Advanced CancerPROOFNCT06963723
Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer
A study testing Financial Hardship Screening in people with Advanced Cancer and Metastatic Cancer, run by Alliance Foundation Trials, LLC. at 7 sites in 2 countries.
Trial summary
The study aims to determine whether monthly remote digital financial hardship screening among adults with advanced/metastatic cancer, undergoing outpatient systemic therapy with non-curative intent, improves patient-centered outcomes, including financial worry, health-related quality of life (HRQoL), symptom burden… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer
- What is being tested?
- Financial Hardship Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 Jul 2025to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 21
- Understands English and/or Spanish
- Has a diagnosis of advanced/metastatic cancer
- Currently undergoing systemic therapy (enteral or parenteral) with non-curative intent
- Has been receiving treatment for at least 2 months
- Life expectancy of at least 6 months, in the opinion of the treating oncologist
- Cognitively able to give informed consent
Who cannot join
- Under the age of 21
- Does not understand English or Spanish
- Has cognitive deficits that would preclude understanding of consent form and/or questionnaires
- Undergoing treatment with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer, primary curative therapy for testis cancer or lymphoma)
- Not undergoing systemic therapy (enteral or parenteral) with non-curative intent
- Receiving treatment for fewer than 2 months
- Life expectancy is less than 6 months, in the opinion of the treating oncologist
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
AFT Quality Management Group Inbox contact
7 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
New Hampshire Oncology-Hematology, PA
Concord, New Hampshire, 03301
- Recruiting
Sanford Health
Fargo, North Dakota, 58102
Samuel Milanovitch, MD, 701-234-6161, samuel.milanovich@sanfordhealth.org
- Recruiting
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103
- Recruiting
New York City Health and Hospitals
New York, New York, 10004
Debra Ferman, MD, FERMAND@nychhc.org
- Recruiting
Dignity Health
Phoenix, Arizona, 85004
Vamsee Torri, MD, vamsee.torri@commonspirit.org
- Recruiting
Gibbs Cancer Center
Spartanburg, South Carolina, 29303
Amarinthia Curtis, MD, 864-560-6812, acurtis@gibbscc.org
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Center for Oncology Trials
San Juan, 00935
Marcia Cruz-Correa, MD, marcia.cruzcorrea@panoncologytrials.com
About this study
The study aims to determine whether monthly remote digital financial hardship screening among adults with advanced/metastatic cancer, undergoing outpatient systemic therapy with non-curative intent, improves patient-centered outcomes, including financial worry, health-related quality of life (HRQoL), symptom burden, patient-reported cancer treatment adherence, and exploratory outcomes of overall survival, patient-reported economic burden, patient-reported support received, patient-reported financial coping strategies, and health insurance literacy.
Read the detailed description
Financial hardship is a common problem that affects patients treated for advanced cancer and leads to poor outcomes related to financial worry, health related quality of life (HRQoL), symptom burden, treatment adherence, and overall survival. Prior studies have shown that financial navigation may be an effective strategy to attenuate the impact of financial hardship. However, patients and clinicians have identified communication as a key barrier that prevents patients from being connected to sources of financial assistance. To address this critical gap in patient care, and based on strong preliminary data that financial hardship screening may improve patient outcomes, this financial hardship screening intervention will help connect patients to financial navigation resources. It is hypothesized that by connecting patients experiencing financial hardship with financial navigation resources, this intervention will lead to improved patient-centered outcomes.
- Conditions
- Advanced Cancer, Metastatic Cancer
- Being tested
- Financial Hardship Screening, Enhanced Usual Care
- Keywords
- Financial Toxicity
- Medical subject headings
- Neoplasm Metastasis, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Hardship ScreeningOther
Financial Hardship Screening and Financial Needs Assessment
Enhanced Usual CareOther
Enhanced Usual Care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants randomized to the intervention arm will complete their monthly screening using the single-item screening question (every 4 weeks for 12 months). Receives: Other: Financial Hardship Screening |
| Enhanced Usual Care | Active comparator | Participants randomized to receive enhanced usual care will not be systematically screened for financial hardship through the electronic PRO Core system. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Financial Worry
Patient-reported financial worry will be measured by the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) total scale.
