Therapy-related Symptoms Research Articles

Information and Training Needs Regarding Complementary and Alternative Medicine: A Cross-sectional Study of Cancer Care Providers in Germany.

Background: Among cancer care providers (CCPs), lack of knowledge constitutes an important barrier to the discussion of complementary and alternative medicine (CAM) use with patients. This study assessed CCPs’ needs and preferences regarding CAM information and training (I&T). Methods: An online survey was completed by 209 general practitioners, 437 medical specialists, 159 oncology nurses and medical assistants, and 244 psychologists and social workers engaged in cancer care. Latent class analysis (LCA) was used to identify subgroups of individuals with distinct preference patterns regarding I&T content. Results: CCPs prefer CAM I&T to be provided as lectures, information platforms on the internet, workshops, and e-mail newsletters. Concerning subject matters, many CCPs considered CAM therapy options for the treatment of a variety of cancer disease- and therapy-related symptoms to be very important (75%-72% of the sample); the same applies to an “overview of different CAM therapies” (74%). LCA identified 5 latent classes (LCs) of CCPs. All of them attached considerable importance to “medical indication,” “potential side effects,” and “tips for usage.” LCs differed, however, in terms of overall importance ratings, the perceived importance of “patients’ reasons” for using specific CAM therapies, “case examples,” and “scientific evidence.” Notably, the 5 LCs were clearly present in all 4 occupational groups. Conclusions: CAM I&T should provide CCPs with an overview of different CAM therapies and show how CAM might help in treating symptoms cancer patients frequently demonstrate (eg, fatigue). Moreover, I&T programs should be flexible and take into account that individual information needs vary even within the same occupational group.

Patient perceptions of a 1-h art-making experience during blood and marrow transplant treatment.

Patients with various forms of cancer receiving blood and marrow transplant (BMT) treatment at an outpatient clinic develop chemotherapy-related symptoms and an increased desire to use complementary and alternative medicine in order to address these symptoms. Art-making offers an inexpensive way to pass time and relieve symptoms during long hours in treatment. Twenty-one BMT patients painted a tile and participated in research. Researchers used semi-structured interviews to understand patients' experiences with art-making. Interviews were recorded, transcribed and coded independently by researchers who met to agree on themes. Ten themes emerged from the data including, meaningful activity (32.2%), expression (18.7%), passing time (13.2%), BMT process (12.1%), social outlet (8.1%), therapy-related symptoms (7.3%), negative aspects of painting (5.9%) and encouragement to paint (2.6%). The results of this study revealed that art-making experience can provide patients a meaningful activity during treatment and an outlet to express their feelings.

Recommendations for Follow-up Care for Gynecologic Cancer Survivors.

Gynecologic cancer survivors are expected to increase in number over the coming years. This is attributable in part to an increased incidence of gynecologic malignancies as the population ages. Earlier detection and improved treatments will lead to improved survival. Women who have completed their cancer treatment and are disease-free enter a phase of follow-up care. This care can be provided by gynecologic oncologists, general gynecologists, or primary care practitioners, depending on local practices and geographic area. The key components of follow-up include complete history and physical examination. There should be judicious use of appropriate testing to detect disease recurrence, assessment, and management of therapy-related symptoms and provision of psychosocial support. Well-woman care and ongoing screening for other malignancies remain an important component of care that should not be overlooked. This review provides recommendations regarding follow-up care for women with gynecologic malignancies. There is very little high-quality evidence available to guide such care.

Systemic cancer treatment in geriatric patients

Functional health issues and the ability to autonomously participate in social life play a more pronounced role for geriatric patients than the mere prolongation of life. Quality-adjusted life years reflect the relation of health and life span. Comorbidities and functional or cognitive impairment represent independent predictors for the overall survival of geriatric patients. This must be kept in mind when planning systemic cancer treatment. All forms of cancer-specific therapy should evaluate whether the patient can truly benefit taking into consideration geriatric aspects. This particularly demands a great deal of palliative chemotherapy. When curation is no longer possible, a cancer-specific treatment must not lead to therapy-related symptoms. Clear communication of the aims of therapy is indispensable. In addition to routine urooncologic data, other relevant information must be inquired in advance of cancer-specific treatment in order to identify those functionally or cognitively impaired patients who may not benefit from systemic cancer treatment. A precise indication with respect of age-dependent physiological changes and a clear prioritization of symptoms outline the approach for systemic cancer-specific treatment.

