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IIR 08-309 – HSR Study

IIR 08-309
Web-based support for caregivers of Veterans undergoing chemotherapy
Maria J. Silveira, MD MA MPH
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, MI
Funding Period: October 2009 - September 2014
Most interventions to improve cancer symptoms rely on patient self-management, which can be challenging for some. "Cancer CarePartners" is a system designed to engage informal caregivers to support patients' efforts to maintain quality of life as they receive chemotherapy. The system provides weekly, automated telephonic symptom assessment to patients, and symptom alerts plus tailored management advice to their caregivers. We conducted randomized control trial to test the efficacy of this program in controlling symptoms and improving adherence to chemotherapy.

1) To determine if Veterans undergoing chemotherapy who receive Cancer CarePartners report significant improvement in the summed severity of symptoms (the sum of 0-10 severity across 8 core symptoms) compared to Veterans receiving symptom monitoring and self-management advice; secondarily, to determine if they experience better adherence to chemotherapy and utilization. (2) To determine if caregivers participating in the intervention provide significantly more social support to patients than do controls; secondarily, to determine if they experience more caregiver burden and distress than do controls. (3) To determine whether impacts on patients are mediated by mastery. (4) To determine whether impacts on caregivers are mediated by mastery.

Consenting patients with solid tumors undergoing chemotherapy who reported any symptom at a 3 (out of 10) or higher and also had a consenting caregiver were randomly assigned to 10 w of either Cancer CarePartners or an attention control. Arms were balanced for lung cancer status and caregiver type. Subjects were surveyed at 0, 10, and 14 weeks; charts were reviewed at 14 weeks. We tracked patient and caregiver use of the system.

371 (45%) of 834 patients referred to the study met eligibility criteria. Among the 151 (41%) patients who consented, 91% entered the study and 82% completed the trial. Patients completed assessments for most weeks on study (mean 8.3 for controls 8.3 vs. 7.7 for intervention patients). Intervention caregivers logged into the Website an average of 4.1 times over 10 weeks (range 0-10). At 10 weeks, intervention patients experienced lower summed symptom severity (mean 19.5) than controls (mean 23.2), but this was not statistically significant after adjusting for baseline symptoms (P=0.107). They also experienced fewer inpatient stays (mean 0.19 vs. 0.34, P=0.1814) and phone calls with providers (mean 0.46 vs. 0.62, P=0.3019). They received more chemotherapy (# agents per cycle 3.6 vs. 3.1 P=0.0395; # agents per infusion 2.2 vs. 2.0 P=0.0054). Intervention caregivers, in turn, reported less depression (CESD Coef -1.08, P=0.094, 95% CI -2.35 to 0.19), but similar burden as controls.

The Cancer CarePartners system is already being offered at the Ann Arbor VAMC to help patients undergoing chemotherapy manage their symptoms. One barrier to broader implementation of this program is the need to migrate it behind the VA firewall and fund programmer time for its maintenance; both of which are works in progress.

External Links for this Project

NIH Reporter

Grant Number: I01HX000162-01

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None at this time.

DRA: Aging, Older Veterans' Health and Care, Health Systems, Cancer
DRE: Treatment - Efficacy/Effectiveness Clinical Trial, Treatment - Observational, Prevention
Keywords: Access, Cancer, Caregivers – not professionals, Quality of life
MeSH Terms: none

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