Possible score range: 0 to 44, with higher scores indicating better outcomes
Measured: 6 months
Secondary outcomes (3)
Health-related quality of life
Patient-reported health-related quality of life will be measured by the Functional Assessment of Cancer Therapy-General (FACT-G) total scale.
Possible score range: 0 to 108, with higher scores indicating better outcomes
Measured: 6 months
Symptom burden
Patient-reported symptom burden will be measured by the Functional Assessment of Cancer Therapy-General (FACT-G) physical well-being scale.
Possible score range: 0 to 28, with higher scores indicating better outcomes
Measured: 6 months
Cancer treatment adherence
Patient-reported cancer treatment adherence will be measured by the Domains of Subjective Extent of Nonadherence-Cancer (DOSE-Nonadherence-Cancer) extent of nonadherence scale, with patients classified as adherent (i.e., all responses of "none of the time" on the DOSE-Nonadherence-Cancer items for missing, skipping, or not taking a dose of medicine) versus nonadherent
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Jul 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance Foundation Trials, LLC.
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Victoria Blinder, MD, MSc, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963723
- Sponsor's protocol ID
- A232403
- Acronym
- PROOF
- Status last verified
- May 2026
- First submitted
- 1 Apr 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT06963723
- Acronym / sponsor ID
- PROOF / A232403
- Conditions
- Advanced Cancer, Metastatic Cancer
- Keywords
- Financial Toxicity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Alliance Foundation Trials, LLC.University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine whether monthly remote digital financial hardship screening among adults with advanced/metastatic cancer, undergoing outpatient systemic therapy with non-curative intent, improves patient-centered outcomes, including financial worry, health-related quality of life (HRQoL), symptom burden, patient-reported cancer treatment adherence, and exploratory outcomes of overall survival, patient-reported economic burden, patient-reported support received, patient-reported financial coping strategies, and health insurance literacy.
Detailed description
Financial hardship is a common problem that affects patients treated for advanced cancer and leads to poor outcomes related to financial worry, health related quality of life (HRQoL), symptom burden, treatment adherence, and overall survival. Prior studies have shown that financial navigation may be an effective strategy to attenuate the impact of financial hardship. However, patients and clinicians have identified communication as a key barrier that prevents patients from being connected to sources of financial assistance. To address this critical gap in patient care, and based on strong preliminary data that financial hardship screening may improve patient outcomes, this financial hardship screening intervention will help connect patients to financial navigation resources. It is hypothesized that by connecting patients experiencing financial hardship with financial navigation resources, this intervention will lead to improved patient-centered outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Financial Hardship ScreeningParticipants randomized to the intervention arm will complete their monthly screening using the single-item screening question (every 4 weeks for 12 months). |
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareParticipants randomized to receive enhanced usual care will not be systematically screened for financial hardship through the electronic PRO Core system. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Minimum age of 21
- Understands English and/or Spanish
- Has a diagnosis of advanced/metastatic cancer
- Currently undergoing systemic therapy (enteral or parenteral) with non-curative intent
- Has been receiving treatment for at least 2 months
Key exclusion criteria (7 listed)
- Under the age of 21
- Does not understand English or Spanish
- Has cognitive deficits that would preclude understanding of consent form and/or questionnaires
- Undergoing treatment with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer, primary curative therapy for testis cancer or lymphoma)
- Not undergoing systemic therapy (enteral or parenteral) with non-curative intent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial Hardship ScreeningFinancial Hardship Screening and Financial Needs Assessment | Other | Intervention |
| Enhanced Usual CareEnhanced Usual Care | Other | Enhanced Usual Care |
Primary outcome
Financial Worry
Time frame: 6 months
Patient-reported financial worry will be measured by the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) total scale. Possible score range: 0 to 44, with higher scores indicating better outcomes
3 secondary outcomes
Health-related quality of life
Time frame: 6 months
Symptom burden
Time frame: 6 months
Cancer treatment adherence
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AFT Quality Management Group Inbox contact
Victoria Blinder, MD, MSc principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Hardship Screening in people with Advanced Cancer and Metastatic Cancer, run by Alliance Foundation Trials, LLC. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AFT Quality Management Group Inbox (617-732-8727, clinicaltrials.queries@alliancefoundationtrials.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Financial Worry (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.