Clinical trial NCT05214144: The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients
Official title: The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Function
Cancer, Breast
Lymphoma
Patient Empowerment
Patient Education
Quality of Life
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2022-01-28
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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)

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 and over;
2. English- or Spanish-speaking;
3. Pregnant and non-pregnant patients are eligible for participation in this study
4. Eligible cancer type and planned intravenous cytotoxic chemotherapy regimen (defined as including 1 or more cytotoxic agents)
5. ECOG Performance Score of \< 3
6. Breast cancer patients

   a) 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)
7. Lymphoma patients

   a) 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)
8. 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
9. Willing and able to give consent and participate in study
10. 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
11. 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.
12. 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.

Exclusion Criteria

1. Prior intravenous cytotoxic chemotherapy within 3 weeks prior to study enrollment
2. Excluded regimens (due to length of hospitalization required for chemotherapy administration):

   1. R-CODOX-M/IVAC,
   2. DA-R-EPOCH (inpatient)
3. Excluded histology (due to length of hospitalization and inpatient predominant treatment for required chemotherapy): primary central nervous system lymphoma

   a) Other regimens with an anticipated high duration of inpatient care time, at PI discretion
4. Lack of access to a mobile device (smartphone or tablet) or computer with web access
5. Unable or unwilling to connect Fitbit to device
6. Unable or unwilling to use the health data sharing platform
7. Unable to give consent and be enrolled

Primary outcomes:
measure: To measure Physical Function using Clinician Reported Outcomes (ClinRo) at baseline.
timeFrame: baseline
measure: Change in Patient Reported Outcomes Questionnaire: PRO-CTCAE
timeFrame: 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.
measure: Change in Patient Reported Outcomes Questionnaire: PROMIS
timeFrame: 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.
measure: Change in Patient Reported Outcomes Questionnaire: PRO ECOG
timeFrame: baseline, Week 2, Week 4, Week 6, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
measure: Change in Patient Reported Outcomes Questionnaire: EORTC Quality of Life (QLQ)-F17
timeFrame: baseline, Week 2, Week 4, Week 6, Week 8, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, and Month 9.
measure: Change in Patient Reported Outcomes Questionnaire: FACT-GP5
timeFrame: 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.
measure: Change in Patient Reported Outcomes Questionnaire: Patient Global Impression-Change (PGI-C) and Patient Global Impression-Severity (PGI-S)
timeFrame: 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.
measure: Change in Physical Function using Performance Outcome 6-Minute Walk Test
timeFrame: baseline and 3 months
measure: Steps Data From Wearable Device
timeFrame: baseline through month 9
measure: Heart Rate Data From Wearable Device
timeFrame: baseline through month 9
measure: Patient Activity Data From Wearable Device
timeFrame: baseline through month 9
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Yale University
name: Cary Gross, MD
role: PRINCIPAL_INVESTIGATOR
References: