Advanced CancerNCT00625638
Interactive Voice Response System in Advanced Cancer Patients
A study testing Interactive Voice Response System in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Interactive Voice Response System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2008to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with advanced cancer (incurable disease) who are seen in the Supportive Care Center at M.D. Anderson Cancer Center.
- 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
- 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).
- Individuals with advanced cancer who are able to identify a primary caregiver who also agrees to participate in the study
- Individuals with advanced cancer who have no clinical evidence of cognitive failure in the opinion of the referring MD.
- Individuals with advanced cancer and caregivers who are at least 18 years of age
Show all 14Show fewer
- Individuals with advanced cancer and caregivers who have access and utilize a touch-tone telephone
- 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.
- 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)
- Individuals with advanced cancer and caregivers who are willing and able to provide written informed consent
- Must be English speaking [The IVR only available in English]
- Caregiver must be a partner, parent, sibling, or child of the individual with advanced cancer.
- Caregiver must reside with the individual with advanced cancer and be responsible for most of the individual with advanced cancer's care
- Individuals with advanced cancer and caregivers must be able to understand the instructions for the study
Who cannot join
- Individuals with advanced cancer or caregivers who cannot complete the baseline assessment forms
- Individuals with advanced cancer or caregivers who cannot understand the requirements for participation in the study
- 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)
- Individuals with advanced cancer or caregivers who cannot understand and speak English (The IVR is only available in English)
- Individuals with advanced cancer with caregivers who refuse to participate in the study
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Symptom Assessment in Advanced Cancer Patients Using an Interactive Voice Response (IVR) System
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.
Read the 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 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.
- Conditions
- Advanced Cancer
- Being tested
- Interactive Voice Response System, Standard Care
- Keywords
- Advanced Cancer, Caregiver, Interactive Voice Response, Symptom Control, IVR System, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Voice Response SystemBehavioural
Phone calls made once daily, each taking about 3-5 minutes to complete.
Standard CareOther
Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Only | Experimental | Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes. Receives: Other: Standard Care |
| Standard Care + IVR System | Experimental | Standard Care + Interactive Voice Response (IVR) System Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes. Phone calls made once daily, each taking about 3-5 minutes to complete. Receives: Behavioral: Interactive Voice Response System; Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if follow up by an IVR system results in better symptom management and improved quality of life for participants than standard care.
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study start28 Jan 2008
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sriram Yennurajalingam, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625638
- Sponsor's protocol ID
- 2006-0591
- Other IDs
- NCI-2012-01747
- Status last verified
- Sep 2023
- First submitted
- 19 Feb 2008
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Assessment in Advanced Cancer Patients Using an Interactive Voice Response (IVR) System
- ClinicalTrials.gov ID
- NCT00625638
- Acronym / sponsor ID
- 2006-0591
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Caregiver, Interactive Voice Response, Symptom Control, IVR System, Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 28 Jan 2008 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Only | Experimental | Other: Standard CareParticipants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes. |
| Standard Care + IVR System | Experimental | Behavioral: Interactive Voice Response System, Other: Standard CareStandard Care + Interactive Voice Response (IVR) System Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes. Phone calls made once daily, each taking about 3-5 minutes to complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Individuals with advanced cancer (incurable disease) who are seen in the Supportive Care Center at M.D. Anderson Cancer Center.
- 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
- 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).
- Individuals with advanced cancer who are able to identify a primary caregiver who also agrees to participate in the study
- Individuals with advanced cancer who have no clinical evidence of cognitive failure in the opinion of the referring MD.
Key exclusion criteria (7 listed)
- Individuals with advanced cancer or caregivers who cannot complete the baseline assessment forms
- Individuals with advanced cancer or caregivers who cannot understand the requirements for participation in the study
- 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)
- Individuals with advanced cancer or caregivers who cannot understand and speak English (The IVR is only available in English)
- Individuals with advanced cancer with caregivers who refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Voice Response SystemPhone calls made once daily, each taking about 3-5 minutes to complete. | Behavioural | Standard Care + IVR System |
| Standard CareParticipants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes. | Other | Standard Care + IVR System, Standard Care Only |
Primary outcome
Determine if follow up by an IVR system results in better symptom management and improved quality of life for participants than standard care.
Time frame: 6 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Advanced Cancer
Active, not recruitingPhase 1
Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
Advanced Cervical Adenocarcinoma, Advanced Cervical Adenosquamous Carcinoma
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer and HR+/HER2- Metastatic Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sriram Yennurajalingam, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Voice Response System in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 6 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023; AzTrials last refreshed its copy on 1 Nov 2026.