Treatment-related symptom severity and occurrences among oncology adults in Australia

Objective:Cancer treatments cause a range of distressing symptoms that can be well managed with pharmacological and nonpharmacological interventions. Treatment-related symptom screening and management by health care professionals is required to provide appropriate guidance to help patients to complete successfully their treatment regimen and achieve the best possible outcomes for patients. The aims of this study were to explore treatment-related symptom severity and occurrences among oncology adults in Australia and compare the results with the Chinese and Filipino studies.Methods:A cross-sectional descriptive survey of 84 adult patients over 18 years of age undergoing chemotherapy (CT) and/or radiotherapy (RT) in the Radiation Oncology and Medical Oncology Departments in one public teaching hospital in Canberra, Australia using the 25-item treatment-related symptom checklist (TRSC) was used in this study.Results:Six symptom clusters emerged from combining the 25 symptoms. Patients receiving CT experienced highest fatigue symptom occurrences (95.8%) and greater symptom severity (mean = 2.59) for fatigue symptom cluster for patients receiving a combination of CT-RT. Australians treatment-related symptom severity and occurrences were higher compared with the Filipino and Chinese adult cancer patients.Conclusions:Nurses in oncology settings are uniquely placed to assess patients’ therapy-related symptoms that will assist them to target education to cancer patients’ individual needs. For all types of cancer, it is important to assess treatment-related symptoms and to provide the most appropriate interventions in consideration to the patients’ preferences.

New trends in biomedical engineering and bioinformatics applied to biomedicine - special issue of IWBBIO 2014.

New trends in biomedical engineering and bioinformatics applied to biomedicine - special issue of IWBBIO 2014.

Symptom Burden of Busulfan + Melphalan Versus Melphalan Alone for Multiple Myeloma

