Clinical trial · Interventional
Perioperative Ostomy Self-Management Telehealth for Cancer Patients and Family Caregivers
Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) for Cancer Patients and Family Caregivers
NCT03970070CI-TRIAL-00066455completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) provides patients and their caregivers information about ostomy and ostomy care. Periop-OSMT may help to understand patient preparedness to do ostomy self-care, confidence in doing ostomy self-care, knowledge of ostomy self-care, quality of life, mood, use of medical services, and financial burden.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Informational Intervention | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Health service research (Periop-OSMT)
- description
- Patients and/or support persons/family caregivers complete Periop-OSMT session in-person or via telephone over 20-40 minutes before surgery and before hospital discharge and group telehealth session over 1.5-2 hours at weeks 1-3, 4, 5, 6, and 7 post discharge
- interventionNames
- Other: Informational Intervention
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Other: Survey Administration
Primary outcomes (1)
- measure
- Patient and family caregiver (FCG) participation
- timeFrame
- Up to 24 months
- description
- Assessed by ratio of eligible participants (patient and FCGs) to those enrolled and those who decline participation, reasons for non-participation, number of scheduled study encounters completed, attrition rate between pre- and post-intervention, reasons for attrition/dropout, level of intervention participation including the total number of sessions, number of sessions completed without break-offs, number of break-offs, length (minutes) of sessions, and the ratio of all participants to those who completed \>= 80% of the study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * PATIENT: Scheduled to undergo a surgical procedure that includes the creation of an intestinal stoma (fecal or urinary). * PATIENT: Able to read and understand English. * PATIENT: Patients scheduled for temporary ostomy procedures * SUPPORT PERSON/FCG: Family member/friend identified by the patient as the primary caregiver before and after surgery. * SUPPORT PERSON/FCG: Able to read and understand English. * Patients with all stages of disease are eligible for the study. * The study is open to anyone regardless of gender or ethnicity. Efforts are made to extend the accrual to a representative population. Exclusion Criteria: * Subjects, who in the opinion of the principal investigator (PI), may not be able to comply with the requirements of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.