Malignant NeoplasmPhase 2NCT03970070
Perioperative Ostomy Self-Management Telehealth for Cancer Patients and Family Caregivers
A Phase 2 study testing Informational Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Neoplasm, run by City of Hope Medical Center at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Informational Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jan 2020to 12 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects, who in the opinion of the principal investigator (PI), may not be able to comply with the requirements of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
City of Hope Medical Center
Duarte, California, 91010
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
About this study
Official title: Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Malignant Neoplasm
- Being tested
- Informational Intervention, Quality-of-Life Assessment, Questionnaire Administration, Survey Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Complete Perioperative Ostomy Self-Management Telehealth program
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Health service research (Periop-OSMT) | Experimental | 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 Receives: Other: Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start23 Jan 2020
- Primary completion12 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Virginia Sun, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970070
- Sponsor's protocol ID
- 18327
- Other IDs
- NCI-2019-02385, 18327, P30CA033572
- Status last verified
- May 2023
- First submitted
- 1 May 2019
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) for Cancer Patients and Family Caregivers
- ClinicalTrials.gov ID
- NCT03970070
- Acronym / sponsor ID
- 18327
- Conditions
- Malignant Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health service research (Periop-OSMT) | Experimental | Other: Informational Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Survey AdministrationPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects, who in the opinion of the principal investigator (PI), may not be able to comply with the requirements of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational InterventionComplete Perioperative Ostomy Self-Management Telehealth program | Other | Health service research (Periop-OSMT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Health service research (Periop-OSMT) |
| Questionnaire AdministrationAncillary studies | Other | Health service research (Periop-OSMT) |
| Survey AdministrationAncillary studies | Other | Health service research (Periop-OSMT) |
Primary outcome
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.
3 secondary outcomes
Patient reported outcomes
Time frame: Up to 6 months post-discharge
Support person/FCG reported outcomes
Time frame: Up to 6 months post-discharge
Acceptability of Perioperative Ostomy Self-Management Telehealth
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Sun principal investigator
City of Hope Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Informational Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Neoplasm, run by City of Hope Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and family caregiver (FCG) participation (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.