Background: High-dose melphalan at 200 mg/m2 (Mel) is the standard for autologous hematopoietic stem cell transplantation (autoHSCT) for multiple myeloma. Two recent retrospective analyses suggested that a combination of busulfan and melphalan (Bu-Mel) may be associated with a longer progression-free survival (PFS). A secondary aim of a randomized phase III trial that compared the safety and efficacy of Bu-Mel vs Mel was to compare the symptom severity and symptom burden of the two regimens. Symptom burden is defined as the combined impact of disease- and therapy-related symptoms on patient functional ability.Methods: Patients were randomized to Bu-Mel or Mel. In the Bu-Mel arm, Bu 130 mg/m2 was infused daily for 4 days, either as a fixed dose or to target an average daily area under the curve (AUC) of 5000 μmol-min, followed by 2 daily doses of Mel at 70 mg/m2. A subset of patients completed the 20 symptom severity and 6 interference items of MD Anderson Symptom Inventory for Multiple Myeloma (MDASI-MM) prior to the start of the treatment regimen and weekly for 5 weeks post autoHSCT. Symptoms and interference are rated on 0-10 scales (0 = none or no interference, 10 = worst imaginable or complete interference). Differences in individual symptom severity and interference and symptom burden (the composite mean scores of the 5 most severe symptoms and the 6 interference items) between the two arms were assessed by t-tests and mixed modeling at each time point.Results: As previously reported, 92 patients (Bu-Mel: 49, Mel: 43) were enrolled between October 2011 and August 2013. Grade 3-4 non-hematologic toxicity was seen in 41 (84%) and 20 (47%) patients in Bu-Mel and Mel, respectively (p=0.0003). At day 90, 8 (18%) and 15 (35%) patients had achieved a CR (p=0.05), and 13 (27%) and 20 (47%) patients had achieved a CR + nCR (p=0.05) in Bu-Mel and Mel, respectively. One-year PFS was 93% and 82% (p=0.26), and 1-year OS was 100% and 100% in Bu-Mel and Mel arms, respectively. Fifty-six of the patients (Bu-Mel: 29, Mel: 27) completed at least one MDASI-MM assessment between October 2011 and July 2013. Median ages at autoHSCT were 55.5 and 55.1 years in Bu-Mel and Mel groups, respectively (p=0.862). At baseline, t-tests showed significantly higher mean severity for bone aches (3.00, standard deviation [SD] = 2.85 vs 1.40, SD = 1.94; p=0.022), drowsiness (2.96, SD = 3.12 vs 1.44, SD = 1.87; p=0.034), muscle weakness (2.98, SD = 2.68 vs 0.79, SD = 1.14; p=0.001, appetite (1.93, SD = 2.60 vs 0.44, SD = 1.19; p=0.009), and overall interference (3.46, SD = 2.89 vs 1.03, SD = 1.04; p<0.001) in the Bu-Mel arm than the Mel arm. Longitudinal analysis using mixed modeling showed a significant difference in the combined mean of the 5 most severe symptoms (fatigue, pain, drowsiness, disturbed sleep, and lack of appetite) at baseline (estimated difference [ED] = 1.16, p=0.016) between the arms and a significant increase in the top 5 symptoms for both arms between baseline and Weeks 1 (ED = 3.30, p<0.0001), 2 (ED = 2.06, p=0.002), and 3 (ED = 2.28, p=0.003). The Bu-Mel arm had a significantly lower mean severity of disturbed sleep at Week 4 (ED = -3.69, p=0.022) and significantly lower mean severity of lack of appetite at Week 2 (ED = -3.08, p=0.016) and 3 (ED = –3.15, p=0.033) than the Mel arm, but a significantly higher mean severity of sore mouth at Week 1 (ED = 2.35, p=0.018) and 2 (ED = 2.51, p=0.009).Conclusions: Patients with MM undergoing autoHSCT report a significant increase in symptom severity and interference during Weeks 1 to 3 post autoHSCT, with the greatest increase occurring during the first week. In addition, patients receiving Bu-Mel vs Mel report differences in individual symptom severity, with Mel patients having significantly more problems with disturbed sleep and lack of appetite and Bu-Mel patients reporting significantly more severe sore mouth and throat. The effect of the significant differences prior to the start of autoHSCT between these two groups, despite randomization, in the severity of the top 5 symptoms and interference on symptom report during autoHSCT is unclear and will be further explored. Additional differences in symptom severity may have gone undetected in this study because of initial differences. Systematic measurement of symptom burden during clinical trials can provide useful information for clinicians and patients in evaluating the full impact of different treatment regimens. DisclosuresOff Label Use: Busulfan and melphalan for conditioning regimen prior to autologous hematopoietic stem cell transplantation for multiple myeloma. Qazilbash:Otsuka Pharmaceutical Company: Research Funding.

Perspectives of postmenopausal breast cancer survivors on adjuvant endocrine therapy-related symptoms.

To conduct an investigation of women's experiences related to adjuvant endocrine therapy (AET) and managing AET-related symptoms. Qualitative, focus group design. Main campus of the University of Pittsburgh in Pennsylvania. 14 breast cancer survivors, aged 50 years or older, with AET-related symptoms. Semistructured discussion guides were used to elicit recollections of conversations with healthcare providers about starting AET, symptom experiences, symptom management, and suggestions for improving management. Audiotaped discussions were transcribed and analyzed to identify themes. Women reported that, initially, AET was not viewed as a choice, but rather as the necessary next step to save their lives. After starting AET, women experienced difficulties making sense of, communicating about, and managing unanticipated AET-related symptoms. Women who experienced persistently bothersome symptoms began weighing the pros and cons of AET to decide whether to continue treatment. Focus group findings suggest multiple opportunities to better prepare patients for AET and to improve assessment and management of AET-related symptoms. By exploring AET-related symptom experiences, nurses may be able to promote AET adherence in breast cancer survivors.

