Status:
COMPLETED
Interactive Voice Response System in Advanced Cancer Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 Objec...
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 pal...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 2 2022
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00625638
Start Date
January 28 2008
End Date
December 2 2022
Last Update
September 21 2023
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030