Effective 08/07/2025 Sites MI221 (Brighton) and MI347 GenHur Cancer Hematology Centers are Re-Activated for Accrual

CREDENTIALING REQUIRED. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED:

Eligibility Criteria: SJMH (AA, Brighton, Canton, Chelsea), Livonia, GenHur

**TT SJMH: MI013, MI221, MI294, and MI327 only

- Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy.

- May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer that is felt to be stable and/or controlled and not rapidly progressive as per treating clinician judgement at the time of screening.

- Patients who are no longer receiving anticancer therapy must be ≤ 5 years since the completion of their anticancer therapy (e.g., time since the last day of chemotherapy administration, time since last day of radiotherapy, etc.).

- Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview within the Screening Interview.

- Must have a score of “Most Days” or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview within the Screening Interview.

Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen over a period of at least 14 days prior to enrollment.

- Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment.

***See the Protocol for the full eligibility criteria list***

**MI013 IS THE ONLY SJMH SITE ELIGIBLE TO OPEN**

*DTL Required- Physicians must sign toxicity grid

CREDENTIALING REQUIRED. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED: TH SJMH Ann Arbor , Genesys

Eligibility Criteria:

4.1.1 At least one intact brain metastasis or resection cavity ≥ 2 cm in diameter or ≥ 4 cc volume with no prior history of radiation therapy for brain metastasis.

• Both patients at initial diagnosis of brain metastases and patients known brain metastasis treated with systemic therapy alone are eligible

• Lesion volume will be approximated by measuring the lesion’s three perpendicular diameters WF-2201 Version Date: 01/15/2023 Page 16 of 73 Wake Forest NCORP Research Base HYPOGRYPHE on contrast-enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g., xyz/2). Alternatively, direct volumetric measurements via slice-by-slice contouring on a treatment planning software package can be used to calculate the total tumor volume.

• Any extent of non-CNS disease is allowed. There is no requirement for non-CNS disease to be controlled prior to study entry. 

4.1.2 Age ≥ 18 years at the time of enrollment.

4.1.3 Total number of brain metastases (including resection cavities) 15 on diagnostic MRI; all lesions must be amenable to SSRS and FSRS as determined by the treating radiation oncologist. Treatment must take place at a facility credentialed by the Imaging and Radiation Oncology Core (IROC) for SRS and that offers both SSRS and FSRS as treatment options.

4.1.4 Total gross tumor volume must be 30 cc. Lesion volume will be approximated by measuring each lesion’s three perpendicular diameters on contrast-enhanced T1 MRI and the product of those diameters will be divided by 2 (V = xyz/2). Direct volumetric measurements by contouring all lesions on all visible slices on treatment planning software is also acceptable. If there is a cavity, only gross residual disease within or adjacent to the cavity is counted toward the 30 cc total volume.

4.1.5 Ability to tolerate MRI brain with gadolinium-based contrast.

4.1.6 Pathologically confirmed melanoma, renal cell carcinoma, non-small cell lung cancer, or breast cancer.

4.1.7 Has received, is currently receiving, or is planned to receive immune checkpoint inhibitor therapy (defined as agent targeted to PD-1/PD-L1 axis) within 30 days of the planned first day of SSRS/FSRS. Dual ICI therapy with PD-1/PD-L1 and CTLA-4 targeted agents are allowed, but patients treated with a single agent CTLA-4 targeted agent only are ineligible.

4.1.8 Karnofsky Performance Status (KPS) ≥ 70. Refer to Appendix A. 4.1.9 Negative serum or urine pregnancy test within 14 days of randomization for women of childbearing potential 

 ***PLLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELGIBILITY LIST***

Eligibility Criteria

4.1 Inclusion Criteria

4.1.1 History of Stage 0-III breast cancer diagnosis. History of non-breast malignancies are permitted. 4.1.2 ≥12 weeks following last primary cancer treatment. For this protocol, primary cancer treatments are defined as chemotherapy, cytotoxic antibody-drug conjugates, checkpoint inhibitors, radiation, and surgical procedures intended to remove malignant tissue. Ongoing adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors), adjuvant cdk 4/6-inhibitors (e.g., abemaciclib), HER2-based Monoclonal antibody therapy (e.g., trastuzumab, pertuzumab), HER2 targeted Tyrosine Kinase inhibitors(e.g., neratinib), and/or pending breast reconstructive surgery are allowed. (There is no upper limit on time since treatment. This is due to criterion 4.1.7 below – participants must endorse current sexual morbidity that they believe is related to their breast cancer. Breast cancer-related sexual morbidity often persists, or even worsens, years following treatment

4.1.3 Age ≥18 years at the time of study enrollment. Items below will be asked on the Self-reported Eligibility Screener to the patient directly:

