Neoplasms

All Conditions

Digestive System Diseases

Behaviors and Mental Disorders

Adenocarcinoma

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.

Quality-of-Life Assessment

Questionnaire Administration

George Chang

George J. Chang

George J Chang

This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.

PRIMARY OBJECTIVE:

I. To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years.

SECONDARY OBJECTIVES:

I. To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy.

II. To characterize the impact of treatment on quality of life and utilities among patients with rectal cancer.

III. To assess changes in quality of life and utilities among patients treated for rectal cancer over time.

OUTLINE:

Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.

Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer

Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer

A health state utility is the degree of preference that individuals or society has for a particular health state or condition.

M.D. Anderson Cancer Center

Financial Stress

Colonic Neoplasms

Colonic Diseases

Stress, Psychological

Behavioral Symptoms

Herbal and Botanical

All Drugs and Chemicals

Cola

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

Sheetal Kircher

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.

PRIMARY OBJECTIVES:

I. Evaluate the change in level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

SECONDARY OBJECTVIES:

I. 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.

II. Evaluate the change in level of self-reported financial burden and employment limitations from baseline (within 60 days of diagnosis) to 3, 6, and 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

III. Evaluate long term outcomes at 24 months after diagnosis including financial burden, employment limitations and adherence to clinical follow-up guidelines.

IV. Evaluate the change of quality-of-life outcome (QoL) from baseline to 12 months and its association with predictors.

V. Evaluate the change in level of self-reported financial burden from baseline to 12 months using alternate measures of financial burden (i.e. impact of cost questions and single item from European Organization for Research and Treatment of Cancer \[EORTC\] questionnaire \[Q\]30).

OUTLINE:

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

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

Longitudinal Assessment of Financial Burden in Patients With Colon or Rectal Cancer Treated With Curative Intent

Will calculate the difference of Comprehensive Score for Financial Toxicity (COST) measurements from baseline to 12-month follow up for the completers who provide data at both time points, and use the paired t-test to assess if the mean difference is significantly different from zero. In case the data are not normally distributed, nonparametric methods (e.g., Wilcoxon signed-rank test) will be used instead to assess the difference. In addition, linear regression models with the change of COST from baseline to 12-month follow up as the response variable will be fit to investigate the impact of other factors, including demographics variables (e.g., age, sex, marital status), clinical variables (e.g., stage of disease, malignancy type, chemotherapy status), baseline questionnaire variables (e.g., self-efficacy,). The three-level treatment status (intravenous \[IV\] chemotherapy, chemotherapy without IV, and no chemotherapy) will also be evaluated as a predictor.

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.

Will be assessed by Work Productivity and Activity Impairment Questionnaire, Work Ability Index, and Work after cancer survey. If the distributions are normal, will conduct the paired t tests to examine the differences of these variables. If not normally distributed, Wilcoxon signed rank tests will be used. The association with COST measures will be evaluated using the Pearson or Spearman correlation coefficients.

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.

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.

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.

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.

Will use alternate measures of financial burden (i.e. impact of cost questions and single item from European Organization for Research and Treatment of Cancer Questionnaire 30).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer	NCT02107105	Rectal Adenocar... Stage I Rectal ... Stage II Rectal... Stage IIA Recta... Stage IIB Recta... Stage IIC Recta... Stage III Recta... Stage IIIA Rect... Stage IIIB Rect... Stage IIIC Rect... Stage IV Rectal... Stage IVA Recta... Stage IVB Recta... Stage IVC Recta...	Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment	NCT03516942	Stage I Colon C... Stage I Rectal ... Stage II Colon ... Stage II Rectal... Stage IIA Colon... Stage IIA Recta... Stage IIB Colon... Stage IIB Recta... Stage IIC Colon... Stage IIC Recta... Stage III Colon... Stage III Recta... Stage IIIA Colo... Stage IIIA Rect... Stage IIIB Colo... Stage IIIB Rect... Stage IIIC Colo... Stage IIIC Rect...	Quality-of-Life... Questionnaire A...	18 Years -	Eastern Cooperative Oncology Group

Spots Global Cancer Trial Database for stage i rectal cancer ajcc v8