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Ostomy Rural Telehealth Training Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03913715
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Ostomy Quality of Life Telehealth Behavioral: Ostomy Self-Management Training Not Applicable

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.1-13 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 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, and recreation and sporting activities. However, improved self-efficacy eases 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Ostomy Rural Telehealth Self-management Training for Cancer Survivors
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : February 29, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ostomy Self-Management Training
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
Behavioral: Ostomy Self-Management Training
include the dose and intensity of the intervention in the description, if applicable

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.
Behavioral: Ostomy Self-Management Training
include the dose and intensity of the intervention in the description, if applicable




Primary Outcome Measures :
  1. Patient Activation [ 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.

  2. Patient Activation [ 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.

  3. Patient Activation [ 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.

  4. Patient Activation [ Time Frame: 12 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Cancer 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.

    2. Residence within a zip code that is designated as non-metropolitan. 2. All participants must have a full understanding of the protocol and be able to sign an informed consent form.

    3. Having an identified caregiver/support person is not a requirement for eligibility, but will be strongly encouraged if possible.

    4. All participants will attend their first training session at least six weeks after their operation.

    5. There is no maximum time since surgery.

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913715


Contacts
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Contact: Sabreen Raza, MPH 2154303855 sabreen.raza@uphs.upenn.edu
Contact: Mary Wagner 5202715722

Locations
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United States, California
City Of Hope Recruiting
Duarte, California, United States, 91010
Contact: Elizabeth Bustamante    626-218-3202 ext 83202    ebustamante@coh.org   
Principal Investigator: Virginia Sun, RN         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Dana Mueller, MPH    919-962-4671    dana_mueller@med.unc.edu   
Principal Investigator: Matthew Nielsen, MD         
United States, Pennsylvania
Geisnger Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Kirstint Kirstin Rabinowitz, MPH    570-214-1976    krabinowitz@geisinger.edu   
Contact: Andrew Zechman, MBS    570-214-3894    agzechman@geisinger.edu   
Principal Investigator: Tullika Garg, MD         
Penn Medicine Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Robert Krouse, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03913715     History of Changes
Other Study ID Numbers: 832343
R01CA204193 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No