Clinical trial · Interventional
A Research Study to Collect Patient Reported Outcomes Using Electronic Surveys
A Randomized Clinical Trial of Electronic Tumour-Specific Patient-Reported Outcomes in Early-Stage Breast and Colorectal Cancer Patients Undergoing Neoadjuvant/Adjuvant Chemotherapy
NCT04990895CI-TRIAL-00102516terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow study accrual. Study sponsor decided to terminate the study in consultation with the DSMB.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- 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.
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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.
- interventionNames
- Other: Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participant has provided informed consent prior to initiation of any study specific activities/procedures. 2. 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. 3. 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). 4. For the purposes of the current study, fluency and literacy in English will be required. Exclusion Criteria: 1. Lack of fluency or literacy of the English language. 2. Lack of access to a computer or internet at home. 3. Inability to complete or enter data on the REDCap system. 4. 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). 5. Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial.
References
Publications (0)
Data not yet available
No reference posted for this study.