Cancer Quality Of Life Questionnaire Core Research Articles

Management of radiation-induced nausea and vomiting with palonosetron in patients with pre-existing emesis: a pilot study.

Approved almost 15 years ago for use in the chemotherapy setting, palonosetron, a 2nd generation 5-hydroxtryptamine 3 receptor antagonist (5-HT3 RA), has demonstrated efficacy in preventing chemotherapy-induced nausea and vomiting. However, its utility in the prophylaxis and treatment of radiation-induced nausea and vomiting (RINV) has yet to be evaluated. In this pilot study, we investigated the rates of control in RINV in patients with pre-existing emesis. Patients with pre-existing emesis undergoing palliative radiotherapy to sites with emetic risk were prescribed palonosetron 0.5 mg before the start of radiation treatment, and every other day until completion of treatment. Patients were followed up in acute (day 1 of treatment to day 1 after treatment) and delayed phases (days 2-10 after treatment). Prophylaxis and rescue (PR) was defined as a decrease in anti-emetic use, or episodes of nausea and/or vomiting from baseline. Complete prophylaxis (CP) was defined as no increase in anti-emetic use, or episodes of nausea and/or vomiting. Secondary endpoints included control of nausea and quality of life (QOL), as assessed with the Functional Living Index-Emesis and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15 Palliative. Fourteen patients were enrolled. Rates of control were higher in the acute phase (n=14) for nausea (PR =42.9%, CP =42.9%) and vomiting (PR =21.4%, CP =71.4%) compared to the delayed phase (n=13) for nausea (PR =42.9%, CP =7.7%) and vomiting (PR =15.4%, CP =53.8%). Palonosetron appears to be safe and patients with pre-existing emesis receiving palliative radiotherapy. More studies are needed to investigate its efficacy in this patient population.

Relaxation and Exercise in Lymphoma Survivors (REIL Study): A Randomised Clinical Trial Protocol

Background: Cancer survivors commonly report ongoing physical and psychological needs and adverse effects due to disease and treatment exposures including fatigue, pain, depression and decreased quality of life (QoL). Both relaxation and exercise interventions have demonstrated a positive effect on these symptoms. However these benefits have been relative to a control group, and there has been a call for further intervention studies in survivors to move beyond wait-list control groups and to compare with active control or other empirically supported interventions, such as comparison of relaxation to exercise intervention, to determine which is more beneficial. Aim: This paper presents the REIL (Relaxation and Exercise In Lymphoma) study protocol using recommended SPIRIT 2013 guidelines. The primary aim of the REIL Study is to compare the effect of two interventions - exercise and relaxation on QoL in a sample of lymphoma patients in remission postchemotherapy. Secondary aims are to investigate the effects of the two interventions on body composition, cardiovascular status, pulmonary function, muscle strength, functional exercise capacity, well-being and psychological status; and explore perceptions about participation in the posttreatment intervention program. Methods: Eligible participants (n=36) will be randomized to an exercise or relaxation home-based program to perform at least three times per week. The primary outcome measure is QoL, assessed by the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30). Secondary outcome measures include body composition, cardiovascular status, pulmonary function, strength, functional exercise capacity, well-being and psychological status. Total duration of the study will be 12 weeks and outcome measures will be assessed at baseline, 6 weeks and at the end of the study. Results: Results from this study will inform development of effective care pathways for the increasing population of cancer survivors in general, and lymphoma in particular. It is anticipated that preliminary results from this study will be available by October 2018. Conclusion: Although it is well documented that cancer survivors commonly suffer from consequences of treatment which have a negative impact on their QoL, there are currently no recommended care pathways following completion of primary medical treatment. Evidence suggests that both relaxation and exercise can significantly improve ongoing symptoms in cancer survivors, but there is no consensus on which intervention is more effective. Results from the REIL study will aid in the development of evidence-based survivorship care pathways for cancer and lymphoma survivors, potentially prevent long-term complications, and help in a smooth transition from being a cancer patient to a fully-functioning member of society. This may lead to reduced use of healthcare resources by this population.

