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

NCT ID: NCT04594473

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2023-11-10

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.

Detailed Description

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:

1. Physical Medicine & Rehabilitation (PM&R): This rehab service is aimed at improving complex and acute functional deficits. Participants with a T-score < 40 on PROMIS will be triaged to PM&R, regardless of current exercise engagement.

2. Personal Optimism With Exercise Recovery (POWER): POWER is our institution's exercise oncology program. POWER is aimed at improving mild functional deficits and physical deconditioning. Participants with a T-score of 40-50 on PROMIS who are not meeting activity guidelines, will be triaged to POWER. Participants with a T-score of ≥ 40 who are meeting activity guidelines, may choose to participate in POWER or be re-triaged to Exercise Self-Management.

3. Exercise Self-Management: This arm is aimed for participants who are fit and free of functional deficits and impaired physical conditioning. Participants with a T-score of ≥ 51 on PROMIS and currently meeting activity guidelines will be triaged to this group. They may choose to participate in POWER.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care (SOC)

Participants randomized to SOC will be instructed to continue their typical lifestyle activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Comprehensive Oncology Rehabilitation and Exercise (CORE) Program

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.

Group Type: EXPERIMENTAL

Comprehensive Oncology Rehabilitation and Exercise (CORE) Program

Intervention Type: BEHAVIORAL

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Interventions

Comprehensive Oncology Rehabilitation and Exercise (CORE) Program

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Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Adriana Coletta

Assistant Professor, Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 31410640 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40289623 (View on PubMed)

Other Identifiers

IRB_00137018

Identifier Type: -

Identifier Source: org_study_id