Co-creating and Testing the Reach and Effectiveness of an Integrated Peer-to-peer Self-management Program for Breast Cancer Survivors: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Reach of intervention assessed by ratio of eligible patients vs. participating patients
研究概览
简要总结
The adjusted Cancer Thriving and Surviving Program (CTS) for women with breast cancer living in Switzerland (CTS-BC-CH) is a course of 7 weekly sessions of 2.5 - 3 hours led by trained peer-leaders (women with breast cancer experience). This pilot study aims to explore the reach of the CTS-BC-CH program (integrated into the clinical pathway) and to investigate its preliminary effectiveness with regard to Swiss breast cancer patients' self-efficacy and self-management.
详细描述
In 2016/17, the self-management program for cancer survivors, the Cancer Thriving and Surviving Program (CTS) was translated into German. The content of the CTS was adapted to breast cancer specific needs in three interdisciplinary workshops based on a participatory approach including active patient engagement. Additional disease-specific topics were developed and confirmed applying a multi-stakeholder e-rating approach. After a consensus meeting with the participation of breast cancer survivors, health care professional and international experts in the field of self-management, consensus on the program was reached in June 2017, resulting in the CTS-BC-CH program, i.e. a standardized manual for course leaders.
This pilot study aims to explore the reach of the CTS-BC-CH program (integrated into the clinical pathway) and to investigate its preliminary effectiveness for female Swiss breast cancer patients. The CTS-BC-CH is delivered in two breast cancer centers in in the German-speaking part of Switzerland as a group-based program with seven weekly sessions of 2.5 - 3 hours led by trained peer-leaders. Course leaders have to complete a 4-days training provided by certified master trainers. First, participants are enrolled for usual care, followed by participants who will attend the CTS-BC-CH course. Participants will complete self-reported questionnaires at three time points over a period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion breast cancer patients
- •female gender
- •written informed consent
- •aged 18 years or older
- •diagnosed with an early stage breast cancer (stage 0, stage I, stage IIA, stage IIB, and stage IIIA breast cancers)
- •completed primary therapy (i. e. surgery, chemotherapy and/or radiation therapy)
- •at the beginning of follow-up care (including long-term endocrine therapy or targeted therapy)
- •free of recurrence
- •mentally able to participate, assessment of the psychological state performed by the responsible psychologist/psycho-oncologist in the breast center
- •treated in the participating breast center
- •Inclusion course leaders
- •female gender
- •written informed consent
- •aged 18 years or older
- •diagnosed with an early stage breast cancer (stage 0, stage I, stage IIA, stage IIB, and stage IIIA breast cancers)
- •> than 2 years post diagnosis
- •free of recurrence
- •mentally able to participate, assessment of the psychological state performed by the responsible psychologist/psycho-oncologist in the breast center
- •treated in the participating breast center
- •willing to participate in a course leaders training
- •Exclusion breast cancer patients and course leaders
- •participation in another psycho-social intervention study
- •known illiteracy (reading and writing difficulties)
- •lack of language proficiency (German)
- •Inclusion breast care nurses for CTS-BC-CH implementation
- •female gender
- •employed at breast care center > 1 year
- •participation in 4-days CTS-BC-CH course leader training
- •Inclusion breast care nurses for evaluating self-management support practices
- •nurses: graduated with a nurses diploma > 1 year of breast cancer care experience
排除标准
- 未提供
研究组 & 干预措施
Usual care
Usual follow-up care offered in the breast centers after primary treatment by breast care team (e. g. breast care nurses, gynaecologist, oncologist, psychologist).
Usual care and CTS-BC-CH
CTS-BC-CH as 7 weekly group session à 2.5 - 3 hours.
干预措施: CTS-BC-CH (Behavioral)
结局指标
主要结局
Reach of intervention assessed by ratio of eligible patients vs. participating patients
时间窗: 21 weeks after baseline
Changes in self-management skills assessed by heiQ
时间窗: Change from baseline to 20 weeks after baseline
Assessed by the Health Education Impact Questionnaire (heiQ)
次要结局
- Change in patient-reported self-efficacy assessed by SES6G(Change from baseline to 20 weeks after baseline)
- Change in patient-reported health literacy assessed by HLS-EU-Q6(Change from baseline to 20 weeks after baseline)
- Change in patient-reported symptom burden assessed by BCPT Symptom Scales(Change from baseline to 20 weeks after baseline)
- Change in patient-reported health service navigation assessed by heiQ(Change from baseline to 20 weeks after baseline)
- Change in nurse-reported self-efficacy and self-management support practices assessed by SEPSS(Change from baseline to 30 weeks after baseline)
研究者
Manuela Eicher
Associate Professor
University of Lausanne