Interactive Voice Response System in Advanced Cancer Patients - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00625638

Purpose

Primary Objectives:

To determine whether the Interactive Voice Response (IVR) system, supplemented by Nursing Telephone Intervention (NTI), results in better symptom management and quality of life than standard care for participants with advanced cancer as evidenced by reduced scores on symptom measures.
To determine whether the IVR system, supplemented by NTI, results in reduced caregiver burden, increased caregiver satisfaction with care, and improved coping strategies.
To determine the feasibility of using an IVR system, supplemented by NTI, for symptom assessment in participants with advanced cancer and their caregivers by conducting a process evaluation of the system. Variables to be evaluated include rates of participant recruitment and retention, frequency of use of the system, acceptability of the system to participants and caregivers, and barriers to participation. The researchers' goal is to identify and improve aspects that affect external validity (recruitment rate, cohort maintenance), internal validity (implementation, contamination), participant acceptability and satisfaction, and reaction to study procedures. The findings from this evaluation will also allow the researchers to evaluate delivery of interventions in future studies.

Condition	Intervention
Advanced Cancer	Behavioral: Interactive Voice Response System Other: Standard Care

MedlinePlus related topics: Cancer Caregivers

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Symptom Assessment in Advanced Cancer Patients Using an Interactive Voice Response (IVR) System

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn the best way to bring about better and more timely symptom control for patients by their caregivers. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	136
Study Start Date:	January 2008
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Standard Care Only	Other: Standard Care Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes.
2: Experimental Standard Care + Interactive Voice Response (IVR) System	Behavioral: Interactive Voice Response System Phone calls made once daily, each taking about 3-5 minutes to complete. Other: Standard Care Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes.

Detailed Description:

For Patients:

If you and the patient you care for agree to take part in this study, you will be randomly assigned (as in the toss of the coin) to be in 1 of 2 groups. Group A will receive no phone calls. Group B will receive daily phone calls by the Interactive Voice Response (IVR) system.

After completing the consent form, you will answer questions about the diagnosis of the patient you care for, the medication that the patient you care for is taking, and the symptoms that the patient you care for is having (for example, pain, fatigue, anxiety and depression, and their overall feeling of well-being). You will either be asked these questions verbally or you will complete a written questionnaire. This should take about 30 minutes to complete.

If you and the patient you care for are assigned to Group A, the patient will continue with the standard of care provided at the palliative care center at M.D. Anderson. On Day 15, both you and the patient you care for will be seen in the outpatient clinic by the research nurse, and complete the same questionnaire you had at the beginning of the study, either verbally or written. This should take about 30 minutes to complete.

If you and the patient you care for are assigned to Group B, a research nurse will train you both to operate the IVR system. The IVR call will be made to the preferred telephone number(s) provided by you and the patient you care for. The telephone calls will be made 1 time a day at times chosen by you and the patient. You will both be given a 3-digit code number to enter as a way of confirming who you are.

Once you have entered the requested numbers, the IVR system will ask you to answer questions about pain, fatigue, anxiety, depression, and the overall feeling of well-being of the patient you care for. The phone calls should take about 3-5 minutes to complete. You and the patient you care for should complete the phone calls separately and should not attempt to influence each other's answers.

A research nurse will review the answer in the IVR system. If you haven't responded to the IVR questions in 3 days, if you answer that you would like to be contacted by a nurse, or if a symptom has reached a concerning level, you and the patient you care for will receive a phone call from the a nurse. The nurse may ask about symptoms, medications being taken, concerns or doubts about the medication, and if you have any concerns about the physical or emotional well being of the person you are caring for. You will be reminded of the different telephone numbers you can use to receive assistance 24 hours a day. The nurse will also ask the patient you care for during the phone call if he or she would like the nurse to talk to you for the purpose of information and support. If the patient you care for expresses interest, the nurse will contact you.

On Days 8 and 15, both you and the patient you care for will be seen in the outpatient clinic by the research nurse and will complete the same questionnaire you had at the beginning of the study, either verbally or written. This should take about 30 minutes to complete.

Your participation on the study ends on Day 15.

This is an investigational study. Up to 68 patient-caregiver groups (or a total of 136 participants) will take part in this study. All the participants will be enrolled at M.D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Advanced cancer (incurable metastatic disease) participants who are seen in the Palliative Care Clinic at M.D. Anderson Cancer Center
Participants who have a pain score of 4 or higher on the average pain scale item of the Brief Pain Inventory for at least 2 weeks
Participants who have fatigue and a score of 4 or higher on at least one other symptom on the ESAS
Participants who are able to identify a primary caregiver who also agrees to participate in the study
Participants who have no clinical evidence of cognitive failure in the opinion of the referring MD
Participants and caregivers who are at least 18 years of age
Participants and caregivers who have access and utilize a touch-tone telephone
Participants and caregivers who are willing to engage in a telephone follow-up with the IVR system and nurses every Monday, Wednesday and Friday
Participants and caregivers who are willing to return for follow-up visits on day 8 and 15 (+/-3 days)
Participants and caregivers who are willing and able to provide written informed consent
Must be English speaking (the IVR is only available in English)
Caregiver must be a partner, parent, sibling, or child of the participant
Caregiver must reside with the participant and be responsible for most of the participant's care
Participants and caregivers must be able to understand the instructions for the study

Exclusion Criteria:

Participants or caregivers who cannot complete the baseline assessment forms
Participants or caregivers who cannot understand the requirements for participation in the study
Participants or caregivers who have hearing or visual impairments severe enough to prevent use of the IVR or Nursing Telephone Intervention (NTI)
Participants or caregivers who cannot understand and speak English (the IVR is only available in English)
Participants with caregivers who refuse to participate in the study
If participants are found to screen positive for severe mood disorders according to the HADS questionnaire for anxiety and/or depression, [ >/= to 20], they will be immediately referred to their primary palliative care physician for initial assessment and management including potentially a referral to psychiatry (participants that are referred for psychiatric evaluation will be excluded from the study)
Caregivers who are suspected to have severe mood disorders will be instructed to contact their personal physician for assessment and management including potentially a referral to psychiatry (those that are referred for psychiatric evaluation will be excluded from the study)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625638

Contacts

Contact: Sriram Yennurajalingam, MD

713-792-6085

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Sriram Yennurajalingam, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Sriram Yennurajalingam, MD

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Sriram Yennurajalingam, MD/Assistant Professor )
Study ID Numbers:	2006-0591
Study First Received:	February 19, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00625638
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Advanced Cancer
Caregiver
Interactive Voice Response

Symptom Control
IVR System
Questionnaire

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009