OstomyNCT03913715
Ostomy Rural Telehealth Training Cancer Survivors
A study testing Ostomy Self-Management Training in people with Ostomy and Quality of Life, run by Abramson Cancer Center at Penn Medicine at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Ostomy, Quality of Life, Telehealth
- What is being tested?
- Ostomy Self-Management Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Aug 2019to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- There is no maximum time since surgery.
- Eligible patients with temporary ostomies must NOT undergo ostomy reversal:
- 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.
Who cannot join
- N/A
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of North Carolina
Chapel Hill, North Carolina, 27599
Geisinger
Danville, Pennsylvania, 17822
City Of Hope
Duarte, California, 91010
Sanford Research Center
Fargo, North Dakota, 58122
University of South Carolina Greenville (Prisma Health)
Greenville, South Carolina, 21111
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
University of Arkansas For Medical Sciences
Little Rock, Arkansas, 72205
Loma Linda University Health
Loma Linda, California, 11005
Penn Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Ostomy Rural Telehealth Self-management Training for 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 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.
Read the detailed description
An ostomy adversely affects health-related quality of life in a diverse population of cancer survivors. For cancer, ostomies are most commonly placed for rectal cancers, followed by urinary bladder cancer. Ostomies may be needed for other cancers related to bulky or metastatic disease, or in emergencies. In addition, ostomies may be placed on a temporary or a permanent basis. Temporary ostomies may be created in emergencies, such as perforation or obstruction due to tumor, or in planned procedures, as with a low rectal resection for cancer where an ostomy is placed to "protect" a new anastomosis while it heals. Temporary ostomies may become permanent as a result of underlying comorbidities, need for other treatments related to cancer, or poor outcome of anastomosis (leak or stricture). Peri-operative needs are the same regardless of ostomy permanence; survivors should receive clear, systematic, evidence-based ostomy self-management instruction and support.
To cope with the challenges of their diseases, cancer survivors with ostomies should have confirmed levels of self-management skills, as well as strong commitments to self-management. Cognitive restructuring, problem-solving, and self-efficacy/locus of control are essential tools for effective self-management. As in most chronic conditions, this tends to be long-term, complex, and multidimensional. Trial-and-error ostomy self-care, nurse counseling, and community referral have been the primary modes of self-management education and support in the peri-operative period. Clearly, ostomates face many obstacles in coping with their condition, not least of which is medical care that often does not meet their needs for effective information, clinical management, psychological support, and patient activation These obstacles are likely compounded for ostomates living in rural areas. Approximately 14-19% of the US population resides in rural areas. Rural cancer survivors face significant barriers to ongoing care including lack of access to specialists and cancer-specific specialized support, longer travel distances to access follow-up care, and transportation challenges due to financial barriers or lack of a vehicle. Individuals in rural areas travel a median of 51-59 minutes to reach specialized oncology care. Additionally, some studies suggest that rural cancer patients have worse quality of life and mental health than their urban counterparts, and up to a quarter of rural cancer patients have unmet cancer information needs. Telehealth delivery of an ostomy self-management program offers an opportunity to reduce these access disparities among rural ostomates.
Ostomates and their families must engage in ostomy self-management, make behavior changes, and adjust to the consequences of their condition, becoming the principal caretakers and navigators. Preparation of the survivor and unpaid designated caregiver/support person (usually family members) is requisite to assure optimal functioning and HRQOL, as well as to prevent or ameliorate ostomy-related complications and associated health care utilization. Multiple communication issues make it difficult for ostomy survivors to access resources for improving their self-management, and undermine opportunities to improve and sustain HRQOL. These resources include lack of consistent follow-up, travel issues, lack of surgeon focus on ostomy-related problems, and lack of ostomy nurse clinic resources.
Ostomies are associated with multiple HRQOL difficulties. Ongoing problems include pouching care, travel out of the home (especially relevant for rural populations), social interactions, intimacy, and acceptance of/satisfaction with appearance. Studies document persistent challenges including sexuality psychological problems and interference with work, recreation, and sporting activities. However, improved self-efficacy eases the psychological and social burden of ostomies. No reports have been published on the results of a systematic ostomy self-management program to ensure optimal post-operative care, including adaptation, self-management, and ostomy comfort.
