PCORI: Ostomy Telehealth For Cancer Survivors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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 |
Other: 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
|
| 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 |
Other: 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Penn Medicine | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
- City of Hope Medical Center
- Yale University
- University of Arizona
Investigators
- Principal Investigator: Robert Krouse, MD, University of Pennsylvania
Study Documents (Full-Text)
More Information
Additional Information:
- Cancer Survivors' Challenges With Ostomy Appliances and Self-Management: A Qualitative Analysis
- Ostomy Telehealth for Cancer Survivors: Design of the Ostomy Self-management Training (OSMT) Randomized Trial
Publications
None provided.- 826150
Study Results
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 Detail | 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. |
| Arm/Group Title | Ostomy Self Management Training | Usual Care |
|---|---|---|
| Arm/Group Description | 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 | Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys. |
| Period Title: Overall Study | ||
| STARTED | 106 | 110 |
| COMPLETED | 78 | 89 |
| NOT COMPLETED | 28 | 21 |
Baseline Characteristics
| Arm/Group Title | Ostomy Self Management Training | Usual Care | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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. | Total of all reporting groups |
| Overall Participants | 106 | 110 | 216 |
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
61.6
|
61.6
|
61.6
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
50
47.2%
|
53
48.2%
|
103
47.7%
|
| Male |
56
52.8%
|
57
51.8%
|
113
52.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
12
11.3%
|
8
7.3%
|
20
9.3%
|
| Not Hispanic or Latino |
94
88.7%
|
102
92.7%
|
196
90.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
0.9%
|
0
0%
|
1
0.5%
|
| Asian |
6
5.7%
|
3
2.7%
|
9
4.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
10
9.4%
|
7
6.4%
|
17
7.9%
|
| White |
76
71.7%
|
90
81.8%
|
166
76.9%
|
| More than one race |
2
1.9%
|
3
2.7%
|
5
2.3%
|
| Unknown or Not Reported |
11
10.4%
|
7
6.4%
|
18
8.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
106
100%
|
110
100%
|
216
100%
|
Outcome Measures
| Title | Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat participants who provided baseline and at least one followup measurement |
| Arm/Group Title | Ostomy Self Management Training | Usual Care |
|---|---|---|
| Arm/Group Description | 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 | Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys. |
| Measure Participants | 89 | 101 |
| Baseline |
66.9
(12.9)
|
64.2
(15.8)
|
| Post session |
67.6
(12.9)
|
66.2
(13.5)
|
| 6 months follow up |
70.7
(13.3)
|
66.5
(12.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ostomy Self Management Training, Usual Care |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.06 |
| Comments | Comparison of intervention and usual care at 6 month follow up | |
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% -3.5 to 5.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.32 |
|
| Estimation Comments | Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model | |
| Title | Self-Efficacy to Perform Ostomy Self-Management Behaviors |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat participants who provided baseline and at least one followup measurement |
| Arm/Group Title | Ostomy Self Management Training | Usual Care |
|---|---|---|
| Arm/Group Description | 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. 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 | Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys. |
| Measure Participants | 89 | 101 |
| Baseline |
6.7
(2.1)
|
7.0
(2.2)
|
| Post session |
7.1
(2.0)
|
7.3
(1.9)
|
| 6 months follow up |
7.3
(2.2)
|
7.1
(2.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ostomy Self Management Training, Usual Care |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.68 |
| Comments | Comparison of intervention and usual care at 6 month follow up | |
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.34 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.91 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model | |
Adverse Events
| Time Frame | Adverse events were collected during the time subjects were part of the study from for 6 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Ostomy Self Management Training | Usual Care | ||
| Arm/Group Description | 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. 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 | Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys. | ||
All Cause Mortality |
||||
| Ostomy Self Management Training | Usual Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/106 (7.5%) | 11/110 (10%) | ||
Serious Adverse Events |
||||
| Ostomy Self Management Training | Usual Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/106 (0%) | 0/110 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Ostomy Self Management Training | Usual Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/106 (0%) | 0/110 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Robert Krouse |
|---|---|
| Organization | University of Pennsylvania |
| Phone | 215-615-4573 |
| robert.krouse@pennmedicine.upenn.edu |
- 826150