Physical FunctionNCT05214144
The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients
An observational study of Physical Function and Cancer, Breast, run by Yale University at 2 sites in United States.
Trial summary
This is a prospective observational cohort study. Breast cancer and lymphoma patients planned to receive cytotoxic therapy will be recruited at Yale and Mayo Clinic. The Study Period is 9 months, during which enrolled patients will use their personal smartphone, computer, or other web-connected device to connect with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Function, Cancer, Breast, Lymphoma
- What is being tested?
- PRO Instruments assessment questionnaire, Baseline Survey Clinician- reported (ClinRO) ECOG and Fitbit
- Type of treatment
- Medical device
- How many people
- 208 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2022to 24 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two hundred patients will be recruited from two main sites: Yale and Mayo Clinic Rochester. Patient sampling will be stratified by site enrolled and cancer type. The investigator will seek to optimize diversity of the patient sample. Race/ethnicity will be determined by participant self-report, offering the opportunity for participants to select multiple races. Participants who self-define as part of a racial or ethnic minority and as white will be classified by their non-white race/ethnicity for purposes of counting enrollment quotas. The project team (including representatives from the FDA) will evaluate the enrollment throughout the study both in terms of counts as well as demographic mix. For the purposes of this study, specific goals or quotas are not being set.
Who may be able to join
- Age 18 and over;
- English- or Spanish-speaking;
- Pregnant and non-pregnant patients are eligible for participation in this study
- Eligible cancer type and planned intravenous cytotoxic chemotherapy regimen (defined as including 1 or more cytotoxic agents)
- ECOG Performance Score of < 3
- Breast cancer patients
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- Patients with any stage breast cancer for whom a new intravenous cytotoxic chemotherapy regimen is planned within the next 8 weeks (patients with local/regional/distant recurrences are allowed; patients with concurrent/prior/future immunotherapy/radiotherapy, targeted therapy, and endocrine therapy for breast cancer are allowed)
- Lymphoma patients
- Lymphoma patients of any histology, stage or line of treatment planned to receive a new intravenous cytotoxic containing chemotherapy regimen (patients planned to receive radiation, maintenance chemotherapy, consolidation stem cell transplant or chimeric antigen receptor T (CAR-T) cell therapy are allowed)
- If patients are receiving the above standard therapies as part of a clinical trial which may include a novel agent or combination, they are also eligible for the present study if the therapeutic protocol permits enrollment in both studies
- Willing and able to give consent and participate in study
- Able to access a mobile device (smartphone or tablet) or computer with web access every day to complete study surveys; able to regularly upload data from the Fitbit to a device in a way that it can be transferred to Hugo
- Willing and able to perform an in-clinic 6-minute walk test (gait aides are permitted if regularly used by the patient). If a patient is recruited remotely outside of Mayo Clinic Rochester or Yale Smilow Cancer Center New Haven, 6-minute walk test may be omitted.
- Willing to use the health data sharing platform Potential subjects who do not meet all of the enrollment criteria will not be enrolled. Any deviations from these criteria must be reported in accordance with IRB Policies and Procedures.
