Trial Outcomes & Findings for Ostomy Telehealth For Cancer Survivors (NCT NCT02974634)
NCT ID: NCT02974634
Last Updated: 2020-08-19
Results Overview
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.
COMPLETED
NA
216 participants
baseline, on completion of session ( 5 weeks) and 6 month follow up
2020-08-19
Participant Flow
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.
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.
Participant milestones
| Measure |
Ostomy Self Management Training
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
|
Usual Care
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.
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
110
|
|
Overall Study
COMPLETED
|
78
|
89
|
|
Overall Study
NOT COMPLETED
|
28
|
21
|
Reasons for withdrawal
| Measure |
Ostomy Self Management Training
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
|
Usual Care
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.
|
|---|---|---|
|
Overall Study
Advanced disease
|
12
|
3
|
|
Overall Study
Noncompliance
|
3
|
7
|
|
Overall Study
intervention technology related issues
|
5
|
0
|
|
Overall Study
Death
|
8
|
11
|
Baseline Characteristics
Ostomy Telehealth For Cancer Survivors
Baseline characteristics by cohort
| Measure |
Ostomy Self Management Training
n=106 Participants
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
|
Usual Care
n=110 Participants
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
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
n=5 Participants
|
61.6 years
n=7 Participants
|
61.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
106 participants
n=5 Participants
|
110 participants
n=7 Participants
|
216 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, on completion of session ( 5 weeks) and 6 month follow upPopulation: Intent to treat participants who provided baseline and at least one followup measurement
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.
Outcome measures
| Measure |
Ostomy Self Management Training
n=89 Participants
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
|
Usual Care
n=101 Participants
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.
|
|---|---|---|
|
Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.
Baseline
|
66.9 score on a scale
Standard Deviation 12.9
|
64.2 score on a scale
Standard Deviation 15.8
|
|
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
|
66.2 score on a scale
Standard Deviation 13.5
|
|
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
|
66.5 score on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: baseline, on completion of session ( 5 weeks) and 6 month follow upPopulation: Intent to treat participants who provided baseline and at least one followup measurement
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
Outcome measures
| Measure |
Ostomy Self Management Training
n=89 Participants
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
|
Usual Care
n=101 Participants
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.
|
|---|---|---|
|
Self-Efficacy to Perform Ostomy Self-Management Behaviors
Baseline
|
6.7 score on a scale
Standard Deviation 2.1
|
7.0 score on a scale
Standard Deviation 2.2
|
|
Self-Efficacy to Perform Ostomy Self-Management Behaviors
Post session
|
7.1 score on a scale
Standard Deviation 2.0
|
7.3 score on a scale
Standard Deviation 1.9
|
|
Self-Efficacy to Perform Ostomy Self-Management Behaviors
6 months follow up
|
7.3 score on a scale
Standard Deviation 2.2
|
7.1 score on a scale
Standard Deviation 2.1
|
Adverse Events
Ostomy Self Management Training
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place