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

Cancer Clinical Trial

Official title:

Web-based Support for Caregivers of Veterans Undergoing Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983892
• Other study ID #: IIR 08-309
• Status: Completed
• Phase: N/A
• First received: September 22, 2009
• Last updated: April 23, 2015
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	VA Loma Linda Healthcare System, Loma Linda, CA	Loma Linda	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Michigan State University, University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (2)

Silveira MJ, Given CW, Cease KB, Sikorskii A, Given B, Northouse LL, Piette JD. Cancer Carepartners: Improving patients' symptom management by engaging informal caregivers. BMC Palliat Care. 2011 Nov 25;10:21. doi: 10.1186/1472-684X-10-21. — View Citation

Thompson AJ, Silveira MJ, Vitale CA, Malani PN. Antimicrobial use at the end of life among hospitalized patients with advanced cancer. Am J Hosp Palliat Care. 2012 Dec;29(8):599-603. doi: 10.1177/1049909111432625. Epub 2012 Jan 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient symptom severity (MDASI)	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.	3 months	No
Secondary	adherence to chemotherapy		3 months	No
Secondary	function (SF36)		3 months	No
Secondary	utilization		3 months	No