Colorectal CancerNCT02308345
MiVideo - Video Visit Summary for Cancer Patients
A study testing Pre-chemotherapy visit summary Video in people with Colorectal Cancer, run by University of Michigan at 1 site in United States.
Trial summary
Cancer patients about to begin chemotherapy receive large amounts of information regarding their prognosis, how chemotherapy improves their prognosis, and the usual side effects of the chemotherapy during their first visit to the oncologist. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Pre-chemotherapy visit summary Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Mar 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Diagnosis of colon cancer with treatment plan to include chemotherapy
- Sufficient command of English language to read and understand consent and survey forms
- Working email address and access to the Internet (computer, tablet, smartphone) to view treatment summary video
Who cannot join
- Previous history of chemotherapy or cancer (excepting in situ cancers)
- History of drug or alcohol abuse or unmedicated mental or psychiatric disorder
- Medical history or diagnosis of debilitating medical disorder such as progressive muscle paralysis, advanced cardiac, respiratory, or renal disease, or AIDS
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
Cancer patients about to begin chemotherapy receive large amounts of information regarding their prognosis, how chemotherapy improves their prognosis, and the usual side effects of the chemotherapy during their first visit to the oncologist. Prior studies have documented that less than half of this information is retained after the visit, making it difficult for patients to participate in their care and difficult for them to enlist the help of their social support. The MiVideo project allows the physician to create a custom 5-minute summary video summary of a pre-chemotherapy clinic visit and upload it to a secure web site. The video will emphasize the major points of the forty-five minute office discussion, allowing patients to review the physicians' recommendations and share the information and recommendations with others. By providing the patient with this re-cap of their visit, the investigators hope to engage them more actively in their cancer treatment. Making the information available to friends and family can also help a patient receive both intellectual and emotional support during the course of treatment. The primary endpoint of this study is improvement of patient care, not research activity.
Primary Hypothesis: Creating a 5-minute video summarizing information about diagnosis, stage, chemotherapy treatment plan, and anticipated side effects for patients starting chemotherapy for colon cancer will not significantly lengthen the pre-chemotherapy clinic visit as compared to visits that do not include video production.
- Conditions
- Colorectal Cancer
- Being tested
- Pre-chemotherapy visit summary Video
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-chemotherapy visit summary VideoOther
| Study group | Role | What they receive |
|---|---|---|
| Video summary | Experimental | Participants in this arm will be given online access to a 5-minute video summary of their pre-chemotherapy visit, recorded by their physician. Receives: Other: Pre-chemotherapy visit summary Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of visit (minutes)
Measured: Day of consent
Secondary outcomes (3)
Number of patient views of their visit summary prior to chemotherapy
Measured: 2-4 weeks post-visit
Number of video summary shares prior to chemotherapy
Measured: 2-4 weeks post visit
Participant-rated usefulness of video summary
Usefulness is measured using a short post-video online survey.
Measured: 2-4 weeks post visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence C. An, University of Michigan
- Investigators
- Larry C An, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308345
- Sponsor's protocol ID
- HUM00090259
- Status last verified
- Mar 2017
- First submitted
- 22 Oct 2014
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiVideo - Video Visit Summary for Cancer Patients
- ClinicalTrials.gov ID
- NCT02308345
- Acronym / sponsor ID
- HUM00090259
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Dec 2014 (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.
Cancer patients about to begin chemotherapy receive large amounts of information regarding their prognosis, how chemotherapy improves their prognosis, and the usual side effects of the chemotherapy during their first visit to the oncologist. Prior studies have documented that less than half of this information is retained after the visit, making it difficult for patients to participate in their care and difficult for them to enlist the help of their social support. The MiVideo project allows the physician to create a custom 5-minute summary video summary of a pre-chemotherapy clinic visit and upload it to a secure web site. The video will emphasize the major points of the forty-five minute office discussion, allowing patients to review the physicians' recommendations and share the information and recommendations with others. By providing the patient with this re-cap of their visit, the investigators hope to engage them more actively in their cancer treatment. Making the information available to friends and family can also help a patient receive both intellectual and emotional support during the course of treatment. The primary endpoint of this study is improvement of patient care, not research activity.
Primary Hypothesis: Creating a 5-minute video summarizing information about diagnosis, stage, chemotherapy treatment plan, and anticipated side effects for patients starting chemotherapy for colon cancer will not significantly lengthen the pre-chemotherapy clinic visit as compared to visits that do not include video production.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video summary | Experimental | Other: Pre-chemotherapy visit summary VideoParticipants in this arm will be given online access to a 5-minute video summary of their pre-chemotherapy visit, recorded by their physician. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80
- Diagnosis of colon cancer with treatment plan to include chemotherapy
- Sufficient command of English language to read and understand consent and survey forms
- Working email address and access to the Internet (computer, tablet, smartphone) to view treatment summary video
Key exclusion criteria (3 listed)
- Previous history of chemotherapy or cancer (excepting in situ cancers)
- History of drug or alcohol abuse or unmedicated mental or psychiatric disorder
- Medical history or diagnosis of debilitating medical disorder such as progressive muscle paralysis, advanced cardiac, respiratory, or renal disease, or AIDS
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 |
|---|---|---|
| Pre-chemotherapy visit summary Video | Other | Video summary |
Primary outcome
Length of visit (minutes)
Time frame: Day of consent
3 secondary outcomes
Number of patient views of their visit summary prior to chemotherapy
Time frame: 2-4 weeks post-visit
Number of video summary shares prior to chemotherapy
Time frame: 2-4 weeks post visit
Participant-rated usefulness of video summary
Time frame: 2-4 weeks post visit
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 31 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Larry C An, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-chemotherapy visit summary Video in people with Colorectal Cancer, run by University of Michigan 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 4 inclusion and 3 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 31 Mar 2017. 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?
Length of visit (minutes) (time frame: Day of consent). 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 31 Mar 2017.