跳至主要内容
临床试验/NCT04559854
NCT04559854已完成不适用

Mindful After Cancer Study: Fostering Positive Body Image, Sexual Health, and Well-being

Oregon State University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Feasibility/ Enrollment in the Study

研究概览

简要总结

The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.

详细描述

The specific aims are: 1) Assess the feasibility of the MAC program when delivered via videoconference and 2) Assess preliminary effects of the the program.

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

入选标准

  • Diagnosis of breast or gynecologic cancer at least one year prior to enrollment
  • Completed primary cancer treatment
  • English speaking
  • Have access to a computer, smart phone, or tablet with internet access
  • Ability to spend 15-30 minutes per day on program activities

排除标准

  • Stage 0 (carcinoma in situ)

结局指标

主要结局

Feasibility/ Enrollment in the Study

时间窗: Baseline (T1)

Percentage of participants enrolled of those eligible

Feasibility/ Retention in the Study

时间窗: 1 month post-intervention (T2)

Number and percentage of participants completing all assessments

Feasibility/ Retention in the Intervention

时间窗: 1 month post-intervention (T2)

Number and percentage attending at least 6 of 8 sessions

Acceptability of the Intervention

时间窗: 1 month post-intervention (T2)

Endorsement of 10 items characterizing acceptability of the intervention (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability.

次要结局

  • Change From Baseline Interest in Sexual Activity at 1 Month(Baseline (T1) and 1 month post-intervention (T2))
  • Change From Baseline Satisfaction With Sex Life at 1 Month(Baseline (T1) and 1 month post-intervention (T2))
  • Change From Baseline Self-efficacy at 1 Month(Baseline (T1) and 1 month post-intervention (T2))
  • Change From Baseline Body Image at 1 Month(Baseline (T1) and 1 month post-intervention (T2))
  • Change From Baseline Body Appreciation at 1 Month(Baseline (T1) and 1 month post-intervention (T2))
  • Change From Baseline Anxiety at 1 Month(Baseline (T1) and 1 month post-intervention (T2))
  • Change From Baseline Depression at 1 Month(Baseline (T1) and 1 month post-intervention (T2))
  • Change in Facets of Baseline Mindfulness at 1 Month(Baseline (T1) and 1 month post-intervention (T2))
  • Change From Baseline Self-compassion at 1 Month(Baseline (T1) and 1 month post-intervention (T2))
  • Change From Baseline Relationship Quality at 1 Month(Baseline (T1) and 1 month post-intervention (T2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Gorman

Associate Professor

Oregon State University

研究点 (2)

Loading locations...

相似试验