Malignant Neoplasms of Independent (Primary) Multiple SitesNCT03035448
Communication Strategies to Introduce Psychology Services
A study testing Questionnaires and Video Presentation in people with Malignant Neoplasms of Independent (Primary) Multiple Sites, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn about advanced cancer patients' preferences about how psychology services are introduced. This is an investigational study. Up to 110 participants will be enrolled in this study. All will take part at MD Anderson. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms of Independent (Primary) Multiple Sites
- What is being tested?
- Questionnaires and Video Presentation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age >/= 18 years-old
- Can speak, read, and understand English
- Diagnosis of locally advanced, recurrent, or metastatic disease
- Patients treated as outpatients by the supportive and palliative care team
- Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process
Who cannot join
- Previous psychological counseling received in supportive care department
- Patients with severe symptom distress as assessed by nursing staff
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized Controlled Trial of Communication Strategies to Introduce Psychology Services in the Palliative Care Setting
The goal of this research study is to learn about advanced cancer patients' preferences about how psychology services are introduced.
This is an investigational study.
Up to 110 participants will be enrolled in this study. All will take part at MD Anderson.
Read the detailed description
If you agree to take part in this study, during an already-scheduled office visit, you will complete 3 questionnaires about your symptoms, your emotional health, and if you have ever participated in psychiatric or psychology services. These questionnaires should take about 9 minutes to complete.
All participants will watch 2 short videos. The videos show actors playing a doctor, counselor, and patient, discussing psychology service options. Each video is about 1 minute and 30 seconds long and will discuss the same material, but the content of each video will be different. The order in which they are presented will be randomly assigned (as in the flip of a coin). You will have an equal chance of seeing either video first.
After you watch the second video, you will complete 3 questionnaires about whether you think 1 of the videos was better than the other, and about your attitude toward psychology services. These questionnaires should take about 4 minutes to complete.
Length of Study:
It should take about 16 minutes to watch both videos and to complete all questionnaires. Your participation on this study will be over after you have completed the last questionnaire.
Other Information:
We will ask your caregiver(s) to leave the room while the videos are played. In case they decide to stay, we will ask them to keep silent.
- Being tested
- Questionnaires, Video Presentation
- Keywords
- Malignant neoplasms of independent (primary) multiple sites, Advanced cancer, Recurrent cancer, Metastatic disease, Palliative care, Videos, Questionnaires, Surveys
- Medical subject headings
- Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
Participants complete 3 assessment questionnaires during an already-scheduled office visit. These questionnaires should take about 9 minutes to complete.
Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. These questionnaires should take about 4 minutes to complete.
Video PresentationOther
Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.
| Study group | Role | What they receive |
|---|---|---|
| Video 1: Counselor Alone | Experimental | Participants complete 3 assessment questionnaires during an already-scheduled office visit.
Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.
Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. Receives: Behavioral: Questionnaires; Other: Video Presentation |
| Video 2: Doctor + Counselor | Experimental | Participants complete 3 assessment questionnaires during an already-scheduled office visit.
Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.
Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. Receives: Behavioral: Questionnaires; Other: Video Presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's Video Preference of Strategies in Introducing Psychology Services in a Palliative Care Setting
Participants asked the preference to the introduction of counselor. The possible answers are The First Video, The Second Video, Neither, or No Difference. The actual content of the answers will be decoded by the study team at the end of the study to "Counselor Alone" or "MD + Counselor" depending on each patient's assigned arm.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start13 Feb 2017
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Independent (Primary) Multiple SitesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sujin Ann-Yi, PHD, MA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035448
- Sponsor's protocol ID
- 2016-0679
- Other IDs
- NCI-2018-01285
- Status last verified
- Oct 2023
- First submitted
- 26 Jan 2017
- Last updated
- 12 Oct 2023
- 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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Communication Strategies to Introduce Psychology Services in the Palliative Care Setting
- ClinicalTrials.gov ID
- NCT03035448
- Acronym / sponsor ID
- 2016-0679
- Keywords
- Malignant neoplasms of independent (primary) multiple sites, Advanced cancer, Recurrent cancer, Metastatic disease, Palliative care, Videos, Questionnaires, Surveys
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 30 Jan 2017 (estimated)
- 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.
The goal of this research study is to learn about advanced cancer patients' preferences about how psychology services are introduced.
This is an investigational study.
Up to 110 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed description
If you agree to take part in this study, during an already-scheduled office visit, you will complete 3 questionnaires about your symptoms, your emotional health, and if you have ever participated in psychiatric or psychology services. These questionnaires should take about 9 minutes to complete.
All participants will watch 2 short videos. The videos show actors playing a doctor, counselor, and patient, discussing psychology service options. Each video is about 1 minute and 30 seconds long and will discuss the same material, but the content of each video will be different. The order in which they are presented will be randomly assigned (as in the flip of a coin). You will have an equal chance of seeing either video first.
After you watch the second video, you will complete 3 questionnaires about whether you think 1 of the videos was better than the other, and about your attitude toward psychology services. These questionnaires should take about 4 minutes to complete.
Length of Study:
It should take about 16 minutes to watch both videos and to complete all questionnaires. Your participation on this study will be over after you have completed the last questionnaire.
Other Information:
We will ask your caregiver(s) to leave the room while the videos are played. In case they decide to stay, we will ask them to keep silent.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video 1: Counselor Alone | Experimental | Behavioral: Questionnaires, Other: Video PresentationParticipants complete 3 assessment questionnaires during an already-scheduled office visit. Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options. Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. |
| Video 2: Doctor + Counselor | Experimental | Behavioral: Questionnaires, Other: Video PresentationParticipants complete 3 assessment questionnaires during an already-scheduled office visit. Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options. Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >/= 18 years-old
- Can speak, read, and understand English
- Diagnosis of locally advanced, recurrent, or metastatic disease
- Patients treated as outpatients by the supportive and palliative care team
- Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process
Key exclusion criteria (2 listed)
- Previous psychological counseling received in supportive care department
- Patients with severe symptom distress as assessed by nursing staff
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 |
|---|---|---|
| QuestionnairesAlso: SurveysParticipants complete 3 assessment questionnaires during an already-scheduled office visit. These questionnaires should take about 9 minutes to complete. Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. These questionnaires should take about 4 minutes to complete. | Behavioural | Video 1: Counselor Alone, Video 2: Doctor + Counselor |
| Video PresentationParticipant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options. | Other | Video 1: Counselor Alone, Video 2: Doctor + Counselor |
Primary outcome
Participant's Video Preference of Strategies in Introducing Psychology Services in a Palliative Care Setting
Time frame: Day 1
Participants asked the preference to the introduction of counselor. The possible answers are The First Video, The Second Video, Neither, or No Difference. The actual content of the answers will be decoded by the study team at the end of the study to "Counselor Alone" or "MD + Counselor" depending on each patient's assigned arm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Sujin Ann-Yi, PHD, MA 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?
A study testing Questionnaires and Video Presentation in people with Malignant Neoplasms of Independent (Primary) Multiple Sites, 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 12 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant's Video Preference of Strategies in Introducing Psychology Services in a Palliative Care Setting (time frame: Day 1). 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 12 Oct 2023.