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

This study is ongoing, but not recruiting participants.
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: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cancer
Behavioral: Caregiver website

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 214
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Arm 2
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983892

Locations
United States, California
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Michigan State University
University of Michigan
Investigators
Principal Investigator: Maria J. Silveira, MD MA MPH VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00983892     History of Changes
Other Study ID Numbers: IIR 08-309
Study First Received: September 22, 2009
Last Updated: June 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cancer
caregiver
pain
symptom
information technology
palliative care

ClinicalTrials.gov processed this record on September 18, 2014