Effect of medical payment case management service on financial toxicity and catastrophic health expenditure in patients with bone tumors

NCT ID NCT07888244

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Recruiting now This study
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Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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First seen Oct 22, 2026 · Last updated Oct 22, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed primary bone tumor, with surgery planned at Shanghai Sixth People's Hospital 2. Registered on the whole-course patient management program of the hospital's Comprehensive Oncology Center (COC) 3. Able to complete the study questionnaires, either independently or with assistance from a parent 4. 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 Exclusion Criteria: 1. Secondary or metastatic bone tumor 2. Cognitive impairment or psychiatric illness that prevents completion of the questionnaires 3. Surgery is not the main treatment modality 4. Refusal to participate 5. 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

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Conditions

The condition(s) this trial relates to.

bone cancer bone neoplasm Caregiver Burden Financial Stress Treatment Adherence and Compliance

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Shanghai Sixth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200233, China

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