Back to results

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

Primary Purpose

Family, End of Life, Cancer Metastatic

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Narstaende.se

About this trial

This is an interventional supportive care trial for Family focused on measuring Palliative care, Family caregiver, Web-based support, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Marie Cederschiöld UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Access to web-site

Standard care

Outcomes

Primary Outcome Measures

Change in Preparedness for caregiving

Preparedness for caregiving scale (PCS)

Secondary Outcome Measures

Change in Quality of Life

The Quality of Life in Life-Threatening Illness Family caregiver version (QOLLTI-F)

Change in health

RAND- 36

Change in Anxiety and Depression

The Hospital Anxiety and Depression Scale (HADS)

Change in pre-loss grief

Prolonged Grief-12

Change in post-loss grief

Prolonged Grief-13

Full Information

NCT ID

NCT05785494

First Posted

February 27, 2023

Last Updated

March 14, 2023

Sponsor

Ersta Sköndal University College

1. Study Identification

Unique Protocol Identification Number

NCT05785494

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ersta Sköndal University College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Family, End of Life, Cancer Metastatic, Chronic Illness

Keywords

Palliative care, Family caregiver, Web-based support, Intervention

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Access to web-site

Arm Title

Control

Arm Type

No Intervention

Arm Description

Standard care

Intervention Type

Other

Intervention Name(s)

Narstaende.se

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Preparedness for caregiving

Description

Preparedness for caregiving scale (PCS)

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in Quality of Life

Description

The Quality of Life in Life-Threatening Illness Family caregiver version (QOLLTI-F)

Time Frame

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

Title

Change in health

Description

RAND- 36

Time Frame

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

Title

Change in Anxiety and Depression

Description

The Hospital Anxiety and Depression Scale (HADS)

Time Frame

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

Title

Change in pre-loss grief

Description

Prolonged Grief-12

Time Frame

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

Title

Change in post-loss grief

Description

Prolonged Grief-13

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anette Alvariza, Professor

Phone

+46707915773

anette.alvariza@mchs.se

First Name & Middle Initial & Last Name or Official Title & Degree

Cecilia Högberg, MSc

Phone

+46733021162

cecilia.hogberg@mchs.se

Facility Information:

Facility Name

Marie Cederschiöld University

City

Stockholm

ZIP/Postal Code

100 61

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anette Alvariza

Phone

0707915773

anette.alvariza@mchs.se

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs