AzTrials
AzTrials

CancerTeleSPCNCT05231070

Specialized Palliative Telemedicine for Patients with Advanced Cancer

A study testing TeleSPC in people with Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
TeleSPC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteDenmark
Study dates
1 Dec 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    Copenhagen, København Ø., 2100

Other trials in Denmark

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Cancer
Being tested
TeleSPC
Keywords
Cancer, telemedicine, dyadic coping, palliative care
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05231070
Study groupRoleWhat they receive
TeleSPCExperimentalPatients 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).
Receives: Other: TeleSPC
ControlNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months

Secondary outcomes (11)

  1. 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

    Measured: Baseline and 6 months

  2. 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.

    Measured: Baseline, 4 weeks, 8 weeks, and 6 months

  3. 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.

    Measured: Baseline, 4 weeks, 8 weeks, and 6 months

  4. 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.

    Measured: Baseline, 4 weeks, 8 weeks, and 6 months

  5. Healthcare professionals' satisfaction with intervention at 6 months

    Interview with healthcare providers

    Measured: 6 months

  6. 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.

    Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months

  7. 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.

    Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months

  8. 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.

    Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months

  9. 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

    Measured: 6 months

  10. 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.

    Measured: Baseline, 4 weeks, 8 weeks, and 6 months

  11. 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.

    Measured: Baseline, 4 weeks, 8 weeks, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2022
  2. Study start1 Dec 2022
  3. Primary completion30 Nov 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial, in which patients will be randomly assigned either to one of the two arms (1:1): intervention (TeleSPC) or control group (standard care). Assessment will occur at inclusion (baseline) and after 2 weeks, 4 weeks, 8 weeks, and 6 months. sample will be composed by 87 patients in each group and their informal caregiver (1 informal caregiver per patient) .
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05231070
Sponsor's protocol ID
R315A18018
Acronym
TeleSPC
Status last verified
Dec 2024
First submitted
28 Jan 2022
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TeleSPC in people with Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05231070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.

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