Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients (Fit2ThriveMB)

September 28, 2026 updated by: Siobhan M Phillips, Northwestern University

The purpose of this study is to examine which of four components of a digital health intervention using an App and Fitbit meaningfully contribute to increased physical activity in Metastatic Breast Cancer Patients.

Participants will be asked to:

  • Wear a Fitbit and use an app, use 0 to 3 other components for 24 weeks and attend 6 or 12 coaching coaching calls in the first 12 weeks to increase daily steps.
  • Complete a questionnaire at baseline, week 12 and week 24
  • Complete functional performance test (FPT) via Zoom at baseline, week 12 and week 24
  • Wear a research activity monitor (Accelerometer) for 7 days at baseline, week 12 and week 24

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Multiphase Optimization Strategy (MOST) methodology will be used to determine which intervention components or component combinations optimally increase daily steps in a 12-week intervention with a 12-week follow-up. MOST is a framework adapted from engineering that uses highly efficient factorial experiments to evaluate individual, and combined, effects of intervention components to determine which ones can be reduced, eliminated, or replaced to improve efficiency. Insufficiently active people with metastatic breast cancer (MBC) will receive a core intervention consisting of the FIt2ThriveMB app and Fitbit and be randomly assigned to four components, each with two-levels, under consideration for inclusion in the optimized intervention: 1) EHR-integration (on v. off); 2) coaching dose (weekly v. bi-weekly; 3) social+ (on v. off) and 4) goal-setting type (highly tailored v. static). The effects of increasing PA on symptom burden, other intensity activities (i.e. moderate to vigorous, light and sedentary), and functional performance and potential mediators and moderators of component effects will also be examined. Knowledge gained from this study will inform the development of more effective and scalable interventions to improve health and disease outcomes in this population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
224

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female sex assigned at birth, age 18 years or older
  • Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection.
  • Self-report engagement in <150 min/week of moderate to vigorous physical activity
  • Ownership of an Android or iPhone with an up-to-date version of the operating system
  • Internet access to complete assessments
  • Fluency in spoken and written English
  • Willingness to obtain medical clearance to participate.

Exclusion Criteria:

  • Untreated brain metastases
  • Breast cancer with metastases to only the axillary lymph nodes.
  • Self-reported absolute contraindications to exercise (i.e., non-ambulatory, acute myocardial infarction, severe cognitive or functional impairment)
  • Currently pregnant or plans to become pregnant
  • Plans to move out of the United States in next 12 months
  • Current enrollment in another dietary or physical activity trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: EHR Integration (On v. Off)

Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients.

Behavioral: Weekly Coaching

Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Social+ (on v. off)

Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants.

Behavioral: Highly Tailored Goal Setting

Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day.
Experimental: 2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: EHR Integration (On v. Off)

Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients.

Behavioral: Social+ (on v. off)

Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants.

Behavioral: Highly Tailored Goal Setting

Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day.

Behavioral: Bi-Weekly Coaching

Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.
Experimental: 3- Core, EHR, Weekly Coaching, Static Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: EHR Integration (On v. Off)

Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients.

Behavioral: Weekly Coaching

Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Static Goal Setting

Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.).
Experimental: 4- Core, EHR, Bi-Weekly Coaching, Static Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: EHR Integration (On v. Off)

Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients.

Behavioral: Bi-Weekly Coaching

Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Static Goal Setting

Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.).
Experimental: 5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: EHR Integration (On v. Off)

Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients.

Behavioral: Weekly Coaching

Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Social+ (on v. off)

Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants.

Behavioral: Static Goal Setting

Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.).
Experimental: 6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: EHR Integration (On v. Off)

Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients.

Behavioral: Social+ (on v. off)

Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants.

Behavioral: Bi-Weekly Coaching

Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Static Goal Setting

Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.).
Experimental: 7- Core, EHR, Weekly Coaching, Highly Tailored Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: EHR Integration (On v. Off)

Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients.

Behavioral: Weekly Coaching

Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Highly Tailored Goal Setting

Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day.
Experimental: 8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: EHR Integration (On v. Off)

Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients.

Behavioral: Highly Tailored Goal Setting

Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day.

Behavioral: Bi-Weekly Coaching

Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.
Experimental: 9- Core, Weekly Coaching, Social+, Static Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: Weekly Coaching

Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Social+ (on v. off)

Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants.

Behavioral: Static Goal Setting

Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.).
Experimental: 10- Core, Bi-Weekly Coaching, Social+, Static Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: Social+ (on v. off)

Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants.

Behavioral: Bi-Weekly Coaching

Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Static Goal Setting

Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.).
Experimental: 11- Core, Weekly Coaching, Highly Tailored Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: Weekly Coaching

Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Highly Tailored Goal Setting

Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day.
Experimental: 12- Core, Bi-Weekly Coaching, Highly Tailored Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: Highly Tailored Goal Setting

Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day.

