Palliative CareNCT03676283
Increasing Preparedness Through a Website
A study testing Web-based psycho-educational support for family caregivers in people with Palliative Care, run by Ersta Sköndal University College at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Web-based psycho-educational support for family caregivers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 31 Dec 2022
- 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
Who may be able to join
- Being a partner of a patient with a cancer diagnose and a life expectancy of less than 12 months
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Preparedness for Caregiving, Death and Continued Life in Partners of Patients With Incurable Cancer - a Webtrial
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.
Read the detailed 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.
- Conditions
- Palliative Care
- Being tested
- Web-based psycho-educational support for family caregivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based psycho-educational support for family caregiversOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based psycho-educational support for family caregivers | Experimental | Gaining access to the website (närstående.se) with supportive films and texts Receives: Other: Web-based psycho-educational support for family caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ersta Sköndal University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anette Alvariza, Ersta Sköndal University College
- Investigators
- Anette Alvariza, PhD, Principal investigator, Ersta Sköndal Bräcke University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676283
- Sponsor's protocol ID
- ErstaSUC2
- Status last verified
- Feb 2023
- First submitted
- 12 Sep 2018
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doveson S, Tibell LH, Arestedt K, Holm M, Kreicbergs U, Alvariza A, Wallin V. Communication about incurable illness and remaining life between spouses and patients with incurable illness receiving specialized home care: effects of a family caregiver-targeted web-based psycho-educational intervention. BMC Palliat Care. 2024 Dec 16;23(1):282. doi: 10.1186/s12904-024-01614-0.
PubMed 39681862Alvariza A, Hager-Tibell L, Holm M, Steineck G, Kreicbergs U. Increasing preparedness for caregiving and death in family caregivers of patients with severe illness who are cared for at home - study protocol for a web-based intervention. BMC Palliat Care. 2020 Mar 17;19(1):33. doi: 10.1186/s12904-020-0530-6.
PubMed 32183803
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Preparedness for Caregiving, Death and Continued Life in Partners of Patients With Incurable Cancer - a Webtrial
- ClinicalTrials.gov ID
- NCT03676283
- Acronym / sponsor ID
- ErstaSUC2
- Conditions
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ersta Sköndal University CollegeUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based psycho-educational support for family caregivers | Experimental | Other: Web-based psycho-educational support for family caregiversGaining access to the website (närstående.se) with supportive films and texts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being a partner of a patient with a cancer diagnose and a life expectancy of less than 12 months
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based psycho-educational support for family caregiversA 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. | Other | Web-based psycho-educational support for family caregivers |
Primary outcome
Preparedness for caregiving scale
Time frame: 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 39681862Doveson S, Tibell LH, Arestedt K, Holm M, Kreicbergs U, Alvariza A, Wallin V. Communication about incurable illness and remaining life between spouses and patients with incurable illness receiving specialized home care: effects of a family caregiver-targeted web-based psycho-educational intervention. BMC Palliat Care. 2024 Dec 16;23(1):282. doi: 10.1186/s12904-024-01614-0.
- Derived from this study: PubMed 32183803Alvariza A, Hager-Tibell L, Holm M, Steineck G, Kreicbergs U. Increasing preparedness for caregiving and death in family caregivers of patients with severe illness who are cared for at home - study protocol for a web-based intervention. BMC Palliat Care. 2020 Mar 17;19(1):33. doi: 10.1186/s12904-020-0530-6.
- Individual participant dataSharing planned: No
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SPAMLO-3.0 : Having Fun Shedding Light on Darkness, a Playful Approach to Reduce Anxiety in Palliative Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anette Alvariza, PhD principal investigator
Ersta Sköndal Bräcke University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based psycho-educational support for family caregivers in people with Palliative Care, run by Ersta Sköndal University College at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 16 Feb 2023. 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 Sweden. 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?
Preparedness for caregiving scale (time frame: 4 weeks). 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 NCT03676283, which also lists 2 linked publications.
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 16 Feb 2023.