Several psychometrically sound general measures of QOL have been used to assess QOL in ovarian cancer. The Functional Assessment of Cancer Therapy-General (FACT-G [1]) is a 27-item general measure of QOL in cancer that assesses four domains of well-being: physical well-being, functional well-being, emotional well-being, and social well-being. The FACT-G can be used alone or in combination with disease and/or treatment-specific subscales. The European Organization for the Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30 [8]) is a 30-item general measure of QOL in cancer that is comprised of five functional subscales, three symptom subscales and a global health and QOL scale. Like the FACT-G, it can be used alone or combined with cancer-specific modules. Finally, the Short-Form 36 health survey (SF-36 [9]) is a generic measure of QOL that has been widely used in numerous disease and treatment conditions. It consists of 36 items comprising eight subscales which form two higher-order scales: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

Several instruments have been developed to measure aspects of QOL specific to women with ovarian cancer. The Functional Assessment of Cancer Therapy-Ovarian (FACT-O [10]) consists of the FACT-G plus an ovarian cancer-specific subscale. The 11-item ovarian subscale was developed with input from ovarian cancer patients and gynecologic oncology clinical experts. The FACT-O provides a reliable and valid assessment of QOL in ovarian cancer that is sensitive to change. The Physical Well-Being scale, Functional Well-Being scale, and the Ovarian Cancer Subscale can be combined to create the Trial Outcome Index (TOI), which is frequently used in clinical trials to assess change in physical/functional outcomes. In addition to the FACT-O, the European Organization for the Research and Treatment of Cancer Quality of Life Ovarian Cancer (QLQ-OV28 [11]) is a 28-item ovarian cancer symptom-specific questionnaire module developed to supplement the EORTC QLQ-C30. The EORTC QLQ-OV28 measures abdominal/gastrointestinal symptoms, neurotoxicity, chemotherapy side effects, hormonal symptoms, body image, perception of disease/treatment, and sexual functioning and demonstrates good reliability and validity [11].

A number of valid and reliable instruments have been developed to assess the QOL issues associated with specific types of treatment. The 11-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx [12, 13]) questionnaire measures peripheral neuropathy secondary to platinum/paclitaxel chemotherapy. Similarly, the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane [14]) is a 16-item questionnaire that measures the symptoms and QOL effects associated with the taxane class of chemotherapeutic agents. Although these measures were not developed for specific use among women with ovarian cancer, given that platinum/paclitaxel is a common chemotherapy regimen for ovarian cancer, they provide an opportunity to assess treatment impact on QOL in ovarian cancer.

In response to the FDA’s statement that pharmaceutical company claims of improved QOL must be specific to the QOL domain measured, several valid and reliable instruments have recently been developed to measure ovarian cancer-specific symptoms and their impact on QOL. The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort (FACT/GOG-AD [15]) is a four-item measure of abdominal discomfort that was created in an effort to more accurately measure patients’ perceptions of abdominal discomfort and its impact on QOL. The FACT/GOG-AD was created in response to evidence suggesting greater pain among intraperitoneal chemotherapy recipients [16]. It can be used to measure differences in treatment response as well as symptoms and complications resulting from both disease and treatment in ovarian cancer.

A recent addition to the measures of ovarian cancer-specific symptoms and QOL is the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18 [17]). The NFOSI-18 is an 18-item symptom index that reflects the symptoms rated as highest priority by both oncology clinical experts and women with advanced ovarian cancer (see Table 14.1). It was developed to address the potential discrepancy between symptoms reported as high priority by oncologists and patients in an effort to provide a more comprehensive perspective on symptoms and QOL in advanced ovarian cancer. It is comprised of three subscales: disease-related symptoms, treatment-related symptoms, and general function/well-being. Preliminary evidence suggests good reliability and validity [17].

In addition to these ovarian cancer-specific symptom indices, several non-disease-specific instruments measure symptoms of relevance among women with ovarian cancer. Table 14.2 lists instruments from the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT) Measurement System which can be administered individually or in combination with the FACT-O. Additionally, the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) initiative has resulted in the development of a host of item banks measuring QOL-related domains in chronic illness, such as physical function [18], pain [19, 20], sleep [21], emotional distress [22], and social health [23]. The availability of psychometrically sound measures, such as those described, enables a better understanding of the impact of symptoms on QOL in ovarian cancer.

Women with ovarian cancer are at risk for diminished QOL due to the disease itself, as well as aggressive treatments such as abdominal surgeries and chemotherapy [2, 24]. While these therapies may have antineoplastic benefits, they can also result in a host of toxicities, which, along with disease-related symptoms, have the potential to adversely affect a variety of QOL domains. Table 14.3 lists common symptoms affecting QOL in ovarian cancer.

Given the impact of symptoms on QOL, QOL is an important end point when assessing the effects of cancer treatment. Measuring QOL provides the ability to examine how well treatment ameliorates disease-related symptoms, as well as whether treatment-related toxicities outweigh the potential clinical benefits. The assessment of QOL may also serve as a prognostic factor across the disease trajectory. For example, two independent randomized controlled trials have found QOL to be predictive of survival outcomes in ovarian cancer. In a randomized controlled trial of interval secondary cytoreduction, Wenzel and colleagues found that QOL at the third chemotherapy cycle predicted overall survival in women with advanced ovarian cancer [29]. In a randomized trial comparing cisplatin/cyclophosphamide and cisplatin/paclitaxel chemotherapy, Carey and colleagues found that better baseline global QOL predicted longer progression-free survival and overall survival, independent of performance status [52]. These findings suggest that perhaps QOL may also serve as an indicator of which patients may not respond well to treatment. Another clinical implication of assessing QOL is the opportunity for enhanced patient-provider communication surrounding treatment decision-making and symptom management. As previously noted, patients and oncology clinicians may differ in terms of the symptoms and aspects of QOL they perceive as most important [17]. Thus, assessing and discussing QOL enables oncology providers to develop a better understanding of the patients’ perception of QOL as it pertains to their treatment. Incorporating QOL into discussions regarding treatment decision-making is especially important in situations where different treatments demonstrate similar survival benefits but different toxicity profiles.

In addition to the benefits of QOL assessment in the clinical setting, there are also benefits of incorporating QOL measurement into ovarian cancer research. This is reinforced by the National Cancer Institute (NCI) and the FDA, both of which have recently asserted that the improvement of survival and QOL should be the aims of cancer research [53]. Given that approximately three-fourths of women with ovarian cancer are diagnosed with advanced disease [54], as well as the limited curative treatment options for advanced disease, the improvement and maintenance of QOL is an important outcome in clinical trials. Clinical trials that include QOL as an outcome can measure treatment success by the extent to which the treatment manages or improves ovarian cancer-specific symptoms affecting QOL.

The preservation and improvement of QOL represents an important aim of clinical trials investigating advances in treatment modalities for ovarian cancer. The development of validated QOL measurement tools has enabled clinical trials to collect and report on QOL data in the context of newly emerging treatment modalities. In recent years, a number of treatment advances have emerged, including new chemotherapeutic agents, innovations in the timing and mode of chemotherapy administration, and new surgical procedures. Research has increasingly sought to identify how these new treatment strategies affect QOL in women with ovarian cancer, and efforts are necessary to continue to more comprehensively incorporate measures of QOL in trials assessing novel therapies. Table 14.6 summarizes recent research evaluating new treatment modalities that has included QOL as an end point.