- Conditions
- Ostomy, Quality of Life, Telehealth
- Being tested
- Ostomy Self-Management Training
- Keywords
- Ileostomy, Urostomy, Colostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostomy Self-Management TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Ostomy Self-Management Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12months
Secondary outcomes (18)
Self-efficacy
Self-Efficacy to Perform Ostomy Self-Management Behaviors.Modified from Lorig and colleagues' Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains (with reported Cronbach's alpha for original scales,physical activity , information seeking, support, communication with HC providers, ostomy management, social and recreational, symptom management and depression.
Measured: 0 months
Self-efficacy
Self-Efficacy to Perform Ostomy Self-Management Behaviors.Modified from Lorig and colleagues' Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains (with reported Cronbach's alpha for original scales,physical activity , information seeking, support, communication with HC providers, ostomy management, social and recreational, symptom management and depression.
Measured: 2 months
Self-efficacy
Self-Efficacy to Perform Ostomy Self-Management Behaviors.Modified from Lorig and colleagues' Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains (with reported Cronbach's alpha for original scales,physical activity , information seeking, support, communication with HC providers, ostomy management, social and recreational, symptom management and depression.
Measured: 6 months
Self-efficacy
Self-Efficacy to Perform Ostomy Self-Management Behaviors.Modified from Lorig and colleagues' Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains (with reported Cronbach's alpha for original scales,physical activity , information seeking, support, communication with HC providers, ostomy management, social and recreational, symptom management and depression.
Measured: 12 months
Health-related quality of life
COH-QOL-CRC Scale.The City of Hope QOL-Ostomy questionnaire was designed for all adult ostomates, and has a 4-dimensional HRQOL (physical, psychological, social and spiritual well-being) framework gathering demographic, personal (e.g. diet, work, and activity) and clinical data. It has an open-ended question of the greatest challenge of ostomy survivors. A multi-item scale section assesses overall Health-related quality of life and the four Health-related quality of life dimensions on a 0 to 10 scale. The full survey will be used at baseline; for post intervention and follow-up, only the 43 scaled items (those items sensitive to change over time) will be used. Reported Cronbach's alphas are .94 total scale and .80-.90 subscales.
Measured: 0 months
Health-related quality of life
COH-QOL-CRC Scale.The City of Hope QOL-Ostomy questionnaire was designed for all adult ostomates, and has a 4-dimensional HRQOL (physical, psychological, social and spiritual well-being) framework gathering demographic, personal (e.g. diet, work, and activity) and clinical data. It has an open-ended question of the greatest challenge of ostomy survivors. A multi-item scale section assesses overall Health-related quality of life and the four Health-related quality of life dimensions on a 0 to 10 scale. The full survey will be used at baseline; for post intervention and follow-up, only the 43 scaled items (those items sensitive to change over time) will be used. Reported Cronbach's alphas are .94 total scale and .80-.90 subscales.
Measured: 2 months
Health-related quality of life
COH-QOL-CRC Scale.The City of Hope QOL-Ostomy questionnaire was designed for all adult ostomates, and has a 4-dimensional HRQOL (physical, psychological, social and spiritual well-being) framework gathering demographic, personal (e.g. diet, work, and activity) and clinical data. It has an open-ended question of the greatest challenge of ostomy survivors. A multi-item scale section assesses overall Health-related quality of life and the four Health-related quality of life dimensions on a 0 to 10 scale. The full survey will be used at baseline; for post intervention and follow-up, only the 43 scaled items (those items sensitive to change over time) will be used. Reported Cronbach's alphas are .94 total scale and .80-.90 subscales.
Measured: 3 months
Health-related quality of life
COH-QOL-CRC Scale.The City of Hope QOL-Ostomy questionnaire was designed for all adult ostomates, and has a 4-dimensional HRQOL (physical, psychological, social and spiritual well-being) framework gathering demographic, personal (e.g. diet, work, and activity) and clinical data. It has an open-ended question of the greatest challenge of ostomy survivors. A multi-item scale section assesses overall Health-related quality of life and the four Health-related quality of life dimensions on a 0 to 10 scale. The full survey will be used at baseline; for post intervention and follow-up, only the 43 scaled items (those items sensitive to change over time) will be used. Reported Cronbach's alphas are .94 total scale and .80-.90 subscales.
