Cancer, BreastNCT05400941
Aim 3, Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
A study testing Practice Led Intervention in people with Cancer, Breast and Health Care Utilization, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This mixed methods study evaluates the effectiveness of an organizational intervention to enhance implementation of strategies to increase breast cancer survivorship symptom and risk management. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Breast, Health Care Utilization
- What is being tested?
- Practice Led Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 910 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 31 Dec 2026
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identification as a staff member or patient who has had breast cancer in a participating practice
Who cannot join
- Unable to speak, understand and/or read English
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
This mixed methods study evaluates the effectiveness of an organizational intervention to enhance implementation of strategies to increase breast cancer survivorship symptom and risk management.
Read the detailed description
Aim 3 is a hybrid type 1 effectiveness-implementation cluster randomized study with a waitlist control in 26 primary care practices. This study uses a tailored combination of practice facilitation, expert consultation, collaborative learning events, and audit and feedback as intervention strategies, and a mixed-methods comparative case study learning evaluation for primary care practices to adapt priority recommendations of evidence-based activities for breast cancer survivorship care. Intervention effectiveness will be assessed in two groups of clinics: 13 cases that will receive the implementation intervention and 13 waitlist controls. Impact of this implementation will be measured using mixed methods to assess Exploration, Preparation, Implementation and Sustainment factors related to how organizational and contextual variables affect adoption, implementation and early sustainability for provision of follow-up care, symptom, and risk management activities at 6 and 12 months post implementation. Aim 3 surveys 20 clinicians and staff members from 26 intervention practices (n=520) and conducts key informant interviews with 5 health care team members (who have participated in the survey; n=130) and 15 breast cancer survivors per practice (n=390; 5 per assessment point at baseline, 6 months and 12 months post intervention). Medical records of 20 patients with a history of breast cancer per practice per assessment point at baseline, 6 months and 12 months post intervention will be randomly selected for review (N=1,560) to assess and compare comprehensive breast cancer follow-up care outcomes. Sustainment will be measured through continued monitoring of the medical records for the 13 initial intervention practices at 18 and 24 months (N=520).
- Conditions
- Cancer, Breast, Health Care Utilization
- Being tested
- Practice Led Intervention
- Medical subject headings
- Breast Neoplasms, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice Led InterventionBehavioural
This is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback.
| Study group | Role | What they receive |
|---|---|---|
| Practice Led Intervention | Active comparator | Clinic staff will participate in learning collaborative and practice facilitation as well as receive expert consultation and audit and feedback. Receives: Behavioral: Practice Led Intervention |
| Standard of Care | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Comprehensive Breast Cancer Follow-up Care
Percent of eligible recommendations performed per patient to assess the comprehensiveness of the follow up care received
Measured: Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start24 Jun 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Masking
- None (open label)
- Enrolment
- 910 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Shawna V. Hudson, PhD, Rutgers, The State University of New Jersey
- Investigators
- Shawna V Hudson, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400941
- Sponsor's protocol ID
- Pro2021000838
- Other IDs
- R01CA257197
- Status last verified
- May 2026
- First submitted
- 23 May 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fadem SJ, Hudson SV, Crabtree BF, Howard J, Hemler JR, Ferrante J, Mikesell L, April-Sanders AK, Bator A, O'Malley DM. Using co-design to develop actionable strategies to identify and follow-up on breast cancer survivors in primary care. BMC Health Serv Res. 2026 Apr 18;26(1):777. doi: 10.1186/s12913-026-14538-7.
PubMed 42001107Fadem SJ, Maniaci A, Devine KA, O'Malley DM, Hemler JR, Holover G, Hudson SV, Crabtree BF. "I had to work it out for myself": opportunities for primary care to fill a void for early-onset breast cancer survivors. J Cancer Surviv. 2026 Mar 18:10.1007/s11764-026-02001-9. doi: 10.1007/s11764-026-02001-9. Online ahead of print.
PubMed 41844926Fadem SJ, Crabtree BF, O'Malley DM, Mikesell L, Ferrante JM, Toppmeyer DL, Ohman-Strickland PA, Hemler JR, Howard J, Bator A, April-Sanders A, Kurtzman R, Hudson SV. Adapting and implementing breast cancer follow-up in primary care: protocol for a mixed methods hybrid type 1 effectiveness-implementation cluster randomized study. BMC Prim Care. 2023 Nov 9;24(1):235. doi: 10.1186/s12875-023-02186-3.
