Clinical trial NCT04871477: Adoption of Audio Recording in the Outpatient Supportive Care Center
Official title: The Adoption of Audio Recording in the Outpatient Supportive Care Center
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Advanced Malignant Solid Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced cancer at MD Anderson Cancer Center.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who will select "Complete Agree/Partially Agree" in Question 1 "I found the audio recording useful after the visit"
timeFrame: through study completion, an average of 1 year
measure: 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
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of times the recording is listened to
timeFrame: through study completion, an average of 1 year
measure: To assess the ease of use of the technology.
timeFrame: through study completion, an average of 1 year
measure: 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.
timeFrame: through study completion, an average of 1 year
measure: To assess the patient perception of whether the audio recording caused any disruption to the clinic
timeFrame: through study completion, an average of 1 year
measure: Patient participation rate
timeFrame: through study completion, an average of 1 year
measure: To explore the association between the frequency of caregivers' use of audio recording
timeFrame: through study completion, an average of 1 year
measure: To explore the association of the ease of use of the technology and the type of device and application used
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michael J Tang
role: PRINCIPAL_INVESTIGATOR
References: