An interventional study of Caregiver website in Cancer, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-22.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Supportive care
Given the growing strain on the Veterans Administration resulting from increasing caseloads of cancer patients, interventions are badly needed that assist patients in managing their illness, improve quality of life and avoid acute episodes that result in urgent care use and increased mortality. Previous studies have found that cancer patients undergoing chemotherapy can effectively manage their own symptoms when monitored using automated telephone calls. Such technology, however, may challenge the number of Veterans who lack social support and/or independence. The goal was to develop and test a technology that not only monitors patients automatically by telephone, but also gives them self management advice and engages a friend or family member to serve as a CarePartner willing to play a limited role in identifying patient symptoms and psychosocial needs to reinforce self management and provide social support. The investigators found that this technology indeed helped patients better control their symptoms, especially when a caregiver participated in the program along with them.
Cancer is a prevalent problem that causes much suffering among Veterans and their families. Most interventions to improve symptom control require Veterans to engage in activities such as managing medications, altering diets, or accessing outside resources that may be beyond their reach due to limitations in physical and mental functioning. Friends and family inside and outside of the Veteran's household can help, but often lack the skills and resources they need to do so.
"Cancer CarePartners" was designed to address these needs by providing cancer-stricken Veterans and their informal caregivers with the information they need to make effective management decisions, decrease symptom burden, and improve outcomes. Cancer CarePartners is a Web-enabled program that alerts caregivers of patients' symptoms and provides them with a framework for identifying problems, receiving structured advice, formulating a 'task list,' and following up with their patients as they receive chemotherapy. Specifically, Cancer CarePartners includes weekly, automated telephonic symptom assessment (ATSA) with self-management (SM) support to the Veteran paired with Web-based alerts to the caregiver pointing them to a website where s/he can obtain customized advice. A randomized control trial was conducted to test the efficacy of this program in controlling symptoms as well as improving adherence to chemotherapy.
Objectives
Methods Consenting Veterans with solid tumors undergoing chemotherapy at one of three VAMCs (Ann Arbor, Loma Linda and Fargo) who reported at least one core symptom at a moderate level or higher and had a caregiver willing to enroll in the study were randomly assigned to either 10 weeks of Cancer CarePartners or 10 weeks of automated, telephonic symptom assessment (ATSA) with self management support. Arms were balanced for non-small cell lung cancer status and caregiver type. Patients and caregivers were surveyed at intake, 10, and 14 weeks. In addition, the investigators tracked patient participation with ATSA and (in the experimental arm) caregiver use of the Cancer CarePartners Website. The investigators reviewed all medical records for content of care received during the 14 weeks on study.
VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive the intervention (Intervention = access to a caregiver Web site that updates them on patient's symptoms and provides tailored problem solving advice).
Behavioral: Caregiver website
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing (i.e. no access to the caregiver website, or 'intervention').
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.
Also known as: Care Partners
Summed Symptom Severity
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.
Time frame: 3 months
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.
| Milestone | CarePartners + | CarePartners - |
|---|---|---|
| Started | 66 | 68 |
| Completed | 56 | 56 |
| Not completed | 10 | 12 |
| Withdrew: Withdrawal by subject | 10 | 12 |
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.
| units on a scale | CarePartners Intervention + | Control |
|---|---|---|
| Summed Symptom Severity | 23.2 ± 16.4 | 19.9 ± 14.9 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CarePartners+ | — | 0/66 (0%) | 0/66 (0%) |
| CarePartners- | — | 0/68 (0%) | 0/68 (0%) |
| Age, Continuous(years) | CarePartners + | CarePartners - | Total |
|---|---|---|---|
| Mean | 64 (46 to 87) | 62 (29 to 82) | 63 (29 to 87) |
| Sex: Female, Male(Participants) | CarePartners + | CarePartners - | Total |
|---|---|---|---|
| Female | 9 | 5 | 14 |
| Male | 57 | 63 | 120 |
| Ethnicity (NIH/OMB)(Participants) | CarePartners + | CarePartners - | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 55 | 55 | 110 |
| Unknown or Not Reported | 9 | 11 | 20 |
| Race (NIH/OMB)(Participants) | CarePartners + | CarePartners - | Total |
|---|---|---|---|
| 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(units on a scale 0-80) | CarePartners + | CarePartners - | Total |
|---|---|---|---|
| Mean | 27.8 ± 13.7 | 28.1 ± 16.6 | 28.0 ± 15.2 |
Plan to share: No
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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