Mar 30, 2026
Protocol for a Planned Prospective Community-Based Pilot of the AfterFIRE Survivorship and Inequity Model (ASIM): A Nurse-Led Survivorship Support Intervention for Black Women After Cancer
- Chinonye Nwadinobi, MSN, RN1
- 1AfterFIRE Foundation
- ASIM Community-Based Pilot Protocol
Protocol Citation: Chinonye Nwadinobi, MSN, RN 2026. Protocol for a Planned Prospective Community-Based Pilot of the AfterFIRE Survivorship and Inequity Model (ASIM): A Nurse-Led Survivorship Support Intervention for Black Women After Cancer. protocols.io https://dx.doi.org/10.17504/protocols.io.4r3l2dzq4g1y/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: In development
This protocol describes a planned prospective community-based pilot study. Participant enrollment has not yet begun.
Created: March 30, 2026
Last Modified: March 30, 2026
Protocol Integer ID: 314091
Keywords: cancer survivorship, Black women, pilot protocol, oncology nursing, implementation, feasibility, acceptability, community-based pilot, health equity, ASIM, survivorship support intervention for black women, led survivorship support intervention for black women, black women cancer survivor, responsive survivorship intervention, led survivorship support intervention, black women after cancer, limited survivorship care planning, survivorship support, based pilot of the afterfire survivorship, afterfire survivorship, uneven access to survivorship support, practical barriers during the survivorship period, survivorship period, survivorship equity, completion of active cancer treatment, completed active cancer treatment, survivorship navigation, planned prospective community, pilot study, based pilot study, prospective community, active cancer treatment, prospective testing, structured nurse, reported outcome measurement, outcome measurement, black women, exploratory patient
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Abstract
Background: Black women after cancer continue to face structural and practical barriers during the survivorship period, including fragmented follow-up, psychosocial strain, uneven access to survivorship support, and limited survivorship care planning. A structured, culturally responsive survivorship intervention tailored to this population warrants prospective testing. The present protocol builds on founder-led developmental pre-pilot field testing involving 12 Black women cancer survivors, which informed intervention refinement and supported next-stage protocol development.
Objective: To describe the planned protocol for a prospective community-based pilot study of an ASIM-aligned nurse-led survivorship support intervention for Black women after completion of active cancer treatment, with primary focus on feasibility, acceptability, implementation performance, and exploratory patient-reported outcome measurement.
Methods: This manuscript describes a planned single-arm, prospective, mixed-methods community-based pilot study. Up to 30 Black women who have completed active cancer treatment within the prior 24 months are expected to be enrolled over an anticipated 6-month recruitment period after ethics approval and study activation. Participants will receive a 12-week ASIM-aligned intervention consisting of a structured nurse-led intake, scheduled healing check-ins, survivorship navigation, culturally responsive education, peer connection opportunities, and tailored resource linkage. Assessments are planned for baseline, week 6, week 12, and week 24.
Results: Not applicable. This paper presents the study protocol, planned measures, and analytic approach. No participant enrollment or outcome data are reported.
Conclusions: This protocol is designed to determine whether ASIM can be delivered with sufficient feasibility, acceptability, fidelity, and measurement performance to justify a larger controlled study. It translates survivorship equity into a prospectively testable implementation pathway without overstating efficacy.
Troubleshooting
Safety warnings
This is a low-risk survivorship support intervention, but distress or unmet clinical needs may emerge during study contacts. A nurse-led escalation workflow will be used when urgent psychosocial, medical, or safety concerns are identified.
Ethics statement
This manuscript reports a planned prospective community-based pilot protocol. At the time of this protocol manuscript, participant enrollment has not yet begun. Appropriate ethics review and approval will be obtained before any recruitment, consent, data collection, or intervention delivery occurs. Informed consent will be obtained from all participants before baseline assessment. The study is designed to minimize burden, protect confidentiality, and support participant safety through a defined distress-escalation workflow.
10. Oversight, Intervention Delivery, and Fidelity Monitoring
Intervention delivery will be led by a registered nurse or comparably qualified nurse-delivered survivorship support professional operating under the study protocol and supervision structure. All interventionists will complete protocol orientation before participant contact. Orientation will include review of the intervention manual, intake and check-in structure, documentation expectations, confidentiality procedures, distress-escalation workflow, mock-session practice, and use of the study data platform and contact templates.
