Preparatory Services for the Delivery of Individualized Exercise Recommendations for Breast Cancer Survivors _SOW.pdf

Version 4 05/13/2026

STATEMENT OF WORK

Preparatory Services for the Delivery of Individualized Exercise Recommendations for Breast Cancer Survivors

I. BACKGROUND AND INTRODUCTION

Exercise can reduce the risk of breast cancer recurrence, death due to breast cancer, all-cause mortality, and common side effects of treatment among breast cancer survivors. However, the complexity of recommending exercise to survivors with varying clinical characteristics, needs, and preferences means that the potential of exercise to address health disparities and improve survivors’ lives has yet to be realized.

Exercise guidelines for cancer survivors have been disseminated or endorsed by the American College of Clinical Oncology, American Cancer Society, and American College of Sports Medicine (ACSM). According to current guidelines, both aerobic and muscle strengthening exercise are recommended for cancer survivors. Existing resources, such as ACSM’s Physical Activity Vital Sign and Moving Through Cancer initiative, we as well as the Exercise in Cancer Evaluation and Decision ‘algorithm’ offer healthcare providers some support to assess, advise, and refer in alignment with guidelines. However, these resources do not facilitate the efficient delivery of individualized exercise recommendations (i.e., discussions, prescriptions, referrals) as outlined by cancer exercise guidelines. Thus, there is a need for a means to offer specific, more individualized exercise discussions, prescriptions, and referrals that engage patients and providers to increase exercise among breast cancer survivors.

Communication of exercise information to breast cancer survivors has been shown to increase their exercise participation. However, historically, conversations about exercise between healthcare providers and cancer survivors do not appear to have been standard practice, and referrals are even less common. In addition, evidence raises concerns about the ability of healthcare providers to have constructive exercise discussions with survivors. With respect to breast cancer survivors, in addition to a lack of time, providers perceived lack of training, knowledge, and confidence concerning exercise discussions.

We have developed a novel clinical decision tool to support the delivery of efficient, effective, evidence-based exercise advice to breast cancer survivors via individualized exercise discussions, prescriptions and/or referrals. The next step involves preparing the operational materials and institutional documentation necessary for NIH to conduct a future, NIH led implementation study involving breast cancer survivors and their clinicians to assess the impact of the tool on Exercise Prescriptions, Clinician Confidence, Exercise Referrals, Patient Satisfaction and Intention to Exercise, and Exercise Participation (up to 3-months post-intervention). NIMHD will determine study sites and participant access for any future NIH led study; this contract provides only preparatory services.

The overall purpose of this project is to develop documentation and infrastructure necessary for NIH to establish a future clinical trial which includes obtaining technical clearance and supporting documents, developing surveys, and establishing data collection infrastructure necessary for a future clinical trial with breast cancer survivors and clinicians in real-world settings. This contract provides professional, administrative, and technical support only, and it does not involve any human subjects research. There will be no data collection during this study period.

II. PURPOSE/OBJECTIVES

The purpose of this contract is to procure non-R&D professional services to establish study protocol documents and supporting materials, obtain institutional technical clearances required for NIH to conduct a future study involving a clinical decision tool for individualized exercise recommendations in the contractor’s institution; develop surveys; and data collection infrastructure necessary for a future clinical trial with breast cancer survivors and clinicians to support a future NIH led evaluation of the tool. The contractor’s role is limited to preparatory and administrative support; no research activities will occur under this contract.

III. SCOPE

The Contractor will develop the trial protocol, obtain institutional clearances, and prepare data collection instruments for future implementation of the study. No data will be collected during this contract.

The contract will be firm fixed price.

IV. SPECIFIC TASKS TO BE PERFORMED

The Contractor shall successfully perform the following specialized tasks:

• 1.0 – Preparation and submission of the Contractor’s Technology Review Office approvals for clinical use of the web-based tool

• 2.0 – Prepare and submit the material for technical and IRB clearance, in consultation with NIMHD DIR Investigator, which are required for NIH to later conduct human subjects research at the Contractor's Institution.

• 3.0 – Prepare and facilitate documentation for data sharing agreement between NIH and the contractor’s institution between Contractor and NIMHD.

• 4.0 – Develop data infrastructure that NIH will later use for participant tracking over the course of the study period.

• 5.0 – Prepare procedures and tools NIH may use to identify participants in a future study and curate related information for participant contact (e.g., email addresses, telephone numbers).

• 6.0 – Develop REDCap forms for all study surveys

• 7.0 – Develop a study communications plan for use across the healthcare system.

V. PROJECT MANAGEMENT AND ADMINISTRATION

The Contractor shall successfully perform the following project management and administration tasks:

• 1.0 - Contract Management

The Contractor shall:

o Provide overall management, integration, and coordination of all contract activities, including the management and coordination of activities carried out under subcontracts.

o Provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and timely completion of all projects carried out under this contract and effective communications with the Contracting Officer’s Representative (COR) o Provide for Project Manager with responsibility for overall project management and communications, tracking, monitoring, and reporting on project status and progress, and recommending modifications to project requirements and timelines.

