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

NCT00983892 | Completed Results

• 1 other identifier: IIR 08-309
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

CarePartners+

EXPERIMENTAL

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

CarePartners-

NO INTERVENTION

Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing (i.e. no access to the caregiver website, or 'intervention').

Interventions

Caregiver website BEHAVIORAL

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

CarePartners+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18 years 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Michigan State University: collaborator
• University of Michigan: collaborator

Study Sites (2)

VA Loma Linda Healthcare System, Loma Linda, CA

Loma Linda, California, 92357, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (1)

• 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.

  PMID: 22117890 RESULT

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Recruitment rates were lower than expected.

Results Point of Contact

• Title: Maria J. Silveira MD MA MPH
• Organization: Ann Arbor Veterans Administration

mariajs@med.umich.edu

734-763-4550

Study Officials

• Maria J. Silveira, MD MA MPH

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 22, 2016
• Results First Posted: March 22, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)