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
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.