Education level and health-related quality of life after oesophageal cancer surgery: a nationwide cohort study

ObjectiveThe purpose of the study was to investigate whether low education level was associated with patients’ health-related quality of life (HRQOL) after oesophageal cancer resection.SettingA nationwide cohort study in Sweden.ParticipantsIn...

The role of psychosocial resources for long-term breast, colorectal, and prostate cancer survivors: prevalence and associations with health-related quality of life.

Many long-term cancer survivors still have to adjust to possible adverse consequences of the illness or treatment. Resources can play an important role in this adjustment process, but research on this topic is limited, especially for very long-term survivors. This study explores, which resources are most frequently indicated by different subgroups of cancer survivors, and what role resources play for functioning and health-related quality of life (HRQL) in cancer survivors with and without recurrence. The sample of 6030 breast, colorectal, and prostate cancer survivors (5-16years post-diagnosis) was recruited in a German multi-regional population-based study. Personal resources were assessed by a 27-item checklist; HRQL was assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). General linear models were used to analyze associations of resources with HRQL. Participants indicated on average 11.4 (SD 5.1) resources as helpful. Family, activities with others, and partnership were indicated most commonly overall, but frequencies varied according to age, sex, and tumor site. Physical activity, health, professional help, calmness, hope, optimism, and hobbies were most important in explaining HRQL variance. Cancer survivors with recurrence and many resources were found to report similar HRQL as survivors without recurrence and only few resources. The study underlines the importance and situational variability of personal and social resources for cancer survivors' HRQL, even years post-diagnosis. Not only the availability, but also the individual perception and significance of resources should be considered in follow-up cancer care.

Body composition, fatigue and exercise in patients with prostate cancer undergoing androgen-deprivation therapy.

To investigate the association between lean mass (LM) and fat mass (FM) with fatigue and vitality before and after exercise in patients with prostate cancer already undergoing androgen-deprivation therapy (ADT). Cross-sectional associations between LM and FM with fatigue and/or vitality measures were examined in 229 patients (aged 43-90 years). Prospective analysis was undertaken in 129 patients who underwent a supervised 3-6 months exercise programme (predominantly resistance + aerobic). Whole body and appendicular LM, and total and trunk FM were assessed by dual X-ray absorptiometry. Fatigue was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-30) and vitality using the Short Form-36. Based on the EORTC QLQ-30, 19% of patients had clinically relevant fatigue. There was no association between LM and fatigue; however, total (P = 0.013), trunk (P = 0.015) and percentage (P = 0.008) FM were higher in fatigued than not fatigued patients, with total and trunk FM 5.0 and 2.6 kg higher, respectively. For quartiles of vitality, a similar pattern emerged for FM with those in the lowest quartile of vitality having the highest FM values (P = 0.014-0.034). In contrast, following supervised exercise, change in fatigue and vitality were associated with change in total LM (r = -0.182, P = 0.042 and r = 0.309, P = 0.001, respectively) but not FM. Patients fatigued at baseline but not fatigued following the exercise programme gained a median (interquartile range) of 2.1 (0.7-3.2) kg LM. In patients with prostate cancer treated with ADT, body composition is associated with fatigue, with higher total and trunk FM in those with clinically relevant fatigue. However, following exercise those no longer fatigued had an accompanying substantial increase in LM. Modifying body composition, both LM and FM, in patients with prostate cancer may favourably alter cancer-related fatigue levels and should be a target of exercise medicine in this population.

A prospective observational study to assess clinical decision-making, prognosis, quality of life and satisfaction with care in patients with relapsed/refractory multiple myeloma: the CLARITY study protocol

BackgroundTreatment decision-making in patients with relapsed/refractory multiple myeloma (RRMM) is challenging for a number of reasons including, the heterogeneity of disease at relapse and the number of possible therapeutic approaches. This study broadly aims to generate new evidence-based data to facilitate clinical decision-making in RRMM patients. The primary objective is to investigate the prognostic value of patient self-reported fatigue severity for overall survival.MethodsThis multicenter prospective observational study will consecutively enroll 312 patients with multiple myeloma who have received at least 1 prior line of therapy and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria. Eligible RRMM participants will be adults (≥ 18 years old) patients and will be enrolled irrespective of comorbidities and performance status. At the time of study inclusion, data to calculate the frailty score are to be available. Patients will be followed up for 30 months and patient-reported outcome (PRO) assessment is planned at baseline and thereafter at 3, 6, 12, and 24 months. The following PRO validated questionnaires will be used: the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the EORTC QLQ-MY20 and the EORTC QLQ-INFO25. Satisfaction with care and preference for involvement in treatment decisions will also be evaluated. Clinical, laboratory and treatment related information will be prospectively collected in conjunction with pre scheduled PRO assessments. Cox regression analyses will be used to assess the prognostic value of baseline fatigue severity (EORTC QLQ-C30) and other patient-reported health-related quality of life parameters.DiscussionClinical decision-making in RRMM is a challenge and outcome prediction is also an important aspect to enhance personalized treatment planning. Given the paucity of PRO data in this population, this prospective observational study aims to provide novel information that may facilitate patients’ management in routine practice.Trial registrationThis trial is registered as identifier NCT03190525.

Treatment Satisfaction of Patients With Advanced Non–Small-cell Lung Cancer Receiving Platinum-based Chemotherapy: Results From a Prospective Cohort Study (PERSONAL)

IntroductionIn patients with advanced non–small-cell lung cancer, the treatment benefits and risks need to be constantly weighed. We explored patient-reported satisfaction with therapy (SWT) and assessed its value in addition to quality of life (QoL) and adverse events (AEs). Patients and MethodsIn a prospective multicenter cohort study, patients with stage IIIB/IV non–small-cell lung cancer received platinum-pemetrexed chemotherapy. They completed the World Health Organization Quality of Life-BREF (WHOQoL-BREF) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) before and during chemotherapy. After the last cycle, patients reported on SWT, expectations of therapy, and feelings about side effects (FSE) using the Cancer Therapy Satisfaction Questionnaire. The explained variance (R2) of QoL after treatment by SWT was calculated. Using multivariable linear regression, we examined the association of SWT with patient- and treatment-related variables, FSE, and AEs. ResultsEighty-nine patients finished 4 cycles of chemotherapy, 65 of whom completed the Cancer Therapy Satisfaction Questionnaire. Fifty-six patients (86.2%) would probably or definitely decide to undergo the same treatment again, regardless of deterioration or improvement in QoL or a high or low frequency of AEs during chemotherapy. The explained variance of QoL by SWT was greatest for the EORTC QLQ C-30 global health status/QoL scale (R2 = 0.170). Patient age (β = 0.43; 95% confidence interval [CI], 0.05-0.82), FSE (β = 0.17; 95% CI, 0.06-0.29), and tumor response (β = 7.93; 95% CI (1.64 to 14.22)) were independently associated with SWT. ConclusionSWT could provide important supplementary information in addition to QoL assessments and treatment toxicities. Tumor response, older age, and FSE score were associated with better SWT. These insights could affect decision-making during palliative chemotherapy.

Health-related quality of life in patients with chronic myeloid leukemia receiving first-line therapy with nilotinib.

Although a wealth of efficacy and safety data is available for many tyrosine kinase inhibitors used in chronic myeloid leukemia (CML), there is a dearth of information on their impact on patients' health-related quality of life (HRQOL). The primary objective of this study was to evaluate HRQOL and fatigue outcomes in patients with CML receiving first-line therapy with nilotinib. This was a multicenter, prospective study enrolling 130 patients with chronic-phase CML. HRQOL and fatigue were evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and its validated Fatigue module at the baseline and then at 3, 6, 12, 18, and 24 months. The primary prespecified HRQOL endpoints defined in the study protocol for longitudinal analysis were the Physical Functioning, Social Functioning, Role Functioning, and Fatigue scales. The remaining scales were investigated on an exploratory basis. The rate of baseline compliance with the HRQOL assessment was 95.4% (124 of 130), and the rate of overall compliance with HRQOL forms was 91%. Among the 4 prespecified primary HRQOL endpoints, statistically significant improvements over time were found for Physical Functioning (P = .013), Role Functioning (P = .004), and Fatigue (P < .001). Clinically meaningful improvements were found already 3 months after the treatment start. The baseline patient self-reported fatigue severity was an independent predictive factor for the achievement of a major molecular response with an odds ratio of 0.960 (95% confidence interval, 0.934-0.988; P = .005). For most patients, HRQOL improvements with nilotinib occur during the early phase of therapy and are maintained over time. Also, a more systematic HRQOL evaluation during the diagnostic workup of CML may help to predict clinical outcomes. Cancer 2018;124:2228-37. © 2018 American Cancer Society.