Contributors to nonadherence and nonpersistence with endocrine therapy in breast cancer survivors recruited from an online research registry.

Rates of adherence and persistence with endocrine therapy regimens (i.e., tamoxifen, aromatase inhibitors) by breast cancer survivors are suboptimal, with negative implications for prognosis. This study identified potential contributors to nonadherence and nonpersistence. From an online breast cancer research registry (Army of Women) including approximately 51,000 breast cancer survivors, we recruited 1,371 women who currently were taking endocrine therapy and 94 nonpersisters (i.e., diagnosed during the prior 5years and on endocrine therapy within the prior 12months, but no longer taking it). Participants completed an online questionnaire assessing demographic/medical characteristics, general and cancer-related psychosocial variables (i.e., depressive symptoms, anxiety, patient-oncologist relationship quality, cancer recurrence worry, general symptoms), and endocrine therapy-specific variables (i.e., endocrine therapy-related symptoms, perceived endocrine therapy necessity, long-term therapy use concern, endocrine therapy-related emotions). Two weeks later, current users were re-contacted to complete an endocrine therapy adherence measure. In a final regression model, patient-reported nonadherence among current users was significantly associated with lower financial status, a prior switch in endocrine therapies, a poorer relationship with the oncologist, and lower perceived need for and more negative emotions regarding endocrine therapy (adjusted R (2)=0.15, P<0.001). In a final logistic regression model, endocrine therapy nonpersisters were significantly more likely than current users to report depressive symptoms, as well as more negative emotions and lower positive emotions related to endocrine therapy (adjusted R (2)=0.10, P<0.001). In addition to demographic/medical variables, several potentially modifiable psychosocial characteristics are likely to contribute to endocrine therapy nonadherence and nonpersistence.

Confirmatory Factor Analysis of the Chinese Version of the Pediatric Quality-of-Life Inventory Cancer Module

Before the Chinese version of the Pediatric Quality-of-Life Inventory Cancer Module can be used to assess the multidimensional construct of quality of life among Hong Kong Chinese pediatric patients with cancer, its psychometric properties need to be further empirically tested. The objectives of the study were to establish the construct validity, including hypothesis testing and a confirmatory factor analysis of factor structure, of the Chinese version of the Pediatric Quality-of-Life Inventory Cancer Module. A cross-sectional study was used; 200 children hospitalized with cancer (9- to 16-year-olds) were recruited. Participants were asked to respond to the Chinese version of the Cancer Module, Therapy-Related Symptom Checklist, and Rosenberg's Self-esteem Scale. The results showed that there was a strong positive correlation between children's self-esteem and quality of life (r = 0.50) and a strong negative correlation between children's therapy-related symptoms and quality of life (r = -0.65). Confirmatory factor analysis indicated that there were 7 factors underlying the Chinese version of the Cancer Module. The study added further evidence of the construct validity of the Chinese version of the Cancer Module, patient version. The Cancer Module can be used to assess and evaluate psychological interventions directed toward promoting the quality of life of children hospitalized with cancer.

Quality of life following completion of treatment for adult acute lymphoblastic leukemia with a pediatric-based protocol

Using multiple validated self-report instruments, we evaluated the health-related quality of life (HRQoL) of 29 adult ALL patients a median of 28 months after completing a pediatric-based treatment regimen. Global health was similar to normative data, but leukemia survivors had lower cognitive and social function, and reported more financial difficulty. Fatigue and pain affected 83% and 53% of patients, respectively, and both showed significant inverse correlation with overall health and all functional scales. Vincristine-related peripheral neuropathy was reported by 43%. Although therapy-related symptoms were persistent, long-term ALL survivors have a global HRQoL similar to the general population.

