- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07390019
Families Experiencing Cancer - Support to Prevent Cancer-related Illness (FamCASP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants are adult (≥18years) family members to patients diagnosed with CRC. Inclusion criteria are the ability to read and understand Swedish and having access to a computer, tablet or mobile phone to access the digital screening tool as well as the study information.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Intervention group
|
Support model
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Support needs
Time Frame: 12 months post diagnosis
|
The Supportive Care Needs Survey - Partners and Caregivers
|
12 months post diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health
Time Frame: 12 months post diagnosis
|
EQ5D
|
12 months post diagnosis
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety and depression
Time Frame: 12 months post diagnosis
|
Hospitla Anxiety and Despression Scale
|
12 months post diagnosis
|
|
Coping
Time Frame: 12 months post diagnosis
|
Brief Coping Scale
|
12 months post diagnosis
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAU 2025/588
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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