跳至主要内容
临床试验/NCT06121258
NCT06121258进行中(未招募)不适用

Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
2
主要终点
Acceptability of the educational video series after six-months of access and use by breast cancer patients as measured by AIM instrument.

研究概览

简要总结

The purpose of this study is to assess the acceptability, appropriateness, and feasibility of a educational video series for patients going through breast cancer treatment.

详细描述

This is a prospective, mixed methods pilot study to evaluate the acceptability, appropriateness, and feasibility of a novel educational video series for patients going through breast cancer treatment. The video series addresses topics such as what to expect from breast surgery, how to prepare for breast surgery, treatment effects of breast cancer therapies, and mitigation and communication strategies for navigating breast cancer treatment.

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 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Stage I-III invasive breast cancer within one month of initial multi-disciplinary clinic visit or surgical consultation
  • Ability to complete survey material independently
  • Able to read and speak English
  • Willingness to comply with study material and procedures

排除标准

  • Age < 18 years old
  • Stage 0 or IV breast cancer
  • Non-breast cancer diagnoses
  • History of anti-hormonal therapy, chemotherapy, or radiotherapy not related to breast cancer
  • Prior breast cancer diagnosis

结局指标

主要结局

Acceptability of the educational video series after six-months of access and use by breast cancer patients as measured by AIM instrument.

时间窗: 6 months

The Acceptability of Intervention Measure (AIM) is a validated instrument used to measure the acceptability of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater acceptability).

Appropriateness of the educational video series after six-months of access and use by breast cancer patients as measured by IAM instrument.

时间窗: 6 months

The Intervention Appropriateness Measure (IAM) is a validated instrument used to measure the appropriateness of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater appropriateness).

Determine the sustainability of the educational video series after six-months of access and use by breast cancer patients as measured by the FIM instrument.

时间窗: 6 months

The Feasibility of Intervention Measure (FIM) is a validated instrument used to measure the feasibility, or sustainability, of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater feasibility).

次要结局

  • Change from baseline in sexual health and function at six-months, as measured by the PROMIS Sexual Function v2 Brief Profile (Female)(Baseline, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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