Adoption of Audio Recording in the Outpatient Supportive Care Center

The Adoption of Audio Recording in the Outpatient Supportive Care Center

This study evaluates how patients feel about having an audio recording of their visit to help remember information given to them and share that information with family members and/or caregivers not present during a clinic visit. Information from this study may help evaluate the effectiveness of using technology to help improve patient care by recording consultation recommendations.

Study Overview

• Status: Not yet recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Advanced Malignant Solid Neoplasm; Locally Advanced Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Communication Intervention

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the patient's perception of the usefulness of the audio recording in helping to recall information given to him/her in the visit along with the perception of usefulness in the dissemination of information to family member(s) and/or caregiver(s) not present at the clinic visit.

SECONDARY OBJECTIVES:

I. To assess the number of times the recording is listened to. II. To assess the ease of use of the technology. III. To assess the ability to share the information with the patient's family member(s) and/or caregiver(s) if he or she chooses to do so.

IV. To assess the patient perception of whether the audio recording caused any disruption to the clinic.

V. To estimate the participation rate of patients. VI. To explore association between patient's perception of the usefulness of the audio recording and patient's demographic/clinical characteristics.

VII. To explore the association between age and sex of the caregiver and frequency of caregiver's use of the audio recording.

VIII. To explore the association of the ease of use of the technology and the type of device and application used.

OUTLINE:

Patients audio record the recommendations and instructions given to them by the doctor record as part of their clinic visit at the Supportive Care Center.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
      • Contact: Michael J. Tang; Phone Number: 713-792-6085; Email: ctang1@mdanderson.org
      • Principal Investigator: Michael J. Tang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced cancer at MD Anderson Cancer Center.

Description

Inclusion Criteria:

• Patients with the diagnosis of advanced cancer as defined as locally advanced, recurrent or metastatic cancer. Both solid and liquid tumors are eligible for the study
• Patients who are seen in the outpatient supportive care center at M.D. Anderson Cancer Center
• Patients who have access to a recording device or cellphone with recording technology
• Patients who can be contacted 7 to 11 days from the clinic visit that the recording took place
• Patients who can sign informed consent
• Patients who are able to read and write in English
• Patients 18 years or older

Exclusion Criteria:

• Patients who have been diagnosed with delirium or cognitive impairment. This will be defined by chart review along with review of the MD Anderson Symptom Inventory (MDAS) the day of clinic visit. An MDAS of 7 or greater will be considered to define delirium in this study
• Patients who are unwilling to sign informed consent
• Patients who have used audio recordings before in clinic visits
• Patients who have severe hearing impairments without access to assisted devices or programs to aid in listening to the recorded material

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (audio recording); Patients audio record the recommendations and instructions given to them by the doctor record as part of their clinic visit at the Supportive Care Center.	Other: Questionnaire Administration; Ancillary studies; Other: Communication Intervention; Audio record part of clinic visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who will select "Complete Agree/Partially Agree" in Question 1 "I found the audio recording useful after the visit"	Will be summarized using proportion along with a 95% confidence interval.	through study completion, an average of 1 year
Proportion of patients who will select "Complete Agree/Partially Agree" in Question 2 "I was able to effectively discuss my medical condition with my family member(s) and/or caregiver(s) who were not present at the clinical visit	Will be summarized using proportion along with a 95% confidence interval.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of times the recording is listened to	Descriptive statistics will be used to summarize the results. Wilcoxon rank sum test or Kruskal-Wallis test will be applied to examine differences in continuous variables between or among patient's demographic/clinical characteristics.	through study completion, an average of 1 year
To assess the ease of use of the technology.	Descriptive statistics will be used to summarize the results. Chi squared test or Fisher's exact test will be applied to examine the association between the ease of use of the technology and patient's demographic/clinical characteristics.	through study completion, an average of 1 year
To assess the ability to share the information with the patient's family member(s) and/or caregiver(s) if he or she chooses to do so.	Descriptive statistics will be used to summarize the results. Chi-squared test or Fisher's exact test will be applied to examine the association between the ability to share and patient's demographic/clinical characteristics.	through study completion, an average of 1 year
To assess the patient perception of whether the audio recording caused any disruption to the clinic	Descriptive statistics will be used to summarize the results. Chi-squared test or Fisher's exact test will be applied to examine the association between the patient perception of whether audio recording caused any disruption to the clinic and patient's demographic/clinical characteristics.	through study completion, an average of 1 year
Patient participation rate	The participation rate of patients in this study will be estimate using proportion along with 95% confidence interval.	through study completion, an average of 1 year
To explore the association between the frequency of caregivers' use of audio recording	Pearson or Spearman correlation coefficient will be used to assess the association between caregivers' age and frequency of their use of the audio recording. Wilcoxon rank sum test will be applied to examine differences in frequency of caregivers' use of audio recording between their sexes.	through study completion, an average of 1 year
To explore the association of the ease of use of the technology and the type of device and application used	Chi-squared test or Fisher's exact test will be applied to examine the association between the ease of use of the technology and the types of recording devices/applications.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Michael J Tang, M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2020-0240 (Other Identifier: M D Anderson Cancer Center); NCI-2021-02621 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No