Interactive Voice Response System in Advanced Cancer Patients

NCT00625638 | Completed DMC

• 2 other identifiers: 2006-0591NCI-2012-01747
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Keywords

Advanced Cancer; Caregiver; Interactive Voice Response; Symptom Control; IVR System; Questionnaire

Outcome Measures

Primary Outcomes (1)

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

  6 Years

Study Arms (2)

Standard Care Only

EXPERIMENTAL

Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes.

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.

Behavioral: Interactive Voice Response System; Other: Standard Care

Interventions

Interactive Voice Response System BEHAVIORAL

Phone calls made once daily, each taking about 3-5 minutes to complete.

Standard Care + IVR System

Standard Care OTHER

Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes.

Standard Care + IVR System; Standard Care Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sriram Yennurajalingam, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: January 28, 2008
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (1)