Phase III study of the European Organisation for Research and Treatment of Cancer Quality of Life cancer survivorship core questionnaire.

PURPOSE: The purpose of this study is to develop a European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) questionnaire that captures the full range of physical, mental, and social health-related quality of life (HRQOL) issues relevant to disease-free cancer survivors. In this phase III study, we pretested the provisional core questionnaire (QLQ-SURV111) and aimed to identify essential and optional scales. METHODS: We pretested the QLQ-SURV111 in 492 cancer survivors from 17 countries with one of 11 cancer diagnoses. We applied the EORTC QLG decision rules and employed factor analysis and item response theory (IRT) analysis to assess and, where necessary, modify the hypothesized questionnaire scales. We calculated correlations between the survivorship scales and the QLQ-C30 summary score and carried out a Delphi survey among healthcare professionals, patient representatives, and cancer researchers to distinguish between essential and optional scales. RESULTS: Fifty-four percent of the sample was male, mean age was 60 years, and, on average, time since completion of treatment was 3.8 years. Eleven items were excluded, resulting in the QLQ-SURV100, with 12 functional and 9 symptom scales, a symptom checklist, 4 single items, and 10 conditional items. The essential survivorship scales consist of 73 items. CONCLUSIONS: The QLQ-SURV100 has been developed to assess comprehensively the HRQOL of disease-free cancer survivors. It includes essential and optional scales and will be validated further in an international phase IV study. IMPLICATIONS FOR CANCER SURVIVORS: The availability of this questionnaire will facilitate a standardized and robust assessment of the HRQOL of disease-free cancer survivors.

Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire.

BACKROUND: The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used. METHODS: We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors. RESULTS: We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment. CONCLUSIONS: Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.

Cross-cultural development of a quality-of-life measure for patients with melanoma: phase 3 testing of an EORTC Melanoma Module.

Melanoma is an increasingly common skin cancer worldwide. Recent treatment advances have provided patients and healthcare professionals (HCPs) with choices where quality of life (QoL) and toxicity are important considerations. A melanoma-specific QoL questionnaire is being developed in a cross-cultural setting using a four phase process developed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. In phase 1, a literature search identified a list of pertinent QoL issues; this was shown to HCPs and patients in eight countries and rated for importance and relevance. Questions were constructed for the highest-rated issues (phase 2) and piloted in another patient sample (phase 3). Using EORTC Quality of Life Group criteria and sequential use of factor and Rasch analysis, scales were hypothesized for field testing (phase 4). Seven QoL domains (disease symptoms, treatment issues, financial issues, access/quality of information, satisfaction with care, psychosocial issues and support), comprising 73 QoL issues, were rated by 46 HCPs and 78 patients. Fifty-six issues were rephrased as questions and piloted with 132 patients. A 38-item questionnaire (QLQ-MEL38) is available for field testing in conjunction with the EORTC QLQ-C30. This study has shown that melanoma patients have important QoL issues that have been incorporated into a new cross-culturally validated instrument. Future testing of this EORTC module is planned and will be an important step forward in providing reliable QoL data to aid future decision-making in the management and clinical trials of this complex group of patients.

Assessing the feasibility of using acupuncture and moxibustion to improve quality of life for cancer survivors with upper body lymphoedema.

PURPOSE: Within a three-step mixed-methods study to investigate using acupuncture and moxibustion (acu/moxa) in the management of cancer treatment-related upper body lymphoedema, Step 2 obtained preliminary data about: 1) whether acu/moxa can improve quality of life, 2) the most troublesome symptoms, and 3) adverse effects. METHODS AND SAMPLE: An exploratory single-arm observational clinical study included breast (BC) and head and neck cancer (HNC) survivors with mild-to-moderate uncomplicated lymphoedema for ≥3 months, ≥3 months post active-cancer treatment, no active cancer disease, undergoing routine lymphoedema maintenance. Participants received seven individualised treatments (S1), and six optional additional treatments (S2). MYMOP, SF-36 and PANAS were administered at baseline, during each series, and at follow-up 4 and 12 weeks after end-of-treatment. The primary outcome was change in MYMOP scores at the end of each series. KEY RESULTS: Of 35 participants recruited, 30 completed S1 and S2, 3 completed S1, 2 were lost to the study. Mean MYMOP profile change scores for BC participants were 1.28 points improvement on a 7-point scale (sd = 0.93, p < 0.0001, n = 25) for S1; and 1.41 for S2 (sd = 0.94, p < 0.0001, n = 24). S1 HNC change scores were 2.29 points improvement (sd = 0.62, p < 0.0001, n = 7); and 0.94 for S2 (sd = 0.95, p = 0.06, n = 6). Changes in some SF-36 scores for BC participants were significant to 4 weeks after treatment. No serious adverse effects were reported. CONCLUSION: This small study suggests acu/moxa is an acceptable adjunct to usual care for cancer survivors with lymphoedema. Further rigorous research is warranted to explore the effectiveness of acu/moxa in reducing the symptom burden.

Using traditional acupuncture for breast cancer-related hot flashes and night sweats.

OBJECTIVES: Women taking tamoxifen experience hot flashes and night sweats (HF&NS); acupuncture may offer a nonpharmaceutical method of management. This study explored whether traditional acupuncture (TA) could reduce HF&NS frequency, improve physical and emotional well-being, and improve perceptions of HF&NS. DESIGN/SETTINGS/LOCATION: This was a single-arm observational study using before and after measurements, located in a National Health Service cancer treatment center in southern England. SUBJECTS: Fifty (50) participants with early breast cancer completed eight TA treatments. Eligible women were ≥ 35 years old, ≥ 6 months post active cancer treatment, taking tamoxifen ≥ 6 months, and self-reporting ≥ 4 HF&NS incidents/24 hours for ≥ 3 months. INTERVENTIONS: Participants received weekly individualized TA treatment using a core standardized protocol for treating HF&NS in natural menopause. OUTCOME MEASURES: Hot Flash Diaries recorded HF&NS frequency over 14-day periods; the Women's Health Questionnaire (WHQ) assessed physical and emotional well-being; the Hot Flashes and Night Sweats Questionnaire (HFNSQ) assessed HF&NS as a problem. Measurements taken at five points over 30 weeks included baseline, midtreatment, end of treatment (EOT), and 4 and 18 weeks after EOT. Results for the primary outcome: Mean frequency reduced by 49.8% (95% confidence interval 40.5-56.5, p < 0.0001, n = 48) at EOT over baseline. Trends indicated longer-term effects at 4 and 18 weeks after EOT. At EOT, seven WHQ domains showed significant statistical and clinical improvements, including Anxiety/Fears, Memory/Concentration, Menstrual Problems, Sexual Behavior, Sleep Problems, Somatic Symptoms, and Vasomotor Symptoms. Perceptions of HF&NS as a problem reduced by 2.2 points (standard deviation = 2.15, n = 48, t = 7.16, p < 0.0001). CONCLUSIONS: These results compare favorably with other studies using acupuncture to manage HF&NS, as well as research on nonhormonal pharmaceutical treatments. In addition to reduced HF&NS frequency, women enjoyed improved physical and emotional well-being, and few side-effects were reported. Further research is warranted into this approach, which offers breast cancer survivors choice in managing a chronic condition.