Clinical trial NCT05231070: Specialized Palliative Telemedicine for Patients with Advanced Cancer
Official title: The Effect of Specialized Palliative Telemedicine for Patients with Advanced Cancer At Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer, telemedicine, dyadic coping, palliative care
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2022-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, in which patients will be randomly assigned either to one of the two arms (1:1): intervention (TeleSPC) or control group (standard care). Assessment will occur at inclusion (baseline) and after 2 weeks, 4 weeks, 8 weeks, and 6 months. sample will be composed by 87 patients in each group and their informal caregiver (1 informal caregiver per patient) .
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Patient inclusion criteria:

* adults (at least 18 years old)
* solid organ cancer
* no longer receives curativ treatment
* provide written informed consent
* are able to speak and understand Danish Language
* are cognitively able to participate in the study
* have at least one symptom or problem with score ≥ 3 at the EORTC QLQ-C30

Patient exclusion criteria:

* primary brain cancer or central nervous system metastases
* a prognosis of less than six months
* incapable of cooperating in the trial
* already receive SPC

Informal caregiver inclusion criteria:

* adults (at least 18 years old)
* indicated by the patient as the closest informal caregiver
* able to speak and understand danish langues
* provide written informed consent

Informal caregiver exclusion criteria:

- refuse to participate in the study

Primary outcomes:
measure: Change from baseline patient's health-related quality of life at 2 weeks, 4 weeks, 8 weeks, and 6 months
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months
Secondary outcomes:
measure: Change from baseline patients' use of health care system at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline patients and informal caregiver dyadic coping at 4 weeks, 8 weeks, and 6 months
timeFrame: Baseline, 4 weeks, 8 weeks, and 6 months
measure: Change from baseline caregiver burden at 4 weeks, 8 weeks, and 6 months
timeFrame: Baseline, 4 weeks, 8 weeks, and 6 months
measure: Change from baseline informal caregiver health related quality of life at 4 weeks, 8 weeks, and 6 months
timeFrame: Baseline, 4 weeks, 8 weeks, and 6 months
measure: Healthcare professionals' satisfaction with intervention at 6 months
timeFrame: 6 months
measure: Change from baseline patients' sleep at 2 weeks, 4 weeks, 8 weeks, and 6 months
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months
measure: Change from baseline patients' anxiety at 2 weeks, 4 weeks, 8 weeks, and 6 months
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months
measure: Change from baseline patient's depression at 2 weeks, 4 weeks, 8 weeks, and 6 months
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months
measure: Patients and informal caregivers' satisfaction with intervention at 6 months
timeFrame: 6 months
measure: Change from baseline informal caregivers' anxiety at 4 weeks, 8 weeks, and 6 months
timeFrame: Baseline, 4 weeks, 8 weeks, and 6 months
measure: Change from baseline informal caregivers' depression at 4 weeks, 8 weeks, and 6 months
timeFrame: Baseline, 4 weeks, 8 weeks, and 6 months
Other outcomes:
Locations:
city: København
country: Denmark
facility: Rigshospitalet
state: København Ø.
Study officials:
affiliation: Rigshospitalet, Denmark
name: Geana P Kurita, PhD
role: PRINCIPAL_INVESTIGATOR
References: