Improving Health of Patients With Colon Cancer Following... | NCT02301338

Studies
Improving Health of Patients With Colon Cancer Following Surgery: A Trial of SA-ICAN Via Videoconferencing

NCT02301338

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Terminated

Last Update Posted

Mar 13, 2017Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Colon Cancer

Interventions

Usual care
Phone Calls

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of accrual

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Mar 16, 2016Actual

Completion Date

Mar 16, 2016Actual

First Submitted Date

Nov 21, 2014

First Submission Date that Met QC Criteria

Nov 24, 2014

First Posted Date

Nov 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2017

Last Update Posted Date

Mar 13, 2017Actual

Description Module

Brief Summary

The purpose of this study is to assess the impact of more frequent follow-up (by videoconference) of these patients. Videoconference is a method of communication over a distance. In this method, the patient will hear the person's voice (like on the telephone) and will see that person over video.

The study will compare more frequent follow-up of patients by videoconferencing to routine follow-up of patients. The investigators will compare each type of follow-up to see the effect on the number of times patients need to visit emergency rooms or need admission to hospitals. The study will also look at the difference between each type of follow-up on patients' quality of life and social support thirty days after hospital discharge.

The study will also measure satisfaction and acceptability of this intervention among those who had follow-ups by videoconference.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Care		The patient will get instructions on: - Follow-up appointment date/time with your surgeon - Proper diet - Medications - Communicating concerning symptoms with the surgeon The patient will answer questions on: Social support Quality of life	Other: Usual care
Phone Calls		In addition to what the usual care group gets, the patient will also receive weekly phone calls by a geriatrics RN following hospital discharge. The patient will answer questions on: Social support Quality of life	Other: Usual care Other: Phone Calls

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Usual care	Other		Phone Calls Usual Care
Phone Calls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
acute healthcare utilization (AHCU) rates	(i.e. hospital readmission and/or ER visit)	30 days post -discharge

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 65 or older.
Newly diagnosed cancer.
Referred to the geriatrics service for pre-operative evaluation before surgical resection of his/her tumor.

Exclusion Criteria:

Inability to comprehend English.
Deafness , measured by the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) [16], score equal or above 30. (appendix 5)
Cognitive impairment (score of 0-1 in Mini-Cog Test).
Nursing home resident.
Planned hospital length of stay of one day or less.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Newly diagnosed older colon cancer patients require pre-operative evaluation before undergoing surgery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin Shahrokni, MD, PhD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Cancer Center		New York	New York	10065	United States

Label	URL
Memorial Sloan Kettering Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided