NCT07390019

Brief Summary

In this planned project, we aim to evaluate the FamCASP model and the digital screening tool SCa-N as an intervention within routine cancer care. An expected outcome of FamCASP is an increase in family health as expressed in lower levels of psychological distress, improved coping strategies and family climate and a decrease in unmet needs as measured by family members' self-reports as well as their descriptions during interviews. Hence, the specific aims are to: I. Describe differences in psychological distress, coping strategies, family climate and unmet needs between baseline and follow-up in family members receiving support according to the FamCASP model in outpatient cancer clinics and to explore whether or not there are differences between family members receiving support and those who do not receive support. II. Describe family members' experiences of receiving support according to the FamCASP model. III. Describe family members' experiences of interacting with the digital tool.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable cancer

Timeline
81mo left

Started Feb 2026

Longer than P75 for not_applicable cancer

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Feb 2026Dec 2032

First Submitted

Initial submission to the registry

January 29, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2032

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

4.9 years

First QC Date

January 29, 2026

Last Update Submit

January 29, 2026

Conditions

CancerFamily MembersSupport, Family

Outcome Measures

Primary Outcomes (1)

  • Support needs

    The Supportive Care Needs Survey - Partners and Caregivers

    12 months post diagnosis

Secondary Outcomes (1)

  • Health

    12 months post diagnosis

Other Outcomes (2)

  • Anxiety and depression

    12 months post diagnosis

  • Coping

    12 months post diagnosis

Study Arms (2)

Intervention group

EXPERIMENTAL
Other: FamCASP

Control group

NO INTERVENTION

Interventions

FamCASPOTHER

Support model

Intervention group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

December 30, 2030

Study Completion (Estimated)

December 30, 2032

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share