Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Care Partners: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy

This study has been completed.
Sponsor:
Collaborators:
Michigan State University
University of Michigan
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00983892
First received: September 22, 2009
Last updated: February 29, 2016
Last verified: February 2016
Results First Received: February 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Cancer
Intervention: Behavioral: Caregiver website

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    CarePartners +     CarePartners -  
STARTED     66     68  
COMPLETED     56     56  
NOT COMPLETED     10     12  
Withdrawal by Subject                 10                 12  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    CarePartners +     CarePartners -     Total  
Number of Participants  
[units: participants]
  66     68     134  
Age  
[units: years]
Mean (Full Range)
  64  
  (46 to 87)  
  62  
  (29 to 82)  
  63  
  (29 to 87)  
Gender  
[units: participants]
     
Female     9     5     14  
Male     57     63     120  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     2     4  
Not Hispanic or Latino     55     55     110  
Unknown or Not Reported     9     11     20  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     1     2  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     4     9  
White     42     48     90  
More than one race     0     0     0  
Unknown or Not Reported     18     15     33  
Summed symptom severity [1]
[units: units on a scale 0-80]
Mean (Standard Deviation)
  27.8  (13.7)     28.1  (16.6)     28.0  (15.2)  
[1] symptom severity = the sum across 8 core symptoms rated by the patient on a scale of 0 to 10 (higher is worse).



  Outcome Measures

1.  Primary:   Summed Symptom Severity   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Recruitment rates were lower than expected.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Maria J. Silveira MD MA MPH
Organization: Ann Arbor Veterans Administration
phone: 734-763-4550
e-mail: mariajs@med.umich.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00983892     History of Changes
Other Study ID Numbers: IIR 08-309
Study First Received: September 22, 2009
Results First Received: February 2, 2016
Last Updated: February 29, 2016
Health Authority: United States: Federal Government