Trial Outcomes & Findings for Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment (NCT NCT03516942)

Last Updated: 2025-11-12

Results Overview

The Comprehensive Score for Financial Toxicity (COST) COST is an 11-item patient-reported outcome (PRO) of financial hardship that uses a 7-day time window and 5-point Likert response scale (ranging from 0, indicating not at all, to 4, very much). Higher COST scores (range, 0-44) represent better financial well-being. The primary objective is to evaluate the change in the level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months from study registration. (12 mo - baseline)

Recruitment status

ACTIVE_NOT_RECRUITING

Target enrollment

565 participants

Primary outcome timeframe

Baseline and 12 months after cancer diagnosis

Results posted on

2025-11-12

Participant Flow

This was a, longitudinal cohort study of financial burden in patients with colon, rectal, or rectosigmoid junction cancer. Measurements of financial burden (COST score) were collected at 5 time points over a 24-month follow-up period. Surveys were completed both by sites, to identify available clinical resources, and by participants, to assess the QoL and cost. The primary endpoint of this study was the change of the COST score from the baseline measurement to the 12-month follow-up (FU).

Participant milestones

Participant milestones
Measure	Observational (questionnaire) Patients submitted questionnaires assessing financial burden
T0: Baseline NOT COMPLETED	13
Registration through baseline survey com STARTED	565
Registration through baseline survey com Activated Surveys	463
Registration through baseline survey com COMPLETED	463
Registration through baseline survey com NOT COMPLETED	102
T0: Baseline STARTED	463
T0: Baseline Submitted T0 baseline survey	450
T0: Baseline COMPLETED	450
T1: 3 Months Survey STARTED	450
T1: 3 Months Survey Submitted T0 and T1 surveys	264
T1: 3 Months Survey COMPLETED	264
T1: 3 Months Survey NOT COMPLETED	186
T2: 6 Month Survey STARTED	450
T2: 6 Month Survey Completed T0 and T2 surveys	241
T2: 6 Month Survey Completed T0, T1, and T2 surveys	203
T2: 6 Month Survey COMPLETED	241
T2: 6 Month Survey NOT COMPLETED	209
T3: 12 Month Survey STARTED	450
T3: 12 Month Survey Completed T0 and T3 surveys	207
T3: 12 Month Survey Completed T0, T1, T2 and T3 surveys	151
T3: 12 Month Survey COMPLETED	207
T3: 12 Month Survey NOT COMPLETED	243

Reasons for withdrawal

Reasons for withdrawal
Measure	Observational (questionnaire) Patients submitted questionnaires assessing financial burden
Registration through baseline survey com Withdrawal by Subject	36
Registration through baseline survey com Death	8
Registration through baseline survey com Could not contact patient after enrollment	58
T0: Baseline LOST	13
T1: 3 Months Survey Withdrawal by Subject	13
T1: 3 Months Survey Death	10
T1: 3 Months Survey Lost	163
T2: 6 Month Survey Withdrawal by Subject	15
T2: 6 Month Survey Death	14
T2: 6 Month Survey Lost	180
T3: 12 Month Survey Withdrawal by Subject	15
T3: 12 Month Survey Death	19
T3: 12 Month Survey Lost	209

Baseline Characteristics

Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observational (Questionnaire) n=450 Participants Patients complete questionnaires to assess financial burden
Age, Continuous	61.0 years STANDARD_DEVIATION 12.0 • n=10 Participants
Sex: Female, Male Female	210 Participants n=10 Participants
Sex: Female, Male Male	240 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	424 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=10 Participants
Race (NIH/OMB) Asian	21 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=10 Participants
Race (NIH/OMB) Black or African American	33 Participants n=10 Participants
Race (NIH/OMB) White	379 Participants n=10 Participants
Race (NIH/OMB) More than one race	4 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=10 Participants
Employment Employed	214 Participants n=10 Participants
Employment Retired	153 Participants n=10 Participants
Employment Unemployed	77 Participants n=10 Participants
Employment Not Answered	6 Participants n=10 Participants
Cancer Type Colon Cancer	289 Participants n=10 Participants
Cancer Type Rectal Cancer	140 Participants n=10 Participants
Cancer Type Rectosigmoid Junction	21 Participants n=10 Participants
Cancer Stage at Enrollment Stage l	68 Participants n=10 Participants
Cancer Stage at Enrollment Stage lI	140 Participants n=10 Participants
Cancer Stage at Enrollment Stage III	242 Participants n=10 Participants
Chemotherapy Schedule Chemotherapy	267 Participants n=10 Participants
Chemotherapy No Chemtherapy	183 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months after cancer diagnosis