Abstract P1-13-12: Quality of life and patient-reported outcomes in US patients enrolled in the MONALEESA-2 study

Abstract Background: Improvement to and maintenance of the highest possible health-related quality of life (QoL), in addition to disease control, are key goals of treatment in patients with advanced breast cancer (ABC). Endocrine therapy is preferred as first-line therapy in ABC because of its preferable safety profile compared with chemotherapy. In the MONALEESA-2 study, the cyclin-dependent kinases 4 and 6 inhibitor ribociclib, in combination with letrozole, significantly extended progression-free survival (PFS) compared with placebo + letrozole in patients with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2−) ABC. Patient-reported outcomes demonstrated similar QoL among patients in both treatment groups. Here, we present data from US patients enrolled in the MONALEESA-2 study on overall QoL as well as individual domains. Methods: Postmenopausal women (N=668) with HR+, HER2− ABC who did not receive prior systemic treatment for ABC and had an Eastern Cooperative Oncology Group performance status score of ≤1, adequate bone marrow and organ function, and no history of active cardiac dysfunction were randomized 1:1 to receive either ribociclib (600 mg/d, 3 weeks on/1 week off) + letrozole (2.5 mg/d, continuous) or placebo + letrozole. The primary end point was locally assessed PFS. Quality of life was reported using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the EuroQol 5-domain 5 level (EQ-5D-5L) visual analog scale (VAS) of overall health, and the breast symptom score of the EORTC QLQ-Breast Cancer 23 (EORTC QLQ-BR23) module. Data cutoff in this analysis was January 29, 2016. Results: Patient characteristics and QoL survey reports were well balanced across treatment groups in US patients (n=213). The global health status/QoL scores of the EORTC QLQ-C30 were maintained between groups, and improved over time in the ribociclib group (mean ± standard deviation [SD] score at baseline, 69.1 ± 19.0; at 8 months, 71.3 ± 18.2; and at 16 months, 73.0 ± 16.0) and the placebo group (mean ± SD score at baseline, 69.9 ± 20.0; at 8 months, 75.9 ± 19.2; and at 16 months, 77.0 ± 15.0), which was consistent with scores in the overall population. At 16 months, the proportion of patients who did not experience ≥10% deterioration of all QoL scores was similar among treatment groups. Quality of Life Outcomes of US Patients in the MONALEESA-2 Study at 16 MonthsOutcomeTreatment, nPatients without ≥10% deterioration in score, % (95% CI, %)EORTC QLQ-C30 Global health status/QoLRIB + LET, 2664.0 (49.4–75.4) PBO + LET, 3550.5 (36.2–63.2)Physical functioningRIB + LET, 2175.7 (62.6–84.7) PBO + LET, 1773.1 (57.2–83.9)Emotional functioningRIB + LET, 2271.6 (58.6–81.2) PBO + LET, 3159.7 (45.7–71.2)Social functioningRIB + LET, 1780.1 (68.5–87.8) PBO + LET, 2660.2 (44.1–73.0)EORTC QLQ-BR23 breast symptom scoreRIB + LET, 888.0 (76.6–94.0) PBO + LET, 886.2 (70.6–93.9)EQ-5D-5L VAS of overall healthRIB + LET, 1386.6 (76.9–92.4) PBO + LET, 1873.4 (56.8–84.4)LET, letrozole; PBO, placebo; RIB, ribociclib. Conclusions: Addition of ribociclib to letrozole in US patients enrolled in MONALEESA-2 led to significant prolongation of PFS while maintaining QoL. Citation Format: Tolaney SM, Tan-Chiu E, Truica C, Volas-Redd G, Shtivelband M, Dalal AA, Chandiwana D, Hortobagyi G. Quality of life and patient-reported outcomes in US patients enrolled in the MONALEESA-2 study [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P1-13-12.

