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

NCT07888244 | Recruiting

• 1 other identifier: 2026-KY-351(K)
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if adding a medical payment case management service to the hospital's usual follow-up care can reduce the financial hardship of cancer treatment in patients of any age, including children and teenagers, who have a primary bone tumor and are scheduled to have surgery at Shanghai Sixth People's Hospital. It will also learn whether the service lowers the number of families who spend a large share of their yearly income on medical care. The main questions it aims to answer are: Does the service improve patients' scores on a questionnaire that measures financial hardship (the COST-FACIT) from the start of the study to 6 months later? Does the service lower the number of families whose out-of-pocket medical costs reach 10% or more of the family's yearly income? The study will enroll 124 patients, randomly assigned in a 1:1 ratio to two groups of 62: Payment service group: patients receive the hospital's usual follow-up care, plus help from a dedicated payment specialist (called a Co-Pay Navigator). Control group: patients receive the hospital's usual follow-up care only. They can still ask the hospital about payment questions at any time. Researchers will compare the two groups to see if the payment service reduces financial hardship. Both groups receive the whole-course patient management program of the hospital's Comprehensive Oncology Center (COC), which includes: Reminders to return for scheduled check-ups, with alerts if a check-up is missed A record of their medications, with reminders to take them as prescribed Questionnaires they fill in through the program, which the system checks for warning signs that a case manager then follows up Patient education materials about the disease and about follow-up care Online access to a case manager for questions at any time All participants will also: Answer short questionnaires about their family's medical costs at the start of the study and again about 3, 6, 9, and 12 months later, on a mobile phone and with help from the study staff if needed Have a parent or other family member who helps care for them answer a short questionnaire about the strain of caregiving Participants in the payment service group will also work with a Co-Pay Navigator, who: Reviews the family's insurance coverage and out-of-pocket costs Explains which payment programs the family may be able to use: basic medical insurance, critical illness insurance, supplemental medical insurance, charity programs, drug company assistance programs, social assistance, and fundraising Helps the family apply for these programs and follows the applications Reviews the hospital bill when the patient leaves the hospital Checks in every three months to update the family's payment plan Taking part does not involve extra clinic visits, blood tests, or study drugs, and the study does not change any medical treatment.

Conditions

Bone Tumor; Bone Cancer

Keywords

medical payment case management; out-of-pocket costs; health insurance; treatment adherence; caregiver burden; financial toxicity; catastrophic health expenditure; financial navigation; patient navigation; bone tumor

Outcome Measures

Primary Outcomes (1)

• Change in Financial Toxicity Score

  Financial toxicity is assessed with the 11-item Comprehensive Score for Financial Toxicity (COST-FACIT), each item scored 0-4 for a total of 0-44, with lower scores indicating greater financial toxicity. The outcome is the change in total score from baseline to 6 months after enrollment.

  Baseline and 6 months

Secondary Outcomes (6)

• Incidence of Catastrophic Health Expenditure

  6 months and 9 months

• Incidence of Cost-Related Treatment Non-Adherence

  6 months and 9 months

• Incidence of Cost-Coping Strategies

  6 months and 9 months

• Out-of-Pocket Costs as a Percentage of Annual Household Income

  6 months

• Change in Caregiver Burden Score

  Baseline, 6 months, 9 months, and 12 months

Other Outcomes (8)

• Follow-up completion rate

  9 months

• Resolution rate of catastrophic health expenditure

  9 and 12 months

• Decomposition of the reduction in out-of-pocket spending by payment channel

  6 and 9 months

Study Arms (2)

Payment service group

EXPERIMENTAL

Participants receive the whole-course patient management program of the hospital's Comprehensive Oncology Center (COC), plus the medical payment case management service. A dedicated Co-Pay Navigator screens the family for financial toxicity, assesses their coverage and out-of-pocket costs, builds an individualized payment plan across seven payment channels (basic medical insurance, critical illness insurance, supplemental medical insurance, charity assistance, pharmaceutical company assistance, social assistance, and compliant fundraising), helps with applications and tracks them, reviews the hospital bill at discharge, follows up every 3 months, and is available for consultation at any time.

Behavioral: Medical payment case management service

Control group

NO INTERVENTION

Participants receive the whole-course patient management program of the hospital's Comprehensive Oncology Center (COC) only: scheduled follow-up reminders, medication records, questionnaires with automatic flagging of warning signs, patient education, and online access to a case manager. No financial screening feedback, payment plan or assistance with applications is provided. Participants may still ask the hospital about payment questions through its public windows, and such requests are recorded for contamination monitoring.

