75N94027R00004_Notice_of_Intent_1.pdf

PRE-SOLICITATION

NOTICE OF INTENT TO SOLE SOURCE

Notice Title: Randomized Controlled Trial of a Novel Clinical Decision Support Tool for Individualized Exercise Recommendations in Breast Cancer Survivors

Agency: Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)

Contracting Office: NIH Office of Acquisition and Logistics Management (OALM)

Notice Type: Pre-solicitation – Notice of Intent to Sole Source

Notice ID: 75N94027R00004

NAICS Code: 541715

Product Service Code (PSC): AN12

Response Deadline: 11/25/2026

Description:

The National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD), Division of Intramural Research (DIR), intends to award a sole-source contract to Kaiser Foundation Research Institute, Oakland, California, pursuant to the authority of 41 U.S.C. 3304(a)(1), as implemented by Revolutionary FAR Overhaul (RFO) FAR 6.103-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

The purpose of this acquisition is to conduct a randomized controlled clinical trial evaluating the effectiveness of an existing clinical decision-support tool designed to provide individualized exercise recommendations for breast cancer survivors.

The clinical decision-support tool was developed using a simulation model based on longitudinal clinical and exercise-related data from the Kaiser Permanente Northern California (KPNC) Pathways Study. The underlying model incorporates patient characteristics and clinical information to estimate the potential benefits of different types and amounts of exercise among breast cancer survivors.

NIMHD DIR will provide the existing clinical decision-support tool, study protocol, and initial research instruments. The Contractor will be responsible for implementing the research activities within the required clinical setting, including participant recruitment, study coordination, intervention implementation, data collection, and preparation of research deliverables.

The proposed acquisition represents a new phase of research involving prospective evaluation of the tool's effectiveness in clinical practice. The research will include recruitment and enrollment of eligible breast cancer survivors and clinicians, implementation of the clinical intervention, collection of clinical and patient-reported outcomes, and assessment of the tool's effectiveness in improving exercise recommendations, exercise participation, and associated health outcomes.

The research will assess clinician-related outcomes, including exercise prescription practices, confidence in providing individualized exercise recommendations, and referrals to exercise specialists. Patient-related outcomes will include exercise behavior and intentions, exercise self-efficacy, patient-clinician communication, health-related quality of life, fatigue, and perceived physical function.

The anticipated research activities will include the following:

Phase 1 – Feasibility and Acceptability Testing (Aim 1):

The Contractor will conduct feasibility and acceptability testing involving approximately 10 clinicians and 30 breast cancer survivors. Activities will include participant recruitment and eligibility screening, administration of the clinical decision-support tool, clinician surveys, patient interviews, and collection of feasibility and acceptability data. Findings from this phase will inform implementation of the randomized controlled clinical trial.

Phase 2 – Randomized Controlled Clinical Trial (Aim 2):

The Contractor will implement a randomized controlled clinical trial involving approximately 64 clinicians and 624 breast cancer survivors. The trial will include intervention and usual-care groups, with approximately 32 clinicians and 312 breast cancer survivors assigned to each group, in accordance with the study protocol provided by NIMHD DIR.

The clinical trial will involve the use of wearable activity-monitoring devices to collect objective physical activity data, including activity intensity, duration, and sedentary behavior. The Contractor will conduct participant interviews, administer clinician surveys, and collect follow-up data at protocol-specified intervals, including assessments of exercise participation at three and six months and patient-reported outcomes at nine months following the intervention.

The Contractor will be responsible for assembling, cleaning, and de-identifying clinical, electronic health record-derived, interview, survey, and objective physical activity data. Required deliverables will include de-identified research datasets, supporting data documentation, feasibility and acceptability findings, progress reports, and a final project report. NIMHD DIR will conduct the primary scientific analyses and prepare manuscripts, with consultation and editorial support from the Contractor as specified in the Statement of Work.

The clinical trial will be conducted in accordance with applicable human subjects’ protection requirements, including Institutional Review Board (IRB) review and approval, informed consent, privacy, and data security requirements. Performance will require the necessary institutional authorizations and arrangements to conduct research involving KPNC patients, clinicians, clinical records, and healthcare operations.

Basis for the Proposed Sole-Source Acquisition

The Government's scientific objective is to conduct the initial randomized controlled trial of the existing clinical decision-support tool within the patient population and clinical environment from which the data used to develop its underlying simulation model were obtained.

Because the model was developed using data from the KPNC population, scientific uncertainties exist regarding the applicability of its estimates to other healthcare populations with different patient characteristics, clinical practices, and health outcomes. Conducting the initial evaluation within the KPNC healthcare environment will allow the Government to assess the tool's effectiveness within its development setting before considering its application to other healthcare populations.

Conducting the initial clinical evaluation in a healthcare population outside KPNC, before further validation of the underlying model, could introduce additional scientific uncertainties regarding the accuracy and applicability of individualized exercise recommendations and the interpretation of study outcomes.

