Specialized Palliative Telemedicine for Patients with Advanced Cancer
- Conditions
- Cancer
- Interventions
- Other: TeleSPC
- Registration Number
- NCT05231070
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
Specialized palliative care (SPC) plays an important role in providing patient-centered care and support to informal caregiver, besides establishing/intensifying/coordinating collaboration with primary and secondary health care sectors (hospital nurse/district nurse and general practitioner/oncologist) to improve care and support for patients and burdened informal caregiver. This study proposes to develop a SPC intervention enriched with a dyadic psychological intervention for patients with advanced cancer and their informal caregiver delivered by telemedicine at home (TeleSPC). It is our hypothesis that the intervention can enhance patient-centered care at home, support their informal caregiver, and improve relations/integration between the SPC teams, oncologic teams, the general practitioners and district nurses.
- Detailed Description
This is a pilot randomized controlled trial in an open-label fashion, which proposes to develop a SPC intervention enriched with a dyadic psychological intervention (needs-based therapeutic framework based on existential-phenomenological therapy) for patients with advanced cancer and their informal caregiver delivered by telemedicine (video consultation) at home. The primary aim is to investigate the intervention effects on the patients' health-related quality of life (HRQoL). The secondary aims will be to analyze the intervention effects on number of hospitalizations, days spent at home, hospital admissions, survival, dyadic coping between patients and informal caregiver, staff satisfaction with the intervention and caregiver burden in patients' informal caregiver.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TeleSPC TeleSPC Patients will be offered regular multidisciplinary video consultations with the SPC team and these patients and their informal caregiver will also be offered a dyadic psychological intervention. Regular multidisciplinary video consultations with multidisciplinary team, involvering cooperation between the section og Palliative medicine and the Department of Oncology, District nurse and the general practitioner. Operationel definition of informal caregiver: Patients will designated the closest person involved in their care (e.g., spouse, son/daughter, other relatives, and friends).
- Primary Outcome Measures
Name Time Method Change from baseline patient's health-related quality of life at 2 weeks, 4 weeks, 8 weeks, and 6 months Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months The European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Core 30 (EORTC QLQ-C30) to assess several physical and psychosocial aspects of the patient's health-related quality of life. Scores range from 0 to 100; high values in the functioning and quality of life scales and low values in the symptoms scales indicate better outcomes.
- Secondary Outcome Measures
Name Time Method Change from baseline caregiver burden at 4 weeks, 8 weeks, and 6 months Baseline, 4 weeks, 8 weeks, and 6 months Zarit Burden Interview to measure subjective burden among caregivers. Sum of scores ranges from 0 to 88. A score of 17 or more is considered high burden.
Change from baseline informal caregiver health related quality of life at 4 weeks, 8 weeks, and 6 months Baseline, 4 weeks, 8 weeks, and 6 months RAND 36-Item Short Form Health Survey version 1.0. Scores range from 0 to 100; a higher score indicates a better result.
Healthcare professionals' satisfaction with intervention at 6 months 6 months Interview with healthcare providers
Change from baseline patients' sleep at 2 weeks, 4 weeks, 8 weeks, and 6 months Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months Pittsburg Sleep Quality Index to determining the quality and patterns of sleep. Global score ranges from 0 to 21; 0 indicates no difficult and 21 indicates severe difficlties in all areas.
Change from baseline informal caregivers' anxiety at 4 weeks, 8 weeks, and 6 months Baseline, 4 weeks, 8 weeks, and 6 months Patient Health Questionnaires' scales (GAD-7). Seven items, each of which is scored 0 to 3, providing a 0 to 21 severity score.
Patients and informal caregivers' satisfaction with intervention at 6 months 6 months Patients and informal caregivers will be requested to rate their satisfaction (scale 1-5), and will have the possibility to write any comment
Change from baseline patients' use of health care system at 6 months Baseline and 6 months Clinical information collected from patients' records regarding number of hospitalizations, days spent in hospital, and date of death
Change from baseline patients and informal caregiver dyadic coping at 4 weeks, 8 weeks, and 6 months Baseline, 4 weeks, 8 weeks, and 6 months Dyadic Coping inventory to assess how patients and informal caregiver manage stress together concerning decision making and giving support to each other. Four subscales were selected to evaluate dyadic coping (dyad patient and relative/caregiver) regarding stress communicated by oneself (max. score 20), stress communication of the partner (max. score 20), common dyadic coping (max. score 25), and evaluation of dyadic coping (max score 10). Higher scores denote greater levels of the constructs measured by each subscale.
Change from baseline patients' anxiety at 2 weeks, 4 weeks, 8 weeks, and 6 months Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months Hospital anxiety and depression scale. Scores range from 0 to 21; 0-7 represent non-cases, 8-10 represent doubtful cases, and 11-21 represent definite cases.
Change from baseline patient's depression at 2 weeks, 4 weeks, 8 weeks, and 6 months Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months Hospital anxiety and depression scale. Scores range from 0 to 21; 0-7 represent non-cases, 8-10 represent doubtful cases, and 11-21 represent definite cases.
Change from baseline informal caregivers' depression at 4 weeks, 8 weeks, and 6 months Baseline, 4 weeks, 8 weeks, and 6 months Patient Health Questionnaires' scales (PHQ). Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score.
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰København, København Ø., Denmark