Exercise capacity and cancer-specific quality of life following curative intent treatment of stage I-IIIA lung cancer.

Lung cancer survivors are at risk for health impairments resulting from the effects and/or treatment of lung cancer and comorbidities. Practical exercise capacity (EC) assessments can help identify impairments that would otherwise remain undetected. In this study, we characterized and analyzed the association between functional EC and cancer-specific quality of life (QoL) in lung cancer survivors who previously completed curative intent treatment. In a cross-sectional study of 62 lung cancer survivors who completed treatment ≥ 1 month previously, we assessed functional EC with the 6-min walk distance (6MWD) and cancer-specific QoL with the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30). Cancer-specific QoL was defined using a validated composite EORTC-QLQ-C30 summary score. Univariable (UVA) and multivariable linear regression analyses (MVA) were performed to assess the relationship between functional EC and cancer-specific QoL. Lung cancer survivors had reduced functional EC (mean 6MWD = 335m, 65% predicted) and QoL (mean EORTC-QLQ-C30 summary score = 77, scale range 0-100). In UVA, 6MWD was significantly associated with cancer-specific QoL (R2 = 0.16, p = 0.001). In MVA, in a final model that also included heart failure, obstructive sleep apnea, and psychiatric illness, 6MWD was independently associated with cancer-specific QoL (partial R2 = 0.20, p = 0.001). Functional EC was independently associated with cancer-specific QoL in lung cancer patients postcurative intent treatment. Exercise-based interventions aimed at improving EC may improve cancer-specific QoL in these patients.

Quality of Life in Breast Cancer Patients using Neoadjuvant AC (Doxorubicin and Cyclophosphamide) in Comparison with PG (Paclitaxel and Gemcitabine) Therapy

Background: Quality of life has become a part of the evaluation criteria for cancer therapy. The aim of this study was to evaluate the quality of life in breast cancer patients under chemotherapy regimens that contained doxorubicin and cyclophosphamide (AC) compared to paclitaxel and gemcitabine (PG).Methods: This cohort study evaluated 100 women with breast cancer treated by doxorubicin and cyclophosphamide or gemcitabine and paclitaxel regimens. We used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 to assess health related quality of life at the beginning and end of chemotherapy. Data were analyzed by the independent t-test at a significance level of 0.05.Results: Most of the 100 patients were married (68%), aged 41-50 years (36%), non-college educated (76%), and had insurance (97%). The mean quality of life scores at the first session of chemotherapy and prior to the onset of treatment-related adverse events were 71.33 for the doxorubicin and cyclophosphamide groups and 71.15 for the gemcitabine and paclitaxel groups. Analysis of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 at the last chemotherapy session showed that the quality of life in both groups deteriorated as a result of side effects. The mean of quality of life scores at the first session of chemotherapy were 66.49 for the doxorubicin and cyclophosphamide group and 59.99 for the gemcitabine and paclitaxel group.Conclusion: Strategies to improve the emotional and role functions of the patients who undergo treatment should be given priority. Financial difficulties faced by breast cancer patients should be addressed from a policy making level at the initiating health financing system.

Real-World Data on Health-Related Quality of Life Assessment in Patients With Breast Cancer Receiving Subcutaneous Trastuzumab.

