- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06883838
Project CASCADE: Community and Academic Synergy for Cancer Survivorship Care Delivery Enhancement (CASCADE)
Enhancing Primary Care Capacity for Cancer Survivorship Care Delivery in Community Health Clinics
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center, Houston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria (participants):
-at least one visit to the Community Health Centers (CHCs) in the prior year
Exclusion Criteria (participants):
- no history of cancer recorded in the problem list or past medical history in the medical record
Inclusion Criteria (clinicians):
-employed clinicians (e.g. physicians, nurses, pharmacists, or other allied health professionals) and non-clinician staff of the participating CHC clinics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Step 1 (2 clinics)-6 months control then 12 months intervention
|
Guided by the Practical, Robust Implementation and Sustainability Model (PRISM), the intervention includes three evidence-based components:
|
|
Experimental: Step 2 (2 clinics)-12 months control then 12 months intervention
|
Guided by the Practical, Robust Implementation and Sustainability Model (PRISM), the intervention includes three evidence-based components:
|
|
Experimental: Step 3 (2 clinics)-18 months control then 12 months intervention
|
Guided by the Practical, Robust Implementation and Sustainability Model (PRISM), the intervention includes three evidence-based components:
|
|
Experimental: Step 4 (2 clinics)- 24 months control then 12 months intervention
|
Guided by the Practical, Robust Implementation and Sustainability Model (PRISM), the intervention includes three evidence-based components:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of eligible cancer survivors screened for second primary cancers
Time Frame: every 6 months from baseline to end of study (about 36 months from baseline)
|
Data derived from electronic health records
|
every 6 months from baseline to end of study (about 36 months from baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in proportion of primary care clinician knowledge of cancer survivorship care
Time Frame: baseline, six months following end of intervention period
|
Assessed by self-administered survey
|
baseline, six months following end of intervention period
|
|
Change proportion of survivors that report better experience of provider communication as assessed by the adapted Consumer Assessment of Healthcare Providers and Systems (CAHPS 4.0)
Time Frame: baseline, six months following end of intervention period
|
baseline, six months following end of intervention period
|
|
|
Change proportion of survivors that report better experience of care coordination as assessed by the adapted Consumer Assessment of Healthcare Providers and Systems (CAHPS 4.0)
Time Frame: baseline, six months following end of intervention period
|
baseline, six months following end of intervention period
|
|
|
Proportion of survivors who received guideline-recommended surveillance for the most prevalent cancers (breast colorectal, prostate, cervical, and lung)
Time Frame: every 6 months from baseline to end of study (about 36 months from baseline)
|
Per national guidelines [National Comprehensive Cancer Network (NCCN), U.S. Preventive Services Task Force (USPSTF)]; data derived from electronic health records
|
every 6 months from baseline to end of study (about 36 months from baseline)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bijal Balasubramanian, MBBS, PhD, The University of Texas Health Science Center, Houston
- Principal Investigator: Simon Craddock Lee, PhD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSC-SPH-24-0777
- U01CA290663 (U.S. NIH Grant/Contract)
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
product manufactured in and exported from the U.S.
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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