An interventional study of TeleSPC in Cancer, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Supportive care
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.
Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient inclusion criteria:
Patient exclusion criteria:
Informal caregiver inclusion criteria:
Informal caregiver exclusion criteria:
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
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.
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
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rigshospitalet, Denmark