Development and Validation of the FACT-Neutropenia

Reviewer: Mary Kara Bucci, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: December 9, 2001

Presenter: Elizabeth A. Calhoun
Presenter's Affiliation: Northwestern University

Background
The Functional Assessment of Cancer Therapy (FACT)is a series of validated scales designed to measure quality of life (QOL). It consists of a general measure (FACT-G) and specific subscales related to the effects of the disease, its symptoms, and treatment. There has not, until now, been a subscale specific to the effect of neutropenia on QOL.

Materials and Methods
The development of a FACT subscale specific to neutropenia (FACT-N) consisted of 4 phases: item generation, item reduction, scale construction, and reliability/validity testing.

Phase I: A total of 51 items were generated through a series of interviews with 15 cancer patients (5 of whom had experienced Grade 2,3, or 4 neutropenia within the last month), 10 healthcare workers with experience diagnosing and treating neutropenia, 25 patients with cyclic neutropenia, and 25 patients with congenital neutropenia.

Phase II: The 51 items developed in Phase I were rated by 12 experts for clarity, relevance, and overlap with existing items, and thereby reduced to 19 items.

Phase III: The 19 items were structured like FACT-G, using a 5 point rating scale for each item.

Phase IV: The 19 items were added to FACT-G and administered to 60 cancer patients (53% with metastatic disease) at the beginning of their chemotherapy, when they developed Grade 2,3, or 4 neutropenia, and with their last cycle of chemotherapy. Patients were also given the 13-item Functional Assessment of Chronic Illness - Fatigue (FACIT-F). Patient responses were evaluated for internal consistency and construct (concurrent) validity within the FACT-N.

Results

Internal consistency: The Chronbach's alpha coefficient for internal consistency within the FACT-N was 0.85. Two subscales of the FACT-N, a 7-item fatigue and a 4-item worry subscale, demonstrated Chronback's alpha coefficients of 0.87 and 0.75, respectively.

Concurrent validity: The correlation coefficient between the FACT neutropenia subscale and FACIT-F was 0.77 (p<.001). The correlation coefficient between the FACT-N 7-item fatigue subscale with the FACIT-F was o.89 (p<.001)

Author's Conclusions

On reliability and validity testing, the FACT-N demonstrated good internal consistency and high concurrent validity.

The FACT-N can be a useful tool to measure the QOL of patients with neutropenia.

The responsiveness of FACT-N to changes in neutrophil counts will be assessed when more of the 60 patients to whom it has been administered have experienced neutropenia.

Clinical/Scientific Implications
Quality of life is increasingly being recognized as an important outcome measure in health care. Valid scales, such as FACT, are necessary in order to accurately measure this parameter. FACT-N provides a new way to assess the effect of neutropenia of patients' quality of life.

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