Fidelity will be monitored using standardized contact templates and component checklists linked to each scheduled encounter. Supervisory review meetings will occur at least monthly during active enrollment to review documentation completeness, protocol adherence, emerging implementation issues, and any protocol deviations. A sample of completed contacts will undergo structured fidelity review using predefined criteria for completion of core components.
Study oversight will include routine review of recruitment flow, retention, contact completion, adverse events or distress escalations, and data completeness. Any material protocol modifications required during the pilot will be documented with date, rationale, and implementation note so that refinement remains transparent.
11. Outcomes and Measures
11.1 Primary Outcomes
Feasibility will be assessed using operational indicators including screening-to-enrollment ratio, proportion of eligible individuals who consent, retention at weeks 12 and 24, completion rate for planned healing check-ins, completion rate for baseline, week 6, week 12, and week 24 assessments, and intervention fidelity based on completion of required core components.
Predefined feasibility thresholds are as follows.
At least 60 percent of eligible survivors consent to participate.
At least 80 percent of enrolled participants complete the week 12 assessment.
At least 75 percent of participants complete 3 or more of the 4 planned healing check-ins.
At least 85 percent completeness for core patient-reported outcome fields.
Acceptability will be assessed at week 12 using the 4-item Acceptability of Intervention Measure (AIM). Appropriateness and perceived feasibility will be assessed using the 4-item Intervention Appropriateness Measure (IAM) and 4-item Feasibility of Intervention Measure (FIM) [3,4]. Participant ratings will be summarized descriptively. A mean score of 4 or higher on the 5-point response scale will be interpreted as favorable.
11.2 Secondary Exploratory Outcomes
Health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item cancer-specific instrument covering physical, social or family, emotional, and functional well-being [8].
Perceived isolation will be assessed using the PROMIS Short Form v2.0 - Social Isolation 4a. Scores will be converted to T-scores according to PROMIS scoring guidance, with higher scores representing greater social isolation [9,10].
Follow-up engagement will be assessed using a structured study form documenting whether the participant completed at least one recommended survivorship, oncology, or relevant specialty follow-up action during the 12-week intervention. This will be coded as completed, scheduled but not completed, or not initiated.
Navigation confidence will be assessed using a 3-item pilot-generated study-specific scale rating confidence in knowing what follow-up is needed, knowing where to seek help, and being able to act on survivorship needs. Each item will be scored from 0 to 10, with higher scores indicating greater confidence. These items are exploratory, nonvalidated pilot-generated items included for refinement and distributional learning rather than for definitive inference.
A purposive subset of approximately 12 to 15 participants will complete semi-structured exit interviews at week 12 to capture lived experience, intervention fit, perceived value, unmet needs, and suggested refinements.
12. Schedule of Assessments
Assessments will occur at baseline, week 6, week 12, and week 24. Intervention contact logs will be maintained continuously across the 12-week active intervention period. Demographics and treatment context will be collected at baseline. The nurse-led intake session will occur at baseline. Healing check-ins will occur during weeks 2, 4, 8, and 12. FACT-G, PROMIS Social Isolation 4a, and the navigation confidence scale will be completed at baseline, week 6, week 12, and week 24. Follow-up engagement will be assessed at baseline status, week 12, and week 24. AIM, IAM, and FIM will be assessed at week 12. A qualitative exit interview subset will be completed at week 12.
13. Data Management
Study data are planned to be entered into a secure, access-restricted study database using unique participant identifiers and audit-capable change tracking after study activation. Contact logs and outcome data will be stored separately from direct identifiers. Access will be limited to approved study personnel using role-based permissions.
Data quality checks will be conducted regularly to identify missingness, out-of-range values, incomplete contact documentation, and timing discrepancies across study visits. The final production platform used at activation will be named in the study activation record and must meet confidentiality, access-control, and audit requirements.