Who cannot join
- Prior intravenous cytotoxic chemotherapy within 3 weeks prior to study enrollment
- Excluded regimens (due to length of hospitalization required for chemotherapy administration):
- R-CODOX-M/IVAC,
- DA-R-EPOCH (inpatient)
- Excluded histology (due to length of hospitalization and inpatient predominant treatment for required chemotherapy): primary central nervous system lymphoma
- Other regimens with an anticipated high duration of inpatient care time, at PI discretion
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- Lack of access to a mobile device (smartphone or tablet) or computer with web access
- Unable or unwilling to connect Fitbit to device
- Unable or unwilling to use the health data sharing platform
- Unable to give consent and be enrolled
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale Cancer Center
New Haven, Connecticut, 06511
Mayo Clinic
Rochester, Minnesota, 55905
About this study
This is a prospective observational cohort study. Breast cancer and lymphoma patients planned to receive cytotoxic therapy will be recruited at Yale and Mayo Clinic. The Study Period is 9 months, during which enrolled patients will use their personal smartphone, computer, or other web-connected device to connect with the Hugo platform which will deliver PRO questionnaires, and sync to the wearable device in the study (Fitbit). The PerfO (6MWT) will be conducted twice in clinic during the study period. Structured information from the electronic health record (EHR) and patient portals will be collected and where needed, the EHR will be directly reviewed to record AEs, hospitalizations/emergency department visits and dose delay/reductions. Required in-person face to face visit is only at baseline for consent, enrollment and receipt of wearable device; patients can be followed remotely afterward (i.e. do not need to be treated at Mayo or Yale)
Read the detailed description
The purpose of this prospective observational study is to collect and evaluate 4 different sources of physical functioning (PF) data over the course of systemic anti-cancer therapy in lymphoma and breast cancer patients: clinician-reported Performance Status (PS), Patient Reported Outcomes (PROs), a Performance Outcome (PerfO) and patient wearable device data.
Aim 1: To measure PF using 4 distinct modalities (ClinRo, PRO, PerfO and wearable device data) on Hugo platform
- Characterize assessment challenges by comparing levels of missing data and reasons for missingness across the PF modalities
- Report on trajectories of function as ascertained by the 4 PF modalities
Aim 2: To explore associations between various sources of physical function data and determine change thresholds
- To identify measurement characteristics of the PF modalities including sensitivity to change and identification of meaningful change thresholds
- Compare change over time in data within and between the PF modalities
- Explore associations between changes in the various PF modalities and subsequent patient-reported adverse events (AEs), acute care use (unplanned hospitalizations or emergency department visits), other patient-reported domains of Health Related Quality of Life (HRQOL), and dose delay/reduction
Aim 3: To assess patient acceptability and experience using the different PF assessment modalities
- Administer an exit questionnaire to understand burden and usability of electronic PROs and wearable device data collection from the patient perspective
The allocation for patient recruitment is 18 months, with 9 months for follow up for each patient. The proposed overall project timeline is 3.5 years/39 months. A total of 200 patients will be enrolled at Yale Cancer Center and the Mayo Clinic, as outlined below. Data will be cleaned, reviewed, and analyzed as it is received from the Hugo platform on a rolling basis. Data analysis will be conducted at Mayo Clinic and Yale. Only de-identified data will be provided to the FDA.
- Conditions
- Physical Function, Cancer, Breast, Lymphoma, Patient Empowerment, Patient Education, Quality of Life
- Being tested
- PRO Instruments assessment questionnaire, Baseline Survey Clinician- reported (ClinRO) ECOG, Fitbit, Hugo Health ("Hugo"), 6 Minute Walk Test (6MWT)
- Medical subject headings
- Breast Neoplasms, Lymphoma, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO Instruments assessment questionnaireOther
Patient Reported Outcome (PRO) questionnaire consisting of:
- PRO-CTCAE (approximately 11 questions plus free text)
- Patient-Reported Outcomes Measurement Information System (PROMIS) physical function short form (version 8c) (8 questions)
- PRO ECOG question (1 question)
- EORTC Quality of Life questionnaire (QLQ)-F17 questions (17 questions)
- Functional Assessment of Cancer Therapy-General version, rated on a 5-point Likert scale, (FACT-GP5) (single item global side effect bother question) (1 question)
- The Patient Global Impression (PGI)-C and PGI-S items (anchors for physical function) (2 questions)
Baseline Survey Clinician- reported (ClinRO) ECOGOther
Baseline Survey completed prior to initiation of chemotherapy
FitbitDevice
wearable device
Hugo Health ("Hugo")Other
an electronic platform that aggregates real world EHR data with patient's wearable and PRO data
6 Minute Walk Test (6MWT)Other
A comprehensive performance measure of exercise capacity, encompassing components of mobility, endurance, and functional capacity measure (PerfO)
| Study group | Role | What they receive |
|---|---|---|
| evaluating sources of physical function (PF) | evaluate 4 distinct modalities of sources of PF (PRO, ClinRo, PerfO and wearable device data) on Hugo Health platform in breast cancer and lymphoma patients undergoing cytotoxic chemotherapy. Receives: Other: PRO Instruments assessment questionnaire; Other: Baseline Survey Clinician- reported (ClinRO) ECOG; Device: Fitbit; Other: Hugo Health ("Hugo"); Other: 6 Minute Walk Test (6MWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure Physical Function using Clinician Reported Outcomes (ClinRo) at baseline.
