Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients (Fit2ThriveMB)
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
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Siobhan Phillips, PhD
- Telefonní číslo: 312-503-4235
- E-mail: smphillips@northwestern.edu
Studijní místa
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60611
- Northwestern University
-
Kontakt:
- Siobhan Phillips, PhD
- Telefonní číslo: 312-503-4235
- E-mail: smphillips@northwestern.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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Experimentální: 1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. 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. 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. |
|
Experimentální: 2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. 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. 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. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. |
|
Experimentální: 3- Core, EHR, Weekly Coaching, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. 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.). |
|
Experimentální: 4- Core, EHR, Bi-Weekly Coaching, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. 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.). |
|
Experimentální: 5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. 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. 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.). |
|
Experimentální: 6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. 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. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. 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.). |
|
Experimentální: 7- Core, EHR, Weekly Coaching, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. 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. |
|
Experimentální: 8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. 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. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. |
|
Experimentální: 9- Core, Weekly Coaching, Social+, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. 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. 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.). |
|
Experimentální: 10- Core, Bi-Weekly Coaching, Social+, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. 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.). |
|
Experimentální: 11- Core, Weekly Coaching, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. 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. |
|
Experimentální: 12- Core, Bi-Weekly Coaching, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. |
|
Experimentální: 13- Core, Weekly Coaching, Social+, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. 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. 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. |
|
Experimentální: 14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. 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. 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. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. |
|
Experimentální: 15- Core, Weekly Coaching, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. 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.). |
|
Experimentální: 16- Core, Bi-Weekly Coaching, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. 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.). |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Steps
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
ActiGraph measured MVPA
Časové okno: 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
|
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ActiGraph measured light activity
Časové okno: 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
Časové okno: 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
|
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Godin Leisure Time Exercise Questionnaire
Časové okno: 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
|
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Short Physical Performance Battery (SPPB) Total Score
Časové okno: 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
|
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PROMIS Physical Function
Časové okno: 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
|
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PROMIS Anxiety
Časové okno: 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
|
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PROMIS Depression
Časové okno: 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
|
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PROMIS Fatigue
Časové okno: 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
|
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PROMIS Ability to Participate in Social Roles and Activities
Časové okno: 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
|
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PROMIS Sleep Disturbance
Časové okno: 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
|
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PROMIS Pain Interference
Časové okno: 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
|
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PROMIS Pain Intensity
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- STU00224173
- R01CA305818 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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