A Comprehensive Oncology Rehabilitation and Exercise (CORE) Program Among Breast Cancer Survivors

NCT04594473 | Completed

• 1 other identifier: IRB_00137018
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Survivors; Exercise

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Percentage of themes identified from focus groups that contain positive feedback

  Upon completion of 24-weeks post-surgery SOC visit for participants and about one year post-implementation (approximately 1 year into data collection)

• Change in exercise engagement assessed via accelerometer

  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

  Measured one-week Post-Diagnosis/Pre-Surgery SOC visit, one-week Post-Surgery SOC visit, and one-week 24-Weeks Post-Surgery SOC visit

Study Arms (2)

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.

Behavioral: Comprehensive Oncology Rehabilitation and Exercise (CORE) Program

Interventions

Comprehensive Oncology Rehabilitation and Exercise (CORE) Program BEHAVIORAL

\[see arm/group descriptions\]

Comprehensive Oncology Rehabilitation and Exercise (CORE) Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed stage I-III breast cancer survivors who have plans to undergo breast cancer surgery

You may not qualify if:

• Stage I-III breast cancer survivors who had received neoadjuvant chemotherapy

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (3)

• 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.

  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.

  PMID: 31410640 BACKGROUND

• 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.

  PMID: 40289623 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Investigator

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 20, 2020
• Study Start: March 24, 2021
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)