Specialized Palliative Telemedicine for Patients with Advanced Cancer

Rigshospitalet, Denmark60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Interventions

TeleSPCOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rigshospitalet

Copenhagen, København Ø., Denmark

Outcomes

Primary Outcomes

Change from baseline patient's health-related quality of life at 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.

Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months

Secondary Outcomes

Change from baseline patients' use of health care system at 6 months

Clinical information collected from patients' records regarding number of hospitalizations, days spent in hospital, and date of death

Time frame: Baseline and 6 months

Change from baseline patients and informal caregiver dyadic coping at 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.

Time frame: Baseline, 4 weeks, 8 weeks, and 6 months

Change from baseline caregiver burden at 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.

Time frame: 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

RAND 36-Item Short Form Health Survey version 1.0. Scores range from 0 to 100; a higher score indicates a better result.

Time frame: Baseline, 4 weeks, 8 weeks, and 6 months

Healthcare professionals' satisfaction with intervention at 6 months

Interview with healthcare providers

Time frame: 6 months

Change from baseline patients' sleep at 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.

Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months

Change from baseline patients' anxiety at 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.

Time frame: 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

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.

Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months

Patients and informal caregivers' satisfaction with intervention at 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

Time frame: 6 months

Change from baseline informal caregivers' anxiety at 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.

Time frame: Baseline, 4 weeks, 8 weeks, and 6 months

Change from baseline informal caregivers' depression at 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.

Time frame: Baseline, 4 weeks, 8 weeks, and 6 months

Data from ClinicalTrials.gov

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