Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT05344950
Eligibility Criteria:
Inclusion Criteria
Phase I: The investigators will only be recruiting patients for this phase
Patients must:
* have been surgically treated for colorectal or bladder cancer with curative intent;
* have had an ostomy with curative intent for at least 90 days;
* be able to read and speak English;
* be 18 years or older;
Phase II: The investigators will be recruiting patients and caregivers as a dyad for this phase
* Patients must:
* have been surgically treated for colorectal or bladder cancer with curative intent;
* be within one month of hospital discharge of a newly created ostomy with curative intent;
* be able to read and speak English;
* be 18 years or older;
* have a caregiver who is willing to participate in the study;
* Caregivers must:
* be 18 years or older;
* be able to read and speak English;
* be identified as the primary caregiver by the patient;
* have not themselves been diagnosed with cancer or received cancer treatment during the study (to ensure that patients and caregivers focus their efforts on care of the patient).
Exclusion Criteria
Patients and their caregivers will be excluded if they:
* are unable to read, speak, or understand English;
* have more than one type of ostomy;
* have other cancer diagnosis (excluding non-melanomatous skin cancer); or
* have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05344950
Study Brief:
Protocol Section:
NCT05344950