The Families or Next of Kin of Patients Treated at MSKCC for Non-cutaneous Squamous Cell Carcinomas of theNCT01632969
Improving End of Life Care in Head and Neck Cancer
An observational study of The Families or Next of Kin of Patients Treated at MSKCC for Non-cutaneous Squamous Cell Carcinomas of the and Upper Aerodigestive Tract, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to improve the quality of care provided for head and neck cancer patients. By better understanding the end of life experiences of dying patients and their families, the investigators hope to better anticipate and improve upon the experiences of future patients and their families. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Families or Next of Kin of Patients Treated at MSKCC for Non-cutaneous Squamous Cell Carcinomas of the, Upper Aerodigestive Tract
- What is being tested?
- The The Family Assessment of Treatment at the End of life (FATE ) survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2014
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Deceased Head and Neck Surgery patients will be queried from Dataline and screened for eligibility. Interviews with family members and next of kin of deceased patients treated at MSKCC for noncutaneous squamous cell carcinomas of the upper aerodigestive tract will be conducted via telephone, employing the survey instruments.
Who may be able to join
- Head and neck cancer patients who received their treatment at MSKCC who have died of noncutaneous squamous cell carcinomas of the upper aerodigestive tract and for whom family / next of kin contact information is available.
- Time of patient death must have been at least 6 months ago and no more than 4 years ago
- Patient age at time of death must be over 21 years of age.
- Those interviewed must be English-fluent.
Who cannot join
- Non-English speaking interviewees
- Next-of-kin who reported being unfamiliar with care received during the last month of life
- Next-of-kin who did not identify themselves as one of the patient's primary social supports during the last month of life
- Next-of-kin who were not physically present with the deceased at least once during the last week of his/her life
- Next-of-kin under age 21
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065-0009
About this study
The purpose of this study is to improve the quality of care provided for head and neck cancer patients. By better understanding the end of life experiences of dying patients and their families, the investigators hope to better anticipate and improve upon the experiences of future patients and their families.
- Conditions
- The Families or Next of Kin of Patients Treated at MSKCC for Non-cutaneous Squamous Cell Carcinomas of the, Upper Aerodigestive Tract
- Being tested
- The The Family Assessment of Treatment at the End of life (FATE ) survey
- Keywords
- 12-136
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The The Family Assessment of Treatment at the End of life (FATE ) surveyBehavioural
Study candidates will be contacted by mail with an initial contact letter with information explaining the study, and then will receive a follow-up phone call to discuss their participation in the study no later than 1 month following the posting of the initial contact letter. If a family member or next-of-kin chooses to participate, verbal informed consent will be obtained over the phone and a one-time telephone interview will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| families or next-of-kin of deceased patients | The families of deceased patients treated at MSKCC for non-cutaneous squamous cell carcinomas of the upper aerodigestive tract for whom contact information is available will be recruited by mail and by phone. Receives: Behavioral: The The Family Assessment of Treatment at the End of life (FATE ) survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of care received by patients
To determine the perception of the family members of the quality of care received by patients with aerodigestive mucosal squamous cell carcinoma of the head and neck at the end of their lives. A survey will be administered to the families and next-of-kin of deceased patients. A recently validated survey instrument, the Family Assessment of Treatment at the End of life (FATE), is designed to assess treatment at the end of life based upon the responses of family members of the deceased (Finlay, Shreve et al. 2008).
Measured: 1 year
Secondary outcomes (2)
quality of death outcomes
To identify specific risk factors or interventions that might predict certain quality of death outcomes. A survey will be administered to the families and next-of-kin of deceased patients.A recently validated survey instrument, the Family Assessment of Treatment at the End of life (FATE), is designed to assess treatment at the end of life based upon the responses of family members of the deceased (Finlay, Shreve et al. 2008).
Measured: 1 year
awareness among caregivers
To raise awareness among caregivers of the perspectives of family members of deceased patients, and of risk factors that might predict patient quality of death. This survey will be administered to the families and next-of-kin of deceased patients. A recently validated survey instrument, the Family Assessment of Treatment at the End of life (FATE), is designed to assess treatment at the end of life based upon the responses of family members of the deceased (Finlay, Shreve et al. 2008).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
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 The Families or Next of Kin of Patients Treated at MSKCC for Non-cutaneous Squamous Cell Carcinomas of theStudies 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Snehal Patel, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632969
- Sponsor's protocol ID
- 12-136
- Status last verified
- Mar 2015
- First submitted
- 29 Jun 2012
- Last updated
- 6 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving End of Life Care in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01632969
- Acronym / sponsor ID
- 12-136
- Conditions
- The Families or Next of Kin of Patients Treated at MSKCC for Non-cutaneous Squamous Cell Carcinomas of the, Upper Aerodigestive Tract
- Keywords
- 12-136
- 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
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Jul 2012 (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 improve the quality of care provided for head and neck cancer patients. By better understanding the end of life experiences of dying patients and their families, the investigators hope to better anticipate and improve upon the experiences of future patients and their families.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| families or next-of-kin of deceased patients | – | Behavioral: The The Family Assessment of Treatment at the End of life (FATE ) surveyThe families of deceased patients treated at MSKCC for non-cutaneous squamous cell carcinomas of the upper aerodigestive tract for whom contact information is available will be recruited by mail and by phone. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Deceased Head and Neck Surgery patients will be queried from Dataline and screened for eligibility. Interviews with family members and next of kin of deceased patients treated at MSKCC for noncutaneous squamous cell carcinomas of the upper aerodigestive tract will be conducted via telephone, employing the survey instruments.
Key inclusion criteria (4 listed)
- Head and neck cancer patients who received their treatment at MSKCC who have died of noncutaneous squamous cell carcinomas of the upper aerodigestive tract and for whom family / next of kin contact information is available.
- Time of patient death must have been at least 6 months ago and no more than 4 years ago
- Patient age at time of death must be over 21 years of age.
- Those interviewed must be English-fluent.
Key exclusion criteria (5 listed)
- Non-English speaking interviewees
- Next-of-kin who reported being unfamiliar with care received during the last month of life
- Next-of-kin who did not identify themselves as one of the patient's primary social supports during the last month of life
- Next-of-kin who were not physically present with the deceased at least once during the last week of his/her life
- Next-of-kin under age 21
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 |
|---|---|---|
| The The Family Assessment of Treatment at the End of life (FATE ) surveyStudy candidates will be contacted by mail with an initial contact letter with information explaining the study, and then will receive a follow-up phone call to discuss their participation in the study no later than 1 month following the posting of the initial contact letter. If a family member or next-of-kin chooses to participate, verbal informed consent will be obtained over the phone and a one-time telephone interview will be conducted. | Behavioural | families or next-of-kin of deceased patients |
Primary outcome
quality of care received by patients
Time frame: 1 year
To determine the perception of the family members of the quality of care received by patients with aerodigestive mucosal squamous cell carcinoma of the head and neck at the end of their lives. A survey will be administered to the families and next-of-kin of deceased patients. A recently validated survey instrument, the Family Assessment of Treatment at the End of life (FATE), is designed to assess treatment at the end of life based upon the responses of family members of the deceased (Finlay, Shreve et al. 2008).
2 secondary outcomes
quality of death outcomes
Time frame: 1 year
awareness among caregivers
Time frame: 1 year
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 6 Mar 2015.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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.
Snehal Patel, MD 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 The Families or Next of Kin of Patients Treated at MSKCC for Non-cutaneous Squamous Cell Carcinomas of the and Upper Aerodigestive Tract, 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 4 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 6 Mar 2015. 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?
quality of care received by patients (time frame: 1 year). 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 6 Mar 2015.