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The objective of this study is to demonstrate the feasibility and acceptability of the algorithm utilized within a cancer rehab program, named Comprehensive Oncology Rehabilitation and Exercise (CORE) program, among newly diagnosed stage I-III breast cancer survivors, providers, and clinic staff. Additionally, this study aims to generate preliminary estimates on the extent to which CORE, compared with standard of care (SOC), elicits engagement in exercise and impacts changes in physical function and quality of life within this population.
Enrollment: The study team will recruit 72 newly diagnosed stage I-III breast cancer survivors to participate in a 24-week randomized controlled trial. Participants will be randomized to CORE or SOC in a 2:1 ratio, stratified by adherence to national physical activity guidelines.
Exercise Intervention: Participants randomized to standard of care will be instructed to continue their typical lifestyle activity. Participants randomized to CORE will complete an in-clinic assessment consisting of the PROMIS Physical Function and Godin surveys to identify the appropriate pathway for triage. Results from the questionnaires will be used to triage participants into one of three groups:
Assessments: Five assessment methods will be collected over three time points: (1) Post-Diagnosis/Pre-Surgery, (2) Post-Surgery, and (3) 24-weeks Post-Surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SOC) | No Intervention | Participants randomized to SOC will be instructed to continue their typical lifestyle activity. | |
| Comprehensive Oncology Rehabilitation and Exercise (CORE) Program | Experimental | Participants randomized to CORE will be instructed to follow the clinical algorithm for this study. An in-clinic assessment consisting of two questionnaires will be used to identify the appropriate pathway for triage. Participants will be triaged into one of three pathways: Physical Medicine & Rehabilitation, Personal Optimism With Exercise Recovery, or Exercise Self-Management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Oncology Rehabilitation and Exercise (CORE) Program | Behavioral | [see arm/group descriptions] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who complete in-clinic assessment | Percentage of participants who complete the in-clinic assessment will be used to determine the feasibility of CORE. Clinic staff will ask the participant to complete the PROMIS and Godin surveys for triaging into the CORE algorithm. CORE will be considered feasible if ≥ 66% of participants complete the in-clinic assessment and are assigned to one of the three pathways in the algorithm. | Measured at Post-Diagnosis/Pre-Surgery assessment |
| Percentage of participants who complete their referral | Percentage of participants who complete their referral to a service pathway will be used to determine the feasibility of CORE. If the participant is triaged into PM&R or POWER groups based on in-clinic assessment, provider will submit a referral in participant's electronic medical record. Once the referral is submitted, patient navigation staff will be notified and immediately reach out to the participant to schedule with the referred service. CORE will be considered feasible if ≥ 50% of those referred to a service pathway (PM&R or POWER) complete their referral. | Measured at Post-Diagnosis/Pre-Surgery assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of themes identified from focus groups that contain positive feedback | To determine the acceptability of CORE, the study team will conduct focus groups one year after implementation of CORE. Four focus groups will be conducted among participants in CORE, and one focus group will be conducted among providers and clinic staff. | Upon completion of 24-weeks post-surgery SOC visit for participants and about one year post-implementation (approximately 1 year into data collection) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | U.S. Department of Health and Human Services. Physical Activity Guidelines for Americans, 2nd edition. Washing, DC: US. Department of Health and Human Services; 2018. | ||
| 31410640 | Background | Rothrock NE, Cook KF, O'Connor M, Cella D, Smith AW, Yount SE. Establishing clinically-relevant terms and severity thresholds for Patient-Reported Outcomes Measurement Information System(R) (PROMIS(R)) measures of physical function, cognitive function, and sleep disturbance in people with cancer using standard setting. Qual Life Res. 2019 Dec;28(12):3355-3362. doi: 10.1007/s11136-019-02261-2. Epub 2019 Aug 13. | |
| 42292298 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Change in exercise engagement assessed via accelerometer | Researchers will examine the extent to which CORE elicits exercise engagement before and after breast cancer surgery compared to standard of care. At each assessment visit, participants will be provided with an Actigraph GT9X Link tri-axial accelerometer to objectively assess exercise engagement, and will be instructed to wear the device for seven days following their assessment. | Measured one-week Post-Diagnosis/Pre-Surgery SOC visit, one-week Post-Surgery SOC visit, and one-week 24-Weeks Post-Surgery SOC visit |
| Change in exercise engagement assessed via modified Godin survey | Researchers will examine the extent to which CORE elicits exercise engagement before and after breast cancer surgery compared to standard of care. At each assessment visit, participants will be asked to fill out the modified Godin survey that measures typical weekly frequency of engagement in strenuous, moderate, and mild aerobic exercise. The modified version also inquires about average length of time of aerobic exercise engagement and frequency of resistance exercise. | Measured one-week Post-Diagnosis/Pre-Surgery SOC visit, one-week Post-Surgery SOC visit, and one-week 24-Weeks Post-Surgery SOC visit |
| Derived |
| Simon LH, Saviers-Steiger C, Dunston ER, Zickmund SL, Hansen PA, Ulrich CM, LaStayo PC, Steinberg D, Noren CS, Finch A, Seckinger L, Braun E, Chipman J, Oza S, Brownson KE, Coletta AM. Preliminary Effectiveness of the Comprehensive Oncology Rehabilitation and Exercise (CORE) Clinical Workflow Algorithm on Health Outcomes During Nonmetastatic Breast Cancer Care. Int J Breast Cancer. 2026 Jun 11;2026:8894250. doi: 10.1155/ijbc/8894250. eCollection 2026. |
| 40289623 | Derived | Simon LH, Saviers-Steiger C, Dunston ER, Galyean P, Kimball ER, Mendez J, Zickmund SL, Hansen PA, Ulrich CM, LaStayo PC, Steinberg D, Noren CS, Finch A, Seckinger L, Braun E, Chipman J, Brownson KE, Oza S, Coletta AM. Feasibility and acceptability of the Comprehensive Oncology Rehabilitation and Exercise (CORE) clinical workflow algorithm in patients with newly diagnosed stage I-III breast cancer who undergo surgery as first-line treatment. Cancer. 2025 May 1;131(9):e35798. doi: 10.1002/cncr.35798. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |