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Trial · NCT07888244

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Financial Toxicity ScoreBaseline and 6 months
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.
SecondaryIncidence of Catastrophic Health Expenditure6 months and 9 months
Catastrophic health expenditure is defined as cumulative out-of-pocket medical costs of 10% or more of annual household income. Out-of-pocket costs are obtained from hospital billing and settlement records and from patient-reported out-of-hospital spending; annual household income is self-reported at baseline. Incidence is the number of patients meeting the threshold divided by the group total.
SecondaryIncidence of Cost-Related Treatment Non-Adherence6 months and 9 months
Proportion of patients who, because of treatment costs, downgraded their prosthesis or reconstruction, abandoned treatment, interrupted rehabilitation, or reduced chemotherapy. Assessed with a structured questionnaire administered at follow-up visits.
SecondaryIncidence of Cost-Coping Strategies6 months and 9 months
Proportion of patients reporting at least one of seven cost-coping behaviors: considering abandoning treatment, delaying treatment by more than 7 days, not taking medication as prescribed, missing follow-up visits, reducing leisure spending, reducing basic medical service spending, and borrowing money or taking loans because of illness. Assessed with a seven-item yes/no questionnaire.
SecondaryOut-of-Pocket Costs as a Percentage of Annual Household Income6 months
Cumulative out-of-pocket medical costs divided by annual household income, expressed as a percentage. Costs are collected from hospital billing and settlement records and from patient-reported out-of-hospital expenses; annual household income is self-reported at baseline.
SecondaryChange in Caregiver Burden ScoreBaseline, 6 months, 9 months, and 12 months
Caregiver burden is assessed with the 12-item Zarit Burden Interview (ZBI-12). Each item is scored 0-4, giving a total score of 0-48, with higher scores indicating greater burden. Reported as the change in total score from baseline.
SecondaryPatient Satisfaction with Overall Care Score6 months and 12 monthsPatient-rated satisfaction with the overall care received during the study, on an 11-point numeric rating scale from 0 (least satisfied) to 10 (most satisfied).
OtherFollow-up completion rate9 monthsProportion of participants who complete the post-surgical follow-up visits scheduled by their treating physician.
OtherResolution rate of catastrophic health expenditure9 and 12 monthsProportion of participants who met the catastrophic health expenditure threshold at 9 months after enrollment and no longer met it at 12 months after enrollment.
OtherDecomposition of the reduction in out-of-pocket spending by payment channel6 and 9 months
For each payment channel - basic medical insurance secondary reimbursement, critical illness insurance, supplemental medical insurance, charity assistance, commercial insurance claims, pharmaceutical company assistance, social assistance, compliant fundraising, and the pediatric catastrophic illness assistance program - the amount contributed to the reduction in out-of-pocket spending and its share of the total reduction.
OtherIntervention adherenceThrough study completion, an average of 1 year
Proportion of participants in the payment service group who actually received at least three sessions of the medical payment case management service, together with the completion rate of each of the seven service steps.
OtherSuccess rate of resource linkageThrough study completion, an average of 1 year
Proportion of applications successfully linked to each payment channel, reported separately by channel, including the submission rate of pharmaceutical company assistance applications, the rate at which critical illness insurance secondary reimbursement is received, and the completion rate of commercial insurance claims.
OtherPayment plan execution rateThrough study completion, an average of 1 yearNumber of components of the combined payment plan actually executed by the participant divided by the number planned, expressed as a percentage.
OtherEconomic coping strategies count score6 and 9 monthsNumber of the seven economic coping strategies items answered "yes" by the participant, ranging from 0 to 7, described as a continuous variable and compared between groups.
OtherRecurrence-free survival and overall survival12 months
Recurrence or progression and death events are recorded together with their dates, and recurrence-free survival and overall survival are calculated. Given the limited power of a 12-month follow-up, these are reported as exploratory descriptions using Kaplan-Meier estimates.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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