MD Anderson Symptom Inventory Research Articles

Using the Risk Assessment Index to predict mortality and quality of life in breast and gynecologic cancer patients.

239 Background: Cancer patients vary considerably in health status making it challenging to evaluate the risk of complications from cancer treatment. To aid oncologists in identifying patients with highest risk for adverse outcomes, we investigated the Risk Assessment Index (RAI), a validated tool used to assess frailty in patients prior to elective surgery. We assessed whether the RAI could serve to predict mortality, hospital utilization, and quality of life in cancer patients. Methods: Participants were breast and gynecological cancer patients treated at UPMC Magee Women’s Cancer Center who completed the RAI between July 2016 and December 2017. Patients completed patient reported outcomes (PROs) during each visit including the Short Form (SF)-12, Edmonton Symptom Assessment, anxiety and depression screens, and MD Anderson Symptom Inventory (MDASI) and were analyzed up to 180 days from the RAI date. Mortality was assessed at 90, 180, and 365-day intervals, and hospital utilization was assessed within 90-days of RAI. Results: There were 1,764 unique breast and gynecological cancer patients. Significant correlations between the RAI and mortality were observed for both groups with frail patients having higher rates of mortality at each interval. Frailty was associated with higher rates of hospitalization compared to non-frail patients (31% vs 20%, p = 0.05 & 50% vs 34%, p = 0.02 for breast and gynecologic patients, respectively). Frailty correlated with fair/poor ratings on the SF-12 for breast and gynecologic patients (r = 0.13, p = 0.01; r = 0.37 p < 0.001, respectively). On the Edmonton, frailty correlated with lower ratings of well-being in breast cancer patients (r = 0.11, p = 0.012) and higher symptom burden in gynecological patients (r = 0.23, p = 0.01). No correlations were observed between the RAI and anxiety or depression. For gynecologic patients, there were significant correlations between the RAI and MDASI with frail patients having higher rates of pain, fatigue, appetite, diarrhea, and memory. Conclusions: We demonstrated that the RAI is correlated with mortality, self-reported quality of life, and hospitalizations in breast and gynecologic cancer patients. Using this tool to risk-stratify patients may help to guide shared decision-making discussions and provide appropriate treatment and/or supportive services for this vulnerable population.

Exercise in older women with breast cancer during systemic therapy: study protocol of a randomised controlled trial (BREACE)

IntroductionExercise interventions have been widely investigated in patients with cancer and demonstrate beneficial effects. However, intervention studies that include older women with breast cancer exercising during medical treatment are scarce....

Evaluating the psychometric properties of the Immunotherapy module of the MD Anderson Symptom Inventory

IntroductionImmunotherapies have revolutionized the treatment of various cancers, but little is known about their symptomatic toxicity. Assessing these symptoms is best accomplished by asking the patients themselves. However, such reports...

AML-205: Health-Related Quality of Life in Patients with Untreated Higher-Risk Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia Receiving Glasdegib + Azacitidine

Context Glasdegib + azacitidine (AZA) showed promising remission rates and overall survival in an analysis of BRIGHT MDS & AML 1012 ( NCT02367456 ) in patients with higher-risk myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). Objective To assess the impact of glasdegib + AZA on health-related quality of life(HRQoL) in BRIGHT MDS & AML 1012. Design Phase 1b, open-label study. Data cut-off: September 11, 2019. Setting Multicenter study at centers in Europe and North America Patients Untreated patients with AML, higher-risk MDS, and CMML ineligible for intensive chemotherapy received glasdegib + AZA. Interventions Glasdegib 100 mg QD; AZA 75 mg/m2/D on D1–7 q28D. Main outcome measures Here, we report patient-reported outcomes that characterize HRQoL using the MD Anderson Symptom Inventory (MDASI)-AML/MDS, Patient Global Impression of Severity (PGI-S), and Patient Global Impression of Change (PGIC) tools. PROs were assessed at baseline (except the PGIC), D7 and D15 of cycle 1, D1 of each subsequent Cycle, and at end of treatment. Results For the MDS (n=30, including 3 with CMML) and AML (n=30) cohorts, median (range) number of cycles started was 5 (1–14) and 5 (1–15), respectively. HRQoL was measured by MDASI-AML/MDS within each of the following subscales: Core Cancer Symptoms, AML/MDS Specific Symptoms, Total Symptom Severity, and the composite score of the 6 areas of interference (general activity, mood, work, relations, walking, and enjoyment of life). For both the AML and MDS cohorts, each subscale indicated that patients had a low symptom burden over time. For the PGI-S, both cohorts showed similar trends in patient's impression of current leukemia symptoms remaining constant over time (i.e., absent to mild). For the PGIC, patient's impression of change of leukemia symptoms since starting study medication remained constant over time (i.e., no to minimal change) for the MDS cohort and showed a trend of improvement in the AML cohort (i.e., minimal change to much improved). Conclusions Glasdegib + AZA is a promising first-line treatment option that does not negatively impact the HRQoL of patients with MDS, AML, and CMML ineligible for intensive chemotherapy. Study sponsor Pfizer.

