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NCT03913715 · ClinicalTrials.gov registry record · NA

Ostomy Rural Telehealth Training Cancer Survivors

A NA study of Quality of Life and Ostomy, sponsored by Abramson Cancer Center at Penn Medicine.

Active
Registry status
NA
Development phase
204
Enrollment target
10
Study locations

NCT03913715: Active NA study of Quality of Life and Ostomy, sponsored by Abramson Cancer Center at Penn Medicine.

NCT03913715 is a NA study of Quality of Life and Ostomy that is active but no longer recruiting, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 204 participants, below the 451-participant average among 107 other Quality of Life trials with a reported enrollment target (55% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03913715, a NA study of Quality of Life and Ostomy, is active but no longer recruiting, sponsored by Abramson Cancer Center at Penn Medicine.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
204 participants
Enrollment target
10
Study locations

Study 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.

Primary Outcome

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 hi

Interventions

  • OTHER Ostomy Self-Management Training

Study Locations (10)

Pennsylvania

  • Geisinger - Danville
  • Lancaster General Hospital - Lancaster
  • Penn Medicine - Philadelphia

California

  • City Of Hope - Duarte
  • Loma Linda University Health - Loma Linda

Arkansas

  • University of Arkansas For Medical Sciences - Little Rock

New Mexico

  • University of New Mexico - Albuquerque

North Carolina

  • University of North Carolina - Chapel Hill

North Dakota

  • Sanford Research Center - Fargo

South Carolina

  • University of South Carolina Greenville (Prisma Health) - Greenville

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2019-08-01
Est. Completion 2026-10-31
Phase NA

What the registry record for NCT03913715 still lists

NCT03913715 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 451-participant average among 107 other Quality of Life trials with a reported enrollment target (55% lower).

The record links to 3 conditions, with Quality of Life appearing as the primary indexed condition, and to 1 intervention - of which Ostomy Self-Management Training is the first listed.

NCT03913715 lists 10 locations in 7 states (Pennsylvania, California, Arkansas).

Frequently Asked Questions

What is clinical trial NCT03913715 about?

NCT03913715 is a clinical study titled "Ostomy Rural Telehealth Training Cancer Survivors". 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 gastrointesti...

What is the current status of trial NCT03913715?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 204 participants. The study started on 2019-08-01. Estimated completion is 2026-10-31.

What conditions does trial NCT03913715 study?

This clinical trial studies the following conditions: Quality of Life, Ostomy, Telehealth.

What interventions are being tested in trial NCT03913715?

The interventions under investigation include: Ostomy Self-Management Training (OTHER).

Who is sponsoring clinical trial NCT03913715?

This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03913715 being conducted?

This trial has 10 study locations across Arkansas, California, New Mexico, North Carolina, North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Quality of Life

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03913715's enrollment target sits among peer trials

204 34th of 107 higher than 74 of 107 other Quality of Life trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Quality of Life trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03913715, the US trial registry maintained by the National Library of Medicine. NCT03913715 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.