Ostomy Rural Telehealth Training Cancer Survivors

NCT03913715 | Active Not Recruiting DMC

• 2 other identifiers: 832343R01CA204193
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 10

Brief Summary

Over one million individuals in the U.S. have ostomies. The American Cancer Society estimates 43,030 rectal cancer cases and 81,190 bladder cancer cases will be diagnosed in 2018.Of these, at least 30,000 will receive ostomies, and an additional unknown number due to gynecologic, other gastrointestinal, or other gastro-urinary tumors. The health-related quality of life impact is tremendous and greater than with many other cancer treatments. An ostomy is often a prolonged or lifelong disabling problem for cancer survivors. The adaptation period is quite variable. In our R01 study, 18% of participants took at least one year to be comfortable, or never felt comfortable, in managing their ostomy care. Importantly, many patients cannot attend in-person self-management programs or patient groups for a myriad of reasons, including distance to travel, lack of access to transportation, monetary outlays, competing demands (such as work), or comorbidities making travel difficult. In addition, a national shortage of OCNs means patients with an ostomy, whether newly placed or a long-term issue, receive little help. It is imperative to study interventions for rural survivors aimed to limit family financial burdens, improve ostomy outcomes, and improve survivors' well-being.

Conditions

Ostomy; Quality of Life; Telehealth

Keywords

Ileostomy, Urostomy, Colostomy

Outcome Measures

Primary Outcomes (5)

• Patient Activation - PAM

  Patient Activation Measure. It uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation that involves four stages: (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. The measure can be used at the individual patient level to tailor interventions and assess changes. Those with higher activation scores report significantly better health, and significantly lower rates of doctor office visits, emergency room visits, and hospital nights. High internal consistency and construct validity have been reported.

  0 months

• Patient Activation- PAM

  Patient Activation Measure. It uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation that involves four stages: (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. The measure can be used at the individual patient level to tailor interventions and assess changes. Those with higher activation scores report significantly better health, and significantly lower rates of doctor office visits, emergency room visits, and hospital nights. High internal consistency and construct validity have been reported.

  2 months

• Patient Activation - PAM

  Patient Activation Measure. It uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation that involves four stages: (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. The measure can be used at the individual patient level to tailor interventions and assess changes. Those with higher activation scores report significantly better health, and significantly lower rates of doctor office visits, emergency room visits, and hospital nights. High internal consistency and construct validity have been reported.

  3 months

• Patient Activation- PAM

  Patient Activation Measure.It uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation that involves four stages: (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. The measure can be used at the individual patient level to tailor interventions and assess changes. Those with higher activation scores report significantly better health, and significantly lower rates of doctor office visits, emergency room visits, and hospital nights. High internal consistency and construct validity have been reported.

  6 months

• Patient Activation- PAM

  Patient Activation Measure.It uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation that involves four stages: (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. The measure can be used at the individual patient level to tailor interventions and assess changes. Those with higher activation scores report significantly better health, and significantly lower rates of doctor office visits, emergency room visits, and hospital nights. High internal consistency and construct validity have been reported.

  12months

Secondary Outcomes (18)

• Self-efficacy

  0 months

• Self-efficacy

  2 months

• Self-efficacy

  6 months

• Self-efficacy

  12 months

• Health-related quality of life

  0 months

Other Outcomes (4)

• Hospital Anxiety and Depression Scale

  0 months

• Hospital Anxiety and Depression Scale

  2 months

• Hospital Anxiety and Depression Scale

  6 months

Study Arms (2)

Ostomy Self-Management Training

ACTIVE COMPARATOR

Ostomy Self-management Training group in which subject will learn using pouches and equipment, skincare, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for traveling 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 Training OTHER

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

Ostomy Self-Management Training; Usual care

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer or pre-cancer (e.g. carcinoma in situ or severe dysplasia) survivors over 18 years of age having undergone a procedure that needed an intestinal stoma (fecal or urinary). Survivors with temporary ostomies will be included.
• Residence within a zip code that is designated as non-metropolitan or non-urban.
• All participants must have a full understanding of the protocol and be able to sign an informed consent form.
• Participants must be able to complete the study questionnaires and sessions in English.
• Having an identified caregiver/support person is NOT a requirement for eligibility but will be strongly encouraged if possible.
• All participants will attend their first training session at least six weeks after their operation.
• There is no maximum time since surgery.
• Eligible patients with temporary ostomies must NOT undergo ostomy reversal:
• i. While they are participating in the training sessions (intervention arm). ii. During the corresponding time of the training sessions (usual care arm)
• Subjects must be willing to complete the surveys described in the protocol.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

City Of Hope

Duarte, California, 91010, United States

Location

Loma Linda University Health

Loma Linda, California, 11005, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Sanford Research Center

Fargo, North Dakota, 58122, United States

Location

Geisinger

Danville, Pennsylvania, 17822, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

University of South Carolina Greenville (Prisma Health)

Greenville, South Carolina, 21111, United States

Location

Study Officials

• Robert Krouse, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

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: February 14, 2019
• First Posted: April 12, 2019
• Study Start: August 1, 2019
• Primary Completion: September 1, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE

Locations

US (10)