ClinRo score at baseline using the Eastern Cooperative Oncology Group (ECOG) performance scale. Possible scores range from 0 to 5. The lower the score the better the performance.
Measured: baseline
Change in Patient Reported Outcomes Questionnaire: PRO-CTCAE
PRO-CTCAE is a patient-reported outcome (PRO) measurement system of 11 questions plus free text developed to evaluate symptomatic toxicity in patients on cancer clinical trials. Outcome reported as a count of adverse events.
Measured: baseline, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
Change in Patient Reported Outcomes Questionnaire: PROMIS
Patient-Reported Outcomes Measurement Information System (PROMIS), version 8c, is a patient reported survey which evaluates a patient physical function before and during treatment. It consists of 8 questions each scored from 5 (without any difficulty) to 1 (Unable to do).
Measured: baseline, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
Change in Patient Reported Outcomes Questionnaire: PRO ECOG
PRO ECOG is 1 question where patients describe their activity in the past month. Score ranges from 0 (normal with no limitations) to 3 (unable to perform activities, very limited).
Measured: baseline, Week 2, Week 4, Week 6, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
Change in Patient Reported Outcomes Questionnaire: EORTC Quality of Life (QLQ)-F17
EORTC Quality of Life questionnaire (QLQ)-F17 is a 17 question survey. The first 15 questions assess the patient's physical function and are scored from 1 (Not at all) to 4 (Very much). The final 2 questions asses the patient overall health and overall quality of life. Scoring ranges from 1 (very poor health/quality of life) to 7 (excellent health/quality of life).
Measured: baseline, Week 2, Week 4, Week 6, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
Change in Patient Reported Outcomes Questionnaire: FACT-GP5
Functional Assessment of Cancer Therapy-General version (FACT-GP5) is a single question in which patients report their bother by side effects of treatment. Scores range from 0 (not at all bothered by side effect) to 4 (very much bothered by side effects).
Measured: baseline, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
Change in Patient Reported Outcomes Questionnaire: Patient Global Impression-Change (PGI-C) and Patient Global Impression-Severity (PGI-S)
A two question survey. Question one, PGI-S, describes severity of symptoms of on a scale from 1 (normal severity) to 4 (severe symptoms). Question two, PGI-C, patients report how their physical function has changed from baseline on a scale from 1 (very much improved) to 7 (very much worse).
Measured: baseline, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
Change in Physical Function using Performance Outcome 6-Minute Walk Test
Performance Outcome measured using a 6-minute walk test. The outcome is distance in meters traveled by the patient in a 6 minute time period at baseline and 3 months to evaluate patient performance before and after chemotherapy.
Measured: baseline and 3 months
Steps Data From Wearable Device
Count of total daily steps and maximum cadence (steps/minute) with activity data collected using a Fitbit at baseline (7 days prior to the start of chemotherapy) continually until Month 9.
Measured: baseline through month 9
Heart Rate Data From Wearable Device
Resting heart rate (beats/minute) and heart rate during moderate to vigorous physical activity (MVPA) data collected using a Fitbit at baseline (7 days prior to the start of chemotherapy) continually until Month 9.
Measured: baseline through month 9
Patient Activity Data From Wearable Device
Daily duration of MVPA (in minutes), count of ≥10-minute bouts of MVPA, daily duration of sedentary time (in minutes), and count of ≥ 10-minutes bouts of sedentary time (in minutes) data collected using a Fitbit at baseline (7 days prior to the start of chemotherapy) continually until Month 9.
