Colon CancerNCT02301338
Improving Health of Patients With Colon Cancer Following Surgery: A Trial of SA-ICAN Via Videoconferencing
An observational study of Colon Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Phone Calls
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 16 Mar 2016
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Newly diagnosed older colon cancer patients require pre-operative evaluation before undergoing surgery.
Who may be able to join
- Age 65 or older.
- Newly diagnosed cancer.
- Referred to the geriatrics service for pre-operative evaluation before surgical resection of his/her tumor.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Colon Cancer
- Being tested
- Usual care, Phone Calls
- Keywords
- Videoconferencing, Following Surgery, 14-213
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Phone CallsOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Usual care; Other: Phone Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute healthcare utilization (AHCU) rates
(i.e. hospital readmission and/or ER visit)
Measured: 30 days post -discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion16 Mar 2016
- Study completion16 Mar 2016
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Shahrokni, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301338
- Sponsor's protocol ID
- 14-213
- Status last verified
- Mar 2017
- First submitted
- 21 Nov 2014
- Last updated
- 13 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health of Patients With Colon Cancer Following Surgery: A Trial of SA-ICAN Via Videoconferencing
- ClinicalTrials.gov ID
- NCT02301338
- Acronym / sponsor ID
- 14-213
- Conditions
- Colon Cancer
- Keywords
- Videoconferencing, Following Surgery, 14-213
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 16 Mar 2016 (actual)
- Study completion
- 16 Mar 2016 (actual)
- First posted
- 25 Nov 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | – | Other: Usual careThe 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 |
| Phone Calls | – | Other: Usual care, Other: Phone CallsIn 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Newly diagnosed older colon cancer patients require pre-operative evaluation before undergoing surgery.
Key inclusion criteria (3 listed)
- Age 65 or older.
- Newly diagnosed cancer.
- Referred to the geriatrics service for pre-operative evaluation before surgical resection of his/her tumor.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Usual care | Other | Phone Calls, Usual Care |
| Phone Calls | Other | Phone Calls |
Primary outcome
acute healthcare utilization (AHCU) rates
Time frame: 30 days post -discharge
(i.e. hospital readmission and/or ER visit)
Results and safety
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Armin Shahrokni, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Memorial Sloan Kettering Cancer Center 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 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 was stopped early (reason given: Lack of accrual). Results are not available in the source record.
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?
acute healthcare utilization (AHCU) rates (time frame: 30 days post -discharge). 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 13 Mar 2017.