Outcome measures

Outcome measures
Measure	T0: Observational (questionnaire) n=241 Participants Patients with complete questionnaires to assess financial burden at baseline	T2:Observational (questionnaire) n=241 Participants Patients with complete questionnaires to assess financial burden at 12 months	12-month questionnaire Patient questionnaires completed at 12 months after cancer diagnosis.	24-month questionnaire Patient questionnaires completed at 24 months after cancer diagnosis.
Comprehensive Score for Financial Toxicity (COST)	23.5 score on a scale Standard Deviation 11.9	28.6 score on a scale Standard Deviation 11.7	—	—

SECONDARY outcome

Timeframe: Up to 12 months

Will evaluate reported access and utilization of financial services (i.e. financial counselor, navigator, social workers) and its association to financial burden in the first 12 months after diagnosis of colon or rectal cancer treated with curative-intent. Will be assessed by Consumer Based Cancer Care Value Index (CCVI). For the continuous item variable, will conduct the paired t test to examine the difference if the distribution is normal. If not normally distributed, Wilcoxon signed rank test will be used. For the categorical item variable, the paired proportion test (e.g., McNemar test) will be used instead. The association between CCVI and COST measures will be evaluated using the Pearson or Spearman correlation coefficient.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6, 12, and 24 months after cancer diagnosis

Change in level of self-reported employment limitations from baseline to 6, 12 and 24 months after study registration will be assessed by Work Productivity and Activity Impairment Questionnaire for a Specific Health Problem (WPAI:SHP). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as follows: Questions: 1. = currently employed 2. = hours missed due to specified problem 3. = hours missed other reasons 4. = hours actually worked 5. = degree problem affected productivity while working 6. = degree problem affected regular activities Scores: Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4) Percent impairment while working due to problem: Q5/10 Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))x(Q5/10)\] Percent activity impairment due to problem: Q6/10

Outcome measures

Outcome measures
Measure	T0: Observational (questionnaire) n=192 Participants Patients with complete questionnaires to assess financial burden at baseline	T2:Observational (questionnaire) n=69 Participants Patients with complete questionnaires to assess financial burden at 12 months	12-month questionnaire n=60 Participants Patient questionnaires completed at 12 months after cancer diagnosis.	24-month questionnaire n=57 Participants Patient questionnaires completed at 24 months after cancer diagnosis.
Change in Level of Self-reported Employment Limitations Work Time Missed	39.7 percentage of activity impaired Standard Deviation 39.3	18.2 percentage of activity impaired Standard Deviation 30.7	4.8 percentage of activity impaired Standard Deviation 16.1	6.1 percentage of activity impaired Standard Deviation 18.0
Change in Level of Self-reported Employment Limitations Impairment of Activities at Work	20.8 percentage of activity impaired Standard Deviation 33.4	28.1 percentage of activity impaired Standard Deviation 33.0	14.0 percentage of activity impaired Standard Deviation 24.6	14.4 percentage of activity impaired Standard Deviation 22.3
Change in Level of Self-reported Employment Limitations Overall Work Impairment	51.8 percentage of activity impaired Standard Deviation 37.5	36.6 percentage of activity impaired Standard Deviation 36.6	17.8 percentage of activity impaired Standard Deviation 28.0	19.1 percentage of activity impaired Standard Deviation 26.8
Change in Level of Self-reported Employment Limitations Impairment of Activities Outside of Work	33.2 percentage of activity impaired Standard Deviation 31.8	31.3 percentage of activity impaired Standard Deviation 31.9	17.0 percentage of activity impaired Standard Deviation 25.8	15.8 percentage of activity impaired Standard Deviation 24.2

SECONDARY outcome

Timeframe: Baseline, 6, 12, and 24 months after cancer diagnosis

Outcome measures

Outcome measures
Measure	T0: Observational (questionnaire) n=192 Participants Patients with complete questionnaires to assess financial burden at baseline	T2:Observational (questionnaire) n=69 Participants Patients with complete questionnaires to assess financial burden at 12 months	12-month questionnaire n=60 Participants Patient questionnaires completed at 12 months after cancer diagnosis.	24-month questionnaire n=57 Participants Patient questionnaires completed at 24 months after cancer diagnosis.
Level of Self-reported Employment Limitations (Dichotomized) Impairment of Activities at Work · Impaired ( score >50%)	139 Participants	47 Participants	51 Participants	49 Participants
Level of Self-reported Employment Limitations (Dichotomized) Impairment of Activities Outside of Work · Impaired ( score >50%)	121 Participants	47 Participants	49 Participants	48 Participants
Level of Self-reported Employment Limitations (Dichotomized) Work Time Missed · Impaired ( score <=50%)	68 Participants	14 Participants	2 Participants	3 Participants
Level of Self-reported Employment Limitations (Dichotomized) Work Time Missed · Impaired ( score >50%)	124 Participants	55 Participants	58 Participants	54 Participants
Level of Self-reported Employment Limitations (Dichotomized) Impairment of Activities at Work · Impaired ( score <=50%)	53 Participants	22 Participants	9 Participants	8 Participants
Level of Self-reported Employment Limitations (Dichotomized) Overall Work Impairment · Impaired ( score >50%)	93 Participants	40 Participants	49 Participants	47 Participants
Level of Self-reported Employment Limitations (Dichotomized) Overall Work Impairment · Impaired ( score <=50%)	99 Participants	29 Participants	11 Participants	10 Participants
Level of Self-reported Employment Limitations (Dichotomized) Impairment of Activities Outside of Work · Impaired ( score <=50%)	71 Participants	22 Participants	11 Participants	9 Participants

