NCT02974634

Brief Summary

The purpose of this study is to test the benefits of an educational program, the Ostomy Self-Management Training (OSMT) program, for improving patient activation (preparedness to do self-care), self-efficacy (patients' ability to do self-care), knowledge of ostomy/urostomy self-care, quality of life, mood, use of medical services, and financial burden in patients with ostomies. The study will compare patients in the intervention (training) group and patients in the usual care group. Subjects' participation in this study is expected to last about 7 months. The PI plans to enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be coordinated by the University of Arizona in Tucson, Arizona.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 11, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2.6 years

First QC Date

November 4, 2016

Results QC Date

June 1, 2020

Last Update Submit

August 11, 2020

Conditions

Colostomy Stoma

Keywords

Ileostomy

Outcome Measures

Primary Outcomes (1)

  • Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.

    The patient activation measure (PAM) is a 100-point, quantifiable scale determining patient engagement in healthcare. PAM uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation involving four stages (see below). 0 indicates lower activation (worse) whereas 100 indicates higher activation (better) (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress.

    baseline, on completion of session ( 5 weeks) and 6 month follow up

Secondary Outcomes (1)

  • Self-Efficacy to Perform Ostomy Self-Management Behaviors

    baseline, on completion of session ( 5 weeks) and 6 month follow up

Study Arms (2)

Ostomy Self management Training

ACTIVE COMPARATOR

Ostomy self-management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations

Other: Ostomy self management training

Usual care

PLACEBO COMPARATOR

Usual care in peri-operative and long-term settings is not standardized for ostomy patients. Usual care does not provide any formal, reproducible training for patients or their caregivers. It typically consists of an Ostomy Care Nurse who works with patients and caregivers concerning technical issues (fitting, emptying, supplies, surrounding skin care, etc.) while the new ostomate is still an inpatient

Other: Ostomy self management training

Interventions

Ostomy self management trainingOTHER

Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations

Ostomy Self management TrainingUsual care

Eligibility Criteria

Age21 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All cancer survivors over 21 years of age having undergone a procedure that needed an intestinal stoma (fecal or urinary).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

  • Sun V, Ercolano E, McCorkle R, Grant M, Wendel CS, Tallman NJ, Passero F, Raza S, Cidav Z, Holcomb M, Weinstein RS, Hornbrook MC, Krouse RS. Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial. Contemp Clin Trials. 2018 Jan;64:167-172. doi: 10.1016/j.cct.2017.10.008. Epub 2017 Oct 16.

    PMID: 29051047RESULT

  • Sun V, Bojorquez O, Grant M, Wendel CS, Weinstein R, Krouse RS. Cancer survivors' challenges with ostomy appliances and self-management: a qualitative analysis. Support Care Cancer. 2020 Apr;28(4):1551-1554. doi: 10.1007/s00520-019-05156-7. Epub 2019 Nov 13.

    PMID: 31720825RESULT

  • Rock MC, Cidav Z, Sun V, Ercolano E, Hornbrook MC, Wendel CS, Mo J, Fellheimer H, McCorkle R, Holcomb M, Grant M, Weinstein RS, Krouse RS. Adapting to the burdens of care: a telehealth program for cancer survivors with ostomies. Support Care Cancer. 2022 Dec 14;31(1):15. doi: 10.1007/s00520-022-07461-0.

    PMID: 36513895DERIVED

  • Grant M, Sun V, Tallman NJ, Wendel CS, McCorkle R, Ercolano E, Simons C, Mo J, Raza S, Donahue D, Passero F, Henson J, MacDougall L, Friedlaender J, Pitcher P, Fry D, Yonsetto P, Holcomb MJ, Hornbrook MC, Weinstein RS, Krouse RS. Cancer survivors' greatest challenges of living with an ostomy: findings from the Ostomy Self-Management Telehealth (OSMT) randomized trial. Support Care Cancer. 2022 Feb;30(2):1139-1147. doi: 10.1007/s00520-021-06449-6. Epub 2021 Aug 26.

    PMID: 34435212DERIVED

  • Weinstein RS, Holcomb MJ, Mo J, Yonsetto P, Bojorquez O, Grant M, Wendel CS, Tallman NJ, Ercolano E, Cidav Z, Hornbrook MC, Sun V, McCorkle R, Krouse RS. An Ostomy Self-management Telehealth Intervention for Cancer Survivors: Technology-Related Findings From a Randomized Controlled Trial. J Med Internet Res. 2021 Sep 27;23(9):e26545. doi: 10.2196/26545.

    PMID: 34086595DERIVED

Related Links

Limitations and Caveats

Randomization methods led to equal numbers of males and females,but did not achieve balance.Several intervention subjects completed surveys without attending sessions. Few participants dropped out of the study due to a technology related concern.

Results Point of Contact

Title
Dr. Robert Krouse
Organization
University of Pennsylvania
robert.krouse@pennmedicine.upenn.edu
215-615-4573

Study Officials

  • Robert Krouse, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 28, 2016

Study Start

November 1, 2016

Primary Completion

May 31, 2019

Study Completion

August 29, 2019

Last Updated

August 19, 2020

Results First Posted

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Our Program Project team supports and promotes the sharing of resources as promoted by PCORI. Progress in medical research in general, and patient-reported outcome cancer research in particular, benefits from enhanced collaboration and sharing of data between productive, collaborative investigators. Based on this concept, our policy is to make the data collected as part of this proposal available to outside investigators based on the following guidelines. * Our final research data will be shared with interested colleagues through peer-reviewed publications and presentations at scientific meetings. * Any sharing of data with outside investigators must preserve the anonymity of the subjects per HIPAA guidelines. * Collaboration with key personnel identified in the proposal is encouraged, but not strictly required.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
July 2021.
Access Criteria
• All requests will be reviewed by the Principal Investigator and Co-Investigators named in this proposal who will apply the following principles when deciding whether the data should be shared: 1. The request should be scientifically rigorous. 2. If a collaboration with one or more project investigators is appropriate, such a collaboration should be established. 3. The request should not conflict with ongoing or planned research by the PI or Co-Investigators. 4. The request should not conflict with each institutional requirements. The investigators should agree to acknowledge the contribution in all presentations and publications.

Locations

US(1)