Behavioral: Bi-Weekly Coaching

Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.
Experimental: 13- Core, Weekly Coaching, Social+, Highly Tailored Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: Weekly Coaching

Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Social+ (on v. off)

Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants.

Behavioral: Highly Tailored Goal Setting

Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day.
Experimental: 14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: Social+ (on v. off)

Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants.

Behavioral: Highly Tailored Goal Setting

Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day.

Behavioral: Bi-Weekly Coaching

Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.
Experimental: 15- Core, Weekly Coaching, Static Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: Weekly Coaching

Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Static Goal Setting

Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.).
Experimental: 16- Core, Bi-Weekly Coaching, Static Goal Setting
Behavioral: Core Intervention

The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App.

Behavioral: Bi-Weekly Coaching

Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA.

Behavioral: Static Goal Setting

Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Steps
Time Frame: Baseline, 12 and 24 weeks

The ActiGraph accelerometer will be used. Participants will wear the device during all waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip.
Baseline, 12 and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ActiGraph measured MVPA
Time Frame: Baseline, 12 and 24 weeks

Moderate to vigorous physical activity will be measured using the ActiGraph. Participants will wear the device during waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip. Freedson cut points will be used to determine this activity as 2,690-9,642 CPM.
Baseline, 12 and 24 weeks
ActiGraph measured light activity
Time Frame: Baseline, 12 and 24 weeks

Light intensity physical activity will be measured using the ActiGraph. I Participants will wear the device during waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip. Freedson cutpoints for light activity are defined as Light: 0 - 2,689 CPM.
Baseline, 12 and 24 weeks
ActiGraph measured sedentary behavior
Time Frame: Baseline, 12 and 24 weeks

Sedentary behavior will be measured using the ActiGraph. Participants will wear the device during waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip. Freedson cutpoints for sedentary behavior are defined as <100 CPM.
Baseline, 12 and 24 weeks
Godin Leisure Time Exercise Questionnaire
Time Frame: Baseline, 12 and 24 weeks

Participants will be asked to indicate frequency of participation in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild (e.g., easy walking) exercise over the past 7 days and average time spent in each activity. Activity frequencies will be multiplied by 9, 5, and 3 metabolic equivalents, respectively, and summed to create a total leisure time activity score. Weekly minutes of total, light, moderate, and vigorous activity will be calculated by multiplying the frequency and time of each activity. This value will be divided by 7 to obtain daily averages.
Baseline, 12 and 24 weeks
Short Physical Performance Battery (SPPB) Total Score
Time Frame: Baseline, 12 weeks, 24 weeks

The SPPB score is based on timed measures of gait speed, ability to rise from a chair, and standing balance. Gait speed will be measured using the better of two recorded times over a 4-meter course. Chair stand time will be measured as the time needed to rise five times from a seated position in a chair, with arms folded across the chest. For the balance test, participants will be asked to maintain their feet side-by-side, semi-tandem, and tandem positions for 10 seconds each. Each individual performance measure will be scored according to established cut points and aggregated for a total SPPB score.
Baseline, 12 weeks, 24 weeks
PROMIS Physical Function
Time Frame: Baseline, 12 and 24 weeks

PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure physical function with 4 items over the past 7 days. Items are combined using a t-score metric where higher score is better.
Baseline, 12 and 24 weeks
PROMIS Anxiety
Time Frame: Baseline, 12 and 24 weeks

PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Anxiety with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Baseline, 12 and 24 weeks
PROMIS Depression
Time Frame: Baseline, 12 and 24 weeks

PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Depression with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Baseline, 12 and 24 weeks
PROMIS Fatigue
Time Frame: Baseline, 12 and 24 weeks

PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Fatigue with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Baseline, 12 and 24 weeks
PROMIS Ability to Participate in Social Roles and Activities
Time Frame: Baseline, 12 and 24 weeks

PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Ability to Participate in Social Roles and Activities with 4 items over the past 7 days. Items are combined using a t-score metric where the higher score is better.
Baseline, 12 and 24 weeks
PROMIS Sleep Disturbance
Time Frame: Baseline, 12 and 24 weeks

PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure sleep disturbance with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Baseline, 12 and 24 weeks
PROMIS Pain Interference
Time Frame: Baseline, 12 and 24 weeks

PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure pain interference with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Baseline, 12 and 24 weeks
PROMIS Pain Intensity
Time Frame: Baseline, 12 and 24 weeks

PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure pain intensity with 1 item using a scale 1-10 over the past 7 days. Items are combined using a t-score metric where the lower score is better.
Baseline, 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00224173
  • R01CA305818 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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