Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment
Active, enrolledResults postedLast updated 13 March 2026
What this trial tests
trial testing Quality-of-Life Assessment in Stage I Colon Cancer AJCC v8 in 565 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Stage I Colon Cancer AJCC v8 or Stage I Rectal Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Comprehensive Score for Financial Toxicity (COST)Primary· Baseline and 12 months after cancer diagnosis
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)
Group
Value
95% CI
T0: Observational (Questionnaire)
23.5
± 11.9
T2:Observational (Questionnaire)
28.6
± 11.7
Change in Level of Self-reported Employment LimitationsSecondary· 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. = de
Work Time Missed
Group
Value
95% CI
Baseline Questionnaire
39.7
± 39.3
6-month Questionnaire
18.2
± 30.7
12-month Questionnaire
4.8
± 16.1
24-month Questionnaire
6.1
± 18.0
Impairment of Activities at Work
Group
Value
95% CI
Baseline Questionnaire
20.8
± 33.4
6-month Questionnaire
28.1
± 33.0
12-month Questionnaire
14.0
± 24.6
24-month Questionnaire
14.4
± 22.3
Overall Work Impairment
Group
Value
95% CI
Baseline Questionnaire
51.8
± 37.5
6-month Questionnaire
36.6
± 36.6
12-month Questionnaire
17.8
± 28.0
24-month Questionnaire
19.1
± 26.8
Impairment of Activities Outside of Work
Group
Value
95% CI
Baseline Questionnaire
33.2
± 31.8
6-month Questionnaire
31.3
± 31.9
12-month Questionnaire
17.0
± 25.8
24-month Questionnaire
15.8
± 24.2
Level of Self-reported Employment Limitations (Dichotomized)Secondary· 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. These outcomes were further dichotomized at 50%, such that Impairment \> 50% was considered impaired and Impairment \<=50% was not-impaired
Work Time Missed
Group
Value
95% CI
Baseline Questionnaire
124
6-month Questionnaire
55
12-month Questionnaire
58
24-month Questionnaire
54
Baseline Questionnaire
68
6-month Questionnaire
14
12-month Questionnaire
2
24-month Questionnaire
3
Impairment of Activities at Work
Group
Value
95% CI
Baseline Questionnaire
139
6-month Questionnaire
47
12-month Questionnaire
51
24-month Questionnaire
49
Baseline Questionnaire
53
6-month Questionnaire
22
12-month Questionnaire
9
24-month Questionnaire
8
Overall Work Impairment
Group
Value
95% CI
Baseline Questionnaire
93
6-month Questionnaire
40
12-month Questionnaire
49
24-month Questionnaire
47
Baseline Questionnaire
99
6-month Questionnaire
29
12-month Questionnaire
11
24-month Questionnaire
10
Impairment of Activities Outside of Work
Group
Value
95% CI
Baseline Questionnaire
121
6-month Questionnaire
47
12-month Questionnaire
49
24-month Questionnaire
48
Baseline Questionnaire
71
6-month Questionnaire
22
12-month Questionnaire
11
24-month Questionnaire
9
Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC]Secondary· Baseline and12 months
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")
No difficulty ("Not at All" ) at 12 months
Group
Value
95% CI
No Difficulty ("Not at All" ) at Baseline
74
Some Difficulty ( "A Little", "Quite a Bit", or "Very Much") at Baseline
34
Some Difficulty ( "A little", "Quite a bit", or "Very much") at 12 Months
Group
Value
95% CI
No Difficulty ("Not at All" ) at Baseline
17
Some Difficulty ( "A Little", "Quite a Bit", or "Very Much") at Baseline
80
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 24 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This research trial studies the financial burden in patients with stage I-III colon or rectal cancer who are undergoing treatment. Collecting data from patients about their cost and quality of life may help doctors to better understand the impact of cancer treatment on a patient?s employment and finances.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ECOG-ACRIN Cancer Research Group
Last refreshed: 13 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03516942.