Interventions

Medical payment case management service BEHAVIORAL

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, added to the whole-course patient management program of the hospital's Comprehensive Oncology Center (COC): (1) financial toxicity screening with the COST-FACIT at baseline, with automatic risk grading; (2) needs assessment within 3 days of enrollment; (3) an individualized payment plan across the seven payment channels, within 2 to 7 days of the needs assessment; (4) assistance applying for and tracking each channel throughout treatment; (5) a discharge payment summary at surgical discharge; (6) follow-up every 3 months; and (7) on-demand consultation with a response within 6 hours.

Payment service group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed primary bone tumor, with surgery planned at Shanghai Sixth People's Hospital
• Registered on the whole-course patient management program of the hospital's Comprehensive Oncology Center (COC)
• Able to complete the study questionnaires, either independently or with assistance from a parent
• Provision of informed consent and willingness to participate. For participants under 18 years of age, informed consent is provided by the legal guardian and the participant's own assent is also obtained

You may not qualify if:

• Secondary or metastatic bone tumor
• Cognitive impairment or psychiatric illness that prevents completion of the questionnaires
• Surgery is not the main treatment modality
• Refusal to participate
• Benign bone tumor, such as osteoma, osteoid osteoma, osteochondroma, enchondroma, periosteal chondroma, chondroblastoma, chondromyxoid fibroma, chondromesenchymal hamartoma of the chest wall, or notochordal rest hyperplasia / benign notochordal cell tumor

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Related Publications (8)

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  PMID: 29627161 BACKGROUND

• Wagstaff A. Measuring catastrophic medical expenditures: Reflections on three issues. Health Econ. 2019 Jun;28(6):765-781. doi: 10.1002/hec.3881. Epub 2019 Apr 15.

  PMID: 30986890 BACKGROUND

• Liu M, Huang D, Liu Y. Financial toxicity of patients with lung cancer in China: Results from a National Survey Study. Cancer Med. 2023 Feb;12(4):4751-4760. doi: 10.1002/cam4.5244. Epub 2022 Sep 21.

  PMID: 36128854 BACKGROUND

• Xu K, Evans DB, Kawabata K, Zeramdini R, Klavus J, Murray CJ. Household catastrophic health expenditure: a multicountry analysis. Lancet. 2003 Jul 12;362(9378):111-7. doi: 10.1016/S0140-6736(03)13861-5.

  PMID: 12867110 BACKGROUND

• Wagstaff A, Flores G, Hsu J, Smitz MF, Chepynoga K, Buisman LR, van Wilgenburg K, Eozenou P. Progress on catastrophic health spending in 133 countries: a retrospective observational study. Lancet Glob Health. 2018 Feb;6(2):e169-e179. doi: 10.1016/S2214-109X(17)30429-1. Epub 2017 Dec 13.

  PMID: 29248367 BACKGROUND

• Qiu Z, Yao L, Jiang J. Financial toxicity assessment and associated factors analysis of patients with cancer in China. Support Care Cancer. 2023 Apr 14;31(5):264. doi: 10.1007/s00520-023-07714-6.

  PMID: 37058171 BACKGROUND

• Wheeler SB, Manning ML, Gellin M, Padilla N, Spees LP, Biddell CB, Petermann V, Deal A, Rogers C, Rodriguez-O'Donnell J, Samuel-Ryals C, Reeder-Hayes K, Rosenstein DL. Impact of a Comprehensive Financial Navigation Intervention to Reduce Cancer-Related Financial Toxicity. J Natl Compr Canc Netw. 2024 Oct;22(8):557-562. doi: 10.6004/jnccn.2024.7030.

  PMID: 39413831 BACKGROUND

• De Moor JS, Liang MI, Beauchemin MP, Glaser KM, Badr H, Yabroff KR, Fawzy Doran J, Majid A, Bell RA, Obeng-Gyasi S, Sampson A, Rhoades DA, Blinder V, Graves K, Park ER, Banegas MP, Pisu M, Kirchhoff AC, Wheeler SB, Rosenstein DL, Sadigh G, Edward JS, Bryant M, Jagsi R, Halpern M, You W, Nipp RD, Hershman DL, Henrikson NB. Opportunities and Challenges for Addressing Financial Hardship as an Integrated Part of Cancer Care Delivery. J Natl Cancer Inst. 2026 Mar 24:djag077. doi: 10.1093/jnci/djag077. Online ahead of print.

  PMID: 41875373 BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms; Treatment Adherence and Compliance; Caregiver Burden; Financial Stress

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Health Behavior; Behavior; Stress, Psychological; Behavioral Symptoms

Central Study Contacts

Hongtao Li

CONTACT

+86 21 64369181; Lhtmed@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Department of Medical Oncology

Model Details: Participants are randomized 1:1 to two parallel groups.

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 22, 2026
• Study Start: September 19, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 22, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)