Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03676283
Other study ID # ErstaSUC2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2022

Study information

Verified date February 2023
Source Ersta Sköndal University College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Partners of patients with advanced cancer often take a great responsibility for the patient's care. They are often unprepared for a situation where they are faced both with the role as caregivers and with the patient's impending death. This project holds significant research questions on how to implement a web-based intervention and make it easily available to all those in need and prevent negative consequences related to caregiving and the loss of a partner. The project will study the effects of using a website for support and information. Instruments for measuring outcomes will be available both on paper or electronically. To obtain data for the main outcomes, preparedness for caregiving and for death, 200 partners will be recruited and receive access to the website. Preparedness for caregiving will be measured at baseline and four weeks later (pre- and post-intervention. Further, sem-structured interviews will be performed. Preparedness for death will be measured eight weeks after the patient's death. Because current trends point towards increased levels of home-care, web-based interventions could be a way to reach more partners in a more cost-effective way.


Description:

Partners of patients with advanced cancer often take a great responsibility for the patient's care. They are often unprepared for a situation where they are faced both with the role as caregivers and with the patient's impending death. This lack of preparedness has been associated with psychological and physical unhealth. Interventions delivered by multi-professional palliative care teams have proved to be effective both in promoting preparedness for caregiving, death and the continued life of the bereaved. This project holds significant research questions on how to implement an intervention and make it easily available to all those in need and prevent negative consequences related to caregiving and the loss of a partner. To reach as many partners as possible, a web-based intervention has been developed on a website (närstående.se) which consists of supportive films and text as well as an online forum. The films show conversations between partners (actors) and healthcare professionals (authentic). The conversations concern potentially modifiable topics, such as medical issues and communication, that are associated with preparedness. The project will study the effects of proactive telephone calls that will be delivered to partners with the aim to support their use of the website. Instruments for measuring outcomes will be available both on paper or electronically. To obtain data for the main outcomes, preparedness for caregiving and for death, 200 partners will be recruited and get access to the website. They will also receive a telephone call with instructions on how to use the website and have access to technical support if necessary. Preparedness for caregiving will be measured at baseline and four weeks later (pre- and post-intervention). Preparedness for death will be measured eight weeks after the patient's death. The status of the modifiable topics will be measured at baseline and four weeks later. Physical and psychological health of the partner will be measured one year later. Further, semi-structured interviews will be performed with participants to explore the feasibility and acceptibility of the web intervention. The project will add significant knowledge about whether web-based support has the potential to increase preparedness and decrease negative consequences for partners of patients with advanced cancer during ongoing care and after the patient's death. Because current trends point towards increased levels of home-care, web-based interventions could be a way to reach more partners in a more cost-effective way. This project is meant to be a pilot to a larger study with a randomised controlled design.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being a partner of a patient with a cancer diagnose and a life expectancy of less than 12 months Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Web-based psycho-educational support for family caregivers
A website including potentially modifiable topics shown to be associated with preparedness. The topics cover areas such as knowledge about medical issues including symptoms and symptom relief, communication within the couple, how to spend the time before death, being partner or caregiver, planning of the moment of death and considerations of the partner's future, including psychological issues, logistical issues, economy, and the care for children.

Locations

Country Name City State
Sweden Ersta Sköndal Bräcke University College Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Ersta Sköndal University College

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preparedness for caregiving scale Measures family caregivers' readiness to provide care in real time. It consists of eight items measured on a five point scale ranging from 0-5 where higher values indicate better preparedness. The total score ranges from 0-32. No subscales have been reported for this instrument. 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT04673760 - The PROAKTIV Study N/A
Completed NCT03520023 - Critical Care and Palliative Care Medicine Together in the ICU N/A
Completed NCT01990742 - Improving Palliative Care Through Teamwork N/A
Not yet recruiting NCT05434208 - Effects of Nurse-led Telephone Based Service for Early Palliative Care (PALTEL) N/A
Not yet recruiting NCT03267706 - Introducing the Palliative Care Comprehensive Tool in Family Medicine N/A
Completed NCT02845817 - Requests for Euthanasia and Assisted Suicide N/A
Recruiting NCT02778347 - Development and Validation of a Comprehensive Standardised Clinical Assessment Tool for Patient Needs N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Completed NCT01934413 - Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study N/A
Recruiting NCT01170000 - Timely End-of-Life Communication to Parents of Children With Brain Tumors N/A
Recruiting NCT04052074 - Complementary Therapy in Home Palliative Care Patients and Their Caregivers N/A
Recruiting NCT05935540 - ACP-Family Programme for Palliative Care Patients and Their Family Member N/A
Active, not recruiting NCT02689375 - A Prospective, Open Label, Pilot Study of Patient OutcoMes Following Successful TriAl of High Frequency SpInal CorD Stimulation at 10kHz (HF10™) Leading to Permanent Implant Compared to Trial Failure and Standard CarE for the TreatmeNt of Persistent Low BACK Pain of Neuropathic Origin N/A
Recruiting NCT05520281 - Short-term Psychodynamic Psychotherapy in Serious Physical Illness N/A
Completed NCT06140004 - Home-Based Palliative Care Impact on Providers
Completed NCT04333719 - Prevalence of Deep Sedation in Terminal Palliative Phase
Recruiting NCT03286127 - Palliative Outcome Evaluation Muenster I
Completed NCT06211816 - Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit N/A
Completed NCT04857060 - Palliative Care Educator N/A
Completed NCT04491110 - Intervention to Improve Quality of Sleep of Palliative Patient Carers in the Community: Clinical Trial N/A