Medullary Thyroid Cancer Patient’s Assessment of Quality of Life Tools: Results from the QaLM Study

Background: Medullary thyroid cancer (MTC) is a neuroendocrine tumour and a rare variant of thyroid cancer with different aetiology, presentation and treatment to differentiated thyroid cancer. Currently available thyroid cancer-specific quality of life (QoL) tools focus on issues and treatments more relevant to patients with differentiated thyroid cancer and therefore may not address issues specific to a MTC diagnosis and cancer journey. Method: This prospective multicentre randomised study involved 204 MTC patients completing four quality of life questionnaires (QOLQ) and stating their most and least preferred. The questionnaires were a general instrument, the EORTC QLQ-C30, two disease-specific tools, the MD Anderson Symptom Inventory (MDASI) thyroid module and the City of Hope Quality of Life Scale/THYROID (amended) and the neuroendocrine questionnaire, EORTC QLQ-GINET21. Patients were randomised to complete the four questionnaires in one of 24 possible orders and then answered questions about which tool they preferred. The primary outcome measure was patients’ preferred QoL instrument for describing their concerns and for facilitating communication with their healthcare professional. Secondary analyses looked at differences between preferred QOLQs amongst patient subgroups (WHO performance status [0 and 1+], disease stage: early [T1–3, N0 or N1A], metastatic [T4, any T N1b] and advanced [any T any N M1], and type of MTC [sporadic and inherited]), identification of MTC patients’ least preferred questionnaire and clinicians’ views on the QoL tools in terms of their ability to highlight problems not otherwise ascertained by a standard clinical review. Results: No evidence of a difference was observed for most preferred QOLQ (p = 0.650). There was however evidence of a difference in least preferred questionnaire in the cohort of 128 patients who stated their least preferred questionnaire (p = 0.042), with 36% (46/128) of patients choosing the EORTC QLQ-GI.NET21 questionnaire. Subgroup analyses showed that there was no evidence of a difference in patients’ most preferred questionnaire in sporadic MTC patients (p = 0.637), patients with WHO PS 0 or 1+ (p = 0.844 and p = 0.423) nor when comparing patients with early, advanced local or metastatic disease (p = 0.132, p = 0.463 and p = 0.506, respectively). Similarly, subgroup analyses on patients’ least preferred questionnaires showed no evidence of differences in sporadic MTC patients (p = 0.092), patients with WHO PS 0 or 1+ (p = 0.423 and p = 0.276), nor in early or metastatic disease patients (p = 0.682 and p = 0.345, respectively). There was however some evidence to suggest a difference in least preferred questionnaire in patients with advanced local stage disease (p = 0.059), with 43% (16/37) of these patients choosing the EORTC QLQ-GI.NET21 questionnaire. Conclusions: MTC patients regardless of their performance status, disease aetiology and disease burden did not express a preference for any one particular questionnaire suggesting any of the tools studied could be utilized in this patient cohort. The least preferred questionnaire being a gastrointestinal NET specific tool suggests that diarrhoea was not a significant symptom and concern for the population studied.

