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

This study is currently recruiting participants.
Verified April 2014 by Department of Veterans Affairs
Sponsor:
Collaborators:
Michigan State University
University of Michigan
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00983892
First received: September 22, 2009
Last updated: April 18, 2014
Last verified: April 2014

September 22, 2009
April 18, 2014
October 2010
July 2015   (final data collection date for primary outcome measure)
patient symptom severity (MDASI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Summed severity across 8 symptoms of interest. These 8 symptoms were chosen based on their prevalence of 50% or greater in the population of interest.
patient symptom severity (MDASI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00983892 on ClinicalTrials.gov Archive Site
  • adherence to chemotherapy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • function (SF36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • utilization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Care Partners: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy
Web-based Support for Caregivers of Veterans Undergoing Chemotherapy

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. Our goal is 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. Should such technology be successful, it could substantially improve the quality of life of veterans and their families during the stresses of chemotherapy without substantially increasing the cost of care.

Background:

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. Our goal is 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. Should such technology be successful, it could substantially improve the quality of life of veterans and their families during the stresses of chemotherapy without substantially increasing the cost of care.

Objectives:

1. To determine if VA patients undergoing chemotherapy who receive automated telephonic assessment and symptom management advice plus Web-based feedback to inform and engage a CarePartner report significant improvement in the number and severity of symptoms compared to patients receiving monitoring only. Secondary patient outcomes include adherence to chemotherapy, function, and utilization. 2. To determine if CarePartners receiving weekly notification of patients' symptom severity with problem solving advice through a Web-based system provide significantly more social support to patients than do control CarePartners. Secondarily, to determine if CarePartners receiving the intervention experience more caregiver burden and distress than do control CarePartners. 3. To determine whether the impacts on patients are mediated by improved general adherence and whether this association is moderated by the presence of other caregivers (besides the CarePartner) as well as patient clinical and socio-demographic characteristics. 4. To determine whether the impacts on patients are mediated by improved general adherence and whether this association is moderated by the presence of other caregivers as well as patient clinical and socio-demographic characteristics. 5. To determine whether the abovementioned impacts on CarePartners are mediated by improvements in their knowledge of patients' symptoms and mastery, and whether this association is moderated by CarePartner location (i.e. inside or outside the patient's home), presence of other caregivers, family structure, relationship quality, CarePartner socio-demographics, and geographic access to the patient.

Methods:

214 patients with solid tumors undergoing chemotherapy at 3 VA Medical Centers reporting symptoms who can identify CarePartners (who consent to enroll in the trial) will be assigned to either 10 weeks of automated telephonic symptom assessment or 10 weeks of automated telephonic symptom assessment plus symptom management advice to the patient and notification of symptom severity and problem solving advice to CarePartners. Patients and CarePartners will be surveyed at intake, 10 weeks, and 14 weeks. Both groups will receive standard oncology, hospice, and palliative care.

Status:

This project is recruiting patients.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cancer
Behavioral: 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.
Other Name: Care Partners
  • Experimental: Arm 1
    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.
    Intervention: Behavioral: Caregiver website
  • No Intervention: Arm 2
    Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
214
December 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must be 18years or older, cognitively intact, English-speaking, able to hear, and own a telephone.
  • Patients can have any solid tumor.
  • Patients must be initiating IV cytotoxic chemotherapy and, if recurrent, have experienced a 1 month treatment free interval.
  • Caregivers must be 18 years or older, cognitively intact, English-speaking, and able to hear/speak for interviews.
  • Caregivers must have access to a telephone and computer with high speed internet access.

Exclusion Criteria:

  • Patients will be excluded if they have a hematologic malignancy or are receiving bone marrow transplantation.
  • Patients and caregivers will be excluded if they have an untreated serious mental illness or cognitive impairment, are institutionalized or enrolled in hospice (prior to trial), or plan on not receiving all care from VA
Both
18 Years and older
No
Contact: Maria J Silveira, MD MA MPH (734) 845-3502 Maria.Silveira2@va.gov
Contact: D'Andra Featherstone, BS d'andra.featherstone@va.gov
United States
 
NCT00983892
IIR 08-309
No
Department of Veterans Affairs
Department of Veterans Affairs
  • Michigan State University
  • University of Michigan
Principal Investigator: Maria J. Silveira, MD MA MPH VA Ann Arbor Healthcare System
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP