Colostomy Stoma
Conditions
Keywords
Ileostomy
Brief summary
The purpose of this study is to test the benefits of an educational program, the Ostomy Self-Management Training (OSMT) program, for improving patient activation (preparedness to do self-care), self-efficacy (patients' ability to do self-care), knowledge of ostomy/urostomy self-care, quality of life, mood, use of medical services, and financial burden in patients with ostomies. The study will compare patients in the intervention (training) group and patients in the usual care group. Subjects' participation in this study is expected to last about 7 months. The PI plans to enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be coordinated by the University of Arizona in Tucson, Arizona.
Detailed description
Over one million individuals in the U.S. have ostomies. The American Cancer Society estimates 39,610 rectal cancer cases and 74,000 bladder cancer cases will be diagnosed in 2015. Of these, at least 30,000 will receive ostomies, and an additional unknown number due to gynecologic, other gastrointestinal tumors. The HRQOL 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. 18% of participants took at least one year, or never felt comfortable, in their ostomy care. Importantly, many patients cannot attend selfmanagement programs or patient groups for a myriad of reasons, including distance to travel, monetary outlays, comorbidities making travel difficult, or lack of access to transportation. 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 these cancer survivors aimed to limit family financial burdens, decrease medical care use, and improve well-being. This study has the potential to improve health care outcomes for cancer survivors with ostomies by enhancing their knowledge of and self-efficacy with ostomy care. This will be accomplished by improving the ability to communicate an established educational curriculum developed based on patient needs and desires and refined via a pilot study.
Interventions
OTHEROstomy 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
Sponsors
City of Hope Medical Center
Yale University
University of Arizona
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* All cancer survivors over 21 years of age having undergone a procedure that needed an intestinal stoma (fecal or urinary).
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare. | baseline, on completion of session ( 5 weeks) and 6 month follow up | The patient activation measure (PAM) is a 100-point, quantifiable scale determining patient engagement in healthcare. PAM uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation involving four stages (see below). 0 indicates lower activation (worse) whereas 100 indicates higher activation (better) (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Efficacy to Perform Ostomy Self-Management Behaviors | baseline, on completion of session ( 5 weeks) and 6 month follow up | 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. Range 1 to 10, where higher is better outcome |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at three study sites through several mechanisms. These include identification of potential participants via institutional registry, records,databases.Referrals from site WOCNs, attending surgeons and other clinical providers; and through distribution of Institutional . Subjects were recruited from 11/01/16 to 10/01/2018.
Pre-assignment details
All cancer survivors over 21 years of age who were at least six weeks after a surgical procedure that necessitated the creation of an intestinal stoma (fecal or urinary) were recruited. Survivors with temporary ostomies were included, and there was no maximum time since surgery.
Participants by arm
| Arm | Count |
|---|---|
| Ostomy Self Management Training Comparing OSMT group to UC group The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones.
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 | 106 |
| Usual Care Comparing OSMT group to UC group
Subjects were provided with physician and Wound ostomy nurses contacts and written information about an ostomy care. These study subject were expected only to complete study surveys. | 110 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Advanced disease | 12 | 3 |
| Overall Study | Death | 8 | 11 |
| Overall Study | intervention technology related issues | 5 | 0 |
| Overall Study | Noncompliance | 3 | 7 |
Baseline characteristics
| Characteristic | Ostomy Self Management Training | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 61.6 years | 61.6 years | 61.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 20 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants | 196 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 17 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 18 Participants | 7 Participants |
| Race (NIH/OMB) White | 76 Participants | 166 Participants | 90 Participants |
| Region of Enrollment United States | 106 participants | 216 participants | 110 participants |
| Sex: Female, Male Female | 50 Participants | 103 Participants | 53 Participants |
| Sex: Female, Male Male | 56 Participants | 113 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 106 | 11 / 110 |
| other Total, other adverse events | 0 / 106 | 0 / 110 |
| serious Total, serious adverse events | 0 / 106 | 0 / 110 |
Outcome results
Primary
Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.
The patient activation measure (PAM) is a 100-point, quantifiable scale determining patient engagement in healthcare. PAM uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation involving four stages (see below). 0 indicates lower activation (worse) whereas 100 indicates higher activation (better) (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.
Time frame: baseline, on completion of session ( 5 weeks) and 6 month follow up
Population: Intent to treat participants who provided baseline and at least one followup measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ostomy Self Management Training | Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare. | Baseline | 66.9 score on a scale | Standard Deviation 12.9 |
| Ostomy Self Management Training | Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare. | Post session | 67.6 score on a scale | Standard Deviation 12.9 |
| Ostomy Self Management Training | Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare. | 6 months follow up | 70.7 score on a scale | Standard Deviation 13.3 |
| Usual Care | Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare. | Baseline | 64.2 score on a scale | Standard Deviation 15.8 |
| Usual Care | Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare. | Post session | 66.2 score on a scale | Standard Deviation 13.5 |
| Usual Care | Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare. | 6 months follow up | 66.5 score on a scale | Standard Deviation 12.3 |
p-value: 0.0695% CI: [-3.5, 5.6]t-test, 2 sided
Secondary
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. Range 1 to 10, where higher is better outcome
Time frame: baseline, on completion of session ( 5 weeks) and 6 month follow up
Population: Intent to treat participants who provided baseline and at least one followup measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ostomy Self Management Training | Self-Efficacy to Perform Ostomy Self-Management Behaviors | Baseline | 6.7 score on a scale | Standard Deviation 2.1 |
| Ostomy Self Management Training | Self-Efficacy to Perform Ostomy Self-Management Behaviors | Post session | 7.1 score on a scale | Standard Deviation 2 |
| Ostomy Self Management Training | Self-Efficacy to Perform Ostomy Self-Management Behaviors | 6 months follow up | 7.3 score on a scale | Standard Deviation 2.2 |
| Usual Care | Self-Efficacy to Perform Ostomy Self-Management Behaviors | Baseline | 7.0 score on a scale | Standard Deviation 2.2 |
| Usual Care | Self-Efficacy to Perform Ostomy Self-Management Behaviors | Post session | 7.3 score on a scale | Standard Deviation 1.9 |
| Usual Care | Self-Efficacy to Perform Ostomy Self-Management Behaviors | 6 months follow up | 7.1 score on a scale | Standard Deviation 2.1 |
p-value: 0.6895% CI: [-0.24, 0.91]t-test, 2 sided