The Functional Assessment of Cancer Therapy Scale: Development and Validation of the General Measure.

PURPOSE: We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. METHODS AND RESULTS: The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. CONCLUSION: The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.

Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system.

This paper reports the development and validation of a questionnaire assessing fatigue and anemia-related concerns in people with cancer. Using the 28-item Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire as a base, 20 additional questions related to the symptoms and concerns of patients with anemia were developed. Thirteen of these 20 questions dealt with fatigue, while the remaining 7 covered other concerns related to anemia. Using semi-structured interviews with 14 anemic oncology patients and 5 oncology experts, two instruments were produced: The FACT-Fatigue (FACT-F), consisting of the FACT-G plus 13 fatigue items, and the FACT-Anemia (FACT-An), consisting of the FACT-F plus 7 nonfatigue items. These measures were, in turn, tested on a second sample of 50 cancer patients with hemoglobin levels ranging from 7 to 15.9 g/dL. The 41-item FACT-F and the 48 item FACT-An scores were found to be stable (test-retest r = 0.87 for both) and internally consistent (coefficient alpha range = 0.95-0.96). The symptom-specific subscales also showed good stability (test-retest r range = 0.84-0.90), and the Fatigue subscale showed strong internal consistency (coefficient alpha range = 0.93-0.95). Internal consistency of the miscellaneous nonfatigue items was lower but acceptable (alpha range = 0.59-0.70), particularly in light of their strong relationship to patient-rated performance status and hemoglobin level. Convergent and discriminant validity testing revealed a significant positive relationship with other known measures of fatigue, a significant negative relationship with vigor, and a predicted lack of relationship with social desirability. The total scores of both scales differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < 0.0001). The 13-item Fatigue subscale of the FACT-F and the 7 nonfatigue items of the FACT-An also differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < or = 0.001). The FACT-F and FACT-An are useful measures of quality of life in cancer treatment, adding more focus to the problems of fatigue and anemia. The Fatigue Subscale may also stand alone as a very brief, but reliable and valid measure of fatigue.

Someone to live for: social well-being, parenthood status, and decision-making in oncology.

PURPOSE: Little is known about the influence of social factors on treatment preferences and desire for aggressive cancer therapy. The present study assessed subjective and objective social indicators in patient preferences for treatment. METHODS: Cancer patients (N = 296) with diverse diagnoses and stages read sets of hypothetical vignettes describing patients with early-stage and advanced disease. In the first set, patients made decisions about treatment acceptance given varying levels of either increasing cure or extending survival. In the second set, the point at which patients shifted preferences from mild to severe treatment to improve likelihood of 1-year survival (switch point) was the dependent measure. We assessed the impact of quality-of-life (QL) domains measured by the Functional Assessment of Cancer Therapy-General (FACT-G), having children, marital status, and living arrangements on treatment preferences and switch points. RESULTS: The Social Well-Being (SWB) subscale of the FACT-G predicted both treatment acceptance (P = .007) and switch point (P = .043) in the advanced-disease vignettes, with lower SWB associated with less aggressive preferences. Children living at home was likewise associated with more aggressive intent both in treatment preferences (P = .003, advanced-disease vignette) and switch point (P < .001 and P = .001 for early- and advanced-disease vignettes, respectively). Living with others predicted more aggressive intent in the advanced-disease vignette (P = .03). Marital status did not predict either treatment acceptance or switch point. CONCLUSION: Positive social well-being, as well as having children living at home, predicted patient willingness to accept aggressive treatment. Willingness to receive aggressive treatment may explain or mediate previously reported salutory effects of social support on cancer outcomes.

Patient preferences for treatment of metastatic breast cancer: a study of women with early-stage breast cancer.

PURPOSE: The purpose of this study was to elicit preferences for the treatment of metastatic breast cancer in women with early-stage breast cancer who were given hypothetical treatment scenarios. We predicted that quality of life, demographic, and treatment variables would have an impact on patient preferences. PATIENTS AND METHODS: One hundred fifteen patients with stage 1-IIIA breast cancer were interviewed. All patients had either mastectomy or lumpectomy plus radiotherapy as primary treatment. Sixty-seven (58%) had prior adjuvant chemotherapy. Patients were given four clinical scenarios that described a woman with metastatic breast cancer who was stated to have a life expectancy of 18 months. Side effects of the treatment options were systematically varied from low (hormonal therapy) to life-threatening (high-dose experimental therapy) and were consistent with common clinical situations. Patients were asked to select which treatment, with its associated toxicity, they would accept and prefer for a 50% chance of specified increments in life expectancy, ie, 5 years, 18 months, 1 year, 6 months, 1 month, and 1 week. RESULTS: Quality of life at the time of interview, previous chemotherapy treatment, and degree of difficulty of previous treatments did not predict patient preferences. The greater the toxicity potential of the treatment, the less likely patients were to accept the treatment, although approximately 15% of patients would prefer high-risk treatment for as little as 1 month of added life expectancy. Between 34% and 82% of patients would prefer different therapies for a 6-month addition to life expectancy, whereas almost all patients would accept treatment for a 5-year increase in length of survival. Younger patients were more willing to assume the risks of treatment for a small increase in life expectancy. Of note, between 54% and 78% of patients would elect to start the different treatments even without symptoms related to metastatic disease. Moreover, 76% of patients would prefer standard treatment or an experimental agent to reduce symptoms or pain, even if such treatment did not prolong life. Additionally, only 10% of patients would allow randomization to a clinical trial comparing high-dose with standard chemotherapy. Participation in the study was not distressing to most patients. CONCLUSION: Patients showed clear preferences for specific treatments for metastatic disease when given hypothetical scenarios. There was a wide range of patient preferences for treatment based on risk-benefit assessment, but a substantial percentage of patients would accept the risk of major toxicity for minimal increase in overall survival.

