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A Comprehensive Assessment of Adult Head and Neck Cancer Survivors (A Pilot Study)

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Head and Neck Cancer

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Trial Information

A Comprehensive Assessment of Adult Head and Neck Cancer Survivors (A Pilot Study)

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

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 SASĀ® 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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Functional and Cognitive health status

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Oluwafunmilola T Okuyemi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

February 2012

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Cancer
  • Functional Status
  • Cognitive Status
  • Neurocognitive Assessments
  • Performance-based Assessments
  • Cancer
  • Function
  • Cognition
  • Quality of Life
  • Head and Neck Neoplasms



Washington University School of MedicineSaint Louis, Missouri  63110
University of Alabama at BirminghamBirmingham, Alabama  35294-3300