Quality of Life and Symptom Burden With First- and Second-generation Tyrosine Kinase Inhibitors in Patients With Chronic-phase Chronic Myeloid Leukemia

BackgroundWith the advent of tyrosine kinase inhibitors (TKIs), patients with chronic myeloid leukemia (CML) have a life expectancy similar to those of age- and gender-matched healthy populations. Nevertheless, patients receiving TKIs report chronic adverse events such as fatigue, edema, and muscle cramps, which lead to a decrease in their quality of life (QoL). Therefore, the aim of this study was to assess the QoL and symptom burden in patients receiving original imatinib, generic imatinib, dasatinib, and nilotinib. Patients and MethodsA total of 121 patients with CML who received TKIs for at least 3 months were enrolled in the study. The QoL was assessed with the Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and Quality of Life Questionnaire-Chronic Myeloid Leukemia (QLQ-CML24) modules. The symptom burden was assessed with MD Anderson Symptom Inventory for Chronic Myeloid Leukemia (MDASI-CML) and EORTC QLQ-CML24. ResultsThe median age of the study population was 53 years (range, 28-90 years), and 83 (81.4%) patients had a low-to-medium Sokal risk score. The Eastern Cooperative Oncology Group performance status of most patients were good (< 2; 96%), and comorbidity scores were low (HCT-CI < 3; 90.8%). There was no significant difference between the general health status of patients in terms of EORTC QLQ-C30 and QLQ-CML24. According to the results of the MDASI-CML and QLQ-CML24 modules, the most common symptom was fatigue (58.7%) in all groups, and there were no significant differences between the groups in terms of the effects on the daily life activities of the patients. ConclusionPatients with CML receiving first- and second-generation TKIs were seen to have a similar QoL and symptom burden.

Quality of life and added value of a tailored palliative care intervention in patients with soft tissue sarcoma undergoing treatment with trabectedin: a multicentre, cluster-randomised trial within the German Interdisciplinary Sarcoma Group (GISG)

ObjectivesThe choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating...

A prospective randomized trial comparing liposomal bupivacaine vs standard bupivacaine wound infiltration in open gynecologic surgery on an enhanced recovery pathway

Value in healthcare is reflected by patient-centered outcomes of care per health dollar expended. Although liposomal bupivacaine is more expensive, it has been shown to provide prolonged analgesia (up to 72 hours). This study aimed to evaluate whether the addition of liposomal bupivacaine to standard bupivacaine could decrease opioid intake and improve pain control after laparotomy for gynecologic surgery compared with standard bupivacaine alone in an enhanced recovery after surgery pathway. A prospective randomized controlled single-blinded trial of wound infiltration with liposomal bupivacaine plus 0.25% bupivacaine (study arm) vs 0.25% bupivacaine (control arm) was performed at a National Cancer Institute-designated tertiary referral cancer center. Participants were patients aged ≥18 years undergoing exploratory laparotomy for a gynecologic indication. All patients were treated on an enhanced recovery pathway including local wound infiltration before closure. In this study, 266 mg of liposomal bupivacaine (free base; equal to 300 mg bupivacaine HCL)+150 mg of bupivacaine mixed in the same syringe was used in the study arm, and 150 mg of bupivacaine was used in the control arm. The primary outcome was the proportion of patients who were opioid-free within 48 hours after surgery. Secondary outcomes included number of opioid-free days from postoperative day 0 to postoperative day 3, days to first opioid administration, morphine equivalent daily dose, and patient-reported outcomes collected with the MD Anderson Symptom Inventory. The MD Anderson Symptom Inventory was administered as a preoperative baseline, daily while hospitalized, and at least weekly for 8 weeks after discharge. All outcomes were prespecified before data collection. In this study, 102 patients were evaluated. Among them, 16.7% of patients in the study arm received no opioids up to 48 hours compared with 14.8% in the control arm (P=.99). There were no significant differences in the amount of intraoperative opioids administered or days to first opioid use. There was no significant difference between the 2 arms in median cumulative morphine equivalent daily dose (21.3 [study arm] vs 33.8 [control arm]; P=.36) or between the groups in morphine equivalent daily dose per individual day. There were no significant differences in patient-reported pain or interference with walking between the 2 arms or other patient-reported outcomes. Within an enhanced recovery after surgery pathway, adding liposomal bupivacaine to 0.25% bupivacaine wound infiltration did not decrease the proportion of patients who were opioid-free within 48 hours after surgery, did not decrease opioid intake, or did not improve patient's self-reported pain and functional recovery compared with standard bupivacaine.

