Living Better With Advanced Breast Cancer (LIBERATE) Phase II: Evaluating the Feasibility of a Supportive, Self-management Website in Women Living With Secondary Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Proportion of missing data in self-report outcome questionnaires.
研究概览
简要总结
The LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Overall, this intervention aims to improve quality of life among this growing group of patients through targeted, tailored and accessible information and support.
This randomised waiting list control trial aims to evaluate the feasibility of the clinically integrated LIBERATE intervention. Results of participants' online symptom monitoring questionnaires are integrated with their electronic patient record, enabling clinician review and follow up alongside participants' own self-management activities.
详细描述
Despite ongoing treatment advances for women living with secondary (metastatic, stage IV, advanced) breast cancer, quality of life (QoL) remains a crucial concern. Patients' diverse psycho-social and supportive needs are widely reported to be poorly understood and inadequately addressed.
The LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer.
Phase I of the LIBERATE project informed intervention development though several strands:
- Semi-structured interviews with patients and health & charity professionals explored the supportive needs and factors affecting the quality of life of women living with secondary breast cancer. This guided the components and content of the online intervention.
- A systematic review of online interventions in the context of advanced cancer was also conducted. This guided the design and delivery of the online intervention.
The final intervention comprises five components delivered via an interactive website;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Open label
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
- •Adult females (aged 18 and over).
- •Diagnosed with secondary (metastatic, stage IV) breast cancer.
- •Access to the internet.
排除标准
- •Exhibiting signs of overt psychopathology or cognitive dysfunction.
- •Current involvement in other clinical trials involving completion of QoL or other patient reported outcome measures.
结局指标
主要结局
Proportion of missing data in self-report outcome questionnaires.
时间窗: 12 weeks.
Patients will complete paper based questionnaires relating to quality of life (FACT-B \& EQ-5D-5L) and self-efficacy (B-CBI \& SEMCD-6).
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (B-CBI).
时间窗: 12 weeks
Descriptive statistics of returned B-CBI questionnaires. The 12-item questionnaire Cancer Behaviour Inventory - brief version measures patients' self-efficacy for coping with cancer by asking them to rate their confidence to perform certain behaviours on a scale of 1 (not at all confident) to 9 (totally confident). CBI-B is a single score measure (minimum score = 12, maximum score = 108) with higher scores indicative of greater self-efficacy.
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (SEMCD-6).
时间窗: 12 weeks
Descriptive statistics of returned SEMCD-6 questionnaires. This 6-item SEMCD-6 measures self-efficacy to manage chronic disease, asking patients to rate their confidence in their abilities to perform a range of self-management tasks. Each of the 6 items are rated on a scale from 1 ('not at all confident') to 10 ('totally confident'). Scores for the scale are calculated as a mean of the 6 items (minimum score = 1, maximum score = 10), with higher scores indicating greater self-efficacy.
Number of participants with self-reported outcome data at 12 weeks.
时间窗: 12 weeks.
Patients will complete paper based questionnaires relating to quality of life (FACT-B \& EQ-5D-5L) and self-efficacy (B-CBI \& SEMCD-6).
Acceptability & use of intervention: Number of symptom monitoring reports generated and qualitative interview data.
时间窗: 12 weeks
Number of symptom monitoring reports generated and qualitative interview data.
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (EQ-5D-5L).
时间窗: 12 weeks
Descriptive statistics of returned EQ-5D-5L questionnaires. The standardised EQ-5D-5L measures health outcomes through a descriptive profile and a visual analogue scale (VAS). The descriptive profile encompasses 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, participants choose one of 5 levels that best describes their health on that day (from 'no problem'= 1 to 'unable/extreme'= 5). The numbers chosen for the five dimensions are combined to give a 5 digit score (minimum score = 11111 maximum score = 55555). The VAS provides participant's rating of their health on a scale from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (FACT-B).
时间窗: 12 weeks
Descriptive statistics of returned FACT-B questionnaires.
次要结局
- Estimation of effect size for self-efficacy using participant scores for B-CBI.(12 weeks)
- Estimation of effect size for QOL using participant scores for FACT-B.(12 weeks)
- Estimation of effect size for QOL using participant scores for EQ-5D-5L.(12 weeks)
- Estimation of effect size for self-efficacy using participant scores for SEMCD-6.(12 weeks)
研究者
Galina Velikova
Professor Psychosocial Medical Oncology
University of Leeds