NCT02308345

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

October 22, 2014

Last Update Submit

March 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Length of visit (minutes)

    Day of consent

Secondary Outcomes (3)

  • Number of patient views of their visit summary prior to chemotherapy

    2-4 weeks post-visit

  • Number of video summary shares prior to chemotherapy

    2-4 weeks post visit

  • Participant-rated usefulness of video summary

    2-4 weeks post visit

Study Arms (1)

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.

Other: Pre-chemotherapy visit summary Video

Interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Larry C An, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Health Communications Research

Study Record Dates

First Submitted

October 22, 2014

First Posted

December 4, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations