Breeze-01 (V1 09/2024)
Research type
Research Study
Full title
Three Way Crossover Study: Assessment of Colostomy bags with an Active Chamber Filter System and Incidence of Filter-Related Complication by People Living with a Colostomy
IRAS ID
345346
Contact name
Mireille Hamson
Contact email
Sponsor organisation
Salts Healthcare
Duration of Study in the UK
0 years, 5 months, 2 days
Research summary
Participants will receive a pre-study phone call with the clinical research coordinator to discuss the study and schedule an online meeting via Zoom or Teams. It will also be explained that two copies of the informed consent form, the baseline questionnaire, and pre-paid envelopes will be sent to the participant via post.
The online study meeting via Zoom or Teams will take approximately 40 minutes with either the principal investigator (PI) or the clinical research nurse (CRN). During this meeting, participants will be walked through the study, given time to ask questions, provide informed consent, and complete a stoma assessment, all virtually. The informed consent forms will be discussed and signed during the online meeting, and the baseline questionnaire will need to be started after the online meeting.If eligible, participants will be asked to complete the 7-day baseline questionnaire using their usual colostomy bags. During the 7-day baseline period, participants will need to complete a short set of diary questions after each colostomy bag change. These questions relate to the reason for the bag change, the length of bag wear time, and the incidence of filter-related complications. After 7 days, or once the 21 short sets of diary questions are complete, participants need to return the questionnaire in the pre-paid envelope to the CCSI.
Once the baseline questionnaire has been received by the CCSI, the clinical research coordinator will call the participant to discuss the delivery of study packs A, B, and C. The study packs will include a letter, pre-paid envelopes; study colostomy bags A, B, and C, and study questionnaires A, B, and C for use during the 7-day test periods 1, 2, and 3.
Participants will need to contact the CCSI once they have received the study packs and decided on the start date for test period 1. This will ensure that participants will receive the study/wellness check phone call on day 5 or 6 of each 7-day test period.
7-Day Test Period 1: During the 7-day test period 1, participants will need to use study colostomy bags A, B, or C, depending on the order of study pack use. Participants will need to complete a short set of diary questions after each colostomy bag change. These questions will relate to the reason for the bag change, the length of bag wear time, and the incidence of filter-related complications. On day 5 or 6 of the test period, the participant will receive a study/wellness check phone call from the PI or CRN. After 7 days, or when the 21 short sets of diary questions are complete, participants need to return the questionnaire and any unused colostomy bags from the study pack in the pre-paid envelope to the CCSI.
7-Day Test Period 2: During the 7-day test period 2, participants will again need to use study colostomy bags A, B, or C, depending on the order of study pack use. They will complete the same short set of diary questions after each colostomy bag change. On day 5 or 6 of the test period, the participant will receive a study/wellness check phone call from the PI or CRN. After 7 days, or when the 21 short sets of diary questions are complete, participants need to return the questionnaire and any unused colostomy bags from the study pack in the pre-paid envelope to the CCSI.
7-Day Test Period 3: During the 7-day test period 3, participants will use study colostomy bags A, B, or C, depending on the order of study pack use. As before, participants will complete a short set of diary questions after each colostomy bag change. These questions relate to the reason for the bag change, the length of bag wear time, and the incidence of filter-related complications. On day 5 or 6 of the test period, participants will receive a study/wellness check phone call from the PI or CRN. After 7 days, or when the 21 short sets of diary questions are complete, participants need to return the questionnaire and any unused colostomy bags from the study pack in the pre-paid envelope to the CCSI.
Participants will then have completed the 21-day study and can return to their usual colostomy bag.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0241
Date of REC Opinion
25 Oct 2024
REC opinion
Further Information Favourable Opinion