Nasopharyngeal Carcinoma Post IMRT

Condition(s) studied

Study summary

Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of research in head and neck radiation oncology have largely focused on improvements in survival, which have mostly come at the cost of long term toxicity for surviving patients.

This is an observational study that is being done to learn about the long-term symptoms and side effects that survivors of nasopharyngeal cancer may have following radiation treatment. This study will include assessment of patient report outcomes, physician-graded adverse events, neurocognitive assessment and endocrine and hearing testing

Eligibility

Primary outcome measure(s)

• Evaluation of late toxicities( will be measured using CTCAE v 4.0 criteria) — 1 Year
  • Clinical toxicities will be grade according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03), a well known toxicity grading scale from 0 (asymptomatic) to 5 (death).
• Serum Biochemical Tests for Endocrine Function (fT4, TSH) — 1 Year
  * A single blood test (at same time as the pituitary assessment) will include free thyroxine (fT4; units pmol/L), Thyroid-Stimulating Hormone (TSH; units mIU/L), * Biochemical serum deficiencies in morning testing will be scored individually according to CTCAEv4.03
• Quality of Life Questionnaires: Functional Assessment of Cancer Therapy (FACT-G, FACT-HN) — 1 Year
  * Quality of life as measured by Functional Assessment of Cancer Therapy-Head \& Neck (FACT-HN) and FACIT-Fatigue ranking individual items from 0= not at all to 4 = very much. * An overall score is reported on the sum of individual items. The FACT-HN consists of the FACT-G (which consists of 27 questions from physical, social, emotional and functional domains) and a 12-item specific head and neck module. A maximum score for the FACT-HN of 144 reflects the best possible quality of life.
• Quality of Life Questionnaires: Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-Fatigue) — 1 Years
  A 13-item specific questionnaire scored using individual items from 0= not at all to 4 = very much collated for a total score.
• Quality of Life Questionnaires: Utilities Assessment (EuroQoL - EQ-5D) — 1 YEAR
  A standardized self-reported utility instrument consisting of 5 discrete, 3-level items, and a visual analog scale
• Quality of Life Questionnaires: Symptom Burden of Treatment (MD Anderson Symptom Inventory-Head Neck) — 1 YEAR
  • A patient-reported outcome instrument consisting of 28 items, 19 related to common and severe symptoms experienced by cancer patients and 9 specific to head and neck, rated from 0=not present to 10=as bad as you can imagine
• Quality of Life Questionnaires: Assessment of Depression and Anxiety (Hospital and Anxiety Depression Score) — 1 YEAR
  A 14 question item scale (7 Anxiety and 7 depression) score 0-3 (each item is individually written) for individual anxiety and depressions scores from 0-21 with validated cut-off points
• Assessment of Frontal Lobe Behavior (Frontal Systems Behaviour Scale) — 1 YEAR
  A validated self-rating scale designed to measure the three frontal systems behavioral syndromes: apathy, disinhibition, and executive dysfunction. A 46-item questionnaire rated pre- and post treatment is scored 1=almost never to 5= almost always. Summary scores are calculated and converted to t-scores.
• Cognitive Assessment (Montreal Cognitive Assessment - MoCA) — 1 YEAR
  A short cognitive assessment testing several cognitive domains - visuospatial, naming, memory, attention, language, abstraction, delayed recall and orientation. A maximum score is 30.

Trial sites (1)

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