The proposed clinical trial requires access to KPNC's eligible patient population, participating clinicians, electronic health records, and established clinical workflows. These resources are necessary to identify and recruit eligible participants, implement the research intervention, obtain relevant clinical information, and evaluate study outcomes.

KPNC maintains institutional control over these clinical resources and healthcare operations.

Other research organizations do not independently possess the authority to access KPNC patient records, recruit its patients, engage its clinicians, or implement research interventions within its healthcare delivery system without KPNC's authorization and participation.

The Government previously conducted a competitive acquisition for preparatory research activities associated with the planned clinical trial, including protocol development, institutional and technical approvals, and establishment of research procedures. The proposed acquisition concerns the subsequent phase of research involving implementation and evaluation of the clinical decision-support tool.

Based on the specific scientific requirements of the proposed initial evaluation and the institutional resources necessary to perform the research, the Government has identified Kaiser Foundation Research Institute as the intended sole-source contractor.

Anticipated Contract Information

The Government anticipates awarding a contract consisting of a 12-month base period and two 12-month option periods, for a total potential period of performance of 36 months.

The base period will primarily involve feasibility and acceptability testing, the first option period will involve randomized controlled clinical trial preparation and implementation, and the second option period will involve continued study activities, data finalization, and contract closeout.

The anticipated contract award date is August 2027.

Capability Statements

This notice is not a request for competitive proposals. However, all responsible sources may submit a written capability statement demonstrating their ability to satisfy the Government's requirements. All timely responses will be considered by the Government.

Interested sources must provide sufficient information demonstrating their ability to:

1. Conduct the initial randomized controlled clinical trial of the existing decision-support tool within the KPNC patient population and clinical environment represented by the underlying simulation model.

2. Obtain the necessary institutional authorization and access to KPNC patients, participating clinicians, electronic health records, and clinical workflows.

3. Demonstrate the capability to recruit and enroll approximately 10 clinicians and 30 breast cancer survivors for the feasibility and acceptability phase (Aim 1), and approximately 64 clinicians and 624 breast cancer survivors for the randomized controlled clinical trial (Aim 2), including the capacity to conduct participant follow-up and required study assessments at protocol-specified intervals.

4. Implement the required clinical research activities, including randomization, administration of the clinical intervention and usual-care conditions, clinician and patient interviews, electronic surveys, and collection of clinical and patient-reported outcomes.

5. Conduct objective physical activity monitoring, including the procurement, distribution, and management of wearable activity-monitoring devices and collection of associated research data.

6. Collect, manage, clean, and de-identify clinical and research data, including electronic health record-derived information, interview transcripts, survey responses, and objective physical activity measurements, and provide the required datasets, documentation, and reports to the Government.

7. Comply with applicable human subjects’ protection, IRB, informed consent, privacy, data security, and institutional requirements necessary to conduct the proposed clinical research.

8. Demonstrate the scientific, technical, operational, and institutional capabilities necessary to successfully perform the proposed research within the anticipated period of performance.

Capability statements should identify the respondent's relevant experience conducting randomized controlled clinical trials involving breast cancer survivors, integrating clinical decision-support interventions into healthcare delivery settings, recruiting clinicians and patients, and collecting and managing clinical and patient-reported research data.

Capability statements should specifically explain how the respondent would meet these requirements and identify any institutional agreements, authorizations, partnerships, or other arrangements available or obtainable to conduct the research within the required clinical setting.

General statements of clinical research experience, without sufficient information demonstrating the ability to satisfy the specific requirements described above, may not establish the respondent's capability to perform this acquisition.

Interested sources should include the following information in their responses:

1. Organization name, business address, and primary point of contact.

2. Unique Entity Identifier (UEI).

3. Business size and socioeconomic status under the applicable NAICS code.

4. Description of relevant scientific, technical, and clinical research capabilities.

5. Description of institutional access, agreements, authorizations, or other arrangements necessary to perform the proposed research.

6. Relevant examples of prior experience performing comparable clinical research activities.

Interested sources shall submit their capability statements electronically to the emails below no later than November 25, 2026, at 2:00 p.m. Eastern Time (ET).

Responses must reference 75N94027R00004 in the email subject line.

The Government will evaluate all timely responses to determine whether any other responsible source can satisfy the stated requirements. Determination of whether to proceed with the proposed sole-source acquisition or conduct a competitive procurement will be made by the Government based on the information received.

This notice does not constitute a solicitation or commitment by the Government to award a contract. The Government will not reimburse respondents for costs incurred in preparing or submitting capability statements.

Contracting Points of Contact

Gisele Beaudoin – Contract Specialist

Gannon White – Contracting Officer

Alice Pagan Pereira – Contracting Officer

NIH Office of Acquisition and Logistics Management

Gisele.beaudoin@nih.gov

Gannon.white@nih.gov

Alice.pagan@nih.gov