Medical Payment Case Management for Financial Toxicity in Patients With Primary Bone Tumors: A Randomized Controlled Trial

Background Cancer treatment imposes substantial direct and indirect costs on patients and families. The resulting hardship, termed financial toxicity, is increasingly recognized as a distinct adverse consequence of cancer care and is associated with impaired quality of life, reduced treatment adherence and worse survival. In China, high out-of-pocket spending, wide variation in reimbursement across regions and insurance schemes, and the frequent need to travel to tertiary centers place families at particular risk.

Patients with bone tumors are a high-risk group. Surgery for primary bone tumors frequently requires prosthetic reconstruction, and prostheses are typically among the largest out-of-pocket items in orthopedic oncology. A large proportion of patients at our center travel from outside Shanghai, adding travel, accommodation and lost-income costs. Approximately half of the patients treated in bone tumor surgery are children and adolescents, whose treatment decisions and financial burden fall on their parents; caregiver distress and family financial strain are therefore central to the burden of this disease.

Rationale Financial navigation, in which trained staff screen for financial hardship and help patients obtain insurance, assistance and other resources, has shown benefit internationally. A U.S. National Cancer Institute initiative across 11 cancer centers recommended universal screening with a validated financial toxicity instrument together with financial navigation services. In the LIFT trial, conducted at nine oncology practices in North Carolina, financial navigation improved mean COST scores from 6.4 at baseline to 13.3 after the intervention. Whether such a service is effective in the Chinese payment environment, with its different mix of insurance schemes and assistance programs, has not been tested in a randomized trial.

At our hospital, the whole-course patient management program of the Comprehensive Oncology Center (COC) already provides scheduled follow-up reminders, medication records, adverse-event monitoring and patient education, but has no systematic financial support function. This study adds that function and evaluates it in a randomized controlled trial.

Study design This is a single-center, open-label, parallel-group randomized controlled trial. A total of 124 patients are allocated 1:1 to the payment service group or the control group.

Randomization A statistician independent of patient enrollment, intervention delivery and outcome assessment generates the allocation sequence before the study begins, using block randomization with variable block lengths and a 1:1 ratio. No stratification factors are used, given the limited sample size and the loss of statistical efficiency that stratification would entail. The sequence is held by the statistician alone, and investigators and clinical staff cannot know or predict the next allocation. After confirming eligibility and obtaining informed consent, the investigator requests randomization for that patient; the statistician issues the next allocation in sequence and records the screening number, group and randomization date in the randomization log. The result is entered into the electronic case report form, and allocations are final.

Blinding The intervention and the group assignment cannot be masked from patients or case managers, so the trial is open-label. The primary endpoint is a patient-reported outcome, and no independent blinded endpoint assessment is performed. To control bias: (1) data analysts remain blinded, with analysis datasets exported under masked labels A and B; (2) objective endpoints, including catastrophic health expenditure, out-of-pocket costs and treatment non-adherence, are adjudicated by assessors unaware of group assignment using hospital information system and billing records; and (3) instruments are self-administered in a standardized electronic format with neutral instructions, and the staff administering them are separate from those delivering the intervention. Report bias in patient-reported outcomes under an open-label design will be addressed in the interpretation and reporting of results.

Interventions Payment service group. In addition to the COC whole-course patient management program received by both groups, patients in this group receive a seven-step medical payment service delivered by a dedicated payment specialist (Co-Pay Navigator) and a payment service window on the patient-facing platform.

Financial screening at baseline. The COST-FACIT is pushed to the patient's platform account to screen for financial toxicity, together with collection of insurance type, household income and prior out-of-pocket spending. Scores are graded automatically into mild, moderate and severe financial toxicity risk, and patients with severe risk (COST 18.5 or below) are flagged for priority intervention.

Needs assessment within 3 days of enrollment. A 30-minute interview, in person or by video, covering the family's finances, existing coverage (basic medical insurance, critical illness insurance, supplemental insurance and commercial insurance), estimated total treatment cost and out-of-pocket gap, producing an individualized list of financial problems.

Individualized payment plan within 2 to 7 days of the needs assessment. Using a payment-matching tool, the Co-Pay Navigator maps the family's insurance type, tumor type and stage, treatment plan and financial situation to seven payment channels: basic medical insurance, critical illness insurance, supplemental medical insurance, charity assistance, pharmaceutical company assistance, social assistance and compliant fundraising. Expected coverage and residual out-of-pocket amounts are estimated for each channel and assembled into a combined payment plan. For patients under 18, a dedicated pediatric catastrophic illness assistance program is added. Application conditions, required documents and deadlines are noted for each channel.

Resource linkage throughout treatment, with emphasis on the perioperative period. This includes assistance with insurance procedures such as cross-region settlement registration, outpatient special disease certification and second reimbursement under critical illness insurance; matching and submission of charity assistance applications; eligibility review and application for pharmaceutical company assistance; guidance and document support for commercial insurance claims; guidance on social assistance policies; assistance in launching campaigns on compliant fundraising platforms; and, for caregivers, one-to-one linkage to pediatric cancer assistance resources. For each channel, whether an application was made, the submission date, the approval outcome, and the amount and date received are recorded.

