Telemedicine in Palliative Care: Interventions, Experiences and Perceptions of Patients Diagnosed With Cancer Receiving Outpatient Palliative Care
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Advanced Cancer
- Sponsor
- OncoHelp Association
- Enrollment
- 160
- Primary Endpoint
- Patients' satisfaction .
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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. The participants will benefit from the following categories of interventions depending on their needs : 1. Communication of diagnosis, prognosis, and treatment options 2. Mediation of patient-caregiver communication 3. Symptom control for pain, fatigue, nausea, depression, anxiety, drowsiness, comfort, dyspnoea, sweating, cough, constipation, haemorrhage, itching, secretions, dysphagia, appetite 4. Care of wounds, bedsores, stomas 5. End of life care 6. Patient and caregiver education 7. Psychological counseling 8. Reports for obtaining social rights (sickness pension, disability pension) 9. Reports for obtaining devices provided without personal contribution by the health insurance system 10. Referral for spiritual assistance 11. Management plan 12. Referral for specialized service level III 13. Referral for hospitalization 14. Unscheduled consultations
Investigators
Alexandra Kovacs
Principal Investigator
OncoHelp Association
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Patients' satisfaction .
Time Frame: 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 .
Time Frame: 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 .
Time Frame: 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.
Secondary Outcomes
- 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)