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Symptom Assessment in Advanced Cancer Patients Using an Interactive Voice Response (IVR) System


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

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Trial Information

Symptom Assessment in Advanced Cancer Patients Using an Interactive Voice Response (IVR) System


If you and your caregiver 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 standard of care
provided at the palliative center at M. D. Anderson, but will not receive any phone calls
from the Interactive Voice Response (IVR) system. Group B will receive phone calls by the
Interactive Voice Response (IVR) system on Monday, Wednesday, and Friday for 15 days.

Once you sign this consent form, you will answer questions about your diagnosis, the
medication that you take, and the symptoms that you are having (for example, pain, fatigue,
anxiety, depression, and 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 your caregiver are assigned to Group A, you will continue with the standard of
care provided at the palliative center at M. D. Anderson. On Day 15, both you and your
caregiver 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 your caregiver are assigned to Group B, a research nurse will train you and your
caregiver to operate the IVR system. The IVR call will be made to the preferred telephone
number(s) provided by you and your caregiver. The telephone calls will be made 1 time a day
at times chosen by you and your caregiver. 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 your overall feeling of well-being.
These phone calls should take about 3-5 minutes to complete. You should complete the phone
calls separately and should not attempt to influence each others 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 your caregiver will receive a phone call
from the nurse. The nurse may ask about symptoms, medications being taken, concerns or
doubts about the medication, and if you have any concerns about your physical or emotional
well being. You will be reminded of the different telephone numbers you can use to receive
assistance 24 hours a day. During the phone call, you will also be asked if you would like
the nurse to contact your caregiver for information and support. If you agree, the nurse
will contact your caregiver.

On Day 8, both you and your caregiver will be contacted either in person or by phone by the
research nurse and will complete the same questionnaire you had at the beginning of the
study. On Day 15, both you and your caregiver will be seen in the outpatient clinic by the
research nurse and will complete this same questionnaire again, either verbally or written.
This should take about 30 minutes to complete each time.

Your participation on this study will end 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.


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. Caregiver must be a partner, parent, sibling, or child of the individual with
advanced cancer.

13. Caregiver must reside with the individual with advanced cancer and be responsible for
most of the individual with advanced cancer's care

14. 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine if follow up by an IVR system results in better symptom management and improved quality of life for participants than standard care.

Outcome Time Frame:

6 Years

Safety Issue:

No

Principal Investigator

Sriram Yennurajalingam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0591

NCT ID:

NCT00625638

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Advanced Cancer
  • Advanced Cancer
  • Caregiver
  • Interactive Voice Response
  • Symptom Control
  • IVR System
  • Questionnaire
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030