Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00625638 |
| Other study ID # |
2006-0591 |
| Secondary ID |
NCI-2012-01747 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 28, 2008 |
| Est. completion date |
December 2, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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 individuals 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 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. 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 researchers to evaluate delivery of interventions in future studies.
Description:
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.
