Advanced CancerNCT03040102
Randomized Study of a Hospice Video Educational Tool for Patients With Advanced Cancer and Their Caregivers
A study testing Hospice Video Educational Tool in people with Advanced Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Hospice Video Educational Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2017to 1 Feb 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients Eligibility Criteria:
- Adult patients (≥18 years) with a diagnosis of metastatic solid cancer.
- A prognosis of 12 months or less based on the treating oncologist's assessment.
- The ability to provide informed consent.
- Ability to comprehend and speak English.
- Caregivers Eligibility Criteria:
Show all 9Show fewer
- Adult caregivers (>18 years) of patients who have agreed to participate in study.
- A relative or a friend upon whom the patient relies for help and who will be likely to be present during hospitalization, or willing to participate by phone.
- Ability to comprehend and speak English.
Who cannot join
- Patients Exclusion Criteria:
- -Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts general Hospital
Boston, Massachusetts, 02215
About this study
The purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services
Read the detailed description
The purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services - a video educational tool or a verbal narrative. The study will assess the effect of these methods on patients' and caregivers' knowledge about hospice care, as well as their perceptions and preferences for this service.
Using this research, the investigators hope to find out the best way to help patients and their loved ones better understand hospice care. The educational methods used in this study (the video educational tool or verbal narrative) are meant to serve as an introduction to hospice care. Further details about hospice should be discussed directly with your care team.
This study will enroll 150 patients with advanced cancer and up to 150 of their caregivers in this randomized clinical trial. The study will use questionnaires to measure the participant and the caregivers' knowledge of hospice care, as well as your perceptions and preferences for these services. Study assessments will be completed before and after watching the video or hearing the verbal narrative in the hospital.
- Conditions
- Advanced Cancer
- Being tested
- Hospice Video Educational Tool, Standard of Care
- Keywords
- Advanced Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospice Video Educational ToolOther
it's a 6 minute video regarding hospice care
Standard of CareOther
Standard of Care practice is used
| Study group | Role | What they receive |
|---|---|---|
| Hospice Video Educational Tool | Experimental | * The hospice video educational tool is a 6 minute video
* Participants will watch an approximately 6-minute digital video regarding hospice on an iPad Receives: Other: Hospice Video Educational Tool |
| Hospice Verbal Narrative | Active comparator | * The RA will read a verbal narrative that is identical to the narrative of the video to participants
* Standard of Care practice is used Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preference for Hospice Question
We will ask patients whether they would prefer to receive hospice care at the end of life (yes vs. no)
Measured: immediately after the video intervention or verbal narrative
Secondary outcomes (1)
Patient knowledge about hospice Questionnaire
we will assess knowledge about hospice using 10 knowledge questions
Measured: immediately after the video intervention or verbal narrative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start9 Mar 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040102
- Sponsor's protocol ID
- 17-026
- Status last verified
- Aug 2022
- First submitted
- 28 Jan 2017
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of a Hospice Video Educational Tool for Patients With Advanced Cancer and Their Caregivers
- ClinicalTrials.gov ID
- NCT03040102
- Acronym / sponsor ID
- 17-026
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 2 Feb 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 purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services
Detailed description
The purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services - a video educational tool or a verbal narrative. The study will assess the effect of these methods on patients' and caregivers' knowledge about hospice care, as well as their perceptions and preferences for this service.
Using this research, the investigators hope to find out the best way to help patients and their loved ones better understand hospice care. The educational methods used in this study (the video educational tool or verbal narrative) are meant to serve as an introduction to hospice care. Further details about hospice should be discussed directly with your care team.
This study will enroll 150 patients with advanced cancer and up to 150 of their caregivers in this randomized clinical trial. The study will use questionnaires to measure the participant and the caregivers' knowledge of hospice care, as well as your perceptions and preferences for these services. Study assessments will be completed before and after watching the video or hearing the verbal narrative in the hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospice Video Educational Tool | Experimental | Other: Hospice Video Educational Tool* The hospice video educational tool is a 6 minute video * Participants will watch an approximately 6-minute digital video regarding hospice on an iPad |
| Hospice Verbal Narrative | Active comparator | Other: Standard of Care* The RA will read a verbal narrative that is identical to the narrative of the video to participants * Standard of Care practice is used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients (≥18 years) with a diagnosis of metastatic solid cancer.
- A prognosis of 12 months or less based on the treating oncologist's assessment.
- The ability to provide informed consent.
- Ability to comprehend and speak English.
- Adult caregivers (>18 years) of patients who have agreed to participate in study.
Key exclusion criteria (2 listed)
- -Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures
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 |
|---|---|---|
| Hospice Video Educational Toolit's a 6 minute video regarding hospice care | Other | Hospice Video Educational Tool |
| Standard of CareStandard of Care practice is used | Other | Hospice Verbal Narrative |
Primary outcome
Patient Preference for Hospice Question
Time frame: immediately after the video intervention or verbal narrative
We will ask patients whether they would prefer to receive hospice care at the end of life (yes vs. no)
1 secondary outcome
Patient knowledge about hospice Questionnaire
Time frame: immediately after the video intervention or verbal narrative
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 30 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Areej El-Jawahri, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospice Video Educational Tool in people with Advanced Cancer, run by Massachusetts General Hospital 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 9 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 30 Aug 2022. 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?
Patient Preference for Hospice Question (time frame: immediately after the video intervention or verbal narrative). 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 30 Aug 2022.