Specialized Palliative Telemedicine for Patients With Advanced Cancer

Cancer Clinical Trial

— TeleSPC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05231070
• Other study ID #: R315A18018
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: Geana Kurita, PhD
• Phone: +4535 45 71 24
• Email: geana.kurita[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København	København Ø.

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Healthcare professionals' satisfaction with intervention at 6 months	Interview with healthcare providers	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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