Specialized Palliative Telemedicine for Patients With Advanced Cancer (TeleSPC)

The Effect of Specialized Palliative Telemedicine for Patients With Advanced Cancer at Home

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: TeleSPC

Detailed Description

This is a 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
• Enrollment (Estimated): 348
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geana Kurita, PhD; Phone Number: +4535 45 71 24; Email: geana.kurita@regionh.dk
• Study Contact Backup: Name: Camilla Lykke, PhD; Phone Number: +4535 45 71 24; Email: camilla.charlotte.lykke.01@regionh.dk

Study Locations

• Denmark
  • København Ø.
    • København, København Ø., Denmark, 2100
      • Recruiting
      • Rigshospitalet
      • Contact: Geana Kurita, PHD.
      • Contact: Camilla Lykke, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	Baseline, 4 weeks, 8 weeks, and 6 months
Healthcare professionals' satisfaction with intervention at 6 months	Interview with healthcare providers	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.	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.	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.	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	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.	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.	Baseline, 4 weeks, 8 weeks, and 6 months

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Danish Cancer Society
• Investigators: Principal Investigator: Geana P Kurita, PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cancer, telemedicine, dyadic coping, palliative care
• Other Study ID Numbers: R315A18018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No