Trial Outcomes & Findings for Characterizing and Addressing Financial Toxicity in AYAs With Cancer (NCT NCT06072833)
NCT ID: NCT06072833
Last Updated: 2026-03-16
Results Overview
This is to assess the feasibility of intervention completion. Intervention completion is defined as participants who have demonstrated contact with community partners at any time before the end of 6 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2026-03-16
Participant Flow
Only patients were considered to be enrolled in this study. The enrollment number and number of participants completed represents only patients.
Participant milestones
| Measure |
Participants Eligible (Screed Positive)
Individuals who screen positive will move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months.
Patient Financial Education / Navigation: The investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Participants Eligible (Screed Positive)
Individuals who screen positive will move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months.
Patient Financial Education / Navigation: The investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
Baseline Characteristics
Characterizing and Addressing Financial Toxicity in AYAs With Cancer
Baseline characteristics by cohort
| Measure |
Participants Eligible (Screened Positive)
n=26 Participants
Individuals who screen positive will all move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months.
Patient Financial Education / Navigation: The investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Only AYAs that received the intervention were analyzed for this outcome.
This is to assess the feasibility of intervention completion. Intervention completion is defined as participants who have demonstrated contact with community partners at any time before the end of 6 months.
Outcome measures
| Measure |
Participants Eligible (Screened Positive)
n=23 Participants
Individuals who screen positive will move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months.
Patient Financial Education / Navigation: The investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation.
|
|---|---|
|
Number of Participants Who Completed the Intervention
|
21 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsThis is to measure interest and the need for help by community partners that can provide patient financial education and navigation.
Outcome measures
| Measure |
Participants Eligible (Screened Positive)
n=26 Participants
Individuals who screen positive will move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months.
Patient Financial Education / Navigation: The investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation.
|
|---|---|
|
Number of Eligible Participants Who Received the Intervention
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: COST scores were analyzed for just those that received the intervention and completed both timepoints (baseline and 6-month).
The COST is a patient-reported outcome measure that describes the financial distress experienced by cancer patients. It is a 11-item questionnaire with a score range of 0-44. Lower COST values indicate higher toxicity. Higher scores indicate lower financial toxicity .
Outcome measures
| Measure |
Participants Eligible (Screened Positive)
n=15 Participants
Individuals who screen positive will move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months.
Patient Financial Education / Navigation: The investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation.
|
|---|---|
|
Comprehensive Score of Financial Toxicity (COST Measure) Score
Baseline
|
10.47 score on a scale
Standard Deviation 4.78
|
|
Comprehensive Score of Financial Toxicity (COST Measure) Score
6 months
|
16.53 score on a scale
Standard Deviation 8.58
|
Adverse Events
Participants Eligible (Screed Positive)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melissa Beauchemin
Columbia University School Of Nursing
Phone: 212-342-4111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place