Symptoms in the general Norwegian adult population - prevalence and associated factors

BackgroundPatients´ own perceptions and evaluations of symptoms, functioning and other health-related factors, i.e. Patient Reported Outcomes (PROs), are important elements for providing good patient care. Symptoms are subjective and best elicited by the patient orally or by using PRO measures (PROMs), be it on paper, or as electronic assessment tools. Reference values on frequently used PROMs facilitate the interpretation of scores for use in clinics and research settings, by comparing patient data with relevant samples from the general population. Study objectives were to (1) present reference values for the M.D. Anderson Symptom Inventory (MDASI) (2) examine the occurrence and intensity of symptoms assessed by the MDASI in a general Norwegian adult population sample, and (3) examine factors associated with higher symptom burden defined as the sum score of all symptoms, and factors associated with symptoms` interference on functions.MethodsIn 2015, MDASI was sent by mail as part of a larger survey, to a representative sample of the general Norwegian adult population (N = 6165). Medical comorbidities were assessed by the Self-Administered Comorbidity Questionnaire. Depression was self-reported on the Patient Health Questionnaire 9 (PHQ-9). Linear multivariable regression analysis was used to examine for factors associated with MDASI sum score and factors associated with symptoms’ interference on functions.ResultsThe response rate was 36%. More women (54%) than men (46%) responded. Mean age was 55 years (SD 14). The most frequent symptoms were fatigue (59.7%), drowsiness (56.2%) and pain (56.1%). Fatigue, pain and disturbed sleep had the highest mean scores. The presence of one or more comorbidities, increasing PHQ-9 score and lower level of education were associated with higher MDASI sum score (p < 0.001). The MDASI sum score and the PHQ-9 score were positively associated with all interference items (p < 0.001) except for walking (p = 0.22).ConclusionThis study provides the first Norwegian reference values for MDASI. The presence of one or more comorbidities, higher level of depressive symptoms and lower level of education were significantly associated with higher MDASI sum score. These covariates must be controlled for when using the reference values.

What Do Patients With Non-Small-Cell Lung Cancer Experience? Content Domain for the MD Anderson Symptom Inventory for Lung Cancer.

Symptom monitoring has demonstrated improved outcomes in patients with cancer, including quality of life, resource utilization, ability to continue treatment, and survival. The use of disease-specific patient-reported outcome (PRO) measures facilitates symptom monitoring. While the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC), a PRO measure of symptom burden in lung cancer, is psychometrically validated for use in patients with NSCLC, its content validity has not been verified through direct patient input. Our purpose is to describe the symptom experience of patients with NSCLC and to confirm that the MDASI-LC contains the key symptoms specific to NSCLC from the patient perspective. Patients with NSCLC described their symptom experience in single qualitative interviews. Content analysis was used to define the content domain for a PRO measure of NSCLC symptom burden. Participants (N = 40) had a mean age of 66.1 years (standard deviation, 10.9 years); 60.0% were male, 77.5% were White, and 56.4% had stage IV disease. Thirty-two symptoms were described, with 6 reported by ≥ 20% of participants. Symptom variations were noted by treatment modality but not by stage of disease. Patients with NSCLC commonly reported shortness of breath, cough, distress, fatigue, pain, and constipation. In patients receiving chemotherapy, treatment-related symptoms, including neuropathy and sore mouth, were commonly noted. The presence of these symptoms resulted in interference with daily activities, relationships, life plans, treatment adherence, and mood. The symptoms included in the MDASI-LC are important components of the content domain of an NSCLC symptom burden measure. The presence of these symptoms affect daily life and, therefore, is of clinical consequence.

The impact of tongue-deviating and tongue-depressing oral stents on long-term radiation-associated symptoms in oropharyngeal cancer survivors