Measured: 6 months
Health-related quality of life
COH-QOL-CRC Scale.The City of Hope QOL-Ostomy questionnaire was designed for all adult ostomates, and has a 4-dimensional HRQOL (physical, psychological, social and spiritual well-being) framework gathering demographic, personal (e.g. diet, work, and activity) and clinical data. It has an open-ended question of the greatest challenge of ostomy survivors. A multi-item scale section assesses overall Health-related quality of life and the four Health-related quality of life dimensions on a 0 to 10 scale. The full survey will be used at baseline; for post intervention and follow-up, only the 43 scaled items (those items sensitive to change over time) will be used. Reported Cronbach's alphas are .94 total scale and .80-.90 subscales.
Measured: 12 months
Ostomy knowledge
Ostomy Knowledge Questionnaire.This brief survey, derived at City of Hope, was modified for the pilot study and further adapted by the study team to ensure major topics were included.
Measured: 0 months
Ostomy knowledge
Ostomy Knowledge Questionnaire.This brief survey, derived at City of Hope, was modified for the pilot study and further adapted by the study team to ensure major topics were included.
Measured: 2 months
Ostomy knowledge
Ostomy Knowledge Questionnaire.This brief survey, derived at City of Hope, was modified for the pilot study and further adapted by the study team to ensure major topics were included.
Measured: 6 months
Ostomy knowledge
Ostomy Knowledge Questionnaire.This brief survey, derived at City of Hope, was modified for the pilot study and further adapted by the study team to ensure major topics were included.
Measured: 12 months
Healthcare utilization long form
Based on the model developed by Given, et al., for long-term care, this survey will gather participant self-reports of ostomy-related medical care use, productivity losses, and associated out-of-pocket expenses and time spent for ostomy care in general, and the OSMT intervention, caregivers, and paid housekeeping
Measured: 0 months
Healthcare utilization long form
Based on the model developed by Given, et al., for long-term care, this survey will gather participant self-reports of ostomy-related medical care use, productivity losses, and associated out-of-pocket expenses and time spent for ostomy care in general, and the OSMT intervention, caregivers, and paid housekeeping
Measured: 6 months
Healthcare utilization long form
Based on the model developed by Given, et al., for long-term care, this survey will gather participant self-reports of ostomy-related medical care use, productivity losses, and associated out-of-pocket expenses and time spent for ostomy care in general, and the OSMT intervention, caregivers, and paid housekeeping
Measured: 12 months
Healthcare utilization short form
Based on the model developed by Given, et al., for long-term care, this survey will gather participant self-reports of ostomy-related medical care use, productivity losses, and associated out-of-pocket expenses and time spent for ostomy care in general, and the OSMT intervention, caregivers, and paid housekeeping
Measured: 2 months
Healthcare utilization short form
Based on the model developed by Given, et al., for long-term care, this survey will gather participant self-reports of ostomy-related medical care use, productivity losses, and associated out-of-pocket expenses and time spent for ostomy care in general, and the OSMT intervention, caregivers, and paid housekeeping
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start1 Aug 2019
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstomyStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Krouse, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913715
- Sponsor's protocol ID
- 832343
- Other IDs
- R01CA204193
- Status last verified
- Jul 2025
- First submitted
- 14 Feb 2019
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ostomy Rural Telehealth Self-management Training for Cancer Survivors
- ClinicalTrials.gov ID
- NCT03913715
- Acronym / sponsor ID
- 832343
- Conditions
- Ostomy, Quality of Life, Telehealth
- Keywords
- Ileostomy, Urostomy, Colostomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 12 Apr 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.
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.
Detailed description
An ostomy adversely affects health-related quality of life in a diverse population of cancer survivors. For cancer, ostomies are most commonly placed for rectal cancers, followed by urinary bladder cancer. Ostomies may be needed for other cancers related to bulky or metastatic disease, or in emergencies. In addition, ostomies may be placed on a temporary or a permanent basis. Temporary ostomies may be created in emergencies, such as perforation or obstruction due to tumor, or in planned procedures, as with a low rectal resection for cancer where an ostomy is placed to "protect" a new anastomosis while it heals. Temporary ostomies may become permanent as a result of underlying comorbidities, need for other treatments related to cancer, or poor outcome of anastomosis (leak or stricture). Peri-operative needs are the same regardless of ostomy permanence; survivors should receive clear, systematic, evidence-based ostomy self-management instruction and support.
