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Addressing Challenges in Research Aimed at Reducing Financial Toxicity Among Cancer Patients and Caregivers: An
Ari Bell-Brown1, Bernard Tawfik2, Babara Segarra-Vazquez3
1Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Summary
The CREDIT study successfully adapted its design to overcome recruitment challenges, increasing patient enrollment by over 200% and enabling timely completion of this financial navigation research.
Area of Science:
- Oncology
- Health Services Research
- Psycho-oncology
Background:
- Cancer-related financial hardship significantly impacts patients and caregivers.
- Addressing financial toxicity at the household level is crucial for comprehensive cancer care.
- Proactive financial navigation interventions are being explored to mitigate these hardships.
Purpose of the Study:
- To report on the modifications made to the CREDIT (S1912CD) study to address recruitment challenges.
- To describe how protocol adjustments facilitated the successful completion of a financial navigation intervention study.
- To highlight the importance of pragmatic trial designs in cancer care research.
Main Methods:
- The CREDIT study enrolled cancer patients and spousal caregivers as dyads in NCI Community Oncology Research Program (NCORP) sites.
- Protocol feedback was gathered through various channels, including site meetings and direct communication.
- A patient advocate collaborated to enhance study relevance and accessibility.
Main Results:
- Key barriers included difficulties enrolling dyads, intervention delivery complexities, eligibility criteria, and data privacy concerns.
- Modifications involved making caregiver participation optional, streamlining intervention delivery, and adjusting eligibility criteria.
- These changes led to a significant increase in patient accrual (average 9.5 patients/month) and enabled study completion within the timeline.
- Diverse patient accrual was maintained, and caregiver participation continued for exploratory analyses.
Conclusions:
- Pragmatic intervention designs are essential for translating cancer financial hardship mitigation strategies into sustainable, real-world programs.
- Incorporating feedback from recruiting sites allows for necessary protocol adjustments to ensure study success.
- The CREDIT study demonstrates the feasibility of adapting clinical trial protocols to overcome recruitment barriers in financial navigation research.
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