• 2.0 - Kickoff Meeting

Within one week of award of the contract, the Contractor will participate in a two-hour Contract Initiation Meeting with the COR, CO (Contracting Officer) and NIMHD DIR Investigator to be held by web conferencing. The purpose of this meeting is to orient the Contractor to NICHD and NIMHD contract procedures and the deliverables. The NIMHD DIR Investigator will also provide an initial draft of the semi-structured interview guide and access to the tool.

• 3.0 - Monthly Project Progress Reports for Duration of Contract

One electronic copy each shall be delivered from the contractor to the CO and

COR

o The report will explain the status of contracted work in progress for the entire period covered, addressing problems encountered and resolutions. The report shall describe, by task, the project’s progress during the month; problems encountered and proposed solutions; and an accounting of costs by task.

o First report shall be due 15 days after the reporting period, i.e., on the 15th day of the following month.

• 4.0 - Final Project Report

At the end of the contract one electronic copy each shall be delivered from the contractor to the CO and COR.

o The report shall describe contracted work performed, from the contract award effective date to expiration date. The report shall describe, by task, the project’s progress; problems encountered and proposed solutions; and an accounting of costs by task.

o The final report shall be due no later than the contract expiration date

VI. REPORTING REQUIREMENTS/DELIVERABLES

The Contractor shall then deliver the following deliverables and reports required by the terms of the contract over the subsequent 12 months, as summarized in the following Table, beginning 09/20/2026.

Deliverable Description Due Date Recipients

SPECIFIC TASKS TO BE PERFORMED

1.0 Preparation and submission of the

Contractor’s Technology Review Office approvals

Month 1-8 of contract

2.0 Prepare and submit material for IRB

together with technical clearance, in consultation with NIMHD DIR Investigator, which are required for NIH to later conduct human subjects research at the Contractor's Institution

Month 1-8 of contract

NIMHD DIR

Investigator

3.0 Prepare and facilitate documentation

for data sharing agreement between NIH and the contractor’s institution

Month 1-12 of contract

NIMHD DIR

Investigator

4.0 Develop data infrastructure that NIH

will later use for participant tracking over the course of the study period.

5.0 Develop data infrastructure that NIH

will later use for participant tracking over the course of the study period.

6.0 Develop REDCap forms for all study

surveys

7.0 Develop a study communications

plan for use across the healthcare system.

Month 9-12 of

PROJECT MANAGEMENT AND ADMINISTRATION

1.0 Kickoff Meeting Within 1 week

of start of contract

COR, CO, and

NIMHD DIR

Investigator

2.0 Monthly Progress Reports Due 15 days

after the reporting period, i.e., on the 15th day of the following month

COR, CO, and

NIMHD DIR

Investigator

Deliverable Description Due Date Recipients

3.0 Final Project Report Due no later

than the contract expiration date

COR, CO, and

NIMHD DIR

Investigator

As summarized in the Table above, the Contractor shall submit all reports and deliverables in electronic form as PC-formatted computer files in Microsoft Word (for data documentation, reports, de-identified interview transcripts), and Microsoft Excel (de-identified participant characteristics). All reports shall also be archived and submitted to the COR at the expiration of the contract. If the Contractor becomes unable to deliver the reports specified hereunder within the period of performance because of the unforeseen difficulties, notwithstanding the exercise of good faith and diligent efforts in performance of the work, the Contractor shall give the CO, written notice at least 10 business days prior to the due date of anticipated delays with the reasons. The CO (based on recommendations from the COR) must approve the extension in writing and a new delivery date must be established. All reports required herein shall be submitted in electronic format, via the NICHD Contracts Portal. All electronic contract deliverables shall be submitted via the NICHD Contracts Portal available at the following website:

https://contracts.nichd.nih.gov. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at http://www.hhs.gov/web/508/index.html under "Making Files Accessible." The Contractor must provide to the Contracting Officer/Contract Specialist the name of the person(s) submitting electronic reports via the NICHD Contracts Portal to initiate access to the Portal.

VII. TECHNICAL REQUIREMENTS

The Contractor shall develop documentation for IRB and institutional clearance with input from the NIMHD DIR Investigators. The Contractor will develop surveys and the database for the study as directed by the DIR Investigators. Contractor will also be responsible for identifying patients and clinicians for a future study as outlined in the inclusion/exclusion criteria provided by the NIMHD DIR investigators. Contractor will be responsible for promoting the study within the healthcare system.

The Contractor shall:

• Independently, and not as an agent of the Government, furnish all the necessary services, qualified personnel, material, and facilities not otherwise provided by the Government, as needed to perform the specific tasks outlined below.

• Understand Federal Government policies and procedures and demonstrated ability to meet fast turnaround deadlines.

• Understand Federal Government contracting and billing processes along with experience in cost control management.

• Have prior experience working with the Federal Government.

• Have the capability to obtain IRB and institutional clearance within their healthcare system.

• Have the institutional capacity to support future NIH-led recruitment activities of breast cancer survivors and healthcare providers.