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临床试验/NCT06681077
NCT06681077招募中不适用

I Can Join the Fight Against Cancer: An Intervention to Programmatically Build Grassroots Actions to Reduce the Cancer Burden

Roswell Park Cancer Institute1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年11月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Demand

研究概览

简要总结

This clinical trial evaluates a community health education intervention (I CAN) for increasing community-driven actions to reduce the cancer burden in Western New York. Engaging community members is a critical component of designing impactful programs to reduce the cancer burden. Leaders at the national, state, and local levels have all called for more community partnerships and engagement in design of health intervention and policies. The I CAN intervention is a workshop that includes a presentation outlining key concepts related to social network processes and the cancer burden in Western New York, a structured skill-building activity, and then empowering and motivating activities meant to cultivate momentum and excitement for action. This community health education intervention may be able to provide a formalized process for empowering and facilitating community members to take steps to reduce the community cancer burden.

详细描述

PRIMARY OBJECTIVES:

Phase I - Feasibility and Acceptability - 100 participants to be enrolled

  • Examine the feasibility of the I CAN intervention. (Phase I)
  • Examine the acceptability of the I CAN intervention. (Phase I)
  • Examine topic areas selected for action within participants' I CAN plans for action. (Phase I)

Phase II - Effectiveness of intervention trial for Lung Cancer Screening - 400 participants to be enrolled

  • Determine whether the I CAN intervention will result in higher number of individuals who complete lung cancer screening compared to didactic educational control. (Phase 2 [Effectiveness of intervention trial for lung cancer screening])
  • Evaluate whether the I CAN intervention improves adherence to recommended annual lung cancer screening follow-up among participants who initially received low dose computed tomography of the chest (LDCT) screening. (Phase 2 [Effectiveness of intervention trial for lung cancer screening])
  • Assess whether the I CAN intervention results in different levels of lung cancer screening knowledge and self-efficacy compared to the control group. (Phase 2 [Effectiveness of intervention trial for lung cancer screening])

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being over 18 years old
  • Able to participate in English

排除标准

  • Unwilling or unable to follow protocol requirements

研究组 & 干预措施

Prevention (I CAN intervention) - Phase 1

Experimental

Participants attend an I CAN intervention workshop over 2 hours.

干预措施: Community Health Education (Procedure)

I CAN Intervention - Phase 2

Experimental

Participants attend an I CAN intervention workshop over 2 hours. Two weeks after I CAN intervention workshop, participants receive a coaching call to assess progress, challenges, and revisions to I CAN plan.

干预措施: Community Health Education (Procedure)

I CAN Intervention - Phase 2

Experimental

Participants attend an I CAN intervention workshop over 2 hours. Two weeks after I CAN intervention workshop, participants receive a coaching call to assess progress, challenges, and revisions to I CAN plan.

干预措施: Telephone Based Intervention (Behavioral)

结局指标

主要结局

Demand

时间窗: Up to 2 years

Feasibility will be assessed through demand, which will be evaluated as the number of people enrolled and the demographics of participants. Descriptive analyses will be used.

Practicality

时间窗: Up to 2 years

Practicality will be assessed through the percentage of participants who complete different aspects of the intervention. Descriptive analyses will be used.

Acceptability

时间窗: UP to 2 years

Acceptability will be examined through post-intervention measures, including the Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure. Descriptive analyses will be used.

Demand - Phase 1

时间窗: Up to 2 years

Feasibility will be assessed through demand, which will be evaluated as the number of people enrolled and the demographics of participants. Descriptive analyses will be used.

Practicality - Phase 1

时间窗: Up to 2 years

Practicality will be assessed through the percentage of participants who complete different aspects of the intervention. Descriptive analyses will be used.

Acceptability- Phase 1

时间窗: UP to 2 years

Acceptability will be examined through post-intervention measures, including the Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure. Descriptive analyses will be used.

Lung Cancer Screening Uptake

时间窗: Up to 2 years

Will be assessed by determining if I CAN intervention results in higher number of individuals who complete lung cancer screening

Acceptability- Phase 1

时间窗: Up to 2 years

Acceptability will be examined through post-intervention measures, including the Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure. Descriptive analyses will be used.

次要结局

  • Rate of follow up for Lung cancer screening(6 months post screening (estimated to be 2 years))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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