Trial Outcomes & Findings for Care Partners: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy (NCT NCT00983892)
NCT ID: NCT00983892
Last Updated: 2016-03-22
Results Overview
Summed severity across 8 symptoms of interest, as measured using the MD Anderson Symptom Inventory. 8 core symptoms rated by the patient on a scale of 0 to 10. These 8 symptoms were chosen based on their prevalence of 50% or greater in the population of interest. Higher scores mean WORSE or GREATER SYMPTOM BURDEN.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
3 months
Results posted on
2016-03-22
Participant Flow
This was a five year study from October 1 2009 to Sept 30 2014. Patients were recruited from three VA oncology practices: Ann Arbor, Fargo, and Loma Linda.
Participant milestones
| Measure |
CarePartners +
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.
Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan.
|
CarePartners -
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
68
|
|
Overall Study
COMPLETED
|
56
|
56
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
CarePartners +
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.
Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan.
|
CarePartners -
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
12
|
Baseline Characteristics
Care Partners: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy
Baseline characteristics by cohort
| Measure |
CarePartners +
n=66 Participants
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.
Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan.
|
CarePartners -
n=68 Participants
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
62 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Summed symptom severity
|
27.8 units on a scale 0-80
STANDARD_DEVIATION 13.7 • n=5 Participants
|
28.1 units on a scale 0-80
STANDARD_DEVIATION 16.6 • n=7 Participants
|
28.0 units on a scale 0-80
STANDARD_DEVIATION 15.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsSummed severity across 8 symptoms of interest, as measured using the MD Anderson Symptom Inventory. 8 core symptoms rated by the patient on a scale of 0 to 10. These 8 symptoms were chosen based on their prevalence of 50% or greater in the population of interest. Higher scores mean WORSE or GREATER SYMPTOM BURDEN.
Outcome measures
| Measure |
CarePartners Intervention +
n=66 Participants
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.
Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan.
|
Control
n=68 Participants
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
|
|---|---|---|
|
Summed Symptom Severity
|
23.2 units on a scale
Standard Deviation 16.4
|
19.9 units on a scale
Standard Deviation 14.9
|
Adverse Events
CarePartners+
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CarePartners-
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Maria J. Silveira MD MA MPH
Ann Arbor Veterans Administration
Phone: 734-763-4550
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place