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Completed

NCT Number: NCT03970070

Perioperative Ostomy Self-Management Telehealth for Cancer Patients and Family Caregivers

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.

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banner University Medical Center - Tucson, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Informational intervention

Other

Complete Perioperative Ostomy Self-Management Telehealth program

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Patient and family caregiver (FCG) participation

    Time frame: Up to 24 months

    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.

Secondary outcomes

  1. Patient reported outcomes

    Time frame: Up to 6 months post-discharge

    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.

  2. Support person/FCG reported outcomes

    Time frame: Up to 6 months post-discharge

    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.

  3. Acceptability of Perioperative Ostomy Self-Management Telehealth

    Time frame: Up to 24 months

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) for Cancer Patients and Family Caregivers

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 31, 2019
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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