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Not yet recruiting NCT04871477

Adoption of Audio Recording in the Outpatient Supportive Care Center

Observational Advanced Malignant Solid Neoplasm Hematopoietic and Lymphoid Cell Neoplasm Locally Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Communication Intervention, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Adoption of Audio Recording in the Outpatient Supportive Care Center

Overview

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.

Interventions

  • Other Communication Intervention
    Audio record part of clinic visit
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Proportion of patients who will select "Complete Agree/Partially Agree" in Question 1 "I found the audio recording useful after the visit" [Time frame: 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 [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (7)
  • Number of times the recording is listened to [Time frame: through study completion, an average of 1 year]
  • To assess the ease of use of the technology. [Time frame: 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. [Time frame: through study completion, an average of 1 year]
  • To assess the patient perception of whether the audio recording caused any disruption to the clinic [Time frame: through study completion, an average of 1 year]
  • Patient participation rate [Time frame: through study completion, an average of 1 year]
  • To explore the association between the frequency of caregivers' use of audio recording [Time frame: 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 [Time frame: through study completion, an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04871477 · 2020-0240 · NCI-2021-02621 · 2020-0240

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