Trial · NCT07888244
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Financial Toxicity Score | Baseline 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. |
| Secondary | Incidence of Catastrophic Health Expenditure | 6 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. |
| Secondary | Incidence of Cost-Related Treatment Non-Adherence | 6 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. |
| Secondary | Incidence of Cost-Coping Strategies | 6 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. |
| Secondary | Out-of-Pocket Costs as a Percentage of Annual Household Income | 6 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. |
| Secondary | Change in Caregiver Burden Score | Baseline, 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. |
| Secondary | Patient Satisfaction with Overall Care Score | 6 months and 12 months | Patient-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). |
| Other | Follow-up completion rate | 9 months | Proportion of participants who complete the post-surgical follow-up visits scheduled by their treating physician. |
| Other | Resolution rate of catastrophic health expenditure | 9 and 12 months | Proportion of participants who met the catastrophic health expenditure threshold at 9 months after enrollment and no longer met it at 12 months after enrollment. |
| Other | Decomposition of the reduction in out-of-pocket spending by payment channel | 6 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. |
| Other | Intervention adherence | Through 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. |
| Other | Success rate of resource linkage | Through 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. |
| Other | Payment plan execution rate | Through study completion, an average of 1 year | Number of components of the combined payment plan actually executed by the participant divided by the number planned, expressed as a percentage. |
| Other | Economic coping strategies count score | 6 and 9 months | Number 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. |
| Other | Recurrence-free survival and overall survival | 12 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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