Trial · NCT07909525
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of financial hardship | Baseline up to 6 months after randomization | Will be measured by Comprehensive Score for Financial Toxicity (FACIT-COST). Will calculate the difference in COST from baseline to 6-month follow-ups for adolescents and young adults (AYA) participants who provide data at each time point and use two-sample t-tests (two sided) to assess if mean differences are significantly different between arms. If the data are not normally distributed, nonparametric methods (e.g., Wilcoxon rank-sum test) will be used to assess the difference. To control for confounders, will fit linear regressions with the change of COST from baseline to 6-month follow-up as the response variable and age, race/ethnicity, socioeconomic status, disease type, sex, and other social determinants of health as covariates. Will stratify analysis by age stratum (18-25 years-old versus \[vs\] 26-39 years-old), sex, and race to minimize bias. |
| Primary | Change in health insurance literacy | Baseline up to 6 months after randomization | Will be measured by the Health Insurance Literacy Measure (HILM). The HILM co-primary endpoint will be analyzed restricted to AYA participants insured at baseline (modified intention to treat \[ITT\] for HILM), AYA participants with valid HILM-9 scores at baseline and 6 months. An ITT analysis using multiple imputation will be performed to handle missing HILM scores (including those for uninsured participants), with insurance status and other prespecified covariates included in the imputation model. |
| Secondary | Change of self-reported material financial hardship | Baseline up to 6 months after randomization | Will be assessed using Childhood Cancer Survivor Study Long-Term Follow-Up Survey that assess material subdomains of financial hardship. |
| Secondary | Change of self-reported psychological financial hardship | Baseline up to 6 months after randomization | Psychological financial hardship will be assessed using the applicable CCSS Long-Term Follow-Up Health Insurance Survey items. Item responses will be aggregated into a single domain-level ordinal measure based on the number of psychological hardship instances reported: 0, 1-2, or ≥3 instances. Change from baseline to 6 months will be compared between randomized arms. |
| Secondary | Change of self-reported behavioral aspects of financial hardship | Baseline up to 6 months after randomization | Behavioral financial hardship will be assessed using the 10 behavioral hardship items from the CCSS Long-Term Follow-Up Health Insurance Survey. Item responses will be aggregated into a single domain-level ordinal measure based on the number of behavioral hardship instances reported: 0, 1-2, or ≥3 instances. Change from baseline to 6 months will be compared between randomized arms. |
| Secondary | Change of self-reported material financial hardship | Baseline up to 12 months after randomization | Material financial hardship will be assessed using the 9 material hardship items from the CCSS Long-Term Follow-Up Health Insurance Survey. Item responses will be aggregated into a single domain-level ordinal measure based on the number of material hardship instances reported: 0, 1-2, or ≥3 instances. Longitudinal change in this measure from baseline through 12 months will be compared between randomized arms. |
| Secondary | Change of self-reported psychological financial hardship | Baseline up to 12 months after randomization | Psychological financial hardship will be assessed using the applicable CCSS Long-Term Follow-Up Health Insurance Survey items. Item responses will be aggregated into a single domain-level ordinal measure based on the number of psychological hardship instances reported: 0, 1-2, or ≥3 instances. Longitudinal change in this measure from baseline through 12 months will be compared between randomized arms. |
| Secondary | Change of self-reported behavioral aspects of financial hardship | Baseline up to 12 months after randomization | Behavioral financial hardship will be assessed using the 10 behavioral hardship items from the CCSS Long-Term Follow-Up Health Insurance Survey. Item responses will be aggregated into a single domain-level ordinal measure based on the number of behavioral hardship instances reported: 0, 1-2, or ≥3 instances. Longitudinal change in this measure from baseline through 12 months will be compared between randomized arms. |
| Secondary | Barriers and facilitators of LIFT UP implementation | Up to 13 months after randomization | Assessed via qualitative interviews with AYA participants and non-patient participants. Analysis will be guided by a codebook informed by the Consolidated Framework for Implementation Research and the Theoretical Domains Framework and conducted in Atlas.ti, a multifunctional qualitative data analysis software |
| Other | Proportion of application and approval for financial assistance | At 3, 6, and 12 months after randomization | Will be assessed using Supportive Services (Consumer Cancer Care) questionnaire. The proportions of applications and approval for financial assistance will be calculated at 3-, 6-, and 12-month follow up time points by arm. |
| Other | Health service utilization of emergency departments | At 3, 6, and 12 months after randomization | Will be assessed using Health Service Utilization questionnaire. The number and proportion of AYA participants using the service will be calculated at each time point (e.g., 3, 6, 12 months) by arm. |
| Other | Scheduled and unscheduled hospital admissions | At 3, 6, and 12 months after randomization | Will be assessed using Health Service Utilization questionnaire. The number and proportion of AYA participants using the service will be calculated at each time point (e.g., 3, 6, 12 months) by arm. |
| Other | Scheduled office visits | At 3, 6, and 12 months after randomization | Will be assessed using Health Service Utilization questionnaire. The number and proportion of AYA participants using the service will be calculated at each time point (e.g., 3, 6, 12 months) by arm. |
| Other | Urgent care visits | At 3, 6, and 12 months after randomization | Will be assessed using Health Service Utilization questionnaire. The number and proportion of AYA participants using the service will be calculated at each time point (e.g., 3, 6, 12 months) by arm. |
| Other | Proportion of self-reported return to work or school | At 3, 6, and 12 months after randomization | Will be assessed using Sociodemographic Follow-up questionnaire. The proportion of AYA participants reporting a return to work or school will be calculated at each follow-up (e.g., 3, 6, and 12 months) by arm. |
| Other | Social determinants of health and self-reported financial hardship and health service utilization | Up to 12 months after randomization | Model the effects of financial self-efficacy, health insurance literacy, social determinants of health, clinical, and site variables on financial hardship. Mediation models will include covariates associated with financial hardship. Individual indirect effects of the mediators and total effect will be estimated. |
| Other | Social determinants of health, clinical, and institutional variables | Up to 12 months after randomization | Model the effects of supportive Services (Consumer Cancer Care), Health Service Utilization, and Social determinants of health, clinical, and site variables on financial hardship. Mediation models will include interaction terms between supportive services and patient/institution characteristics (e.g., social determinants of health, insurance type, treatment site). |
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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