ObjectivesTo evaluate whether the use of oral stents during intensity modulated radiation therapy (IMRT) for oropharyngeal cancer (OPC) is associated with long-term patient reported symptoms. Materials and methodsData was obtained from a prospective observational study of disease-free head and neck cancer survivors. Radiation-associated patient reported symptoms were assessed using the MD Anderson Symptom Inventory Head and Neck module (MDASI-HN). Scores of ≥5 (11-point Likert scale, 0-10) were considered moderate/severe. Stratification was performed regarding IMRT volume (uni- versus bilateral neck) and stent utilization, with non-parametric analyses between groups. Results462 OPC survivors formed the cohort (54% tonsil, 46% base of tongue primaries). A tongue-deviating stent was used in 17%, tongue-depressing stent in 46%, and no stent in 37%. Median prescribed dose to the high dose clinical target volume was 66.0 Gy. Median follow-up from RT to MDASI-HN assessment was 68 months. Twenty percent had received unilateral neck RT (all had tonsil primaries), in whom a significant improvement in the proportion of patients with moderate/severe taste impairment (2% vs. 15%, p = 0.047) and lack of appetite (0% vs. 9%, p = 0.019) was associated with the use of tongue-deviating stents compared to no oral stent. In those who had received bilateral neck RT, a significant improvement in the proportion of patients with moderate/severe difficulty swallowing/chewing was associated with use of a tongue-depressing stent (21% vs. 31% without oral stent, p = 0.013). ConclusionDisease-site specific select use of oral stents during IMRT was associated with reduced long-term patient reported symptoms in OPC survivors.

Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial

In the phase 3 LACC trial and a subsequent population-level review, minimally invasive radical hysterectomy was shown to be associated with worse disease-free survival and higher recurrence rates than was open radical hysterectomy in patients with early stage cervical cancer. Here, we report the results of a secondary endpoint, quality of life, of the LACC trial. The LACC trial was a randomised, open-label, phase 3, non-inferiority trial done in 33 centres worldwide. Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy. Participants were randomly assigned (1:1) to receive open or minimally invasive radical hysterectomy. Randomisation was done centrally using a computerised minimisation program, stratified by centre, disease stage according to FIGO guidelines, and age. Neither participants nor investigators were masked to treatment allocation. The primary endpoint of the LACC trial was disease-free survival at 4·5 years, and quality of life was a secondary endpoint. Eligible patients completed validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical [FACT-Cx], EuroQoL-5D [EQ-5D], and MD Anderson Symptom Inventory [MDASI]) before surgery and at 1 and 6 weeks and 3 and 6 months after surgery (FACT-Cx was also completed at additional timepoints up to 54 months after surgery). Differences in quality of life over time between treatment groups were assessed in the modified intention-to-treat population, which included all patients who had surgery and completed at least one baseline (pretreatment) and one follow-up (at any timepoint after surgery) questionnaire, using generalised estimating equations. The LACC trial is registered with ClinicalTrials.gov, NCT00614211. Between Jan 31, 2008, and June 22, 2017, 631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group. 496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group). Median follow-up was 3·0 years (IQR 1·7-4·5). At baseline, no differences in the mean FACT-Cx total score were identified between the open surgery (129·3 [SD 18·8]) and minimally invasive surgery groups (129·8 [19·8]). No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]). Since recurrence rates are higher and disease-free survival is lower for minimally invasive radical hysterectomy than for open surgery, and postoperative quality of life is similar between the treatment groups, gynaecological oncologists should recommend open radical hysterectomy for patients with early stage cervical cancer. MD Anderson Cancer Center and Medtronic.

Health-related quality of life (HRQoL) in patients with untreated higher-risk myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML) receiving glasdegib + azacitidine (AZA).

7527 Background: Glasdegib + AZA showed promising remission rates and overall survival in an analysis of BRIGHT MDS &amp; AML 1012 in patients (pts) with MDS, AML and CMML. Here we assess the impact of glasdegib + AZA on HRQoL in this ongoing Phase Ib study. Methods: Untreated pts with MDS, AML and CMML ineligible for intensive chemotherapy received glasdegib (100 mg QD) + AZA (75 mg/m2/D on D1–7 q28D). Pt-reported outcomes (PRO) that characterize HRQoL were measured using the MD Anderson Symptom Inventory (MDASI)-AML/MDS, Pt Global Impression of Severity (PGI-S), and Pt Global Impression of Change (PGIC) tools. PRO were assessed at baseline (BL; except the PGIC), D7 and D15 of cycle (Cyc) 1, D1 of each subsequent Cyc and at end of treatment. Data cutoff: Sept 11, 2019. Results: For the MDS (n=30, including 3 with CMML) and AML (n=30) cohorts, median (range) number of Cyc started was 5 (1–14) and 5 (1–15), respectively. HRQoL over time, as determined by MDASI-AML/MDS, is shown in the Table, with mean scores indicating low symptom burden over time. For the PGI-S, both cohorts showed similar trends in pt’s impression of current leukemia symptoms remaining constant over time (i.e. absent to mild). For the PGIC, pt’s impression of change of leukemia symptoms since starting study medication remained constant over time (i.e. no to minimal change) for the MDS cohort and showed improvement in the AML cohort (i.e. minimal change to much improved). Conclusions: Glasdegib + AZA is a promising first-line treatment option that does not negatively impact the HRQoL of pts with MDS, AML and CMML ineligible for intensive chemotherapy. Clinical trial information: NCT02367456 . [Table: see text]

