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

Browse trials for

• Colonic Neoplasms 1,432
• Rectal Neoplasms 1,762

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 565 is above the median of 280 across 349 observational studies indexed under Colonic Neoplasms.

Lead sponsor

ECOG-ACRIN Cancer Research Group is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.

Study population

Eligibility criteria

Groups and cohorts

• Observational (questionnaire)

  Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.

  Other: Quality-of-Life Assessment · Other: Questionnaire Administration

Interventions

• OtherQuality-of-Life Assessment

  Ancillary studies

  Also known as: Quality of Life Assessment

• OtherQuestionnaire Administration

  Ancillary studies

Primary outcomes

1. Comprehensive Score for Financial Toxicity (COST)

   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)

   Time frame: Baseline and 12 months after cancer diagnosis

Secondary outcomes

1. Reported Access and Utilization of Financial Services

   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.

   Time frame: Up to 12 months

2. Change in Level of Self-reported Employment Limitations

   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

   Time frame: Baseline, 6, 12, and 24 months after cancer diagnosis

3. Level of Self-reported Employment Limitations (Dichotomized)

   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

   Time frame: Baseline, 6, 12, and 24 months after cancer diagnosis

4. Long Term Outcomes After Diagnosis for Adherence

   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.

   Time frame: At 24 months

5. Long Term Outcomes After Diagnosis for Financial Burden

   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.

   Time frame: At 24 months

6. Long Term Outcomes After Diagnosis for Employment Limitations

   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.

   Time frame: At 24 months

7. Change of Quality-of-life (QoL) Outcome

   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.

   Time frame: Baseline up to 12 months

8. Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC]

   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")

   Time frame: Baseline and12 months

Baseline characteristics

Publications

• Sadigh G, Duan F, An N, Gareen ID, Sicks J, Suga JM, Kehn H, Mehan PT, Bajaj R, Hanson DS, Dalia SM, Acoba JD, Yasar DG, Taylor MA, Park E, Wagner LI, Kircher SM, Carlos RC. Financial Hardship Among Patients With Early-Stage Colorectal Cancer. JAMA Netw Open. 2024 Sep 3;7(9):e2431967. doi: 10.1001/jamanetworkopen.2024.31967. PubMed 39287948 ↗
• Kircher S, Duan F, An N, Gareen IF, Sicks JD, Sadigh G, Suga JM, Kehn H, Mehan PT, Bajaj R, Hanson DS, Dalia SM, Acoba JD, Yasar DG, Park ER, Wagner LI, Carlos RC. Patient-Reported Financial Burden of Treatment for Colon or Rectal Cancer. JAMA Netw Open. 2024 Jan 2;7(1):e2350844. doi: 10.1001/jamanetworkopen.2023.50844. PubMed 38194233 ↗

Study documents

• Protocol and statistical analysis plan · Jun 19, 2019
• Informed consent form · Jun 19, 2019

Documents are hosted by the registry — open the source record to download them.