Head and Neck CancerCAHNCANCT01222481
Comprehensive Assessment of Head and Neck Cancer Survivors
An observational study of Head and Neck Cancer, run by Jay F. Piccirillo, MD at 2 sites in United States.
Trial summary
Cancer survivorship has dramatically improved within the last four decades and a greater number of Americans are living after cancer diagnosis. An increase in the number of survivors has highlighted the need to investigate the quality of life experienced by these survivors. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Feb 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the Washington University Physicians Faculty Practice clinics of Adult Otolaryngology, Medical Oncology and Radiation Oncology
Who may be able to join
- Subjects must be 40 years of age or older.
- Subjects must be able to read, write and speak English fluently.
- Subjects must be newly diagnosed with head and neck squamous cell cancer.
- Subjects must not have already had treatment for this cancer diagnosis.
- Subjects must be anticipated to receive at least one of the following types of therapy: surgery, chemotherapy or radiation.
Who cannot join
- Subjects with prior cancer diagnoses who have evidence of active disease.
- Subjects who have received cancer treatment within the past year.
- Subjects who have received chemotherapy or radiation treatment within the past year (for any disease state).
- Life expectancy of less than 3 months.
- Subjects with melanoma or other non-squamous cell cancer.
- Subjects who score >9 on Short Blessed Test (SBT) at baseline.
- Subjects who are unable to complete all of the required forms and tasks at baseline, either because of cognitive deficits or physical limitations.
- Any medical condition the PI determines to affect safe study participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Comprehensive Assessment of Adult Head and Neck Cancer Survivors (A Pilot Study)
Cancer survivorship has dramatically improved within the last four decades and a greater number of Americans are living after cancer diagnosis. An increase in the number of survivors has highlighted the need to investigate the quality of life experienced by these survivors. While Survivorship research has improved our understanding of the challenges faced by some cancer survivors, there is a paucity of research on the functional and cognitive health status of head and neck cancer survivors.
The purpose of this study is to evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to increase our understanding of the complex interactions between cancer treatment, comorbid health ailments and quality of life.
Read the detailed description
Cancer is the second leading cause of death in the United States today, accounting for nearly a quarter of total deaths. Due to advancements in cancer management, specifically in the areas of surveillance, early diagnosis, and utilization of evidenced-based therapies, there has been an increase in the number of survivors in the United States. As at 2007, there were over 11 million cancer survivors in the United States and this number is projected to reach 15 million by the end of 2010. Investigations into the quality of life experienced by these survivors have therefore become necessary if these survivors are to be effectively managed through their course of cancer.
The increase in the number of cancer survivors has opened up a relatively new avenue of cancer research termed Cancer Survivorship Research. Cancer Survivorship Research seeks to investigate the physical, functional and psychosocial consequences of cancer. Despite advances made in survivorship research, gaps remain in our knowledge concerning the ability of the cancer survivor to reintegrate into life and function at pre-cancer levels. These knowledge-gaps are especially true for head and neck cancer patients as demonstrated by the paucity of studies in the literature evaluating the functional and psychosocial consequences of cancer in this cohort. This is a significant short-coming especially since head and neck cancer patients are at increased risks for adverse consequences due to their advanced age at the time of cancer diagnosis, comorbidity burdens and substantial history of alcohol or tobacco use.
This study will evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to understand the consequences of cancer treatment on the quality of life experienced by these survivors.
Our study will use self-report questionnaires, neurocognitive assessments and novel performance-based assessments to evaluate functional and cognitive health status at two time-points:
- At Baseline (before any cancer treatment modality)
- After the first stage of cancer therapy (chemotherapy, radiation or surgery)
Assessments to be utilized include the Center for Epidemiologic Studies Depression Scale (CES-D), University of Alabama Life Space Assessment Aids form (LSA Aids), Dysexecutive Questionnaire (DEX), Katz Index of Activities of Daily Living (ADLs), Lawton Index of Instrumental Activities of Daily Living (IADLs), University of Alabama Life Space Assessment (LSA), Short Blessed Test (SBT), Short Physical Performance Battery (SPPB), Adult Comorbidity Evaluation-27 (ACE-27), and the Delis Kaplan Executive Function Scale (DKEFS) - Sorting task, Color Word Interference task, and Trail Making task.
Participants will also be assessed using the Executive Function Performance Test (EFPT). The EFPT is a performance-based measure of cognitive function developed at the Program for Occupational Therapy at Washington University School of Medicine that assesses (under direct observation) the amount of assistance needed by participants to complete five basic tasks essential for self-maintenance and independent living. The tasks include hand-washing, cooking, using the telephone, taking medications and paying bills.
Head and Neck cancer patients will undergo these comprehensive assessments at each of the two time-points, allowing for the ability to follow changes in function and cognition over the course of cancer therapy. Statistical analyses will be performed with the SAS® software version 9.1.3 to obtain descriptive statistics and to investigate statistically-significant changes in functional and cognitive health status between the time-points evaluated.