Measured: baseline through month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start27 Jan 2022
- Primary completion22 Aug 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical FunctionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Cary Gross, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214144
- Sponsor's protocol ID
- 2000031319
- Other IDs
- 2U01FD005938-03
- Status last verified
- Nov 2024
- First submitted
- 13 Jan 2022
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thanarajasingam G, Kluetz P, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero MH, Huntington S, Jeffery MM, Jones L, Noble B, Paludo J, Powers B, Ross JS, Ritchie JD, Ruddy K, Schellhorn S, Tarver M, Dueck AC, Gross C. Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study. BMJ Open. 2024 Jan 10;14(1):e074030. doi: 10.1136/bmjopen-2023-074030.
PubMed 38199641Thanarajasingam G, Kluetz PG, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero MH, Huntington SF, Jeffery MM, Jones L, Noble BN, Paludo J, Powers B, Ross JS, Ritchie JD, Ruddy KJ, Schellhorn SE, Tarver ME, Dueck AC, Gross CP. Integrating 4 Measures to Evaluate Physical Function in Patients with Cancer (In4M): Protocol for a prospective study. medRxiv [Preprint]. 2023 Mar 9:2023.03.08.23286924. doi: 10.1101/2023.03.08.23286924.
PubMed 36945495
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients
- ClinicalTrials.gov ID
- NCT05214144
- Acronym / sponsor ID
- 2000031319
- Conditions
- Physical Function, Cancer, Breast, Lymphoma, Patient Empowerment, Patient Education, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational cohort study. Breast cancer and lymphoma patients planned to receive cytotoxic therapy will be recruited at Yale and Mayo Clinic. The Study Period is 9 months, during which enrolled patients will use their personal smartphone, computer, or other web-connected device to connect with the Hugo platform which will deliver PRO questionnaires, and sync to the wearable device in the study (Fitbit). The PerfO (6MWT) will be conducted twice in clinic during the study period. Structured information from the electronic health record (EHR) and patient portals will be collected and where needed, the EHR will be directly reviewed to record AEs, hospitalizations/emergency department visits and dose delay/reductions. Required in-person face to face visit is only at baseline for consent, enrollment and receipt of wearable device; patients can be followed remotely afterward (i.e. do not need to be treated at Mayo or Yale)
Detailed description
The purpose of this prospective observational study is to collect and evaluate 4 different sources of physical functioning (PF) data over the course of systemic anti-cancer therapy in lymphoma and breast cancer patients: clinician-reported Performance Status (PS), Patient Reported Outcomes (PROs), a Performance Outcome (PerfO) and patient wearable device data.
Aim 1: To measure PF using 4 distinct modalities (ClinRo, PRO, PerfO and wearable device data) on Hugo platform
- Characterize assessment challenges by comparing levels of missing data and reasons for missingness across the PF modalities
- Report on trajectories of function as ascertained by the 4 PF modalities
Aim 2: To explore associations between various sources of physical function data and determine change thresholds
- To identify measurement characteristics of the PF modalities including sensitivity to change and identification of meaningful change thresholds
- Compare change over time in data within and between the PF modalities
- Explore associations between changes in the various PF modalities and subsequent patient-reported adverse events (AEs), acute care use (unplanned hospitalizations or emergency department visits), other patient-reported domains of Health Related Quality of Life (HRQOL), and dose delay/reduction
Aim 3: To assess patient acceptability and experience using the different PF assessment modalities
- Administer an exit questionnaire to understand burden and usability of electronic PROs and wearable device data collection from the patient perspective
The allocation for patient recruitment is 18 months, with 9 months for follow up for each patient. The proposed overall project timeline is 3.5 years/39 months. A total of 200 patients will be enrolled at Yale Cancer Center and the Mayo Clinic, as outlined below. Data will be cleaned, reviewed, and analyzed as it is received from the Hugo platform on a rolling basis. Data analysis will be conducted at Mayo Clinic and Yale. Only de-identified data will be provided to the FDA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| evaluating sources of physical function (PF) | – | Other: PRO Instruments assessment questionnaire, Other: Baseline Survey Clinician- reported (ClinRO) ECOG, Device: Fitbit, Other: Hugo Health ("Hugo"), Other: 6 Minute Walk Test (6MWT)evaluate 4 distinct modalities of sources of PF (PRO, ClinRo, PerfO and wearable device data) on Hugo Health platform in breast cancer and lymphoma patients undergoing cytotoxic chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two hundred patients will be recruited from two main sites: Yale and Mayo Clinic Rochester. Patient sampling will be stratified by site enrolled and cancer type. The investigator will seek to optimize diversity of the patient sample. Race/ethnicity will be determined by participant self-report, offering the opportunity for participants to select multiple races. Participants who self-define as part of a racial or ethnic minority and as white will be classified by their non-white race/ethnicity for purposes of counting enrollment quotas. The project team (including representatives from the FDA) will evaluate the enrollment throughout the study both in terms of counts as well as demographic mix. For the purposes of this study, specific goals or quotas are not being set.
