Adjustment to Life After Breast Cancer Treatment: Can a Life-Coach Make a Difference
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline Post-traumatic growth (PTG) assessed by the Post-Traumatic Growth Inventory (PTGI)
研究概览
简要总结
The objectives of our intervention are to
- Ease the transition between cancer treatment and active life, and
- Allow breast cancer survivors to take control of their lives.
The primary objective of this study is to:
- Determine whether individual life coaching (i.e., individualized guidance that helps to put resources into action) can significantly improve quality of life and post-traumatic growth among women who have been recently treated with breast cancer.
It is hypothesized that:
- Participants who receive both "group coaching sessions" and "individualized coaching sessions" will report greater post-traumatic growth and quality of life, and less fear of cancer recurrence when compared to the breast cancer survivors who received only the group coaching sessions or usual care.
- Participants who receive only the group coaching sessions will report greater post-traumatic growth and quality of life, and lesser fear of cancer recurrence when compared to the participants who receive usual care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •have been diagnosed with stage I, II, or III breast cancer;
- •are female breast cancer patients over the age of 18;
- •have completed anti-cancer treatment via surgery and/or chemotherapy and /or radiation therapy at the McGill University Health Centre Breast Clinic;
- •are fluent in written and spoken English or French;
- •are alert and oriented and capable of giving informed consent;
- •have an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom).
排除标准
- •have a recurrence of breast cancer;
- •are diagnosed with a second cancer;
- •are diagnosed with stage IV breast cancer due to their worse prognosis; and 4) have an active psychiatric diagnosis that would render adherence to the study problematic.
结局指标
主要结局
Change from baseline Post-traumatic growth (PTG) assessed by the Post-Traumatic Growth Inventory (PTGI)
时间窗: 12 months
The PTGI consists of 21 items, the response scale is a 6-point Likert scale asking respondents the degree to which changes occurred in their lives as a result of the crisis, where 0 represented "I did not experience this change" and 5 represented "I experienced this change to a very great degree". The PTGI is composed of 5 subscales, with 5 items measuring the construct New Possibilities, 7 items measuring the construct Relating to Others, 4 items measuring the construct Personal Strength, 3 items measuring the construct Appreciation of Life and 2 items measuring the construct Spiritual Change. The scores are summed to provide an overall measure of post-traumatic growth ranging from 0 - 105 where higher scores indicate more reported growth.
次要结局
- Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference(12 months)
- Change from baseline Fear of cancer recurrence (FCR) assessed by the Cancer Worry Scale (CWS)(12 months)
研究者
Dr. Sarkis Meterissian
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre