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387 Feasibility of Multi-Modal Physical Function Data Collection to Assess Treatment Tolerability in Patients with Lymphoma

Program: Oral and Poster Abstracts
Type: Oral
Session: 902. Health Services and Quality Improvement: Lymphoid Malignancies: For a Brighter Tomorrow - Improving Safety of Treatments
Hematology Disease Topics & Pathways:
Research, Clinical Practice (Health Services and Quality), Clinical Research, Health outcomes research, Patient-reported outcomes, Emerging technologies, Technology and Procedures
Saturday, December 7, 2024: 4:30 PM

Jonas Paludo, MD1, Amylou C Dueck, PhD2, Vishal Bhatnagar, MD3*, Abbie Y Brown4*, Elizabeth J Cathcart-Rake, MD5*, Devin B Copley1*, Matthew Diamond, MD, PhD3*, Louis J Faust, Ph.D.6*, Mallorie Fiero, PhD3*, Scott F Huntington7,8, Molly M Jeffery, Ph.D.9,10*, Lee Jones11*, Brie N Noble, MS2*, Brad Power12*, Jessica D Ritchie, MPH, PMP13*, Joseph S Ross, MD, MHS13,14*, Kathryn J Ruddy, MD5*, Sarah E Schellhorn, MD14,15*, Michelle Tarver, MD, PhD3*, Lisa M Torre, MS, CCRP16*, William A. Wood, MD, MPH17, Cary P Gross, MD14,15*, Paul G Kluetz, MD3* and Gita Thanarajasingam, MD1

1Division of Hematology, Mayo Clinic, Rochester, MN
2Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ
3US Food and Drug Administration, Silver Spring, MD
4Health Education and Content Services, Mayo Clinic, Rochester, MN
5Department of Oncology, Mayo Clinic, Rochester, MN
6Division of Health Care Delivery Research, Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
7Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale School of Medicine, New Haven, CT
8Yale School of Medicine, New Haven, CT
9Division of Health Care Delivery Research, Mayo Clinic, Rochester, MN
10Department of Emergency Medicine, Mayo Clinic, Rochester, MN
11Patient Advocate, Arlington, VA
12Patient Advocate, CancerHacker Lab, Boston, MA
13Yale-New Haven Center for Outcomes Research and Evaluation (CORE), Yale School of Medicine, New Haven, CT
14Department of Internal Medicine, Yale School of Medicine, New Haven, CT
15Yale's Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale School of Medicine, New Haven, CT
16Yale Center for Clinical Investigation (YCCI), Yale School of Medicine, New Haven, CT
17Division of Hematology, University of North Carolina, Chapel Hill, NC

Background: Physical function (PF) is an important outcome that can inform cancer treatment tolerability from a clinical and regulatory perspective. PF can be assessed through different modalities: patient-reported (PRO), clinician-reported (ClinRo), performance tests (PerfO), and digital sensors (wearables). No standard approach for PF measurement has been defined, and each modality bears unique implementation challenges. The Integrating 4 Measures to Assess Physical Function study (In4M, NCT05214144) characterized the performance of these PF modalities in patients receiving cytotoxic chemotherapy, with a goal of guiding an assessment strategy in future cancer trials. Here we present feasibility results of the In4M study in patients with lymphoma.

Methods: In4M is a prospective observational study with longitudinal PF assessment of PROs, ClinRo, PerfO, and wearable sensor data for over 9 months in patients initiating chemotherapy for lymphoma or breast cancer at Mayo Clinic and Yale University. Patient-reported PF was assessed using several validated ePRO instruments, ClinRo utilized clinician-reported Eastern Cooperative Oncology Group (ECOG) performance status, PerfO was measured via 6-minute walk test (6MWT), and digital sensor data was obtained from a wearable (Fitbit) provided to all participants. We evaluated the feasibility of implementing these PF modalities through compliance outcomes and a study-specific exit survey. Descriptive statistics included medians and interquartile ranges (IQR) for continuous variables and frequencies for categorical variables. We used a mixed model to estimate mean number of Fitbit compliant days per week.

Results: Among 66 patients with lymphoma in the study (median age was 57 years; 52% were male), 90% self-reported as White, 4.9% as Black, 1.6% as Asian, 1.6% as American Indian or Alaska Native, and 1.6% as multiple races. Ethnicity was reported as non-Hispanic/Latino by 93% of patients. Education status was reported as more than high school by 92% of patients, and 49% reported full-time employment at time of enrollment.

The overall ePROs completion rate was 80.7% for the entire study period. Baseline ePRO completion rate was 93.9%. Completion rate while undergoing chemotherapy was 91.3% and 75.4% in the post-treatment follow-up. The median time to complete ePROs was 4.1 minutes (IQR 2.8–5.9), ranging from 3.1 minutes for surveys with 37 questions to 5.6 minutes for surveys with 55 questions (survey length varied by timepoint).

The baseline 6MWT was completed by 91% of patients. The most common reasons for not completing the baseline 6MWT were: patient refusal (50%, 3/6), patient not physically present (33%, 2/6), and unable to complete due to fatigue (17%, 1/6). The 3-month 6MWT was completed by 66% (40/61) of patients, with the most common reasons for missingness being: patient not physically present (38%, 8/21) and unable to complete due to fatigue (14%, 3/21).

When considering the days when Fitbit was used, the median wear time was 21.3 hours (IQR 18.9–22.5) per day. The proportion of compliant days (>10 hours of wear time during waking hours) was 53% (IQR 20–84). The median of participants’ average compliant days per week was 5.4 (IQR 4.3–6.1) days/week after enrollment, with a slight downward trend over time (-0.017 compliant days per week [95% CI: -0.021, -0.012, p <0.001] over each consecutive week in the study).

The exit survey was completed by 39 (59%) patients. Most participants (85%) indicated they did not find the ePRO surveys burdensome to complete. Using the Fitbit (charging and syncing) was found to be manageable by most patients (87% and 84%, respectively). 60.8% of patients did not find the wearable bothersome to use, while the main themes reported by the remaining patients were related to the operation of the wearable itself (functions, small text size, forgetting login information) or discomfort (band material, wearing at night).

Conclusion: Multi-modal assessment of PF with PRO, ClinRo, PerfO and wearable sensor data in patients with lymphoma undergoing treatment is feasible. Designing lymphoma therapeutic trials that incorporate at least one PF assessment modality, or assessment with a parsimonious combination of modalities, is achievable and may yield valuable insights into treatment tolerability for clinical and regulatory purposes.

Disclosures: Paludo: AbbVie: Membership on an entity's Board of Directors or advisory committees; Biofourmis: Research Funding; Karyopharm: Research Funding; AstraZeneca: Research Funding. Huntington: Genentech: Consultancy; ADC Therapeutics: Consultancy; AstraZeneca: Consultancy, Honoraria; Bayer: Honoraria; Thyme Inc.: Consultancy; Pharmacyclics: Consultancy, Honoraria; Novartis: Consultancy; Arvinas: Consultancy; Servier: Consultancy; Flatiron Health Inc.: Consultancy; Janssen: Consultancy; Ipsen: Honoraria; TG Therapeutics: Consultancy; Seattle Genetics: Consultancy; Merck: Consultancy; Epizyme: Consultancy; BeiGene: Consultancy; AbbVie: Consultancy. Ritchie: Johnson and Johnson: Research Funding; US Food and Drug Administration: Research Funding; Laura and John Arnold Foundation: Research Funding. Ross: Johnson and Johnson: Research Funding; Greene Law Firm: Consultancy. Schellhorn: Eisai: Consultancy; Celgene: Consultancy; SeaGen: Consultancy; Cardinal Health: Consultancy. Wood: Pfizer: Research Funding; ASH Research Collaborative: Consultancy; Teledoc Health: Consultancy; Koneksa Health: Consultancy, Current equity holder in publicly-traded company; Genetech: Research Funding. Gross: Genentech: Research Funding; Johnson and Johnson: Research Funding. Thanarajasingam: Novartis: Other: Advisory Board (one time - completed, no personal remuneration); SeaGen: Other: Advisory Board (one time - completed, no personal remuneration).

*signifies non-member of ASH