NCT02873455

Brief Summary

Patient's anxiety prior to surgery has been linked to more harmful outcome after surgery. The investigators aim to evaluate the effect of video information on preoperative anxiety level in patients with colorectal cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2016

Status
unknown

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

Study Start

First participant enrolled

August 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

August 9, 2016

Last Update Submit

April 24, 2017

Conditions

Colorectal CancerVideo Information

Outcome Measures

Primary Outcomes (1)

  • Change of APAIS ((Amsterdam preoperative anxiety and information scale) from baseline APAIS to watching video.

    baseline and 1 minute after watching video.

Secondary Outcomes (2)

  • Change of HADS (Hospital Anxiety and Depression Scale) from baseline HADS to watching video.

    baseline and 1 minute after watching video.

  • Postoperative hospital stay

    through study completion and an average of 1 year

Study Arms (1)

watching video

EXPERIMENTAL

Short video clip including the circumstance of operation theater, and surgeon's interview

Other: Short video clip including the circumstance of operation theater, and surgeon's interview

Interventions

Short video clip including the circumstance of operation theater, and surgeon's interviewOTHER
watching video

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 20-75
  • Elective surgery

You may not qualify if:

  • History of previous any surgery
  • emergency surgery
  • dementia
  • psychological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Heung-Kwon Oh, MS

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 19, 2016

Study Start

August 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04