Virtual Prehabilitation of Surgical Cancer Patients in Times of the Covid-19 Pandemic
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rational for Low Compliance
研究概览
简要总结
There is a general concern that the backlog of cancer patients waiting for surgery during this period is going to increase and the general impact on patients isolated in their homes is going to cause potential physiological and psychological impairments. Therefore, we propose a distanced-delivered personalized home-based prehabilitation program to all cancer patients scheduled for surgery at the MUHC. The program will be delivered by qualified professionals, supported by technology provided by POP, to all cancer patients waiting for surgery, addressing the patients' risk factors in patients' pandemic reality perspective. Participant contacts will primarily occur virtually using technologies such as video conferencing and digital applications. This will enable us to continue to support people with cancer and deliver safe remote counseling by specialist healthcare providers in their own homes, whilst adhering to the Governmental guidelines on social distancing, self-isolation and shielding.
详细描述
The current project aims to improve the quality of care delivered to oncologic surgical candidates during the COVID-19 pandemic. The specific objectives of the study are: 1. to assess the feasibility of a distance-delivered prehabilitation program to oncologic surgical candidates in light of the current global pandemic, 2. to measure the effect of technology-supported prehabilitation on preoperative and postoperative functional capacity and clinical outcomes, and 3. To qualitatively investigate the impact of distance-delivery of prehabilitation on health-related quality of life, anxiety and depression, which may be exacerbated by the current global phenomenon.
To do so, a convenient study group of 100 patients on the waiting lists to undergo elective thoracic and abdominal surgery, initially at the Montreal General Hospital (MGH) will be recruited over the next year and a half.
Program:
The program for the current study will consist of two parts, the first being individual counseling with different healthcare professionals, the second component would be a home-based prehabilitation program for patients awaiting their surgery. The healthcare providers available for participants' respective needs include exercise physiologist (a), nutritionists (b), psychosocial (c), and if needed smoking cessation (d) personnel who would contact patients via phone, and a videoconferencing platform (Zoom) if possible, facilitated by the use of the tablet.
Exercise physiologists will follow-up with patients regularly throughout the continuum of care (before and after their surgery) and refer them to the relevant specialists as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Adults scheduled for elective cancer surgery that is delayed due to COVID-19 referred by a surgeon;
- •Covered by the RAMQ
- •Have medical clearance to exercise (as provided on the physician referral);
- •Are able to understand English or French.
排除标准
- 未提供
结局指标
主要结局
Rational for Low Compliance
时间窗: Through study completion, for an expected duration of of 1.5 year.
When possible, participant's rational for low compliance to the project was collected.
Recruitment Rate
时间窗: Through study completion, for an expected duration of of 1.5 year.
Recruitment rate is defined as the number of participant recruited, compared to the number of eligible participant contacted.
Adherence
时间窗: Through study completion, for an expected duration of of 1.5 year.
based on self-reported measures and data from the polar watch, compared to prescribed intervention
Program Completion Rate
时间窗: Through study completion, for an expected duration of of 1.5 year.
The completion rate is defined as the number of participant completing all evaluations, compared to the number of participants recruited.
frequency of Technological Failures
时间窗: Through study completion, for an expected duration of of 1.5 year.
Frequency of technological failures is defined as the number of any technological challenge that would prevent participants from doing their interventions or contacting the research team member.
Intervention-Related Adverse Events
时间窗: Through study completion, for an expected duration of of 1.5 year.
Intervention-related adverse events is defined as any event that would cause harm to patients' physical or mental health.
Rational for Refusal to Participate
时间窗: Through study completion, for an expected duration of of 1.5 year.
When possible, patients' rational for refusing to participate in the project was collected.
Rational for Drop-Outs
时间窗: Through study completion, for an expected duration of of 1.5 year.
When possible, participant's rational for abandoning the project was collected.
次要结局
- 30 Second Sit-to-Stand(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- Time-Up and Go (TUG)(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- 2- or 6-Minute Walk Test(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- Abridged-Scored Patient-Generated Subjective Global Assessment (PG-SGA)(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- Body Mass Index (BMI)(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- CRP(During baseline assessment (beginning of prehabilitation period; T0))
- Serum Albumin(During baseline assessment (beginning of prehabilitation period; T0))
- Duke Activity Status Index (DASI)(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- Quality of Life (EQ5D)(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- The Hospital Anxiety and Depression Scale (HADS)(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- Distress Thermometer(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- The WHO Disability Assessment Schedule v2.0 (WHODAS)(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- The Energy Expenditure (CHAMPS)(During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery)
- The Clavien-Dindo Classifications(CDC)(During the post-operative period, data collected on average up to 2 months after the surgery date.)
- The Comprehensive Complication Index (CCI)(During the post-operative period, data collected on average up to 2 months after the surgery date.)
- The 30-day Mortality(During the post-operative period, for a month after the surgery date.)
- Length of Intensive Care Stay(During the post-operative period, data collected on average up to 2 months after the surgery date.)
- Days with a chest tube(During the post-operative period, data collected on average up to 2 months after the surgery date.)
- Length of Hospital Stay(During the post-operative period, data collected on average up to 2 months after the surgery date.)
研究者
Franco Carli
Principal Investigator and Professor of Anesthesia
McGill University Health Centre/Research Institute of the McGill University Health Centre