Patterns of self-reported symptom distress among survivors of head and neck cancers.

e24073 Background: Head and neck cancer (HNC) survivors are known to experience debilitating disease-related symptoms and late effects. Patterns of symptoms among HNC survivors who have transitioned care to survivorship clinics could inform supportive care needs. We sought to assess patterns of self-reported symptoms in HNC survivors and to describe the level to which these symptoms interfered with their function. Methods: Symptoms and their interference were assessed using the MD Anderson Symptom Inventory Head and Neck (MDASI–HN). This validated patient-reported outcome (PRO) instrument consists of 28 questions grouped into 3 subscales; 1) 13 “core” or general symptoms, 2) 9 symptoms specific to HN and 3) 6 daily life interference items. Symptom severity is measured using a 0 to 10 scale, 0 = not present, 10 = as bad as can be imagined. Patients completed the MDASI-HN during a visit to the HNC Survivorship Clinic. Three databases a) MDASI HN, b) institutional, and c) the HNC survivorship provided data. We defined the primary outcome, symptom distress, as the combination of severity and interference rated ≥5 (0-10). Descriptive statistics were used to characterize the sample. Results: The sample included 1390 HNC survivors, majority were male (77%), Caucasian (83%) with a median age of 63 years (range 22- 95 years). The median years since diagnosis was five (range 2-37 years). The top disease sites were oropharynx (37%), oral cavity (35%), and larynx/hypopharynx (15%). The table summarizes the patterns of symptom distress. Conclusions: These results highlight the variation in symptom distress reported by long-term HNC survivors. Understanding the clinical implications of these patterns is important to ensure the well-being of those with head and neck cancers. [Table: see text]

Correlational study of different analgesic programs on patients' quality of life, mood, and dignity.

e24139 Background: To evaluate the effects between oral sustained release opioids and other analgesic drugs on the quality of life, mood and dignity of patients with cancer pain. Methods: Participants were cancer patients with cancer pain recruited from a tertiary cancer hospital in North China. Patients were divided into group A (oral sustained-release strong opioids,) and group B (non-sustained release strong opioid analgesia, as tramadol, oxycodone aminophenol, non-steroidal analgesia, etc.) to assess their quality of life, mood and dignity. Data were collected using the Patient Dignity Inventory, the MD Anderson Symptom Inventory–Chinese, the distress thermometer, the Hospital Anxiety and Depression Scale, and the 30-question core Quality of Life Questionnaire from the European Organisation for Research and Treatment of Cancer, and were analyzed using quantitative methods. Results: The study included 297 cancer pain patients, including 172 males and 125 females, with a median age of 58 years, most of whom were lung cancer (n = 88), esophageal/gastric cancer (n = 63) and colorectal cancer (n = 52). Patients in group A(n = 224) had better pain control (P &lt; 0.001), symptom burden (P &lt; 0.001), psychological distress (P &lt; 0.001), anxiety (P = 0.001) and Sense of dignity (P = 0.014) than those in group B(n = 73). In terms of quality of life assessment, patients in group A were more likely to suffer from nausea and vomiting (P = 0.003), and patients in group A were better than those in group B (Ps &lt; 0.05), except for the similarity of social cognitive function, decreased appetite, diarrhea and constipation. Conclusions: The analgesic program with oral sustained - release strong opioids for cancer pain patients not only has better analgesic effect than other programs, but also has obvious advantages in physical symptoms, psychological emotion, sense of dignity and overall quality of life.

Symptom burden and its functional impact in patients with "symptomatic" relapsed or refractory multiple myeloma.