PubMed 37946132
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care
- ClinicalTrials.gov ID
- NCT05400941
- Acronym / sponsor ID
- Pro2021000838
- Conditions
- Cancer, Breast, Health Care Utilization
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 910 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jun 2022 (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.
This mixed methods study evaluates the effectiveness of an organizational intervention to enhance implementation of strategies to increase breast cancer survivorship symptom and risk management.
Detailed description
Aim 3 is a hybrid type 1 effectiveness-implementation cluster randomized study with a waitlist control in 26 primary care practices. This study uses a tailored combination of practice facilitation, expert consultation, collaborative learning events, and audit and feedback as intervention strategies, and a mixed-methods comparative case study learning evaluation for primary care practices to adapt priority recommendations of evidence-based activities for breast cancer survivorship care. Intervention effectiveness will be assessed in two groups of clinics: 13 cases that will receive the implementation intervention and 13 waitlist controls. Impact of this implementation will be measured using mixed methods to assess Exploration, Preparation, Implementation and Sustainment factors related to how organizational and contextual variables affect adoption, implementation and early sustainability for provision of follow-up care, symptom, and risk management activities at 6 and 12 months post implementation. Aim 3 surveys 20 clinicians and staff members from 26 intervention practices (n=520) and conducts key informant interviews with 5 health care team members (who have participated in the survey; n=130) and 15 breast cancer survivors per practice (n=390; 5 per assessment point at baseline, 6 months and 12 months post intervention). Medical records of 20 patients with a history of breast cancer per practice per assessment point at baseline, 6 months and 12 months post intervention will be randomly selected for review (N=1,560) to assess and compare comprehensive breast cancer follow-up care outcomes. Sustainment will be measured through continued monitoring of the medical records for the 13 initial intervention practices at 18 and 24 months (N=520).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Practice Led Intervention | Active comparator | Behavioral: Practice Led InterventionClinic staff will participate in learning collaborative and practice facilitation as well as receive expert consultation and audit and feedback. |
| Standard of Care | No intervention | –No intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-identification as a staff member or patient who has had breast cancer in a participating practice
Key exclusion criteria (2 listed)
- Unable to speak, understand and/or read English
- Unable to provide informed consent
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 |
|---|---|---|
| Practice Led InterventionThis is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback. | Behavioural | Practice Led Intervention |
Primary outcome
Change in Comprehensive Breast Cancer Follow-up Care
Time frame: Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months
Percent of eligible recommendations performed per patient to assess the comprehensiveness of the follow up care received
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 6 May 2026.
- Derived from this study: PubMed 42001107Fadem SJ, Hudson SV, Crabtree BF, Howard J, Hemler JR, Ferrante J, Mikesell L, April-Sanders AK, Bator A, O'Malley DM. Using co-design to develop actionable strategies to identify and follow-up on breast cancer survivors in primary care. BMC Health Serv Res. 2026 Apr 18;26(1):777. doi: 10.1186/s12913-026-14538-7.
- Derived from this study: PubMed 41844926Fadem SJ, Maniaci A, Devine KA, O'Malley DM, Hemler JR, Holover G, Hudson SV, Crabtree BF. "I had to work it out for myself": opportunities for primary care to fill a void for early-onset breast cancer survivors. J Cancer Surviv. 2026 Mar 18:10.1007/s11764-026-02001-9. doi: 10.1007/s11764-026-02001-9. Online ahead of print.
- Derived from this study: PubMed 37946132Fadem SJ, Crabtree BF, O'Malley DM, Mikesell L, Ferrante JM, Toppmeyer DL, Ohman-Strickland PA, Hemler JR, Howard J, Bator A, April-Sanders A, Kurtzman R, Hudson SV. Adapting and implementing breast cancer follow-up in primary care: protocol for a mixed methods hybrid type 1 effectiveness-implementation cluster randomized study. BMC Prim Care. 2023 Nov 9;24(1):235. doi: 10.1186/s12875-023-02186-3.
- 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.
Shawna V Hudson, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Led Intervention in people with Cancer, Breast and Health Care Utilization, run by Rutgers, The State University of New Jersey 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 1 inclusion and 2 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 6 May 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?
Change in Comprehensive Breast Cancer Follow-up Care (time frame: Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months). 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 NCT05400941, which also lists 3 linked publications.
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 6 May 2026.