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Clinical Trials/NCT05231070
NCT05231070
Completed
Not Applicable

The Effect of Specialized Palliative Telemedicine for Patients with Advanced Cancer At Home

Rigshospitalet, Denmark1 site in 1 country60 target enrollmentDecember 1, 2022
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Rigshospitalet, Denmark
Enrollment
60
Locations
1
Primary Endpoint
Change from baseline patient's health-related quality of life at 2 weeks, 4 weeks, 8 weeks, and 6 months
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Geana P Kurita

Senior Researcher

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from baseline patient's health-related quality of life at 2 weeks, 4 weeks, 8 weeks, and 6 months

Time Frame: 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 Outcomes

  • Change from baseline caregiver burden at 4 weeks, 8 weeks, and 6 months(Baseline, 4 weeks, 8 weeks, and 6 months)
  • 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)
  • Healthcare professionals' satisfaction with intervention at 6 months(6 months)
  • 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)
  • Change from baseline informal caregivers' anxiety at 4 weeks, 8 weeks, and 6 months(Baseline, 4 weeks, 8 weeks, and 6 months)
  • Patients and informal caregivers' satisfaction with intervention at 6 months(6 months)
  • Change from baseline patients' use of health care system at 6 months(Baseline and 6 months)
  • 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)
  • 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)
  • 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)
  • Change from baseline informal caregivers' depression at 4 weeks, 8 weeks, and 6 months(Baseline, 4 weeks, 8 weeks, and 6 months)

Study Sites (1)

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