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Clinical Trials/NCT06883838
NCT06883838Enrolling By InvitationNot Applicable

Enhancing Primary Care Capacity for Cancer Survivorship Care Delivery in Community Health Clinics

The University of Texas Health Science Center, Houston2 sites in 1 country5,584 target enrollmentStarted: September 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
5,584
Locations
2
Primary Endpoint
Proportion of eligible cancer survivors screened for second primary cancers

Study Overview

Brief Summary

The purpose of this study is to implement a clinic-level cancer survivorship care delivery intervention in partnership with community health center clinicians, patients, and community representatives to test effectiveness of the intervention to improve patient and clinician outcomes and to evaluate implementation of the intervention using an iterative, concurrent mixed-methods approach guided by the Practice Change Model.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Step 4 (2 clinics)- 24 months control then 12 months intervention

Experimental

Intervention: Survivorship care delivery intervention (Behavioral)

Step 1 (2 clinics)-6 months control then 12 months intervention

Experimental

Intervention: Survivorship care delivery intervention (Behavioral)

Step 2 (2 clinics)-12 months control then 12 months intervention

Experimental

Intervention: Survivorship care delivery intervention (Behavioral)

Step 3 (2 clinics)-18 months control then 12 months intervention

Experimental

Intervention: Survivorship care delivery intervention (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change in proportion of primary care clinician knowledge of cancer survivorship care(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)(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)(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)(every 6 months from baseline to end of study (about 36 months from baseline))

Investigators

Sponsor
The University of Texas Health Science Center, Houston
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bijal.A.Balasubramanian

Professor

The University of Texas Health Science Center, Houston

Study Sites (2)

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