An interventional study of Best Practice and Educational Intervention in Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, sponsored by ECOG-ACRIN Cancer Research Group. Not yet recruiting. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by ECOG-ACRIN Cancer Research Group · Not applicable, Interventional, and Health services research
This clinical trial addresses the financial hardship among adolescent and young adult (AYA) survivors using the new Lessening the Impact of Financial Toxicity (LIFT) UP intervention. AYAs with cancer experience significant and prolonged disruption in their lives due to their diagnosis and are at greater risk of financial hardship than any other age group with cancer. For AYA patients, health insurance literacy - one's ability to make informed decisions about choosing and using health insurance - is likely an essential component of being able to navigate care and manage costs. A promising strategy for addressing AYA financial hardship is to streamline existing, successful interventions into a single multilevel intervention. More specifically, combining patient education from a health insurance literacy intervention called CHAT (Let's CHAT about health insurance), which helps to address the book knowledge with organization support and financial navigation from an intervention called LIFT, which addresses the experiential knowledge could yield positive outcomes for AYAs. The addition of LIFT UP to usual care may improve AYA access to financial resources and reduce medical costs and distress associated with financial hardship.
PRIMARY OBJECTIVES:
I. To compare the change of self-reported financial hardship from baseline to 6-month follow-up between arms.
II. To compare the change of self-reported health insurance literacy from baseline to 6-month follow-up between arms.
SECONDARY OBJECTIVES:
I. To compare the change of self-reported material financial hardship from baseline to 6-month follow-up between arms.
II. To compare the change of self-reported psychological financial hardship from baseline to 6-month follow-up between arms.
III. To compare the change of self-reported behavioral aspects of financial hardship from baseline to 6-month follow-up between arms.
IV. To assess longitudinal changes of self-reported outcomes (financial hardship, health insurance literacy, material financial hardship, psychological financial hardship, behavioral aspects of financial hardship) from baseline to 12-month follow-up between arms.
V. To identify barriers and facilitators of LIFT UP implementation through qualitative interviews with AYA participants and non-patient participants (National Cancer Institute Community Oncology Research Program [NCORP] staff).
EXPLORATORY OBJECTIVES:
I. To determine proportion of application and approval for financial assistance at 3-, 6-, and 12- month follow-up by arm.
II. To evaluate health service utilization of emergency departments, scheduled and unscheduled hospital admissions, scheduled office visits, and urgent care visits over the duration of the study by arm.
III. To determine proportion of self-reported return to work or school at each of the follow-up assessments by arm.
IV. To assess whether behavioral self-management and health insurance literacy mediate the impact of social determinants of health, as well as clinical and institutional variables, on self-reported financial hardship and health service utilization. V. To assess whether supportive services moderate the relationship between social determinants of health, clinical and institutional variables, and self-reported financial hardship and health service utilization.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (LIFT UP): Patients receive an intervention booklet and attend virtual interactive sessions comprising CHAT and LIFT via videoconference over 60 minutes biweekly for up to 4 sessions. Patients may attend additional sessions if needed. Patients are followed up at 3, 6, and 12 months. Patients may optionally attend a virtual interview over 60 minutes after completion of 12 month survey.
ARM II (USUAL CARE): Patients receive usual care. Patients are followed up at 3, 6, and 12 months.
285 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 54 are open to participants now.
This study's planned enrollment of 448 is above the median of 66 across 207 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →ECOG-ACRIN Cancer Research Group is the lead sponsor of 122 studies on the registry; 16 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Participant must be one or more of the following:
Participant must have completed curative intent therapy
Participant must have a personal email address and private access to the internet (via smartphone, tablet, or computer)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive an intervention booklet and attend virtual interactive sessions comprising CHAT and LIFT via videoconference over 60 minutes biweekly for up to 4 sessions. Patients may attend additional sessions if needed. Patients are followed up at 3, 6, and 12 months. Patients may optionally attend a virtual interview over 60 minutes after completion of 12 month survey.
Other: Educational Intervention · Other: Informational Intervention · Other: Interview · Other: Survey Administration
Patients receive usual care. Patients are followed up at 3, 6, and 12 months.
Other: Best Practice · Other: Survey Administration
Receive usual care
Also known as: standard of care, standard therapy
Receive CHAT and LIFT intervention via videoconference
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive intervention booklet
Attend a virtual interview
Ancillary studies
Change of financial hardship
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.
Time frame: Baseline up to 6 months after randomization
Change in health insurance literacy
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.
Time frame: Baseline up to 6 months after randomization
Change of self-reported material financial hardship
Will be assessed using Childhood Cancer Survivor Study Long-Term Follow-Up Survey that assess material subdomains of financial hardship.
Time frame: Baseline up to 6 months after randomization
Change of self-reported psychological financial hardship
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.
Time frame: Baseline up to 6 months after randomization
Change of self-reported behavioral aspects of financial hardship
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.
Time frame: Baseline up to 6 months after randomization
Change of self-reported material financial hardship
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.
Time frame: Baseline up to 12 months after randomization
Change of self-reported psychological financial hardship
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.
Time frame: Baseline up to 12 months after randomization
Change of self-reported behavioral aspects of financial hardship
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.
Time frame: Baseline up to 12 months after randomization
Barriers and facilitators of LIFT UP implementation
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
Time frame: Up to 13 months after randomization
Proportion of application and approval for financial assistance
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.
Time frame: At 3, 6, and 12 months after randomization
Health service utilization of emergency departments
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.
Time frame: At 3, 6, and 12 months after randomization
Scheduled and unscheduled hospital admissions
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.
Time frame: At 3, 6, and 12 months after randomization
Scheduled office visits
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.
Time frame: At 3, 6, and 12 months after randomization
Urgent care visits
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.
Time frame: At 3, 6, and 12 months after randomization
Proportion of self-reported return to work or school
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.
Time frame: At 3, 6, and 12 months after randomization
Social determinants of health and self-reported financial hardship and health service utilization
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.
Time frame: Up to 12 months after randomization
Social determinants of health, clinical, and institutional variables
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).
Time frame: Up to 12 months after randomization
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Intraductal, Noninfiltrating →
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