Cancer SurvivorshipCASCADENCT06883838
Project CASCADE: Community and Academic Synergy for Cancer Survivorship Care Delivery Enhancement
A study testing Survivorship care delivery intervention in people with Cancer Survivorship, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivorship
- What is being tested?
- Survivorship care delivery intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,584 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -at least one visit to the Community Health Centers (CHCs) in the prior year
- -employed clinicians (e.g. physicians, nurses, pharmacists, or other allied health professionals) and non-clinician staff of the participating CHC clinics
Who cannot join
- no history of cancer recorded in the problem list or past medical history in the medical record
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center, Houston
Houston, Texas, 77030
About this study
Official title: Enhancing Primary Care Capacity for Cancer Survivorship Care Delivery in Community Health Clinics
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
- Being tested
- Survivorship care delivery intervention
- Keywords
- cancer survivorship, community health centers, care delivery, primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship care delivery interventionBehavioural
Guided by the Practical, Robust Implementation and Sustainability Model (PRISM), the intervention includes three evidence-based components:
- Training: This will include provider-to-provider tele-mentoring using Enhancing Community Health Outcomes (ECHO).
- Tracking: This includes systematically assessing cancer history and monitoring survivors' care to plan and organize subsequent care.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Step 1 (2 clinics)-6 months control then 12 months intervention | Experimental | Not described Receives: Behavioral: Survivorship care delivery intervention |
| Step 2 (2 clinics)-12 months control then 12 months intervention | Experimental | Not described Receives: Behavioral: Survivorship care delivery intervention |
| Step 3 (2 clinics)-18 months control then 12 months intervention | Experimental | Not described Receives: Behavioral: Survivorship care delivery intervention |
| Step 4 (2 clinics)- 24 months control then 12 months intervention | Experimental | Not described Receives: Behavioral: Survivorship care delivery intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible cancer survivors screened for second primary cancers
Data derived from electronic health records
Measured: 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
Assessed by self-administered survey
Measured: 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)
Measured: 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)
Measured: 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)
Per national guidelines [National Comprehensive Cancer Network (NCCN), U.S. Preventive Services Task Force (USPSTF)]; data derived from electronic health records
Measured: every 6 months from baseline to end of study (about 36 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Sep 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster randomized trial (SW-CRT). There will be 4 clusters (CHCs) having 2 practices each.
- Masking
- None (open label)
- Enrolment
- 5,584 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bijal.A.Balasubramanian, The University of Texas Health Science Center, Houston
- Investigators
- Bijal Balasubramanian, MBBS, PhD, Principal investigator, The University of Texas Health Science Center, HoustonSimon Craddock Lee, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883838
- Sponsor's protocol ID
- HSC-SPH-24-0777
- Other IDs
- U01CA290663
- Acronym
- CASCADE
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Millett ME, Malthaner LQ, McCallister K, Craig DW, Eary R, Valerio-Shewmaker MA, Shay LA, Rajan SS, Ma HY, Ghosh S, Crabtree BF, Lee SJC, Balasubramanian BA. Community and Academic Synergy for Cancer Survivorship Care Delivery Enhancement (Project CASCADE): a study protocol for a pragmatic, stepped-wedge, cluster-randomized trial in Texas primary care community health centers. BMC Prim Care. 2025 Dec 27;27(1):18. doi: 10.1186/s12875-025-03108-1.
PubMed 41454266
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Primary Care Capacity for Cancer Survivorship Care Delivery in Community Health Clinics
- ClinicalTrials.gov ID
- NCT06883838
- Acronym / sponsor ID
- CASCADE / HSC-SPH-24-0777
- Conditions
- Cancer Survivorship
- Keywords
- cancer survivorship, community health centers, care delivery, primary care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,584 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Stepped-wedge cluster randomized trial (SW-CRT). There will be 4 clusters (CHCs) having 2 practices each.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -at least one visit to the Community Health Centers (CHCs) in the prior year
- -employed clinicians (e.g. physicians, nurses, pharmacists, or other allied health professionals) and non-clinician staff of the participating CHC clinics
Key exclusion criteria (1 listed)
- no history of cancer recorded in the problem list or past medical history in the medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survivorship care delivery interventionGuided 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. | Behavioural | 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 |
Primary outcome
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
4 secondary outcomes
Change in proportion of primary care clinician knowledge of cancer survivorship care
Time frame: 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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Derived from this study: PubMed 41454266Millett ME, Malthaner LQ, McCallister K, Craig DW, Eary R, Valerio-Shewmaker MA, Shay LA, Rajan SS, Ma HY, Ghosh S, Crabtree BF, Lee SJC, Balasubramanian BA. Community and Academic Synergy for Cancer Survivorship Care Delivery Enhancement (Project CASCADE): a study protocol for a pragmatic, stepped-wedge, cluster-randomized trial in Texas primary care community health centers. BMC Prim Care. 2025 Dec 27;27(1):18. doi: 10.1186/s12875-025-03108-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bijal Balasubramanian, MBBS, PhD principal investigator
The University of Texas Health Science Center, Houston
Simon Craddock Lee, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship care delivery intervention in people with Cancer Survivorship, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06883838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.