SECONDARY outcome

Timeframe: At 24 months

Will evaluate long term outcomes at 24 months after diagnosis for adherence to clinical follow-up guidelines. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 24 months

Will evaluate long term outcomes at 24 months after diagnosis for financial burden. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time and also the effects of cancer type, stage, treatment plan and demographics, etc. on financial burden. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 24 months

Will evaluate long term outcomes at 24 months after diagnosis for employment limitations. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 12 months

Will evaluate the change of QoL from baseline to 12 months and its association with predictors. Will be evaluated by Functional Assessment of Cancer Therapy-General.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and12 months

Population: participants who completed both the baseline and 12 month EORTC questionnaire

Financial Burden was evaluated using a single item from European Organization for Research and Treatment of Cancer Questionnaire 30 \[EORT30\]) with responses for both baseline and 12 months EORTC30 question: Has your physical condition or medical treatment caused you financial difficulties? * Not at all * A little * Quite a bit * Very much with higher values indicating greater financial difficulty (burden) Responses were dichotomized into No difficulty ("Not at All" ) and some difficulty ( "A little", "Quite a bit", or "Very much")

Outcome measures

Outcome measures
Measure	T0: Observational (questionnaire) n=91 Participants Patients with complete questionnaires to assess financial burden at baseline	T2:Observational (questionnaire) n=114 Participants Patients with complete questionnaires to assess financial burden at 12 months	12-month questionnaire Patient questionnaires completed at 12 months after cancer diagnosis.	24-month questionnaire Patient questionnaires completed at 24 months after cancer diagnosis.
Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC] No difficulty ("Not at All" ) at 12 months	74 Participants	34 Participants	—	—
Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC] Some Difficulty ( "A little", "Quite a bit", or "Very much") at 12 Months	17 Participants	80 Participants	—	—

Adverse Events

before completing any questionaire

Serious events: 13 serious events

Other events: 0 other events

Deaths: 13 deaths

Observational (questionnaire) baseline questionnaire

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Observational (questionnaire) 3 months

Serious events: 4 serious events

Other events: 0 other events

Deaths: 5 deaths

Observational (questionnaire) 6 months

Serious events: 4 serious events

Other events: 0 other events

Deaths: 5 deaths

Observational (questionnaire) 12 months

Serious events: 12 serious events

Other events: 0 other events

Deaths: 4 deaths

Observational (questionnaire) 24 months

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	before completing any questionaire n=57 participants at risk Patients registered for participation but off study before completing any study questionnaire: Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Observational (questionnaire) baseline questionnaire n=455 participants at risk All Patients complete questionnaires over 20-60 minutes after cancer diagnosis at baseline Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Observational (questionnaire) 3 months n=301 participants at risk All Patients complete questionnaires over 20-60 minutes at 3 months after cancer diagnosis. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Observational (questionnaire) 6 months n=272 participants at risk All Patients complete questionnaires over 20-60 minutes at 6 months after cancer diagnosis. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Observational (questionnaire) 12 months n=233 participants at risk All Patients complete questionnaires over 20-60 minutes at 12 months after cancer diagnosis. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Observational (questionnaire) 24 months n=245 participants at risk All Patients complete questionnaires over 20-60 minutes at 24 months after cancer diagnosis. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
General disorders Death Nos	22.8% 13/57 • Number of events 13 • up to 24 months This is an observational study which only collected All-Cause Mortality and Serious Adverse Events, other adverse event data was not collected	0.00% 0/455 • up to 24 months This is an observational study which only collected All-Cause Mortality and Serious Adverse Events, other adverse event data was not collected	1.3% 4/301 • Number of events 4 • up to 24 months This is an observational study which only collected All-Cause Mortality and Serious Adverse Events, other adverse event data was not collected	1.5% 4/272 • Number of events 4 • up to 24 months This is an observational study which only collected All-Cause Mortality and Serious Adverse Events, other adverse event data was not collected	5.2% 12/233 • Number of events 12 • up to 24 months This is an observational study which only collected All-Cause Mortality and Serious Adverse Events, other adverse event data was not collected	0.82% 2/245 • Number of events 2 • up to 24 months This is an observational study which only collected All-Cause Mortality and Serious Adverse Events, other adverse event data was not collected

Other adverse events

Adverse event data not reported

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60