Cancer Surveillance and Support

NCT04749862 | Active Not Recruiting

• 1 other identifier: L424
• Study Type: observational
• Target: 565
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to enhance the support for patients with breast and bowel cancer after treatment. Current follow-up care includes either self-management with patient-initiated contacts (breast cancer) or scheduled hospital visits for scans/tests for recurrence (bowel cancer). Building on extensive experience with online patient self-reporting of symptoms during treatment, the study will develop, implement and evaluate satisfaction with an improved electronic system to engage breast and bowel cancer survivors to self-report symptoms/problems online from home and get immediate tailored advice for self-management or hospital contact. The reports are displayed real-time in the hospital records alongside scans/tests to inform clinical management.

Conditions

Breast Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (8)

• Health related quality of life after cancer treatment

  To assess the effects of the online intervention on participants' health related quality of life after cancer treatment for colorectal and breast. 1\. Quality of Life in Adult Cancer Survivors scale (QLACS): Questions rated on a 1-7 point response scale, ranging from "never" to "always".

  2021-2023

• Disease Specific Quality of Life after cancer treatment in Colorectal - EORTC QLQ-CR29

  1\. European Organisation for Research and Treatment of Cancer: EORTC QLQ colorectal module respectively (CR29): Questions are rated on a 4-7 point scale and overall scale scores are calculated from 0-100 with higher scores indicating better quality of life.

  2021-2023

• Disease Specific Quality of Life after cancer treatment in Breast- EORTC QLQ-BR49

  1\. European Organisation for Research and Treatment of Cancer: EORTC QLQ breast module respectively (BR49): Questions are rated on a 4-7 point scale and overall scale scores are calculated from 0-100 with higher scores indicating better quality of life.

  2021-2023

• Intervention engagement: participant withdrawals

  To examine participants' engagement with the intervention. 1\) Number of participant withdrawals from the study.

  2022-2023

• Intervention engagement: participants returning to routine follow-up.

  To examine participants' engagement with the intervention. 1\) Number of patients who moved back to routine follow-up (from remote follow-up).

  2022-2023

• Intervention engagement: Participants' views on the online system.

  To examine participants' engagement with the intervention. 1\) Participants qualitative interviews.

  2022-2023

• Clinician engagement

  To examine clinicians' engagement with the intervention. Clinician qualitative end of study interviews.

  2022-2023

• Participant Recruitment

  Recruitment, follow-up and attrition. 1. Number of potentially eligible patients, number approached, number recruited vs. number not recruited, reasons for ineligibility and reasons for non-consent. 2. Comparison of patient characteristics in before and after phase. 3. Number of withdrawals.

  2021-2023

Secondary Outcomes (5)

• Patient Safety

  2022-2023

• Patients' Self-efficacy in managing their cancer

  2021-2023

• National Health Service (NHS) Resources

  2021-2023

• Intervention implementation process measures: participant adherence

  2022-2023

• Intervention implementation process measures: frequency of reported problems

  2022-2023

Other Outcomes (1)

• Information systems

  2022-2023

Study Arms (4)

Breast Cancer Participants-Before Phase

Breast cancer patients (16 years old or over) who have completed active treatment will complete a series of patient reported outcomes at baseline, 3, 6 and 12 months time.

Colorectal (bowel) Cancer Participants-Before Phase

Colorectal cancer patients (16 years old or over) who have completed active treatment will complete a series of patient reported outcomes at baseline, 3, 6 and 12 months time.

Breast Cancer Participants-After Phase

Breast cancer patients (16 years old or over) who have completed active treatment will complete a series of patient reported outcomes at baseline, 3, 6 and 12 months time. In addition they will also complete an online symptom report from home with self-management advice (frequency of completion to be determined in phase 2)

Other: Online symptom reporting

Colorectal (bowel) Cancer Participants-After Phase

Colorectal cancer patients (16 years old or over) who have completed active treatment will complete a series of patient reported outcomes at baseline, 3, 6 and 12 months time. In addition they will also complete an online symptom report from home with self-management advice (frequency of completion to be determined in phase 2)

Other: Online symptom reporting

Interventions

Online symptom reporting OTHER

Online symptom reporting questionnaire with linked self-management advice

Breast Cancer Participants-After Phase; Colorectal (bowel) Cancer Participants-After Phase

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast and Colorectal cancer patients who have completed active treatment (up to 12 months after end of treatment).

You may qualify if:

• Breast and colorectal healthcare professionals (e.g. Clinical Nurse Specialists) working at St James' University Hospital
• Participating patients Phases 1 and 2:
• Patients (aged 16 years or over) attending St James' University Hospital Bexley Wing, with breast and/or colorectal cancer in remission, completed their cancer treatment.
• Able and willing to give informed consent
• Able to read and understand English
• Participating patients Phase 3:
• Patients (aged 16 years or over) attending St James' University Hospital Bexley Wing, with breast and/or bowel (colorectal) cancer in remission, completed their cancer treatment.
• Able and willing to give informed consent
• Able to read and understand English
• Access to the internet

You may not qualify if:

• Patients under the age of 16
• Patients exhibiting overt psychopathology/cognitive dysfunction
• Patients taking part in other clinical trials involving the completion of extensive patient reported outcome or quality of life measures

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Galina Velikova

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: February 11, 2021
• Study Start: March 22, 2021
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)