Telemedicine in Palliative Care: Interventions, Experiences and Perceptions of Patients Diagnosed With Cancer Receiving Outpatient Palliative Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Patients' satisfaction .
研究概览
简要总结
The aim of this study is to estimate the effects of a palliative care consultation intervention among adults with advanced cancer delivered either as a remote (telemedicine) or face-to-face consultation, on changing symptom scores, quality of life, communication, participants' experiences, e-health literacy, emergency and unscheduled visits, adherence to treatment, retention rate, adherence rate, the level of satisfaction of patients and healthcare professionals.
详细描述
This is a prospective, single-centre, randomized, with parallel assignment, controlled trial, with a 1:1 allocation across two treatment arms: telemedicine consultations versus face-to-face consultations.
All trial activities will be conducted through the Outpatient Clinic of OncoHelp Association located in Timisoara, Romania.
Participants in this study will be recruited from newly diagnosed cancer patients who have not received palliative care interventions prior to enrollment. They are referred to the Outpatient Clinic of the OncoHelp Association for oncological and palliative registration, consultations, and treatment.
After gaining informed consent, a baseline assessment will be collected, including screening feasibility for the telemedicine arm. The selected patients will be randomly allocated with a 1:1 ratio to receive either:
Telemedicine consultation ( Intervention Arm) Group A Face-to-Face consultation ( Control Arm) Group B The participants will receive three monthly consultation and unscheduled consultations as they need according to the study arm they had been allocated.
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
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
- •Participant Inclusion Criteria
- •Adult patients, age ≥ 18 years
- •Diagnosis of solid tumour in any stage, regardless of location
- •Participant diagnosed within the last 90 days with advanced or metastatic cancer (defined as a newly diagnosed stage II-IV, recurrence, or progressive solid tumour cancer)
- •Eastern Cooperative Oncology Group (ECOG ) 1 ( ambulatory ) - 3 ( symptomatic, bed immobilised> 50% during the day )
- •Estimated life expectancy of at least three months
- •Participants can receive any cancer treatment for their advanced cancer while participating in this study
- •Receiving primary cancer care at the participating site
- •Have access to a telephone that can receive incoming calls
- •Participant/ caregiver can use a personal computer, smartphone, tablet
- •Participants must have access to a Wi-Fi network or a cellular network
- •Participant can communicate verbally
- •Participant can read and respond to questions in the Romanian language
- •Participant able to provide informed consent
- •Participant has a considerable disease burden and complex medical and care needs
- •Participant is at a medium to high risk of worsening their condition, requiring hospitalisation, or having an increased need for health and care services
- •Participant has a high consumption of healthcare services
- •Participant has a reduced level of function
- •Participant is motivated to use telemedicine and will likely benefit from telemedicine solutions
- •Participant are willing to adhere to telemedicine consultations or face-to-face consultations
- •Caregiver Inclusion Criteria
- •Adult , age ≥ 18 years
- •Relative or friend who is identified by the Participant and lives with the Participant or has contact with him/her at least twice per week
- •The ability to read and respond to questions in Romanian language
- •Caregiver who is willing to participate in the study
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Have not themselves been diagnosed with cancer or received cancer treatment during the study (to ensure that the Participant and the caregiver focus their efforts on the care of the Participant)
- •Caregiver must have access to a computer/ tablet/ smartphone and an internet connection at home, on which they would be willing to do a telemedicine study
- •Be able to navigate websites, communicate by email, and have regular access to the internet (assessed by participant self-report)
- •Be capable of independently utilising an online platform for telemedicine medical consultations in a private setting (assessed by participant self-report)
排除标准
- •Participant Exclusion Criteria
- •Participant already receiving outpatient palliative care or hospice services
- •Participant with Eastern Cooperative Oncology Group (ECOG) 4 performance status
- •Participant too medically unstable (or expected to become so during the study period) to participate in a telemedicine group medical visit determined by the investigator
- •Participants with a high level of distress who cannot be managed by telemedicine
- •End of Life
- •Participant with extensive hearing loss such that the ability to participate in the study would be impaired as determined by the investigator
- •Self-reported history of a diagnosis of dementia
- •Self-reported psychotic symptoms in the last 30 days prior to randomisation
- •Active suicidal ideation (currently reported suicidal plan and intent)
- •Self-reported active alcohol or substance abuse in the last 30 days prior to randomisation
- •Any change in psychotropic medications within the last 30 days
- •Participant without medical insurance that covers telemedicine consultations or face-to-face consultations
- •Participant who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
- •Failure/inability/unwillingness to provide names and contact information for two family members or friends to serve as emergency contacts during the study
- •Caregiver Exclusion Criteria
- •Adult caregiver, age ≥ 18 years
- •Cognitive or psychiatric conditions as determined by the researcher investigator to prohibit study participation
- •Non-compliant caregiver with study procedures
结局指标
主要结局
Patients' satisfaction .
时间窗: 12 weeks
To assess the effect of the superiority of telemedicine versus face-to-face consultations about palliative care on patient satisfaction as measured by the 16-item measure of Patient Satisfaction Questionnaire(FAMCARE P 16 Questionnaire). This is a self-report scale assessing patient satisfaction with outpatient palliative oncology care, which is composed of 16 items rated from 1 (very dissatisfied) to 5 (very satisfied). Higher scores are related to higher satisfaction with the care received.
Patients' Quality of Life .
时间窗: 12 weeks
To determine whether telemedicine palliative care consultations are equivalent to face-to-face palliative care consultations for improving patients' quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC-QLQ-C30). All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. Patients' Quality of Life \[ Time Frame:12 weeks\] To determine whether telemedicine consultations palliative care is are equivalent to face-to-face palliative care consultations for improving patients' quality of life as measured by the EORTC-QLQ-C30 Questionnaire.
Changes in symptom control .
时间窗: 12 weeks
Symptom management will be measured through the mean changes in distress score on the Integrated Palliative care Outcome Scale (IPOS). There are 10 questions scored on a scale of 1-4, which assess a patient's symptoms and needs with regards to physical, social, psychological and spiritual. Individual IPOS item scores of zero or one require less clinical attention than items that score three or four.
次要结局
- Domain of intervention .(12 weeks)
- Adherence to intervention .(12 weeks)
- Number of completed telemedicine scheduled visits .(12 weeks)
- eHealth Literacy .(Baseline and 12 weeks after baseline)
- Number of patients satisfied with physician communication .(12 weeks)
- Patients' experiences .(12 weeks)
- Number of emergency room visit .(12 weeks)
- Physicians ability to evaluate a patient through telemedicine .(12 weeks)
- Number of unscheduled visits .(12 weeks)
- Changes in medication adherence .(12 weeks)
研究者
Alexandra Kovacs
Principal Investigator
OncoHelp Association