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Completed

NCT Number: NCT05231070

Specialized Palliative Telemedicine for Patients with Advanced Cancer

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, København Ø., 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TeleSPC

Other

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

Primary outcomes

  1. Change from baseline patient's health-related quality of life at 2 weeks, 4 weeks, 8 weeks, and 6 months

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline and 6 months

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

  2. Change from baseline patients and informal caregiver dyadic coping at 4 weeks, 8 weeks, and 6 months

    Time frame: Baseline, 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.

  3. Change from baseline caregiver burden at 4 weeks, 8 weeks, and 6 months

    Time frame: Baseline, 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.

  4. Change from baseline informal caregiver health related quality of life at 4 weeks, 8 weeks, and 6 months

    Time frame: Baseline, 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.

  5. Healthcare professionals' satisfaction with intervention at 6 months

    Time frame: 6 months

    Interview with healthcare providers

  6. Change from baseline patients' sleep at 2 weeks, 4 weeks, 8 weeks, and 6 months

    Time frame: Baseline, 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.

  7. Change from baseline patients' anxiety at 2 weeks, 4 weeks, 8 weeks, and 6 months

    Time frame: Baseline, 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.

  8. Change from baseline patient's depression at 2 weeks, 4 weeks, 8 weeks, and 6 months

    Time frame: Baseline, 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.

  9. Patients and informal caregivers' satisfaction with intervention at 6 months

    Time frame: 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

  10. Change from baseline informal caregivers' anxiety at 4 weeks, 8 weeks, and 6 months

    Time frame: Baseline, 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.

  11. Change from baseline informal caregivers' depression at 4 weeks, 8 weeks, and 6 months

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

The Effect of Specialized Palliative Telemedicine for Patients with Advanced Cancer At Home

Acronym: TeleSPC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2022
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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