Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749862
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2021-01-11
Brief Title:
Cancer Surveillance and Support
Sponsor:
University of Leeds
Organization:
University of Leeds
Study Overview
Official Title:
Patient Centred Models for Surveillance and Support of Cancer Survivors With Breast and Bowel Cancer
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CANVAS
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 scanstests 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 symptomsproblems 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 scanstests to inform clinical management
Detailed Description:
A structured plan of development evaluation and implementation is proposed based on the Medical Research Council MRC complex interventions framework and the principles of Action Research model namely Purpose choice on solving practical problems Contextual focus Data that helps track changes and sense making Participation in research process and Knowledge diffusion Action research is suited to identifying problems in clinical practice and helping develop potential solutions in order to improve practice The study will use an experimental action research approach incorporating the action research cycle Plan Do Study Act
The effectiveness evaluation of patientclinician acceptance feasibility patient benefitssatisfaction will be performed using a non-randomised Before-After study approach followed by immediate implementation in practice for faster patient benefits
Main outcomes measured will include
1 Patient-Reported Outcomes questionnaires quality of life symptom control and self-efficacy
2 Clinical measures number of hospital contacts recurrence rates
3 Process measures survivors compliance with self-reports clinical tests attendance using online self-management resources
The project will be structured in four phases
PHASE 1 Months 0-12 Develop the content of the surveillance toolkits for breast and bowel colorectal cancers and setup on the electronic system This will include the selection of cancer-specific symptoms for patient self-reporting collating the existing evidence on side-effects management and the development of patient advice corresponding to severity levels Once the two toolkits for breast and bowel colorectal cancers are completed they will be set up on the electronic system Printed booklets can also be produced from these
Recruitment methods
Cancer survivors and caregivers will be invited from outpatient surveillance clinics or by telephone by the cancer team if discharged recently from secondary care and by public advertising for breast and colorectal cancer survivors volunteers Purposive sampling will represent a variety of age groups cancer recurrence risk time post treatment socio-economic background expecting a sample of 8-10 survivorscarers per cancer site Participants will be invited for an interview conducted over the telephone or at St Jamess Hospital
Healthcare professionals HCP involved in breast and colorectal cancer care at St Jamess Hospital will also be invited to participate in interviews This is done face to face at the hospital followed up by a phone call or an individual email depending on the previous conversations had between the researchers and the HCP
Interviews will be transcribed verbatim and subjected to thematic content analysis
Phase 1 Objectives
1 Select questions for self-reporting
2 Determine severity thresholds
3 Determine content of the self-management guidance
4 Describe the current usual care after treatment by cancer type and how to modify it to incorporate remote surveillance
5 Identify potential improvements to the electronic system
PHASE 2Before study Months 6-30 12-months recruitment12-months follow-upThe before study will be a structured audit of current practice running in parallel with Phase 1
Participants who consent will complete outcome measures at baseline 3 6 and 2 months on paper Demographic data will be collected after consent and clinical data will be collected via the EPR
Recruitment methods
The study will include recruitment over 12 months of all consecutive eligible patients with a follow-up of 12 months The estimated numbers are 120 new bowel colorectal cancer patients per year and 300 breast cancer patients The study anticipates 70 consent rate giving approximately 85 bowel colorectal and 210 breast cancer participants
Phase 2 Objectives
1 Establish data on current practice using clinical and patient outcomes and best methods for collecting them
2 Provide Before data to compare to After study to estimate the effects of the new intervention
3 Establish prospectively what proportion of eligible patients would consent to a remote monitoring study
PHASE 3After studyMonths 18-4212-months recruitment 12-months follow-up Participants will be completing the intervention for 12 months The After study will start when Phase 1 is completed including a successful usability testing
Participants who consent will complete outcomes measures at baseline 3 6 and 12 months on paper same as Phase 2 In addition they will also complete the intervention online symptom reporting questionnaire
Demographic data will be collected after consent and clinical data via the Electronic patient records EPR
Recruitment methods
Based on current experience of other studies conducted 15 of breast and 20 of bowel colorectal patients will not use online resources Therefore the estimated number of full participants will be about 170 in breast and 70 in bowel colorectal cancer clinics The remote monitoring will only be available to participants classed as being moderate to lower risk by their clinical team The intervention is an additional service for patients conducted along side their standard cancer care
Phase 3 Objectives
1 Assess the effects of the intervention in terms of participants quality of life at baseline 3 6 and 12 months
2 Examine survivors engagement with the intervention - acceptability feasibility and use of the online system and respective advice
3 Examine clinicians engagement
Secondary objectives
4 Monitor the safety ie diagnoses of recurrences and psychological morbidity how were those detected
5 Evaluate impact on participants self-efficacy in managing cancer consequences and fear of recurrence
6 Evaluate participants satisfaction with care
7 Compare use of National Health Service NHS resources in Before and After phase
The implementation of the intervention
The intervention as developed in Phase 1 will be implemented following the relevant staff and participant training The frequency of participants completions will be determined in Phase 1 Participants will be asked to complete the online symptom monitoring from home with the possibility to complete the questions more often if they experience any symptoms they may wish to report Text message or email reminders will be sent to the participants based on their preferred contact method as a prompt to complete the online monitoring symptom questions and where relevant to attend for the blood tests or surveillance scans
Providers are expected to review and respond to any notifications for significant symptoms in line with the agreed thresholds and are expected to review the self-reports during the clinic visits discuss them with the patient and take any actions as appropriate
