A Research Study to Collect Patient Reported Outcomes Using Electronic Surveys

NCT04990895 | Terminated DMC

• 1 other identifier: IIT-ePRO
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A single-centre, randomized, 2-arm clinical trial comparing follow-up consisting of tumour-specific Electronic Patient-Reported Outcomes (ePROs) with targeted symptom management versus standard of care follow-up during neoadjuvant/adjuvant systemic therapy

Conditions

Colorectal Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Assessment of the Quality of Life of Cancer Patients Using EORTC-QLQ C30 Questionnaire

  Change from baseline EORTC-QLQ C30 scores at the end of the study will be determined using both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  within 1 year

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

  Change from baseline EORTC-QLQ BR23 scores at the end of the study will be determined using five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.

  within 1 year

• Assessment of the Quality of Life of Colorectal Cancer Patients Using EORTC-QLQ CR29 Questionnaire

  Change from baseline EORTC-QLQ CR29 scores at the end of the study will be determined using 4 multi-item scales and 19 single-items assessing a range of symptoms and problems common among patients with colorectal cancer. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.

  within 1 year

Secondary Outcomes (4)

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

  within 1 year

• Health System Cost

  within 1 year

• Rate of Patient satisfaction

  within 1 year

• Patient self-efficacy

  within 1 year

Study Arms (2)

Control group

NO 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.

Intervention

EXPERIMENTAL

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.

Other: Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires

Interventions

Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires OTHER

A web-based portal that prompts participants to enter tumour-specific ePROs at regular intervals in between clinic visits

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• 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.
• Participants or their caregivers will need to have a computer and internet access at home and be willing to learn to use and enter data via the web-based portal (REDCap).
• For the purposes of the current study, fluency and literacy in English will be required.

You may not qualify if:

• Lack of fluency or literacy of the English language.
• Lack of access to a computer or internet at home.
• Inability to complete or enter data on the REDCap system.
• 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).
• Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Tom Baker Cancer Centre: collaborator

Study Sites (1)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nancy A Nixon, M.D.

  Arthur J.E. Child Comprehensive Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: August 5, 2021
• Study Start: March 30, 2022
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)