What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as FOLFOX and FOLFIRI, are associated with side effects including neutropenia, febrile neutropenia, anemia, fatigue, diarrhea, nausea, and vomiting. Targeted therapies like bevacizumab can cause hypertension, bleeding, and thromboembolic events, while cetuximab is known for causing skin reactions, hypomagnesemia, and infusion-related reactions. These side effects can significantly impact the patient's quality of life and may require timely and specific management, which is the focus of ePROs with targeted symptom management.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for colorectal cancer, including bevacizumab, cetuximab, and panitumumab, which target specific pathways involved in tumor growth and progression. Bevacizumab, an anti-VEGF monoclonal antibody, is often used in combination with chemotherapy. Cetuximab and panitumumab, both anti-EGFR monoclonal antibodies, are used in patients with wild-type RAS tumors. These treatments have been shown to improve outcomes when used alongside traditional chemotherapy regimens. The integration of electronic patient-reported outcomes (ePROs) in clinical trials aims to enhance symptom management by allowing timely and specific interventions based on patient feedback, potentially improving overall treatment efficacy and quality of life.

What other types of research exist?

Promising alternatives to ePROs with targeted symptom management for colorectal cancer patients include: 1) Maintenance therapy with fluorouracil plus an anti-EGFR agent for patients initially treated with EGFR inhibitors, 2) Use of angiogenesis inhibitors like bevacizumab for managing refractory ascites, 3) Genome-wide tumor analysis for personalized molecularly-targeted treatments, and 4) Immunotherapy combinations, although further studies are needed to confirm their efficacy.

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ePRO Questionnaires for Colorectal Cancer Symptom Management

Phase 3

Recruiting

Led By Nancy A Nixon, M.D.

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or women ≥18 years old newly diagnosed early stage (stage I, II, or III) breast or colorectal cancer who initiate neoadjuvant/adjuvant systemic therapy after curative intent surgery.

Be older than 18 years old

Must not have

Early-stage breast or colorectal cancer patients who are not receiving neoadjuvant/adjuvant chemotherapy (patients undergoing adjuvant hormonal or targeted therapy alone without chemotherapy will be excluded).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial uses an online system for cancer patients to report their symptoms. Nurses are alerted to help patients with severe symptoms early, while those with mild symptoms get self-care advice. This aims to improve symptom management during treatment.

Who is the study for?

This trial is for men and women over 18 with early-stage breast or colorectal cancer starting systemic therapy after surgery. Participants must speak English, have internet access, a computer at home, and be willing to use an online portal for surveys.

What is being tested?

The study compares the effectiveness of using electronic patient-reported outcome questionnaires (ePROs) with targeted symptom management against standard care during neoadjuvant/adjuvant therapy in a single-center randomized trial.

What are the potential side effects?

Since this trial involves completing questionnaires rather than testing drugs, there are no direct medical side effects. However, participants may experience discomfort or stress from reflecting on their symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 and have early stage breast or colorectal cancer, starting treatment after surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have early-stage breast or colorectal cancer and am not on chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of the Quality of Life of Breast Cancer Patients Using EORTC-QLQ BR23 Questionnaire

Malignant Neoplasms

Colorectal Carcinoma

Secondary study objectives

Health System Cost

Impacts of Electronic Quality of Life Questionnaires on Health Care Resource Utilization

Patient self-efficacy

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants in the intervention group will also have a planned clinic follow-up visit prior to each scheduled chemotherapy appointment. They will be asked to complete a series of HRQOL questionnaires at baseline, at 6 months, and at completion of neoadjuvant/adjuvant chemotherapy to evaluate their HRQOL and satisfaction levels with their care. In addition, however, they will also receive an email reminder at the mid-way point between scheduled clinic visits to prompt them to enter ePROs via the REDCap online system, including measures such as the ESASr, the EORTC-QLQ C30 and EORTC-BR23 or EORTC-CR29 and specific symptom questionnaires.

Group II: Control groupActive Control1 Intervention

Participants in the control group will have a planned clinic follow-up visit prior to each scheduled chemotherapy appointment. Although they will not be asked to complete PROs in between clinic visits, they will be asked to respond to a series of HRQOL questionnaires at baseline, at 6 months (±2 weeks) from enrollment, and at completion of neoadjuvant/adjuvant systemic therapy if this date differs from the 6-month time point by more than 4 weeks. A satisfaction questionnaire will also be administered at the end of study.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include chemotherapy agents like fluorouracil (5-FU) and oxaliplatin, which disrupt DNA synthesis and function, leading to cancer cell death. Targeted therapies such as bevacizumab inhibit angiogenesis by blocking VEGF, reducing the tumor's blood supply, while cetuximab targets EGFR to inhibit cell growth and survival pathways. These treatments are vital as they directly attack cancer cells and their support systems, improving patient outcomes. The integration of ePROs for symptom management ensures timely intervention for side effects, enhancing treatment effectiveness and patient quality of life.

Clinical use of molecular targeted agents for primary small bowel adenocarcinoma: A multicenter retrospective cohort study by the Osaka Gut Forum.The current state of targeted agents in rectal cancer.