Participants and staff interviews will be conducted during and at the end of Phase 3
PHASE 4 starting month 30 with specific launch activities 42-48 Roll-out and implementation in practice Following the principles of the Action research model Act phase the aim is to start roll-out immediately after completion of the 12-month recruitment in the After study This will involve further work to apply the learning from Phase 3
1 Simplify patient approach and consent to integrate it into the routine clinics flow
2 Identify appropriate clinic staff to approach patients
3 Modify if needed the self-reported questions the thresholds or the content of the advice
The effectiveness evaluation of patientclinician acceptance feasibility patient benefitssatisfaction will be performed using a non-randomised Before-After study approach followed by immediate implementation in practice for faster patient benefits
Main outcomes measured will include
1 Patient-Reported Outcomes questionnaires quality of life symptom control and self-efficacy
2 Clinical measures number of hospital contacts recurrence rates
3 Process measures survivors compliance with self-reports clinical tests attendance using online self-management resources
The project will be structured in four phases
PHASE 1 Months 0-12 Develop the content of the surveillance toolkits for breast and bowel colorectal cancers and setup on the electronic system This will include the selection of cancer-specific symptoms for patient self-reporting collating the existing evidence on side-effects management and the development of patient advice corresponding to severity levels Once the two toolkits for breast and bowel colorectal cancers are completed they will be set up on the electronic system Printed booklets can also be produced from these
Recruitment methods
Cancer survivors and caregivers will be invited from outpatient surveillance clinics or by telephone by the cancer team if discharged recently from secondary care and by public advertising for breast and colorectal cancer survivors volunteers Purposive sampling will represent a variety of age groups cancer recurrence risk time post treatment socio-economic background expecting a sample of 8-10 survivorscarers per cancer site Participants will be invited for an interview conducted over the telephone or at St Jamess Hospital
Healthcare professionals HCP involved in breast and colorectal cancer care at St Jamess Hospital will also be invited to participate in interviews This is done face to face at the hospital followed up by a phone call or an individual email depending on the previous conversations had between the researchers and the HCP
Interviews will be transcribed verbatim and subjected to thematic content analysis
Phase 1 Objectives
1 Select questions for self-reporting
2 Determine severity thresholds
3 Determine content of the self-management guidance
4 Describe the current usual care after treatment by cancer type and how to modify it to incorporate remote surveillance
5 Identify potential improvements to the electronic system
PHASE 2Before study Months 6-30 12-months recruitment12-months follow-upThe before study will be a structured audit of current practice running in parallel with Phase 1
Participants who consent will complete outcome measures at baseline 3 6 and 2 months on paper Demographic data will be collected after consent and clinical data will be collected via the EPR
Recruitment methods
The study will include recruitment over 12 months of all consecutive eligible patients with a follow-up of 12 months The estimated numbers are 120 new bowel colorectal cancer patients per year and 300 breast cancer patients The study anticipates 70 consent rate giving approximately 85 bowel colorectal and 210 breast cancer participants
Phase 2 Objectives
1 Establish data on current practice using clinical and patient outcomes and best methods for collecting them
2 Provide Before data to compare to After study to estimate the effects of the new intervention
3 Establish prospectively what proportion of eligible patients would consent to a remote monitoring study
PHASE 3After studyMonths 18-4212-months recruitment 12-months follow-up Participants will be completing the intervention for 12 months The After study will start when Phase 1 is completed including a successful usability testing
Participants who consent will complete outcomes measures at baseline 3 6 and 12 months on paper same as Phase 2 In addition they will also complete the intervention online symptom reporting questionnaire
Demographic data will be collected after consent and clinical data via the Electronic patient records EPR
Recruitment methods
Based on current experience of other studies conducted 15 of breast and 20 of bowel colorectal patients will not use online resources Therefore the estimated number of full participants will be about 170 in breast and 70 in bowel colorectal cancer clinics The remote monitoring will only be available to participants classed as being moderate to lower risk by their clinical team The intervention is an additional service for patients conducted along side their standard cancer care
Phase 3 Objectives
1 Assess the effects of the intervention in terms of participants quality of life at baseline 3 6 and 12 months
2 Examine survivors engagement with the intervention - acceptability feasibility and use of the online system and respective advice
3 Examine clinicians engagement
Secondary objectives
4 Monitor the safety ie diagnoses of recurrences and psychological morbidity how were those detected
5 Evaluate impact on participants self-efficacy in managing cancer consequences and fear of recurrence
6 Evaluate participants satisfaction with care
7 Compare use of National Health Service NHS resources in Before and After phase
The implementation of the intervention
The intervention as developed in Phase 1 will be implemented following the relevant staff and participant training The frequency of participants completions will be determined in Phase 1 Participants will be asked to complete the online symptom monitoring from home with the possibility to complete the questions more often if they experience any symptoms they may wish to report Text message or email reminders will be sent to the participants based on their preferred contact method as a prompt to complete the online monitoring symptom questions and where relevant to attend for the blood tests or surveillance scans
Providers are expected to review and respond to any notifications for significant symptoms in line with the agreed thresholds and are expected to review the self-reports during the clinic visits discuss them with the patient and take any actions as appropriate
Participants and staff interviews will be conducted during and at the end of Phase 3
PHASE 4 starting month 30 with specific launch activities 42-48 Roll-out and implementation in practice Following the principles of the Action research model Act phase the aim is to start roll-out immediately after completion of the 12-month recruitment in the After study This will involve further work to apply the learning from Phase 3
1 Simplify patient approach and consent to integrate it into the routine clinics flow
2 Identify appropriate clinic staff to approach patients
3 Modify if needed the self-reported questions the thresholds or the content of the advice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None