Advanced Malignant Solid NeoplasmNCT04871477
Adoption of Audio Recording in the Outpatient Supportive Care Center
An observational study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm
- What is being tested?
- Communication Intervention and Questionnaire Administration
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2026to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced cancer at MD Anderson Cancer Center.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
M D Anderson Cancer Center
Houston, Texas, 77030
Michael J. Tang, 713-792-6085, ctang1@mdanderson.org
Michael J. Tang
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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.
- Conditions
- Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- Being tested
- Communication Intervention, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication InterventionOther
Audio record part of clinic visit
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Communication Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start30 Dec 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Tang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871477
- Sponsor's protocol ID
- 2020-0240
- Other IDs
- NCI-2021-02621, 2020-0240
- Status last verified
- Jul 2026
- First submitted
- 5 Apr 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adoption of Audio Recording in the Outpatient Supportive Care Center
- ClinicalTrials.gov ID
- NCT04871477
- Acronym / sponsor ID
- 2020-0240
- Conditions
- Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (audio recording) | – | Other: Communication Intervention, Other: Questionnaire AdministrationPatients audio record the recommendations and instructions given to them by the doctor record as part of their clinic visit at the Supportive Care Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced cancer at MD Anderson Cancer Center.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication InterventionAudio record part of clinic visit | Other | Observational (audio recording) |
| Questionnaire AdministrationAncillary studies | Other | Observational (audio recording) |
Primary outcome
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
Will be summarized using proportion along with a 95% confidence interval.
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
Will be summarized using proportion along with a 95% confidence interval.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J Tang principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Tang, MD (832-468-8895, mjtang@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.