Relapsed or refractory multiple myeloma (RRMM) is labeled "symptomatic" based on laboratory values, but not relevant to quantitative measure of patient's perspectives. This study aimed to describe symptom burden, health status, and quality of life in RRMM patients. The cross-sectional study included 184 MM patients (141 RRMM cases and 43 MM patients on follow-up without diagnosis/treatment of RRMM disease as controls), while 64 RRMM patients also provided longitudinal patient-reported outcomes (PROs) data. Symptomatic status was based on clinical measures of disease activity. PROs included the MD Anderson Symptom Inventory multiple myeloma module (MDASI-MM), single-item quality of life (SIQOL), and EuroQol-5D (EQ-5D). Wilcoxon rank test and effect size were used for comparisons. Regression models were used to describe symptom trajectory and to identify predictors of high symptom burden during 3months of RRMM therapy. Most patients were clinically identified as symptomatic (93%). RRMM patients tended to report more severe symptoms, with significantly lower QOL scores and more severe fatigue, poor appetite, and lower enjoyment of life compared with controls (all p < 0.05). In RRMM patients, lower hemoglobin and higher B-2 microglobulin levels significantly correlated with higher burdens of fatigue, pain, and muscle weakness and also with lower QOL and EQ-5D scores (all p < 0.05). During RRMM therapy, being female, with any comorbidity, ≥ 65years old, and ≥ 5years MM history, contributed to high symptoms burden and poor QOL status (each p < 0.05). MDASI-MM modules were sensitive to detect the RRMM-related symptoms burden, which correlated with objective clinical measures. RRMM patients reported a more compromised QOL.

Testing Symptom Severity Thresholds and Potential Alerts for Clinical Intervention in Patients With Cancer Undergoing Chemotherapy.

Symptom monitoring is attracting attention as a way to improve adherence to cancer therapy, reduce treatment-related toxicities, and possibly improve overall survival. How reporting thresholds affect symptom alert generation and clinical outcomes is poorly understood. We analyzed data from 38 US health care institutions collected for the prospective Eastern Cooperative Oncology Group-American College of Radiology Imaging Network E2Z02 Symptom Outcomes and Practice Patterns study. Participants were outpatients receiving chemotherapy for breast (n = 642), colorectal (n = 486), or lung cancer (n = 340) who rated symptom severity using the MD Anderson Symptom Inventory at 2 assessment points 1 month apart. Percentages of patients with pain, dyspnea, fatigue, or distress at different thresholds (score of 4-7 on a 0-10 scale) were compared. The percentage of patients whose performance status had worsened at follow-up was used to estimate risk for missing clinically important symptom data by using higher severity thresholds. At the guideline-recommended threshold of ≥ 4, suprathreshold rates were 60% for any of the 4 symptoms at the initial survey; performance status worsened at follow-up for 27% of all patients with any symptom rated ≥ 4 at the initiate survey. When the threshold was increased to ≥ 7, approximately half of patients (51%) with worsened performance status were not identified. The burden to clinicians from an alert threshold of ≥ 4 (per many current guidelines) would be substantial. However, setting higher alert thresholds may miss a large percentage of patients who need clinical intervention. These results may inform resource planning when implementing electronic symptom screening at an institutional or practice level.

Validation study of the Japanese version of MD Anderson Symptom Inventory for Brain Tumor module.

The MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) module is a widely used instrument for measuring symptom burden and interference of daily activities in brain tumor patients. This study aims to develop and validate its Japanese version (MDASI-BT-Japanese). Following forward and backward translation of the original MDASI-BT into Japanese, understandability and feasibility were assessed by cognitive debriefing. Subsequently, patients with brain tumors were asked to fill out MDASI-BT-Japanese and European Quality of Life-5 Dimensions (EQ-5D). Feasibility, reliability and validity of MDASI-BT-Japanese were assessed. Cognitive debriefing confirmed overall ease of completion and good understandability. The study population composed of 140 patients with brain tumors (most commonly gliomas). The mean symptom severity score and mean interference score were 1.9±1.7 and 2.8±2.7, respectively. The top items included distress and drowsiness for symptom severity and general activity and work for interference. The median time required was 4minutes (range, 0.5-30), and missing values were seen in 1%. Internal consistency was proven by excellent Cronbach's coefficient alpha (0.94 for symptom severity, 0.92 for interference). Test-retest reliability was assessed with acceptable intra-class correlation coefficient (mean, 0.76). Correlation efficient ranged between 0.7 and 0.9 for convergent validity. Known-group validity was confirmed by significantly different mean symptom severity score and mean interference score among patients with different performance status. As evidence of concurrent validity, MDASI-BT-Japanese correlated with EQ-5D in the hypothesized magnitude and direction. The newly developed MDASI-BT-Japanese has demonstrated feasibility, reliability and validity in evaluation of clinical benefit in Japanese-speaking brain tumor patients.

