Project CASCADE: Community and Academic Synergy for Cancer Survivorship Care Delivery Enhancement

NCT06883838 | Enrolling By Invitation

• 2 other identifiers: HSC-SPH-24-0777U01CA290663
• Study Type: interventional
• Target: 5,584
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivorship

Keywords

cancer survivorship; community health centers; care delivery; primary care

Outcome Measures

Primary Outcomes (1)

• Proportion of eligible cancer survivors screened for second primary cancers

  Data derived from electronic health records

  every 6 months from baseline to end of study (about 36 months from baseline)

Secondary Outcomes (4)

• 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)

Study Arms (4)

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

EXPERIMENTAL

Behavioral: Survivorship care delivery intervention

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

EXPERIMENTAL

Behavioral: Survivorship care delivery intervention

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

EXPERIMENTAL

Behavioral: Survivorship care delivery intervention

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

EXPERIMENTAL

Behavioral: Survivorship care delivery intervention

Interventions

Survivorship care delivery intervention BEHAVIORAL

Guided by the Practical, Robust Implementation and Sustainability Model (PRISM), the intervention includes three evidence-based components: 1. Training: This will include provider-to-provider tele-mentoring using Enhancing Community Health Outcomes (ECHO). 2. Tracking: This includes systematically assessing cancer history and monitoring survivors' care to plan and organize subsequent care. 3. Coordinating care for cancer survivors. Each clinic leader will designate a staff member (or members) as the care coordinator champion after exploring current clinic staff, skills, and capacity of various staff roles.

Step 1 (2 clinics)-6 months control then 12 months intervention; Step 2 (2 clinics)-12 months control then 12 months intervention; Step 3 (2 clinics)-18 months control then 12 months intervention; Step 4 (2 clinics)- 24 months control then 12 months intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least one visit to the Community Health Centers (CHCs) in the prior year

You may not qualify if:

• \- no history of cancer recorded in the problem list or past medical history in the medical record
• employed clinicians (e.g. physicians, nurses, pharmacists, or other allied health professionals) and non-clinician staff of the participating CHC clinics

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

Location

Study Officials

• Bijal Balasubramanian, MBBS, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Simon Craddock Lee, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stepped-wedge cluster randomized trial (SW-CRT). There will be 4 clusters (CHCs) having 2 practices each.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)