Discharge payment summary at surgical discharge. Total hospital charges, insurance reimbursement and the in-hospital out-of-pocket amount are reviewed with the patient or family; expected costs during follow-up, rehabilitation and adjuvant chemotherapy are explained; the status of submitted charity, commercial insurance and pharmaceutical assistance applications and expected payment dates are reported; and payment recommendations for the next phase are given. The summary is documented in writing or electronically and retained.

Quarterly follow-up at 3, 6, 9 and 12 months. Video or text follow-up through the platform payment service window updates the family's financial and out-of-pocket situation, verifies progress on each channel and expedites pending items, adjusts the payment plan according to treatment progress, and flags resources available at the next stage.

On-demand consultation at any time. Patients and families may consult the platform payment service window about reimbursement, assistance or claims. A response within 6 hours is committed, and urgent financial difficulty is prioritized.

Control group Patients receive the COC whole-course patient management program only. No financial screening feedback, payment plan or assistance with applications is provided. If a patient in this group seeks help with a financial problem, the case manager provides neutral guidance only, informing the patient of the location and function of the hospital's public windows such as the medical insurance office and social work department, without providing study payment support or acting on the patient's behalf. These requests are recorded and used to monitor contamination; if more than 15% of the control group makes such a request, a sensitivity analysis will be triggered.

Assessments Both groups complete the same assessments at baseline (T0) and at 3 (T1), 6 (T2), 9 (T3) and 12 (T4) months after enrollment, with a window of approximately 2 weeks at baseline and 1 month at follow-up points. The COST-FACIT is administered at every time point. An economic coping strategies questionnaire is administered at T1 through T4. Caregiver burden is measured with the 12-item short version of the Zarit Burden Interview (ZBI-12) at T0, T2, T3 and T4. Overall service satisfaction is collected at T2 and T4. Inpatient and out-of-pocket costs are collected continuously at each treatment milestone, including neoadjuvant chemotherapy admission, surgical admission, adjuvant chemotherapy admission and outpatient settlements, rather than at fixed time points. Recurrence, survival and adverse events are recorded throughout.

Outcomes The primary endpoint is the change in the COST-FACIT total score (11 items, range 0 to 44, with lower scores indicating greater financial toxicity) from baseline (T0) to 6 months after enrollment (T2).

Secondary endpoints are the incidence of catastrophic health expenditure, defined as cumulative out-of-pocket medical spending reaching 10% or more of annual household income; the incidence of economic-related treatment non-adherence, including prosthesis or reconstruction downgrade, abandonment of treatment, interruption of rehabilitation and chemotherapy dose reduction, reported for each behavior and overall; the incidence of economic coping strategies, defined as one or more positive responses on the seven-item coping strategies questionnaire; the ratio of out-of-pocket spending to annual household income; caregiver burden measured by the ZBI-12 total score; and overall service satisfaction.

Exploratory endpoints comprise process measures of intervention delivery and hypothesis-generating economic and clinical outcomes. Process measures include the proportion of the payment service group receiving at least three sessions of the service, the completion rate of each of the seven service steps, the success rate of resource linkage by channel, the payment plan execution rate, and the follow-up completion rate. Economic outcomes include decomposition of the reduction in out-of-pocket spending by payment channel, the resolution rate of catastrophic health expenditure, and the count score of economic coping strategies. Clinical outcomes include recurrence-free survival and overall survival, reported descriptively with Kaplan-Meier estimates given the limited power of a 12-month follow-up.

Sample size The sample size is based on the COST-FACIT score as a continuous variable. Assuming a baseline COST median of approximately 18 with a standard deviation of 6.8, as reported in Chinese cancer populations, and a clinically meaningful improvement of 4 points (approximately 21%), a two-sample t-test with a two-sided alpha of 0.05 and 85% power requires 52 evaluable patients per group. Assuming 85% retention at 6 months, 62 patients per group will be enrolled, for a total of 124.

Statistical analysis The primary analysis will be by intention to treat, with a per-protocol analysis as a sensitivity analysis. Missing data will be handled by multiple imputation using chained equations. A statistical analysis plan will be finalized before database lock. The primary endpoint will be analyzed by analysis of covariance adjusting for baseline financial toxicity, age and insurance type. Catastrophic health expenditure will be analyzed by chi-square test and logistic regression. Longitudinal outcomes will be analyzed using linear mixed models. Pre-specified subgroup analyses will compare patients aged 25 years or younger with older patients, by insurance type, and patients from Shanghai with those from outside Shanghai.

Data management Data are collected at the platform front end and stored in an independent, qualified third-party electronic data capture system with a full audit trail, so that data generation and data custody are not held by the same party. Analysis datasets are exported under masked labels A and B. Monitoring is performed according to the protocol.

Ethics This is a low-risk behavioral intervention study. The protocol and informed consent materials were approved by the Ethics Committee of Shanghai Sixth People's Hospital (Approval No. 2026-KY-351(K)), with continuing review every 12 months.