Patient-generated health data collection using a wearable activity tracker in cancer patients-a feasibility study.

Incorporation of patient-generated health data (PGHD) into clinical research requires an investigation of the validity of outcomes and feasibility of implementation. This single-arm pilot trial investigated the feasibility of using a commercially available activity tracking wearable device in cancer patients to assess adherence to the device and real-time PGHD collection in a clinical research setting. From July to November 2017, enrolled adult patients were asked to wear a wristband-style device. Brief Fatigue Inventory (BFI) and MD Anderson Symptom Inventory (MDASI) were assessed at baseline and on day 29. Furthermore, 29-day Pittsburgh Sleep Quality Index, global impression of the devices, and NCI CTCAE v4 were evaluated. Of 30 patients (mean age, 58.6years; male, 21 [70%]), 15 (50%) and 11 (36.7%) had gastrointestinal and lung cancer, respectively, and 27 (90%, 95% CI: 0.74-0.98) were well adhered (> 70%) to the device for 28days. The mean adherence was 84.9% (range: 41.7-95.2%). More frequent PGHD synchronization tended to show better device adherence, with moderate correlation (r = 0.62, 95% CI: 0.33-0.80, p < 000.1). The feasibility of using a wearable activity tracker was confirmed in cancer patients receiving chemotherapy for a month. For future implementation in clinical trials, there is a need for further comprehensive assessment of the validity and reliability of wearable activity trackers. This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN: UMIN000027575.

Prospective Association of Serum Opioid Levels and Clinical Outcomes in Patients With Cancer Pain Treated With Intrathecal Opioid Therapy.

Opioids remain the mainstay of cancer pain management but are associated with systemic toxicity. In refractory cancer pain, intrathecal therapy (ITT) is associated with improved pain control, reduced systemic side effects, and improved survival. It has been assumed that ITT decreases systemic serum opioid levels and their associated toxicity, but there are limited data to support this assumption. This study hypothesizes that serum opioid levels decrease with ITT. Secondary objectives include comparative measures of pain, bowel function, and other cancer-related symptoms. Fifty-one cancer patients undergoing ITT for cancer pain were recruited in a prospective observational study. Daily oral morphine equivalency (OME) dose, serum opioid levels, Brief Pain Inventory (BPI), MD Anderson Symptom Inventory (MDASI), and a constipation questionnaire were obtained at the time of implant, and 4 and 8 weeks postoperatively. Average baseline daily OME was 375 mg (median, 240; interquartile range, 150-405; range, 0-3160), mean serum morphine concentration was 53.7 ng/mL (n = 17), and mean oxycodone concentration was 73.7 ng/mL (n = 20). At 4 weeks, 87.5% of patients had discontinued non-IT opioids, and 53% had undetectable (<2 ng/mL) serum opioid concentrations. At 8 weeks, 92% remained off all non-IT opioids and 59% had undetectable serum opioid levels. IT morphine doses >4.2 mg/d were invariably associated with detectable serum levels; with doses <4.2 mg, morphine was undetectable in 80% of subjects. IT hydromorphone doses >6.8 mg/d were detectable in the serum. Using linear mixed model analyses, there were statistically significant decreases in the mean "worst pain," "average pain," and MD Anderson symptom severity and interference scores at 4 and 8 weeks. This change was independent of serum opioid levels; when analyzed separately, there was no difference in the pain scores of subjects with detectable serum opioid levels compared to those with undetectable levels at 4 and 8 weeks. Constipation ranked as "quite a bit" or "very much" decreased from 58.7% to 19.2% of subjects at week 4 (P < .001) and to 37.5% at 8 weeks (P = .23). A very low complication rate was observed. ITT for cancer pain was associated with a marked reduction in serum opioid concentrations, with the majority of patients having undetectable serum levels. Reducing serum opioid concentrations in cancer patients may have implications with respect to restoring bowel function, improving fatigue, and promoting the integrity of antitumor immune function and warrants further study.