current age of at least 21 years
- •One or more of the following additional risk factors; blonde or red hair; marked freckling on the upper back; history of 3 or more blistering sunburns prior to age 20; 3 or more years of an outdoor summer job as a teenager; Actinic keratosis
- •Able to give informed consent
- •English speaking
- •Has residential phone service
- •No personal history of CMM or non-melanoma skin cancer
- •No personal history of dysplastic nevi
排除标准
- •2 or more first degree relatives with CMM
- •Has had a total cutaneous examination (TCE) in the past 3 years AND has done skin self-examination (SSE) more than once in the past year AND has a sun protection habits mean score greater than or equal to 4 (often). We are selecting a set participants who are NOT compliant with TCE and are inconsistent/minimal performers of SSE and sun protection practices.
研究组 & 干预措施
2
Group II
干预措施: Reading materials and discussions (Other)
2
Group II
干预措施: Questionnaires (Other)
1
Group I
干预措施: Reading materials and discussions (Other)
1
Group I
干预措施: Questionnaires (Other)
结局指标
主要结局
Impact of generic print and phone counseling vs. tailored print and phone counseling interventions on the engagement in total cutaneous examination (TCE) and self-skin examination (SSE) among first degree relatives (FDRs) at increased risk for CMM.
时间窗: approximately 9 months per participant
次要结局
- Determine whether the interventions have an impact on attitudinal factors and whether these attitudinal factors mediate the expected association between the interventions and skin surveillance and sun exposure/protection.(approximately 9 months per participant)
