- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03913715
Ostomy Rural Telehealth Training Cancer Survivors
Ostomy Rural Telehealth Self-management Training for Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sabreen Raza, MPH
- Phone Number: 2154303855
- Email: sabreen.raza@pennmedicine.upenn.edu
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- University of Arkansas for Medical Sciences
-
Principal Investigator:
- JONATHAN LARYEA, MD FACS FASCRS FWACS
-
-
California
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope
-
Contact:
- Elizabeth Bustamante
- Phone Number: 83202 626-218-3202
- Email: ebustamante@coh.org
-
Principal Investigator:
- Virginia Sun, RN
-
Loma Linda, California, United States, 11005
- Recruiting
- Loma Linda University Health
-
Contact:
- Annette Boggs, BS
- Phone Number: 909-558-7251
- Email: aboggs@llu.edu
-
Contact:
- Lorena Garcia
- Phone Number: (909) 651-5612
- Email: lcgarcia@llu.edu
-
Principal Investigator:
- Fabrizio Luca, MD, FACS, FASCRS
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- Recruiting
- University of New Mexico
-
Contact:
- Isaac Lira
- Phone Number: 505-272-7403
- Email: ilira@salud.unm.edu
-
Principal Investigator:
- Sarah M Popek, MD, FACS, FASCRS
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- University of North Carolina
-
Contact:
- Dana Mueller, MPH
- Phone Number: 919-962-4671
- Email: dana_mueller@med.unc.edu
-
Principal Investigator:
- Matthew Nielsen, MD
-
-
North Dakota
-
Fargo, North Dakota, United States, 58122
- Recruiting
- Sanford Research Center
-
Contact:
- Kevin Rittenhouse, MA
- Phone Number: 701-234-6885
- Email: kevin.rittenhouse@sanfordhealth.org
-
Principal Investigator:
- Sabha Ganai, MD, PhD, MPH, FACS, FSSO
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822
- Recruiting
- Geisinger
-
Contact:
- Kirstin Kirstin Rabinowitz, MPH
- Phone Number: 570-214-1976
- Email: krabinowitz@geisinger.edu
-
Principal Investigator:
- Tullika Garg, MD
-
Lancaster, Pennsylvania, United States, 17604
- Recruiting
- Lancaster General Hospital
-
Contact:
- Sara E Druck, MSN, RN, COCN
- Phone Number: 717-544-3620
- Email: sara.druck@pennmedicine.upenn.edu
-
Principal Investigator:
- Walid Hesham, MD
-
Philadelphia, Pennsylvania, United States, 19104
- Active, not recruiting
- Penn Medicine
-
-
South Carolina
-
Greenville, South Carolina, United States, 21111
- Completed
- University of South Carolina Greenville (Prisma Health)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ostomy Self-Management Training
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 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
|
Placebo Comparator: Usual care
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0 months
|
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.
|
2 months
|
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.
|
3 months
|
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.
|
6 months
|
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.
|
12months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy
Time Frame: 0 months
|
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.
|
0 months
|
Self-efficacy
Time Frame: 2 months
|
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.
|
2 months
|
Self-efficacy
Time Frame: 6 months
|
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.
|
6 months
|
Self-efficacy
Time Frame: 12 months
|
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.
|
12 months
|
Health-related quality of life
Time Frame: 0 months
|
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.
|
0 months
|
Health-related quality of life
Time Frame: 2 months
|
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.
|
2 months
|
Health-related quality of life
Time Frame: 3 months
|
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.
|
3 months
|
Health-related quality of life
Time Frame: 6 months
|
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.
|
6 months
|
Health-related quality of life
Time Frame: 12 months
|
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.
|
12 months
|
Ostomy knowledge
Time Frame: 0 months
|
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.
|
0 months
|
Ostomy knowledge
Time Frame: 2 months
|
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.
|
2 months
|
Ostomy knowledge
Time Frame: 6 months
|
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.
|
6 months
|
Ostomy knowledge
Time Frame: 12 months
|
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.
|
12 months
|
Healthcare utilization long form
Time Frame: 0 months
|
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
|
0 months
|
Healthcare utilization long form
Time Frame: 6 months
|
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
|
6 months
|
Healthcare utilization long form
Time Frame: 12 months
|
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
|
12 months
|
Healthcare utilization short form
Time Frame: 2 months
|
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
|
2 months
|
Healthcare utilization short form
Time Frame: 3 months
|
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
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale
Time Frame: 0 months
|
Hospital Anxiety and Depression Scale.
It is a self-assessment instrument for detecting anxiety and depression in medical outpatients, which has been demonstrated sensitive in community and inpatient cancer studies, with subscales of < 7 not present, 8-10 doubtful, >11 definite.
Reported Cronbach's alpha.
|
0 months
|
Hospital Anxiety and Depression Scale
Time Frame: 2 months
|
Hospital Anxiety and Depression Scale.
It is a self-assessment instrument for detecting anxiety and depression in medical outpatients, which has been demonstrated sensitive in community and inpatient cancer studies, with subscales of < 7 not present, 8-10 doubtful, >11 definite.
Reported Cronbach's alpha.
|
2 months
|
Hospital Anxiety and Depression Scale
Time Frame: 6 months
|
Hospital Anxiety and Depression Scale.
It is a self-assessment instrument for detecting anxiety and depression in medical outpatients, which has been demonstrated sensitive in community and inpatient cancer studies, with subscales of < 7 not present, 8-10 doubtful, >11 definite.
Reported Cronbach's alpha.
|
6 months
|
Hospital Anxiety and Depression Scale
Time Frame: 12 months
|
Hospital Anxiety and Depression Scale.
It is a self-assessment instrument for detecting anxiety and depression in medical outpatients, which has been demonstrated sensitive in community and inpatient cancer studies, with subscales of < 7 not present, 8-10 doubtful, >11 definite.
Reported Cronbach's alpha.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Krouse, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 832343
- R01CA204193 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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