To cope with the challenges of their diseases, cancer survivors with ostomies should have confirmed levels of self-management skills, as well as strong commitments to self-management. Cognitive restructuring, problem-solving, and self-efficacy/locus of control are essential tools for effective self-management. As in most chronic conditions, this tends to be long-term, complex, and multidimensional. Trial-and-error ostomy self-care, nurse counseling, and community referral have been the primary modes of self-management education and support in the peri-operative period. Clearly, ostomates face many obstacles in coping with their condition, not least of which is medical care that often does not meet their needs for effective information, clinical management, psychological support, and patient activation These obstacles are likely compounded for ostomates living in rural areas. Approximately 14-19% of the US population resides in rural areas. Rural cancer survivors face significant barriers to ongoing care including lack of access to specialists and cancer-specific specialized support, longer travel distances to access follow-up care, and transportation challenges due to financial barriers or lack of a vehicle. Individuals in rural areas travel a median of 51-59 minutes to reach specialized oncology care. Additionally, some studies suggest that rural cancer patients have worse quality of life and mental health than their urban counterparts, and up to a quarter of rural cancer patients have unmet cancer information needs. Telehealth delivery of an ostomy self-management program offers an opportunity to reduce these access disparities among rural ostomates.
Ostomates and their families must engage in ostomy self-management, make behavior changes, and adjust to the consequences of their condition, becoming the principal caretakers and navigators. Preparation of the survivor and unpaid designated caregiver/support person (usually family members) is requisite to assure optimal functioning and HRQOL, as well as to prevent or ameliorate ostomy-related complications and associated health care utilization. Multiple communication issues make it difficult for ostomy survivors to access resources for improving their self-management, and undermine opportunities to improve and sustain HRQOL. These resources include lack of consistent follow-up, travel issues, lack of surgeon focus on ostomy-related problems, and lack of ostomy nurse clinic resources.
Ostomies are associated with multiple HRQOL difficulties. Ongoing problems include pouching care, travel out of the home (especially relevant for rural populations), social interactions, intimacy, and acceptance of/satisfaction with appearance. Studies document persistent challenges including sexuality psychological problems and interference with work, recreation, and sporting activities. However, improved self-efficacy eases the psychological and social burden of ostomies. No reports have been published on the results of a systematic ostomy self-management program to ensure optimal post-operative care, including adaptation, self-management, and ostomy comfort.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ostomy Self-Management Training | Active comparator | Other: Ostomy Self-Management TrainingOstomy 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 |
| Usual care | Placebo comparator | Other: Ostomy Self-Management TrainingUsual 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Ostomy Self-Management TrainingOstomy 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 |
Primary outcome
Patient Activation - PAM
Time frame: 0 months
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.
Patient Activation- PAM
Time frame: 2 months
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.
Patient Activation - PAM
Time frame: 3 months
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.
Patient Activation- PAM
Time frame: 6 months
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.
Patient Activation- PAM
Time frame: 12months
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.
18 secondary outcomes
Self-efficacy
Time frame: 0 months
Self-efficacy
Time frame: 2 months
Self-efficacy
Time frame: 6 months
Self-efficacy
Time frame: 12 months
Health-related quality of life
Time frame: 0 months
Health-related quality of life
Time frame: 2 months
Health-related quality of life
Time frame: 3 months
Health-related quality of life
Time frame: 6 months
Health-related quality of life
Time frame: 12 months
Ostomy knowledge
Time frame: 0 months
Ostomy knowledge
Time frame: 2 months
Ostomy knowledge
Time frame: 6 months
Ostomy knowledge
Time frame: 12 months
Healthcare utilization long form
Time frame: 0 months
Healthcare utilization long form
Time frame: 6 months
Healthcare utilization long form
Time frame: 12 months
Healthcare utilization short form
Time frame: 2 months
Healthcare utilization short form
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
Robert Krouse, MD principal investigator
University of Pennsylvania
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ostomy Self-Management Training in people with Ostomy and Quality of Life, run by Abramson Cancer Center at Penn Medicine at 10 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 10 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: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 Activation - PAM (time frame: 0 months). The study lists 5 primary outcomes in all. 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 11 Jul 2025.