Key inclusion criteria (14 listed)
- Age 18 and over;
- English- or Spanish-speaking;
- Pregnant and non-pregnant patients are eligible for participation in this study
- Eligible cancer type and planned intravenous cytotoxic chemotherapy regimen (defined as including 1 or more cytotoxic agents)
- ECOG Performance Score of < 3
Key exclusion criteria (10 listed)
- Prior intravenous cytotoxic chemotherapy within 3 weeks prior to study enrollment
- Excluded regimens (due to length of hospitalization required for chemotherapy administration):
- Excluded histology (due to length of hospitalization and inpatient predominant treatment for required chemotherapy): primary central nervous system lymphoma
- Lack of access to a mobile device (smartphone or tablet) or computer with web access
- Unable or unwilling to connect Fitbit to device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO Instruments assessment questionnairePatient Reported Outcome (PRO) questionnaire consisting of: * PRO-CTCAE (approximately 11 questions plus free text) * Patient-Reported Outcomes Measurement Information System (PROMIS) physical function short form (version 8c) (8 questions) * PRO ECOG question (1 question) * EORTC Quality of Life questionnaire (QLQ)-F17 questions (17 questions) * Functional Assessment of Cancer Therapy-General version, rated on a 5-point Likert scale, (FACT-GP5) (single item global side effect bother question) (1 question) * The Patient Global Impression (PGI)-C and PGI-S items (anchors for physical function) (2 questions) | Other | evaluating sources of physical function (PF) |
| Baseline Survey Clinician- reported (ClinRO) ECOGBaseline Survey completed prior to initiation of chemotherapy | Other | evaluating sources of physical function (PF) |
| Fitbitwearable device | Device | evaluating sources of physical function (PF) |
| Hugo Health ("Hugo")an electronic platform that aggregates real world EHR data with patient's wearable and PRO data | Other | evaluating sources of physical function (PF) |
| 6 Minute Walk Test (6MWT)A comprehensive performance measure of exercise capacity, encompassing components of mobility, endurance, and functional capacity measure (PerfO) | Other | evaluating sources of physical function (PF) |
Primary outcome
To measure Physical Function using Clinician Reported Outcomes (ClinRo) at baseline.
Time frame: baseline
ClinRo score at baseline using the Eastern Cooperative Oncology Group (ECOG) performance scale. Possible scores range from 0 to 5. The lower the score the better the performance.
Change in Patient Reported Outcomes Questionnaire: PRO-CTCAE
Time frame: baseline, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
PRO-CTCAE is a patient-reported outcome (PRO) measurement system of 11 questions plus free text developed to evaluate symptomatic toxicity in patients on cancer clinical trials. Outcome reported as a count of adverse events.
Change in Patient Reported Outcomes Questionnaire: PROMIS
Time frame: baseline, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
Patient-Reported Outcomes Measurement Information System (PROMIS), version 8c, is a patient reported survey which evaluates a patient physical function before and during treatment. It consists of 8 questions each scored from 5 (without any difficulty) to 1 (Unable to do).
