Specialized Palliative Telemedicine for Patients with Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

TeleSPC

Intervention Type OTHER

Multidisciplinary video consultations with the SPC team. The team is multiprofessional and composed by physician, nurse, psychologist, social worker, physiotherapist and a chaplain, which is in line with the staffing of most SPC teams in Denmark and abroad. Video consultations will follow the same approach already used in physical consultations at the Section of Palliative Medicine, considering patients' changing needs and providing differentiated treatment and support, with the addition of a psychological intervention for dyadic coping between patient and closest informal caregiver

Control

Patients will follow the current practice in the healthcare system (standard care). Control patients will be offered information to clarify the options available in case of unmet palliative needs. Patients' informal caregiver will be invited to participate in the study, but no intervention will be offered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TeleSPC

Multidisciplinary video consultations with the SPC team. The team is multiprofessional and composed by physician, nurse, psychologist, social worker, physiotherapist and a chaplain, which is in line with the staffing of most SPC teams in Denmark and abroad. Video consultations will follow the same approach already used in physical consultations at the Section of Palliative Medicine, considering patients' changing needs and providing differentiated treatment and support, with the addition of a psychological intervention for dyadic coping between patient and closest informal caregiver

Intervention Type OTHER

Eligibility Criteria

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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

* 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

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

\- refuse to participate in the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No