Specialized Palliative Telemedicine for Patients with Advanced Cancer (TeleSPC)

Rigshospitalet

Status: Completed

Conditions: Cancer

Treatments: Other: TeleSPC

Study type: Interventional

Funder types: Other

Identifiers

NCT05231070

R315A18018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

TeleSPC

Experimental group

Description:

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).

Treatment:

Other: TeleSPC

Control

No Intervention group

Description:

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.