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Functional Status, Cognitive Status, Neurocognitive Assessments, Performance-based Assessments, Cancer, Function, Cognition, Quality of Life
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newly-diagnosed Head and Neck Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and Cognitive health status
Measured: At the time of cancer diagnosis and Within 1 month of cancer therapy
Secondary outcomes (1)
Assess the effectiveness of novel performance-based tests in detecting subtle functional and cognitive health status changes
Measured: At the time of cancer diagnosis and Within 1 month of cancer therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startJul 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jay F. Piccirillo, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor-investigator, Jay F. Piccirillo, MD, Washington University School of Medicine
- Investigators
- Oluwafunmilola T Okuyemi, MD, Principal investigator, Washington University School of MedicineJay F Piccirillo, MD, FACS, Study director, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222481
- Sponsor's protocol ID
- 09-0433
- Acronym
- CAHNCA
- Status last verified
- Feb 2012
- First submitted
- 15 Oct 2010
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Assessment of Adult Head and Neck Cancer Survivors (A Pilot Study)
- ClinicalTrials.gov ID
- NCT01222481
- Acronym / sponsor ID
- CAHNCA / 09-0433
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Functional Status, Cognitive Status, Neurocognitive Assessments, Performance-based Assessments, Cancer, Function, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jay F. Piccirillo, MDUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Jul 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 Oct 2010 (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.
Cancer survivorship has dramatically improved within the last four decades and a greater number of Americans are living after cancer diagnosis. An increase in the number of survivors has highlighted the need to investigate the quality of life experienced by these survivors. While Survivorship research has improved our understanding of the challenges faced by some cancer survivors, there is a paucity of research on the functional and cognitive health status of head and neck cancer survivors.
The purpose of this study is to evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to increase our understanding of the complex interactions between cancer treatment, comorbid health ailments and quality of life.
Detailed description
Cancer is the second leading cause of death in the United States today, accounting for nearly a quarter of total deaths. Due to advancements in cancer management, specifically in the areas of surveillance, early diagnosis, and utilization of evidenced-based therapies, there has been an increase in the number of survivors in the United States. As at 2007, there were over 11 million cancer survivors in the United States and this number is projected to reach 15 million by the end of 2010. Investigations into the quality of life experienced by these survivors have therefore become necessary if these survivors are to be effectively managed through their course of cancer.
The increase in the number of cancer survivors has opened up a relatively new avenue of cancer research termed Cancer Survivorship Research. Cancer Survivorship Research seeks to investigate the physical, functional and psychosocial consequences of cancer. Despite advances made in survivorship research, gaps remain in our knowledge concerning the ability of the cancer survivor to reintegrate into life and function at pre-cancer levels. These knowledge-gaps are especially true for head and neck cancer patients as demonstrated by the paucity of studies in the literature evaluating the functional and psychosocial consequences of cancer in this cohort. This is a significant short-coming especially since head and neck cancer patients are at increased risks for adverse consequences due to their advanced age at the time of cancer diagnosis, comorbidity burdens and substantial history of alcohol or tobacco use.
This study will evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to understand the consequences of cancer treatment on the quality of life experienced by these survivors.
Our study will use self-report questionnaires, neurocognitive assessments and novel performance-based assessments to evaluate functional and cognitive health status at two time-points:
- At Baseline (before any cancer treatment modality)
- After the first stage of cancer therapy (chemotherapy, radiation or surgery)
Assessments to be utilized include the Center for Epidemiologic Studies Depression Scale (CES-D), University of Alabama Life Space Assessment Aids form (LSA Aids), Dysexecutive Questionnaire (DEX), Katz Index of Activities of Daily Living (ADLs), Lawton Index of Instrumental Activities of Daily Living (IADLs), University of Alabama Life Space Assessment (LSA), Short Blessed Test (SBT), Short Physical Performance Battery (SPPB), Adult Comorbidity Evaluation-27 (ACE-27), and the Delis Kaplan Executive Function Scale (DKEFS) - Sorting task, Color Word Interference task, and Trail Making task.
Participants will also be assessed using the Executive Function Performance Test (EFPT). The EFPT is a performance-based measure of cognitive function developed at the Program for Occupational Therapy at Washington University School of Medicine that assesses (under direct observation) the amount of assistance needed by participants to complete five basic tasks essential for self-maintenance and independent living. The tasks include hand-washing, cooking, using the telephone, taking medications and paying bills.
Head and Neck cancer patients will undergo these comprehensive assessments at each of the two time-points, allowing for the ability to follow changes in function and cognition over the course of cancer therapy. Statistical analyses will be performed with the SAS® software version 9.1.3 to obtain descriptive statistics and to investigate statistically-significant changes in functional and cognitive health status between the time-points evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly-diagnosed Head and Neck Cancer | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the Washington University Physicians Faculty Practice clinics of Adult Otolaryngology, Medical Oncology and Radiation Oncology
Key inclusion criteria (5 listed)
- Subjects must be 40 years of age or older.
- Subjects must be able to read, write and speak English fluently.
- Subjects must be newly diagnosed with head and neck squamous cell cancer.
- Subjects must not have already had treatment for this cancer diagnosis.
- Subjects must be anticipated to receive at least one of the following types of therapy: surgery, chemotherapy or radiation.
Key exclusion criteria (8 listed)
- Subjects with prior cancer diagnoses who have evidence of active disease.
- Subjects who have received cancer treatment within the past year.
- Subjects who have received chemotherapy or radiation treatment within the past year (for any disease state).
- Life expectancy of less than 3 months.
- Subjects with melanoma or other non-squamous cell cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional and Cognitive health status
Time frame: At the time of cancer diagnosis and Within 1 month of cancer therapy
1 secondary outcome
Assess the effectiveness of novel performance-based tests in detecting subtle functional and cognitive health status changes
Time frame: At the time of cancer diagnosis and Within 1 month of cancer therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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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.
Oluwafunmilola T Okuyemi, MD principal investigator
Washington University School of Medicine
Jay F Piccirillo, MD, FACS study director
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Jay F. Piccirillo, MD at 2 sites 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional and Cognitive health status (time frame: At the time of cancer diagnosis and Within 1 month of cancer therapy). 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 2 Mar 2012.