Ignite Creation Date:
2024-05-05 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00625638
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2008-02-19
Brief Title:
Interactive Voice Response System in Advanced Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Symptom Assessment in Advanced Cancer Patients Using an Interactive Voice Response IVR System
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 numbers 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 havent 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
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 numbers 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 havent 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01747 | REGISTRY | NCI CTRP | None |