Purpose:Trastuzumab, a humanized anti-human epidermal growth factor receptor 2 (anti-HER2) antibody delivered intravenously, has revolutionized the treatment of patients with breast cancer overexpressing HER2 protein. Recently, a newer subcutaneous formulation was shown to have comparable efficacy to the initial intravenous trastuzumab. In this study, we aimed to evaluate the impact of subcutaneous trastuzumab on the health-related quality of life (HRQoL) of patients diagnosed with early or metastatic HER2-overexpressing breast cancer.Methods:Patients were provided with the EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) and the BR-23 questionnaires. The scoring of questionnaires and patient’s sociodemographic and clinicopathologic characteristics were recorded and analyzed by descriptive and correlation statistics employing t test and 2-way analysis of variance.Results:A total of 163 patients agreed to participate in the study. About 90 of 163 patients (55.21%) received subcutaneous trastuzumab and 21 patients intravenous trastuzumab (12.88%). A control group of 52 HER2+ patients received chemotherapy without trastuzumab (31.90%). Patients receiving subcutaneous trastuzumab were older and of more advanced disease stage compared with those receiving chemotherapy (58.5 vs 51 years, 39.8% vs 28.8% advanced disease). In univariate analysis, subcutaneous trastuzumab was associated with less nausea and vomiting (P = .002) but worse cognitive function (P = .013) and dyspnea (P = .042). Patients who have received >8 cycles of subcutaneous trastuzumab reported less diarrhea (P = .049) and systemic therapy side effects (P = .015). Multivariate analysis showed that patients without comorbidity receiving subcutaneous trastuzumab had less treatment side effects, less upset by hair loss, and higher emotional functioning. Of note, mastectomy and subcutaneous trastuzumab were associated with improved role functioning (P = .021). In metastatic disease, no negative impact of subcutaneous trastuzumab on HRQoL was found.Conclusions:The administration of subcutaneous trastuzumab improved certain symptoms and did not adversely affect most of the assessed functional scales. Particularly, in the metastatic setting, subcutaneous trastuzumab had no negative impact on HRQoL.

Patient-reported outcomes enhance the survival prediction of traditional disease risk classifications: An international study in patients with myelodysplastic syndromes.

Current prognostic systems for myelodysplastic syndromes (MDS) are based on clinical, pathologic, and laboratory indicators. The objective of the current study was to develop a new patient-centered prognostic index for patients with advanced MDS by including self-reported fatigue severity into a well-established clinical risk classification: the International Prognostic Scoring System (IPSS). A total of 469 patients with advanced (ie, IPSS intermediate-2 or high-risk) MDS were analyzed. Untreated patients (280 patients) were recruited into an international prospective cohort observational study to create the index. The index then was applied to an independent cohort including pretreated patients with MDS from the Dana-Farber Cancer Institute in Boston, Massachusetts (189 patients). At baseline, patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). A new prognostic index was developed: the FA-IPSS(h), in which FA stands for fatigue and h for higher-risk. This new risk classification enabled the authors to distinguish 3 subgroups of patients with distinct survival outcomes (ie, risk-1, risk-2, and risk-3). Patients classified as FA-IPSS(h) risk-1 had a median overall survival (OS) of 23 months (95% confidence interval [95% CI], 19-29 months), whereas those with risk-2 had a median OS of 16 months (95% CI, 12-17 months) and those with risk-3 had a median OS of 10 months (95% CI, 4-13 months). The predictive accuracy of this new index was higher than that of the IPSS alone in both the development cohort as well as in the independent cohort including pretreated patients. The FA-IPSS(h) is a novel patient-centered prognostic index that includes patients' self-reported fatigue severity. The authors believe its use might enhance physicians' ability to predict survival more accurately in patients with advanced MDS. Cancer 2018;124:1251-9. © 2017 American Cancer Society.