Age and clinical decision making in oncology patients.

BACKGROUND: Ageism is a cultural bias that might inappropriately steer oncologists away from recommending aggressive treatments for older patients. The extent to which older patients might prefer less aggressive cancer therapies is unknown. Our lack of knowledge about patients' personal preferences for therapy may perpetuate this bias. PURPOSE: We conducted a study to determine 1) if age influences patient acceptance of cancer therapy and 2) if the older patients would be more or less likely to trade increased survival for maintaining quality of life than their younger counterparts. METHODS: Using an interview format, 244 cancer patients of all ages treated at a tertiary care cancer center read two sets of hypothetical vignettes. The first set consisted of four vignettes that varied in terms of stage of disease and treatment toxicity. Patients were asked to make hypothetical decisions about treatment given with respect to varying levels of either increasing cure or extending survival. The second set of vignettes presumed acceptance of cancer therapy. Within each vignette, two hypothetical treatments (mild versus severe) with different probabilities of 1-year survival were contrasted. The point at which patients shifted preferences from a treatment with mild versus severe side effects was the dependent measure. Mixed analysis of variance (ANOVA) procedures (F test) assessed the impact of age (< 65 years versus > or = 65 years) and patient disease stage (early versus advanced) on hypothetical decisions about treatment. All P values are two sided. RESULTS: In the treatment-preference vignettes, there was no effect of either age [F(1,239) = 2.14; P = .14] or patient stage [F(1,239) = .40; P = .53] on treatment acceptance. Older adults were as likely as their younger counterparts to agree to chemotherapy for both curative and control purposes. In the switch-point vignettes, younger adults switched to a more toxic treatment to gain survival advantage at an earlier point than the older patients in both the early-disease vignette [F(1,232) = 3.88; P = .05] and the advanced-disease vignette [F(1,232) = 4.43; P = .036]. There was neither an effect of disease stage on treatment decisions nor an interaction between disease stage and age. CONCLUSIONS AND IMPLICATIONS: In a tertiary care setting, older adults do not differ from their younger counterparts in terms of acceptance of chemotherapy. However, when treatment is presumed, they differ in terms of willingness to trade survival for current quality of life. Generalization of findings is limited by the relatively small sample of older adults (n = 43) and the referral population from which the sample was drawn. Replication with a larger older adult sample in a community setting is needed.

Quality of life in people with Hodgkin's disease.

The diagnosis and treatment of Hodgkin's disease are not without cost in terms of both short- and long-term sequelae that have an impact on quality of life. This paper reviews quality of life in Hodgkin's disease both during and after treatment, with a focus on medical, psychosocial, and psychological functioning. In general, patients with Hodgkin's disease emerge from successful treatment significantly affected. Often, the impact of the disease and its treatment has both positive and negative aspects. Positive effects include increased appreciation for life, enhanced self-esteem and sense of personal direction, and closer family ties. Negative effects include risk of second malignancy, infertility, difficulty with intimacy and sexuality, employment discrimination, insurance discrimination, increased general distress, and fear of recurrence. The many and diverse needs of Hodgkin's disease survivors merit increased attention from the health-care delivery system.

Cancer support groups: the state of the art.

Support groups serve a large number of people with cancer, and their family members. Their popularity is grounded in the fact that the existing cancer treatment network continues to leave a gap of unmet psychosocial needs. These unmet needs can often be alleviated by mutual aid provided by people who share a common experience. Mutual aid complements professional help by adding a dimension of support that is best provided by other members of the group in need. Themes of discussion in support groups include the emotional impact of illness, the meaning of illness, family difficulty, problems of intimacy, sense of isolation/stigma, role changes, and cancer-specific concerns. Components of mutual aid witnessed in these groups include direct assistance, advice-giving, and emotional support. In cancer support groups, there is an under-representation of people of color, men, and the poor among group participants. Out-reach to underserved groups must include more creative and flexible helping mechanisms.

The Functional Assessment of Cancer Therapy scale: development and validation of the general measure.

PURPOSE: We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. METHODS AND RESULTS: The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. CONCLUSION: The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.

A preliminary investigation of opinions and behaviors regarding advance directives for medical care.

BACKGROUND: Advance directives are a means of promoting patient autonomy in end-of-life decisions but are used infrequently. A recent federal law requires healthcare organizations to provide information to patients about advance directives. This study explored attitudes and behaviors related to the use of advance directives in three areas: familiarity with advance directives, reasons for completing or not completing advance directives and preferences for receiving information about advance directives. METHODS: A questionnaire was administered by personal interview to a nonrandomized convenience sample of 46 inpatients and 50 outpatients at a large, tertiary care, urban academic medical center in the summer of 1991. RESULTS: Most respondents (77%) had heard of either the living will or durable power of attorney for healthcare, but only 52% correctly understood the purpose of these documents. Twenty-nine percent of the sample had executed an advance directive. Those who had advance directives were older and considered themselves less healthy than did those without advance directives. Unfamiliarity with advance directives and procrastination were cited most often as reasons for not having an advance directive. Most subjects (65%) had spoken with someone, usually a family member or close friend, about preferences for treatment during a critical illness. Although they had rarely discussed advance directives, 83% anticipated that they would be comfortable doing so with a physician or a nurse. CONCLUSIONS: Advance directives are used infrequently to document treatment preferences. The success of programs to promote greater use of advance directives depends on a clearer understanding of the factors that influence both decision and action to execute an advance directive. Patients claim to be comfortable in discussing the topic and prefer that such discussions occur in the outpatient setting.