4.1.4 Cisgender female (i.e., assigned female at birth, female gender identity);

4.1.5 Currently in an intimate relationship, as reported on the PROMIS SexFS screener1 (this relationship may be with an individual of any sex and gender identity);

4.1.6 Endorse being at least “somewhat” bothered by ≥1 of the following during the last 30 days: (lack of) interest in sexual activity, vaginal dryness, pain during sexual activity, or (in)ability to orgasm, as reported on the PROMIS SexFS Bother Regarding Sexual Function1 screener;

4.1.7 Endorse that ≥1 of the bothersome sexual symptoms, from the PROMIS SexFS Bother Regarding Sexual Function1 screener (see 4.1.6) is related to their breast cancer;

4.1.8 Has a working email address (or willing to create one) and receive emails from the study.

4.2 Exclusion Criteria

4.2.1 Planned cancer treatment for residual, progressive, or recurrent disease within the 24 weeks following enrollment (defined as chemotherapy, cytotoxic antibody-drug conjugates, checkpoint inhibitors, radiation, and/or surgical procedures intended to remove malignant tissue). Ongoing adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors), adjuvant cdk 4/6-inhibitors (e.g., abemaciclib), HER2- based Monoclonal antibody therapy (e.g., trastuzumab, pertuzumab), HER2 targeted Tyrosine Kinase inhibitors (e.g., neratinib), and/or pending breast reconstructive surgery are allowed.

4.2.2 Unable to read and comprehend English (SHINE intervention currently only available in English) as indicated by being unable to complete the Self-reported Screening Questionnaire independently. Items below will be asked on the Self-reported Eligibility Screener to the patient directly:

4.2.3 Does not have reliable access to Internet (e.g., by home broadband, public network, personal data plan) by computer, tablet, smartphone etc. and is not willing to participate in the tablet lending program for this study.

4.2.4 Recent serious mental illness, as defined by reporting an inpatient psychiatric hospitalization within the past 12 months.

4.2.5 Currently participating in couple, marital, or sex therapy.

**PLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELIGIBILITY LIST**

CREDENTIALING REQUIRED. Please check your site's credentialing status.

CURRENT SITES CREDENTIALED:

Eligibility Criteria:

4.3 APP Eligibility Criteria

4.3.1 Inclusion Criteria

Criteria below are part of the APP Attestation uploaded into the Study Interest Survey and these 

answers should be used to determine eligibility.

• Practicing Nurse Practitioner (NP) or Physician Assistant (PA) registered as an active NPIVR within the NCI RCR.

• Treats oncology patients at practice that is actively recruiting to NCORP and/or NCTN trials.

• Not planning to leave their clinical position within the APP Practice (defined as one or more NCORP affiliate or sub-affiliate site(s) where the APP participating in the study sees patients

and clinical research activities occur) in the next 12 months at enrollment.

• Willing to participate in a 30-minute recorded phone interview, if selected

Criteria below are part of the Study Interest Survey and must be completed for eligibility and to receive the Practice ID required for OPEN enrollment.

• Completed and submitted the APP Attestation within the Study Interest Survey.

• Completed and submitted an APP Support Statement from their direct supervisor approving participation in this study, within the Study Interest Survey.

• Identify and obtain signed Research Care (RC) Team Acknowledgements from two members (defined below) of their research care team to assist them in this study. The RC Team for this study will consist of an oncologist and clinical research professional (i.e., clinical research coordinator, clinical research associate clinical research nurse, etc.) that the APP collaborated with over the past 6 months or could collaborate with in the future to enroll patients on NCORP and/or NCTN trials.

• Must have received the required APP Practice ID for OPEN enrollment in the Study 

Selection Email.  

CREDENTIALING REQUIRED. Please check your site's credentialing status.

CURRENT SITES CREDENTIALED: Trinity Health Ann Arbor Hospital, Genesys, SJMO, Lehigh, MyMichigan

Eligibility Criteria:

4.1 Inclusion Criteria

4.1.1 Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer.

4.1.2 Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and/or immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment.

4.1.3 Participants must be able to comprehend English or Spanish (for survey completion).

4.1.4 Participant must have a working email address and be willing to complete surveys online. This can be completed at home, in the clinic or other location.

4.1.5 Completion of the confidential Self-reported Screening Survey and receipt of a screening result - eligible for enrollment.  

4.2 Exclusion Criteria

4.2.1 Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms. 4.2.2 Participants with known pregnancy 

 **PLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELIGIBILITY LIST**

***If a patient is eligible for continued access to study treatment after the end of study, they can be rolled over to the Access Solutions & Patient Support team (WEBSITE).