Minimal Clinically Important Difference of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) for Fatigue Worsening in Asian Breast Cancer Patients

ContextThe minimal clinically important difference (MCID) of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), a questionnaire that measures cancer-related fatigue, has not been established in patients with cancer. ObjectivesThis study aims to determine the MCID of the MFSI-SF. MethodsBreast cancer patients completed the MFSI-SF and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) before chemotherapy and at least three weeks later. The EORTC-QLQ-C30 fatigue scale (EORTC-FA) was used as an anchor, and a receiver operating characteristic (ROC) curve was also used to identify the optimal MCID cut-off for fatigue deterioration. A distribution-based approach used one-third of the SD, half of the SD, and one SEM of the total MFSI-SF score to determine the MCID. ResultsA total of 201 patients were analyzed. Change scores of the MFSI-SF and EORTC-FA were moderately correlated (r = 0.47, P < 0.001). The EORTC-FA–anchored MCID was 8.69 points (95% CI: 4.03–13.34). The MCID attained from the ROC curve method was 4.50 points (sensitivity: 68.8%; specificity: 64.1%). For the distribution-based approach, the MCIDs corresponding to one-third of the SD, half of the SD, and one SEM were 5.39, 8.99, and 10.79 points, respectively. ConclusionThe MCID of the MFSI-SF identified by all approaches ranged from 4.50 to 10.79 points. The MCID can be used to interpret the clinical significance of fatigue deterioration in patients with breast cancer and to determine sample sizes for future clinical trials.

Effectiveness of the HuCare Quality Improvement Strategy on health-related quality of life in patients with cancer: study protocol of a stepped-wedge cluster randomised controlled trial (HuCare2 study)

IntroductionOur group previously demonstrated the feasibility of the HuCare Quality Improvement Strategy (HQIS), aimed at integrating into practice six psychosocial interventions recommended by international guidelines. This trial will assess whether...

The Effectiveness of a Pain Management Program on Intensify of Pain and Quality of Life Among Cancer Patients in Myanmar

Introduction: Cancer is one of the leading causes of death worldwide and is rapidly becoming a global pandemic. Cancer pain significantly affects the diagnosis, quality of life and survival of patients with cancer. The aim of this study is to analyse the effect of a Pain Management Program (PMP) on pain and quality of life in a patient with cancer.Methods: This study used a quasi-experimental design with a randomised pre-post test design approach. The data was collected from cancer patients in No 2 Military Hospital (500-Bedded), Yangon, Myanmar. The patients were recruited using a random allocation sampling technique and consisted of 30 respondents (experimental group) and 30 respondents (control group) taken according to the inclusion criteria. The Short Form-McGill Pain Questionnaire 2 (SF-MPQ 2) was used to assess pain, and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was used to assess the quality of life.Results: A MANOVA test was used to analyse the effect of PMP. It showed that 1) PMP decreased the pain and 2) PMP increased the quality of life in patients with cancer.Conclusion: Improvements in the quality of life and to do with pain-related cancer suggests that the vicious cycle of chronic pain may be alleviated by PMP. As we look at the results, PMP can be an effective treatment to be used by nurses for decreasing pain and increasing the quality of life in patients with cancer.

Longitudinal and cross-sectional assessment of quality of life in surgically treated advanced (T4) cancer of the buccal mucosa

Quality of life (QOL) has become an important aspect of today's health care management. This study performed longitudinal assessment of QOL in patients with advanced cancers of the buccal mucosa (T4). We compared the QOL between patients who received adjuvant chemoradiation therapy (CTRT) and that of patients who received radiation therapy alone and assessed whether baseline QOL can predict disease recurrence. This was a prospective study of 225 patients with T4 buccal mucosal cancer. Health-related QOL was assessed at baseline and at 3, 6, 9, and 12 months after completion of treatment by means of the European Organization for Research and Treatment of Cancer Core QOL Questionnaire and the HN35 questionnaire. There was persistent improvement in global QOL and pain. Emotional functioning improved at 12 months. Most of the head and neck-specific symptoms deteriorated at 3 months, with subsequent improvement at 12 months except in swallowing, senses, speech, social eating, social contact, and sexuality. Patients who received adjuvant CTRT had poorer QOL. Poorer baseline global QOL (P = .049), dyspnea (P = .04), appetite loss (P = .015), and weight loss (P = .08) may predict recurrence. Although there is an improvement in global QOL and pain, most of the head and neck-specific symptoms worsened in the immediate postoperative period. Adjuvant CTRT has a persistent effect on specific domains compared with adjuvant radiation therapy alone. Poor baseline QOL scores are associated with a higher risk of recurrence.

