A Phase 2 interventional study of Informational Intervention and Quality-of-Life Assessment in Malignant Neoplasm, sponsored by City of Hope Medical Center. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Health services research
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.
PRIMARY OBJECTIVE:
I. Assess the feasibility and acceptability of the Periop-OSMT as measured by the percentage of patients and support persons/family caregivers (FCGs) who agree to participate; complete >= 80% of the intervention; and report satisfaction with the intervention (through structured exit interviews).
SECONDARY OBJECTIVES:
I. Examine the patterns and trajectories for patient outcomes pre- and post-intervention, including patient activation, self-efficacy, ostomy-related knowledge, health related quality of life (HRQOL), medical care utilization, and financial burden.
II. Examine patterns and trajectories for support person/FCG outcomes pre- and post-intervention, including quality of life (QOL).
III. Using qualitative methods, evaluate the acceptability of the intervention as reported by participants.
OUTLINE:
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.
After completion of study intervention, participants are followed up for 6 months.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 6 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →City of Hope Medical Center is the lead sponsor of 674 studies on the registry; 178 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
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Exclusion Criteria:
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
Other: Informational Intervention · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Other: Survey Administration
Complete Perioperative Ostomy Self-Management Telehealth program
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Ancillary studies
Patient and family caregiver (FCG) participation
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.
Time frame: Up to 24 months
Patient reported outcomes
Will be examined pre- and post-intervention, including patient activation, self-efficacy, ostomy-related knowledge, health related quality of life, medical care utilization, and financial burden. Descriptive statistics will be summarized using validated scoring procedures. The data will be used to assess descriptively the trajectory and patterns of outcomes before and after the intervention.
Time frame: Up to 6 months post-discharge
Support person/FCG reported outcomes
Will be examined pre- and post-intervention, including quality of life. Descriptive statistics will be summarized using validated scoring procedures. The data will be used to assess descriptively the trajectory and patterns of outcomes before and after the intervention.
Time frame: Up to 6 months post-discharge
Acceptability of Perioperative Ostomy Self-Management Telehealth
Acceptability will be assessed through qualitative data analysis using the conventional content analysis approach. Data from the tape-recorded interviews are transcribed and analyzed using HyperRESEARCH software. Transcripts will be imported for the development of analytic categories, data coding, and review of coded data. All data will be read repeatedly to achieve immersion and obtain a sense of the whole. Then, data will be read word by word to derive codes. Codes will be then sorted into themes based on links and relationship. Separate investigators will conduct a final validation review of the codes and themes to ensure consistency and clarity across all qualitative data. Data discordantly coded will be discussed for refinement and consensus purposes.
Time frame: Up to 24 months
Ran from Jan 2020 to primary completion in May 2021, 15 months.
Of 392 non-industry phase 2 interventional studies under Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 90. This study's 15 months is below that.
Counting every sponsor, half of 554 studies reached it within 52 months; a quarter within 33 and three quarters within 88.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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