Change in Patient Reported Outcomes Questionnaire: PRO ECOG
Time frame: baseline, Week 2, Week 4, Week 6, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
PRO ECOG is 1 question where patients describe their activity in the past month. Score ranges from 0 (normal with no limitations) to 3 (unable to perform activities, very limited).
Change in Patient Reported Outcomes Questionnaire: EORTC Quality of Life (QLQ)-F17
Time frame: baseline, Week 2, Week 4, Week 6, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
EORTC Quality of Life questionnaire (QLQ)-F17 is a 17 question survey. The first 15 questions assess the patient's physical function and are scored from 1 (Not at all) to 4 (Very much). The final 2 questions asses the patient overall health and overall quality of life. Scoring ranges from 1 (very poor health/quality of life) to 7 (excellent health/quality of life).
Change in Patient Reported Outcomes Questionnaire: FACT-GP5
Time frame: baseline, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
Functional Assessment of Cancer Therapy-General version (FACT-GP5) is a single question in which patients report their bother by side effects of treatment. Scores range from 0 (not at all bothered by side effect) to 4 (very much bothered by side effects).
Change in Patient Reported Outcomes Questionnaire: Patient Global Impression-Change (PGI-C) and Patient Global Impression-Severity (PGI-S)
Time frame: baseline, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
A two question survey. Question one, PGI-S, describes severity of symptoms of on a scale from 1 (normal severity) to 4 (severe symptoms). Question two, PGI-C, patients report how their physical function has changed from baseline on a scale from 1 (very much improved) to 7 (very much worse).
Change in Physical Function using Performance Outcome 6-Minute Walk Test
Time frame: baseline and 3 months
Performance Outcome measured using a 6-minute walk test. The outcome is distance in meters traveled by the patient in a 6 minute time period at baseline and 3 months to evaluate patient performance before and after chemotherapy.
Steps Data From Wearable Device
Time frame: baseline through month 9
Count of total daily steps and maximum cadence (steps/minute) with activity data collected using a Fitbit at baseline (7 days prior to the start of chemotherapy) continually until Month 9.
Heart Rate Data From Wearable Device
Time frame: baseline through month 9
Resting heart rate (beats/minute) and heart rate during moderate to vigorous physical activity (MVPA) data collected using a Fitbit at baseline (7 days prior to the start of chemotherapy) continually until Month 9.
Patient Activity Data From Wearable Device
Time frame: baseline through month 9
Daily duration of MVPA (in minutes), count of ≥10-minute bouts of MVPA, daily duration of sedentary time (in minutes), and count of ≥ 10-minutes bouts of sedentary time (in minutes) data collected using a Fitbit at baseline (7 days prior to the start of chemotherapy) continually until Month 9.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Derived from this study: PubMed 38199641Thanarajasingam G, Kluetz P, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero MH, Huntington S, Jeffery MM, Jones L, Noble B, Paludo J, Powers B, Ross JS, Ritchie JD, Ruddy K, Schellhorn S, Tarver M, Dueck AC, Gross C. Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study. BMJ Open. 2024 Jan 10;14(1):e074030. doi: 10.1136/bmjopen-2023-074030.
- Derived from this study: PubMed 36945495Thanarajasingam G, Kluetz PG, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero MH, Huntington SF, Jeffery MM, Jones L, Noble BN, Paludo J, Powers B, Ross JS, Ritchie JD, Ruddy KJ, Schellhorn SE, Tarver ME, Dueck AC, Gross CP. Integrating 4 Measures to Evaluate Physical Function in Patients with Cancer (In4M): Protocol for a prospective study. medRxiv [Preprint]. 2023 Mar 9:2023.03.08.23286924. doi: 10.1101/2023.03.08.23286924.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cary Gross, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Function and Cancer, Breast, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure Physical Function using Clinician Reported Outcomes (ClinRo) at baseline. (time frame: baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05214144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.