Reliability and Validity of the MD Anderson Dysphagia Inventory Among Japanese Patients.

This study aimed to validate the Japanese version of a dysphagia-specific quality of life questionnaire, the MD Anderson Dysphagia Inventory (MDADI-J), and to verify trends between MDADI-J and Functional Oral Intake Scale (FOIS) scores. The original 20 MDADI items were translated using a forward-backward method following accepted cultural adaptation guidelines. Seventy-two patients with a history of head and neck cancer treatment completed the MDADI-J between October 2015 and August 2016. Concurrent validity was determined by correlations with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 (EORTC QLQ-H&N35) instruments. Discriminant validity was examined using cancer stage grouping between stages I-II and III-IV. Additionally, trends between the FOIS and the MDADI-J total scores were analyzed using a trend test. The Cronbach's α coefficient of the MDADI-J total score was 0.92, indicating high internal consistency. The average inter-item correlation coefficients ranged from 0.39 to 0.49. ICC, an indicator of test-retest reliability, was 0.84 for the total score, and 0.58 to 0.81 for individual subscales. The total score and all subscales were significantly associated with the scores for each factor of the EORTC QLQ-C30 and EORTC QLQ-H&N35. The total score and all subscales were significantly different between clinical tumor stages I-II and III-IV. The total scores all increased with the progress of the FOIS. In conclusion, this study validated the Japanese version of the MDADI and showed that as FOIS scores deteriorate, MDADI-J scores tend to constantly decrease.

Population-based reference values for the European Organization for Research and Treatment of Cancer Head and Neck module.

The purpose of this study was to establish population-based norms for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 (EORTC QLQ-HN35) to be used as references to facilitate the interpretation of results from health-related quality of life (HRQOL) studies of patients with head and neck cancer. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and QLQ-HN35 were sent to a random sample representing the Swedish general population. The response rate was 69% (1504 participants of 2200 invited). The scores for the QLQ-C30 were comparable to previously published reference values. The reference values for the QLQ-HN35 were low, indicating few head and neck-specific problems in the population. For illustrative purposes, we also compared these reference values to our previously published HRQOL results obtained from patients with head and neck cancer at diagnosis and from 3-year survivors. These new reference values for EORTC QLQ-HN35 may be useful in future HRQOL studies.

A pilot randomized controlled trial of acupuncture at the Si Guan Xue for cancer pain

sBackgroundPain is a common symptom in cancer patients. Acupuncture is a suggested treatment for a wide range of clinical conditions, usually for its beneficial effects on pain control. Si guan xue (the four points) have been widely used in clinical practice, and has shown that it is highly effective, effective in obtaining qi, shows strong acupuncture stimulation, and is simple to manipulate and safe to use. Therefore, the aim of this study is to test the protocol and safety of acupuncture at the si guan xue in the management of cancer pain.MethodsThis is a single-blind, randomized controlled pilot trial. 42 patients with moderate to severe cancer pain were randomly assigned to three different arms with seven sessions of treatment; that is, treatment arm 1 (the si guan xue arm, n = 14), treatment arm 2 (the si guan xue plus commonly used acupoints arm, n = 14) and the control arm (the commonly used acupoints arm n = 14). Primary outcomes included acupuncture relieving cancer pain, and patients’ subjective improvement as measured by the Patient Global Impression of Change (PGIC). Secondary outcomes included the scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and Karnofsky’s Performance Status (KPS).ResultsThe analysis showed that the cancer pain reduction in treatment arm 2 was most prominent on day 5 when compared with the control arm (P<0.05). There was no difference in the scores of PGIC, EORTC QLQ-C30 or KPS among the three groups (P>0.05). Furthermore, no serious adverse events were observed.ConclusionsThese results indicate that acupuncture at the si guan xue plus commonly used acupoints tends to be effective in reducing cancer pain. However, the sample size was small, and a future multi-centre study with a larger sample size is warranted.Trial registrationChiCTR-IOR-15007471 (Retroactively registered on 28 NOV 2015)