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Web-based Support for Caregivers of Veterans Undergoing Chemotherapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

Web-based Support for Caregivers of Veterans Undergoing Chemotherapy


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 the Ann Arbor VA Medical Center
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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

patient symptom severity (MDASI)

Outcome Description:

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Maria J. Silveira, MD MA MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Ann Arbor Healthcare System

Authority:

United States: Federal Government

Study ID:

IIR 08-309

NCT ID:

NCT00983892

Start Date:

October 2010

Completion Date:

December 2015

Related Keywords:

  • Cancer
  • Cancer
  • caregiver
  • pain
  • symptom
  • information technology
  • palliative care

Name

Location

VA Ann Arbor Healthcare SystemAnn Arbor, Michigan  48113
VA Loma Linda Healthcare System, Loma Linda, CALoma Linda, California  92357
Fargo VA Medical Center and Regional Office, Fargo, NDFargo, North Dakota  58102
Louis Stokes VA Medical Center, Cleveland, OHCleveland, Ohio  44106