Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528990
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Telehealth Intervention for Ostomy Self-Management
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Perioperative Ostomy Self-Management Telehealth Intervention for Cancer Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Over one million individuals in the US have ostomies An ostomy is a surgical procedure that creates an opening in the abdominal wall that allows bodily waste urinary or fecal to pass through into an external pouch in essence it is the externalization of the gastrointestinal or urinary structures to the abdominal wall For cancer ostomies are most commonly placed for rectal cancers followed by urinary bladder cancer The health-related quality of life impact of an ostomy is tremendous and greater than many other cancer treatments The goal of this study is to pilot-test a perioperative ostomy self-management telehealth intervention Periop-OSMT in patients with colorectal and bladder cancer and their family caregivers Participants will receive seven group telehealth sessions before and after ostomy surgery This pilot clinical trial will study the feasibility of the methodsinterventions and determine the preliminary efficacy to support a larger confirmatory trial
Detailed Description:
An ostomy is a disability that adversely affects the HRQOL of cancer survivors and their support personsfamily caregivers FCGs at all phases of cancer survivorship More than half of survivors experience stoma-related challenges such as pain troublesome odor skin problems around the stoma and leakage Ongoing problems include pouching care travel out of the home especially relevant for rural populations social interactions intimacy and acceptance ofsatisfaction with appearance Studies document persistent challenges including sexuality psychological problems and interference with work and recreation and sporting activities The purpose of this study is to assess the feasibility of a perioperative ostomy self-management telehealth intervention Periop-OSMT and to determine the preliminary efficacy of the intervention on participant-reported outcomes compared to the usual care arm We hypothesize that the intervention will be feasible acceptable and will demonstrate preliminary improvements in outcomes compared to the usual care arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None