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Study Summary
No. 2006-0591:.......Advanced Cancers......Sriram Yennurajalingam......Palliative Care & Rehabilitation Medicine
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Study Summary Title
Study Summary
Number:		2006-0591
Study Title:Symptom Assessment In Advanced Cancer Patients Using an Interactive Voice Response (IVR) System.
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Physician New Patient Referral
Name:Sriram YennurajalingamPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Palliative Care & Rehabilitation MedicineReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6085
Contact us about clinical trials
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General Information
Disease Group:Advanced CancersSupported By:N/A
Phase of Study:N/AReturn
Visit:		Day 8 (optional for all participants) and day 15
Treatment
Agents:		NoneHome Care:Participants will receive IVR with NTI as needed at home during the study
period.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this research study is to learn if using an Interactive Voice
Response (IVR) system can bring about better and more timely symptom control
for patients with advanced cancer.
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Study Objectives / Outcomes
Specific Aim 1 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 individuals with advanced cancer as evidenced by reduced scores on symptom measures.

Specific Aim 2 To determine whether the IVR system, supplemented by NTI, results in reduced caregiver burden, increased caregiver satisfaction with care, and improved coping strategies.

Specific Aim 3 To determine the feasibility of using an IVR system, supplemented by NTI, for symptom assessment in individuals 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 barriers to participation. Our 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 us to evaluate delivery of interventions in future studies.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:01/28/2008
Study Type:Behavioral
Recruitment Status:Closed
Projected Accrual:136 participants and caregivers
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Individuals with advanced cancer (incurable disease) who are seen in the Supportive Care Center at M.D. Anderson Cancer Center.

2) Individuals with advanced cancer 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

3) Individuals with advanced cancer who have a score of 4 or higher on pain and at least one other symptom on the ESAS (fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep).

4) Individuals with advanced cancer who are able to identify a primary caregiver who also agrees to participate in the study

5) Individuals with advanced cancer who have no clinical evidence of cognitive failure in the opinion of the referring MD.

6) Individuals with advanced cancer and caregivers who are at least 18 years of age

7) Individuals with advanced cancer and caregivers who have access and utilize a touch-tone telephone

8) Individuals with advanced cancer and caregivers who are willing to engage in a telephone follow-up with the IVR system and nurses every Monday, Wednesday and Friday.

9) Individuals with advanced cancer and caregivers who are willing to follow-up by phone or in person on day 8 (+/- 3 days) and return for a follow-up visit on day 15 (+/-5 days)

10) Individuals with advanced cancer and caregivers who are willing and able to provide written informed consent

11) Must be English speaking [The IVR only available in English]

12) A primary caregiver is any family member (partner, parent, sibling, or child) or friend of the individual with advanced cancer, that is taking care of the patient for more than 50% of the time. The primary caregiver does not need to live with the patient.

13) Individuals with advanced cancer and caregivers must be able to understand the instructions for the study
Exclusion Criteria:1) Individuals with advanced cancer or caregivers who cannot complete the baseline assessment forms

2) Individuals with advanced cancer or caregivers who cannot understand the requirements for participation in the study

3) Individuals with advanced cancer or caregivers who have hearing or visual impairments severe enough to prevent use of the IVR or Nursing Telephone Intervention (NTI)

4) Individuals with advanced cancer or caregivers who cannot understand and speak English (The IVR is only available in English)

5) Individuals with advanced cancer with caregivers who refuse to participate in the study

6) If individuals with advanced cancer 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.

7) 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.
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Links
Registration Number: NCT00625638
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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