Web-based Support for Family Caregivers of Patients With Advanced Cancer

Family Clinical Trial

Official title:

Web-based Support to Promote Preparedness for Caregiving Among Family Caregivers of Patients With Advanced Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785494
• Other study ID #: MarieCederschiöldUniversity
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: Ersta Sköndal University College
• Contact: Anette Alvariza, Professor
• Phone: +46707915773
• Email: anette.alvariza[@]mchs.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For family caregivers of patients with advanced cancer, preparedness for caregiving is crucial for maintaining health and quality of life both during care and after the death of the patient. This project contributes to earlier research funded by the Swedish Cancer Society, about an intervention that was delivered by a multi-professional team and proved to be successful in promoting preparedness. However, such interventions are often costly and logistically challenging. In addition, the Covid-19 pandemic has further significantly raised the need for digital alternatives in healthcare. As a possible solution, an evidence-based intervention, narstaende.se, has been developed consisting of recorded videos of conversations between clinicians and family caregivers (actors), linked to informational texts and a moderated chat forum. The intervention was pilot tested during 2020 and 2021, exploring feasibility, content and family caregivers' experiences. As preliminary results are promising, the intervention is taken one step further and tested as a web-based intervention in a larger scale.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being a family caregiver, over 18 years of age, to a person with life-threatening illness cared for in specialized home care.

Exclusion Criteria:

• Not being able to communicate in Swedish

Related Conditions & MeSH terms

• Cancer Metastatic
• Chronic Disease
• Chronic Illness
• Death
• End of Life
• Family

Intervention

Other:
• Narstaende.se
Web-site with supportive information, videos and chat forum targeting family caregivers of patients with life-threatening illness.

Locations

Country	Name	City	State
Sweden	Marie Cederschiöld University	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	Change in Preparedness for caregiving	Preparedness for caregiving scale (PCS)	At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)
Secondary	Change in Quality of Life	The Quality of Life in Life-Threatening Illness Family caregiver version (QOLLTI-F)	At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)
Secondary	Change in health	RAND- 36	At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)
Secondary	Change in Anxiety and Depression	The Hospital Anxiety and Depression Scale (HADS)	At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)
Secondary	Change in pre-loss grief	Prolonged Grief-12	At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)
Secondary	Change in post-loss grief	Prolonged Grief-13	At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)