Patient-centered Teleprehabilitation for Women With Breast Cancer: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Incidence of treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
Surgery, the cornerstone of most cancer treatments, is associated with considerable postoperative complications. Adjusting patients' health behavior before surgery may have beneficial effects on postoperative outcomes.
Women (n=50) who will undergo breast surgery because of stage I-III breast cancer are eligible. All participants will receive multimodal patient-centered teleprehabilitation comprising of motivational interviewing, education, exercise therapy, and stress management.
详细描述
Feasibility, participation rate, patient satisfaction, intervention safety, and treatment adherence will be monitored as primary outcomes. Fatigue, pain, quality of life (QoL), physical activity levels, perceived injustice, self-efficacy, and healthcare use are secondary outcomes and will be assessed by self-reported questionnaires at baseline, 0-, 2-, and 6 months post-intervention.
Proof of concept for using telecommunication and exercise therapy in prehabilitation prior to breast cancer surgery is available. We expect the proposed intervention to be feasible and effective at reducing fatigue, pain, perceived injustice, and healthcare use, and at improving treatment adherence, QoL, physical activity levels, and self-efficacy.
Effective prehabilitation interventions can reduce the long-term symptoms that arise/persist beyond treatment completion, improving patients' QoL. By using telecommunication technologies, socio-economic barriers can be reduced, making care accessible to all.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Aged 18 years or older
- •Scheduled for primary breast surgery because of stage I-III breast cancer
- •Able to speak and read Dutch fluently
排除标准
- •Stage IV breast cancer
- •A medical contra-indication for physical activity
- •Not being able to access a computer or mobile device at home
结局指标
主要结局
Incidence of treatment-emergent adverse events (safety and tolerability)
时间窗: within one week after completion of the intervention
To examine the safety of the intervention, participants will be asked whether they experienced any side effects or unexpected events associated with the intervention after each treatment session.
Feasibility of teleprehabilitation in the clinical setting by means of focus group discussions with stakeholders
时间窗: through study completion, an average of 1 year
The feasibility of the patient-centered teleprehabilitation intervention in the clinical setting will be investigated using focus group discussions with all the involved care providers.
Patient satisfaction with the teleprehabilitation intervention (feeling of contentment with the intervention)
时间窗: within one week after completion of the intervention
This will be assessed using a questionnaire ending with an open question ('To what extent is this what you needed? Please explain your answer') and the possibility to suggest alternative treatment content. Patient satisfaction with teleprehabilitation will also be assessed using in-depth interviews with all study participants.
Adherence to treatment (compliance rate)
时间窗: within one week after completion of the intervention
The compliance rate for the teleprehabilitation sessions will be calculated as the ratio of the number of followed treatment sessions versus the number of planned treatment sessions. Next to the supervised sessions, patients will also have sessions without direct supervision that they will have to carry out themselves at home (i.e., exercise sessions, relaxation exercises, and reading the information leaflet). Patients will be asked to record these unsupervised therapy sessions in a personal logbook. The compliance with these home exercise sessions is calculated as the ratio between the number of sessions performed and the number of sessions prescribed.
Participation rate
时间窗: one day before the start of the intervention
This will be calculated as the ratio of the number of patients participating in the study to the number of patients eligible for study participation. Along with that, the participation rate for each of the secondary outcome measures (see further) at each of the time points (baseline and follow-up) will be recorded.
次要结局
- Healthcare and medication use during the study period(one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery)
- Pain (uncomfortable sensations in the body)(one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery)
- Subjective level of physical activity(one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery)
- The feeling of perceived injustice(one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery)
- Fatigue (feeling of tiredness or lack of energy)(one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery)
- Quality of Life (the degree to which an individual is healthy, comfortable, and able to participate in or enjoy life events)(one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery)
- Self-efficacy (self-beliefs to cope with a variety of difficult demands in life)(one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery)