The In4M Study: Integrating 4 Measures to Assess Physical Function in Cancer Patients
Study Details
Study Description
Brief 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 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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
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Characterize assessment challenges by comparing levels of missing data and reasons for missingness across the PF modalities
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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
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To identify measurement characteristics of the PF modalities including sensitivity to change and identification of meaningful change thresholds
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Compare change over time in data within and between the PF modalities
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: PRO Instruments assessment questionnaire
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)
Other: Baseline Survey Clinician- reported (ClinRO) ECOG
Baseline Survey completed prior to initiation of chemotherapy
Device: Fitbit
wearable device
Other: Hugo Health ("Hugo")
an electronic platform that aggregates real world EHR data with patient's wearable and PRO data
Other: 6 Minute Walk Test (6MWT)
A comprehensive performance measure of exercise capacity, encompassing components of mobility, endurance, and functional capacity measure (PerfO)
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Outcome Measures
Primary Outcome Measures
- To measure Physical Function using Clinician Reported Outcomes (ClinRo) at baseline. [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 [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 [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 [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 [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 [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) [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 [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 [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 [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 and over;
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English- or Spanish speaking;
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Eligible cancer type and planned intravenous multi-agent chemotherapy regimen:
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Breast cancer patients
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Patients with stage 1-3 breast cancer diagnosed within previous 9 months
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Planned to receive multi-agent intravenous adjuvant and/or neoadjuvant chemotherapy during their treatment course
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Patients should be enrolled prior to receipt of cytotoxic chemotherapy for breast cancer.
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Patients with concurrent/prior/future immunotherapy/radiotherapy, targeted therapy and endocrine therapy for breast cancer can be included
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Eligible regimens include:
- Taxotere-Cytoxan (TC) ii) Adriamycin-Cytoxan followed by Taxol +/- carboplatin (AC-T +/- carbo) iii) Taxol +/- carbo followed by Adriamycin-Cytoxan (T +/- carbo-AC)
- Taxotere-Carboplatin-Herceptin (TCH) v) Taxotere-Carboplatin-Herceptin-Perjeta (TCH-P) vi) AC-T-Herceptin (AC-TH) vii) AC-T-Herceptin-Perjeta (AC-THP) viii) Other similar multi-agent frontline chemotherapy depending on the state of the field and with approval from the study PI or co-investigators. Ado-trastuzumab (TDM1), capecitabine and immunotherapy are allowed in addition to or following a multi-agent regimen.
- Lymphoma patients a) Newly diagnosed high grade/aggressive lymphoma patients of any stage, including: i) High grade/aggressive B cell lymphoma per the 2016 revision of the World Health Organization (WHO) classification of lymphoid neoplasms62 (including composite, discordant or transformed disease, if applicable).
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High grade/aggressive T cell lymphoma per the 2016 revision of the WHO classification of lymphoid neoplasms (including composite, discordant or transformed disease, if applicable).
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Hodgkin lymphoma (including composite, discordant or transformed disease, if applicable).
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Planned to receive multi-agent chemotherapeutic regimens for a fixed period (4-6 months) on an outpatient basis.
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Patients should be enrolled prior to receipt of cytotoxic chemotherapy for lymphoma.
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Patients with pre-existing low-grade lymphoma who transform to higher grade histology are eligible if the transformation is newly diagnosed and the patient has not previously received cytotoxic chemotherapy b) Eligible regimens include: i) Cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) ii) Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) iii) Brentuximab vedotin, cyclophosphamide, doxorubicin, prednisone (BV-CHP) iv) Rituximab, etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (Outpatient R-EPOCH) v) Doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) vi) Brentuximab vedotin, doxorubicin, vinblastine, dacarbazine (BV+AVD) vii) Cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone (CHOEP) viii) Cyclophosphamide, etoposide, vincristine, prednisone (CEOP) ix) Rituximab with cytarabine alternating with rituximab with maxi-CHOP (Nordic regimen) x) Other similar multi-agent frontline chemotherapy depending on the state of the field and with approval from the study PI or co-investigators. Patient planned to receive radiation, maintenance chemotherapy or consolidation stem cell transplant may also be included.
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If patients are receiving the above standard therapies as part of a frontline 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;
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Receiving chemotherapy on a primarily outpatient basis;
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Willing and able to give consent and participate in study;
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Able to access a mobile device (smartphone or tablet) or computer with web access every day to complete study surveys; able to connect Fitbit to a device that can regularly link to Hugo for data transfer;
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Willing and able to perform an in-clinic 6-minute walk test (gait aides are permitted if regularly used by the patient)
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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 Institutional Review Board (IRB) Policies and Procedures.
Exclusion Criteria:
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Lack of access to a mobile device (smartphone or tablet) or computer with web access
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Unable or unwilling to connect Fitbit to device
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Unable or unwilling to use the health data sharing platform
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Unable to give consent and be enrolled in person
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Prior receipt of cytotoxic chemotherapy within 12 months of study start date
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale Cancer Center | New Haven | Connecticut | United States | 06511 |
| 2 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Yale University
- Food and Drug Administration (FDA)
Investigators
- Principal Investigator: Cary Gross, MD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000031319
- 2U01FD005938-03