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临床试验/NCT02058615
NCT02058615已完成3 期

Living With Hope: Development and Feasibility Evaluation of a Transition Toolkit for Make Partners of Women With Breast Cancer

University of Alberta1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
57
试验地点
1
主要终点
Hope

研究概览

简要总结

Male partners of women with breast cancer experience distress, so we want to develop a way to support them so they, in turn, can care for their wives. The purpose is to pilot test an online male spouse transition toolkit (MaTT) that the research team has developed. The specific aims are to: a) evaluate the Toolkit for ease of use, acceptability, and feasibility, and; b) collect preliminary data to determine potential effectiveness of the Toolkit in increasing hope, general self-efficacy and quality of life, and its potential effectiveness in decreasing guilt scores for male partners of women with breast cancer (stages 1-3).

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
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •18 years of age or older
  • •living with a spouse who has breast cancer (Stage 1, 2, or 3)
  • •English speaking.

排除标准

  • •persons who are non-autonomous adults
  • •cognitively impaired as determined by the Registered Nurse (RN) researcher
  • •unable to participate, in the opinion of the RN researcher
  • •non-English speaking
  • •does not have a spouse who is diagnosed with having breast cancer (State 1, 2, or 3)

研究组 & 干预措施

Male Spouse Transition Toolkit

Experimental

All participants in this group will be given access to the Male Spouse Transition Toolkit (MaTT). MaTT is a website based application that is designed to help male spouses of women with breast cancer to increase their awareness of the transitions and experiences they have as a husband and caregiver as well as to stay organized and seek help and resources as needed. To do so it consists of six sections: about me; common changes to expect; frequently asked questions; resources; calendar; and, important health information. These sections contain activities and exercises, as well as fillable templates (i.e., resources, calendar) that users can download at their convenience, from their home computer, tablet, or smart phone. They will be asked to use the MaTT for one month.

干预措施: Male Spouse Transition Toolkit (Behavioral)

Usual Care

No Intervention

Participants in this group will not receive access to the Male Spouse Transition Toolkit, and thus will not receive an intervention. Data collection for outcome variables will be the same as the participants in the experimental arm.

结局指标

主要结局

Hope

时间窗: Change from baseline at day 7, 14, 28, and 56

Hope is measured by the Herth Hope Index (HHI). The Herth Hope Index is a 12 item (1-4 point) Likert scale that delineates three sub-scales of hope: a) temporarility and future, b) positive readiness and expectancy, and c) interconnectedness. The HHI has been found to take approximately 5 minutes to complete. Summative scores range from 12-48, with a higher score denoting greater hope. This scale has been found to be reliable (test-retest r=91, p\<0.05) and valid (concurrent validity, r=84, p.,0.05; criterion, r=92, p,0.05; divergent, r=-0.73, p. 0.05).

次要结局

  • Quality of Life(Change from baseline at day 7, 14, 28 and 56)

研究者

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

Wendy Duggleby

Professor and Nursing Research Chair, Aging and Quality of Life

University of Alberta

研究点 (1)

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