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NCT Number: NCT04594473

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

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Oncology Rehabilitation and Exercise (CORE) Program

Behavioral

[see arm/group descriptions]

Primary outcomes

  1. Percentage of participants who complete in-clinic assessment

    Time frame: Measured at Post-Diagnosis/Pre-Surgery 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.

  2. Percentage of participants who complete their referral

    Time frame: Measured at Post-Diagnosis/Pre-Surgery assessment

    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.

Secondary outcomes

  1. Percentage of themes identified from focus groups that contain positive feedback

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

    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.

  2. Change in exercise engagement assessed via accelerometer

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

    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.

  3. Change in exercise engagement assessed via modified Godin survey

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

    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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

The Feasibility and Acceptability of a Comprehensive Oncology Rehabilitation and Exercise (CORE) Program Among Breast Cancer Survivors

Acronym: CORE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2020
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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