14. Safety and Distress Escalation
This is a low-risk survivorship support intervention, but distress or unmet clinical needs may emerge during study contacts. A nurse-led escalation workflow will be used when urgent psychosocial, medical, or safety concerns are identified.
The interventionist will first assess immediacy and severity of concern, document the concern in real time, and determine whether same-day escalation is required. For emergent safety concerns, participants will be directed to emergency services or crisis resources immediately. For urgent but non-emergent concerns, the interventionist will facilitate linkage to an appropriate treating clinician, mental health professional, social worker, or other relevant support service as indicated. All escalations will be logged, reviewed in supervision, and followed to closure or documented handoff when possible.
15. Statistical Analysis Plan
All analyses will be descriptive and exploratory.
15.1 Feasibility and Acceptability Analysis. Recruitment, retention, intervention completion, assessment completion, and fidelity metrics will be summarized using counts, proportions, means, and 95 percent confidence intervals where appropriate. AIM, IAM, and FIM total and item-level responses will be summarized descriptively.
15.2 Exploratory Outcome Analysis. FACT-G total and subscale scores, PROMIS Social Isolation T-scores, and navigation confidence scores will be summarized at each timepoint using means and standard deviations or medians and interquartile ranges, depending on distribution. Within-participant change from baseline to week 12 and baseline to week 24 will be estimated using paired t-tests or Wilcoxon signed-rank tests as appropriate. Effect sizes will be reported as exploratory standardized mean change with 95 percent confidence intervals.
Follow-up engagement will be summarized descriptively as the proportion completing at least one recommended follow-up action by week 12 and week 24.
Because this is a pilot study, hypothesis testing will be treated as exploratory and interpreted cautiously. No claim of efficacy will be made based on this study alone.
16. Progression Criteria to a Larger Trial
Advancement to a larger pilot or controlled trial will be supported if the following are met.
Recruitment is operationally achievable within the planned window.
Retention at week 12 is at least 80 percent.
Core intervention fidelity is acceptable.
Participant acceptability is favorable.
The selected patient-reported outcome measures show adequate completion and interpretable score distributions.
Qualitative feedback supports the relevance and value of the intervention with manageable burden.
Failure to meet one or more criteria will not automatically terminate development, but will trigger protocol revision before expansion.
17. Ethical Considerations and Registration
This manuscript reports a planned prospective community-based pilot protocol. At the time of this protocol manuscript, participant enrollment has not yet begun. Appropriate ethics review and approval will be obtained before any recruitment, consent, data collection, or intervention delivery occurs. Informed consent will be obtained from all participants before baseline assessment. The study is designed to minimize burden, protect confidentiality, and support participant safety through a defined distress-escalation workflow.
Prospective study registration will be completed before participant enrollment in an appropriate public registry or protocol repository, consistent with the final ethics and implementation pathway.
Protocol references
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3. Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Administration and Policy in Mental Health and Mental Health Services Research. 2011;38(2):65-76.
4. Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Science. 2017;12:108.
5. Palmer NRA, Weaver KE, Hauser SP, et al. Disparities in barriers to follow-up care between African American and White breast cancer survivors. Supportive Care in Cancer. 2015;23(11):3201-3209.
6. Hoeg BL, Bidstrup PE, Karlsen RV, et al. Follow-up strategies following completion of primary cancer treatment in adult cancer survivors. Journal of Cancer Survivorship. 2019;13(4):556-572.
7. Teresi JA, Ramirez M, Ellis J, et al. Guidelines for designing and evaluating feasibility pilot studies. Medical Care. 2022;60(1):95-103.
8. FACT-G - Functional Assessment of Cancer Therapy. FACIT.org. Accessed March 29, 2026.
9. PROMIS Short Form v2.0 - Social Isolation 4a. HealthMeasures. Accessed March 29, 2026.
10. Walsh C, Jang Y, Currin-McCulloch J, Simon P, Cubbin C, Jones B. Pilot Use of Selected Measures from the Patient-Reported Outcomes Measurement Information System Social and Mental Health Domains with Young Adult Cancer Patients During the Transition to Survivorship Care. Journal of Adolescent and Young Adult Oncology. 2019;8(5):635-639. doi:10.1089/jayao.2019.0022.