NCT05785494

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Dec 2026

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

February 27, 2023

Last Update Submit

August 5, 2025

Conditions

Keywords

Palliative careFamily caregiverWeb-based supportIntervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Quality of Life

    At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)

  • Change in health

    At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)

  • Change in Anxiety and Depression

    At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)

  • Change in pre-loss grief

    At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)

  • Change in post-loss grief

    At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)

Study Arms (2)

Intervention

EXPERIMENTAL

Access to web-site

Other: Narstaende.se

Control

NO INTERVENTION

Standard care

Interventions

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not being able to communicate in Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marie Cederschiöld University

Stockholm, 100 61, Sweden

Location

Related Publications (1)

  • Bauman C, Wallin V, Doveson S, Furst P, Hudson P, Kreicbergs U, Alvariza A. The family caregiver-targeted web-based intervention "narstaende.se" facilitated everyday life for couples facing life-threatening illness: A qualitative study. Palliat Med. 2025 May;39(5):574-583. doi: 10.1177/02692163251327893. Epub 2025 Apr 12.

MeSH Terms

Conditions

DeathNeoplasm MetastasisChronic Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic ProcessesNeoplasmsDisease Attributes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 27, 2023

Study Start

September 1, 2022

Primary Completion

December 31, 2023

Study Completion (Estimated)

December 31, 2026

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations