A Digital Intervention to Improve Skin Self-examination Among Melanoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Body parts examined
研究概览
简要总结
This project, mySmartSkin (MSS), includes an innovative Type 1 hybrid effectiveness-implementation trial designed to enhance the effects of MSS and simultaneously assess key implementation outcomes (e.g., cost, adoption) as well as contextual factors important for scale-up in community and health care settings where melanoma survivors receive follow-up care. A type 1 hybrid effectiveness-implementation design allows us to engage multilevel stakeholders throughout this process, evaluate the effectiveness of the enhanced MSS, and identify critical factors for wide-scale implementation. Aim 1 will focus on enhancing the previous version of MSS by collaborating with multi-level stakeholders in qualitative interviews and usability testing. Aim 2 will evaluate the effects of enhanced MSS on thorough skin-self examinations (SSE) in a randomized-control trial (RCT) and examine its impact on the diagnosis of new/recurrent melanomas. Aim 3 will focus on assessing selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation.
详细描述
This is a type one hybrid effectiveness-implementation study consisting of three aims. Aim one (Months 1-15) focuses on MSS enhancement using stakeholder collaboration. Aim two (Months 16-60) involves the longitudinal randomized control trial (RCT) comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage. Aim three (Months 16-60) will assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 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 primary pathologic stage 0-III cutaneous malignant melanoma
- •Three months to five years post-surgery
- •No current evidence of cancer
- •Not adherent to thorough SSE (i.e., did not check entire body at least once during the past three months)
- •≥ 18 years old
- •Internet access
- •Able to speak/read English
- •Able to provide informed consent
排除标准
- 未提供
研究组 & 干预措施
Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60)
RCT of enhanced MSS testing effectiveness (thorough SSE, sun protection behavior Involves the longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas
干预措施: Educational webpage on Skin Self-Examination (Other)
Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60)
Assessment of implementation outcomes and key contextual factors from the perspective of multi - level stakeholders
干预措施: Assess implementation outcomes (Other)
Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)
Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT)
干预措施: MySmartSkin enhancement (Other)
结局指标
主要结局
Body parts examined
时间窗: 18 months
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Body parts examined
时间窗: Baseline
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Body parts examined
时间窗: 3 months
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Body parts examined
时间窗: 6 months
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Body parts examined
时间窗: 12 months
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
次要结局
- Melanoma Diagnosis(3 months)
- Melanoma Diagnosis Date(18 months)
- Melanoma Stage(18 months)
- Melanoma Diagnosis(6 months)
- Melanoma Diagnosis(12 months)
- Melanoma Diagnosis(18 months)
- Melanoma Stage(3 months)
- Melanoma Stage(6 months)
- Melanoma Stage(12 months)
- Melanoma Diagnosis Date(3 months)
- Melanoma Diagnosis Date(6 months)
- Melanoma Diagnosis Date(12 months)
研究者
Sharon Manne, PhD
Associate Director for Cancer Prevention, Control and Population Science
Rutgers, The State University of New Jersey