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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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:

  1. At Baseline (before any cancer treatment modality)
  2. 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.

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 groups in NCT01222481
Study groupRoleWhat they receive
Newly-diagnosed Head and Neck CancerNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional and Cognitive health status

    Measured: At the time of cancer diagnosis and Within 1 month of cancer therapy

Secondary outcomes (1)
  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.

  1. First posted18 Oct 2010 (estimated)
  2. Study startJul 2009
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

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)
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

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.

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