Relationships Among Therapy-Related Symptoms, Depressive Symptoms, and Quality of Life in Chinese Children Hospitalized With Cancer

Recent advances in cancer screening and treatment have resulted in a decrease in mortality rates in children and adolescents. However, despite the improved prognosis, the course of cancer treatment continues to be a very stressful experience in the life of a child. The objectives of the study were to assess the occurrence and severity of treatment-related symptoms manifested by children and adolescents undergoing active cancer treatment and to examine the relationships between therapy-related symptoms, depressive symptoms, and quality of life of these pediatric patients. A cross-sectional study design was used, and 135 Hong Kong Chinese children (9- to 16-year-olds) who were admitted for treatment of cancer in a pediatric oncology unit were invited to participate in the study. Results indicated that children and adolescents receiving combined cancer treatment generally experienced greater symptom occurrence and severity. In addition, children reporting greater symptom occurrence and severity experienced higher levels of depression and a lower level of quality of life. The study revealed that therapy-related symptoms are a strong predictor of quality of life of children and adolescents hospitalized for cancer treatment. Cancer and its treatments significantly affect the psychosocial well-being and quality of life of children and adolescent hospitalized for cancer care. Therapy-related symptoms can be a useful indicator for screening those pediatric patients who are likely to exhibit psychosocial distress or are at high risk of depression. It is essential for nurses to be sensitive and knowledgeable about the therapy-related symptoms of cancer treatment and their effects on children and adolescents to promote the psychosocial well-being of these patients and enhance their quality of life.

Patients with cancer and family caregivers: management of symptoms caused by cancer or cancer therapy at home

People are diagnosed with cancer sooner nowadays thanks to increased awareness and improvements in cancer screenings. Patients are able to live longer due to cancer treatment regimens; however, they suffer the consequences of living with cancer and therapy-related symptoms. Symptom management is challenging for both patients and family caregivers. Therefore, family members must be integrated in the patient's care plan. For this review, a literature search was conducted to determine what types of interventions were available that involved family members of cancer patients with the management of cancer and therapy-related symptoms. The following interventions were found that were designed for the family caregivers or both the patient and caregiver to aide with symptom management: pain intervention program, massage therapy, telephone intervention, self-efficacy improvement, coping enhancement and a multidimensional intervention. A positive effect was noted in all the studies, but several had no significance in the patient intervention group but did in the caregiver intervention group. However, studies indicated decreased symptom intensity for various symptoms, decreased symptom distress for both the patient and caregiver, increased self-efficacy of the family member, and increased satisfaction with certain interventions. Further research should be conducted on both existing interventions to better determine their effect and on family symptom management of cancer patients as they need support from healthcare professionals as well.

Effect of Art Making on Cancer-Related Symptoms of Blood and Marrow Transplantation Recipients

To examine whether a one-hour art-making session during blood and marrow transplantation (BMT) treatment significantly affects therapy-related symptoms, state anxiety, and stress. A pre- and post-test crossover design. An urban outpatient cancer center in the midwestern United States. A convenience sample of 20 patients, aged 20-68 years (X = 38.5), receiving treatment at a BMT clinic. Participants completed a demographic questionnaire, the Therapy-Related Symptom Checklist, and the Spielberger State-Trait Anxiety Index, and provided salivary cortisol samples. After pretesting, individuals were assigned to either a wait list or intervention. Individuals in the wait-list group received the usual treatment before completing the post-test measures. Individuals in the intervention group participated in a one-hour art-making session, after which they completed post-test measures. Participants then crossed over to the other group. Art making, stress, state anxiety, and therapy-related symptoms. Therapy-related symptom concerns for the intervention group at post-test were significantly lower than at pretest; no change ocurred in the control group. The salivary cortisol levels were significantly lower at post-test in the intervention and control groups. No change occurred in the anxiety levels of participants in the intervention and control groups. The study hypothesis was partially supported. Art making decreased therapy-related symptoms (e.g., feeling sluggish, difficulty concentrating). Use of more physiologic indices to measure stress and replication on a larger sample are suggested. Individuals receiving BMT may benefit from participation in art-making interventions. Art making is easy to implement in a clinic setting and allows for positive interactions between nurses and patients.

Longitudinal relationship between inflammatory markers and patient-reported symptom severity during induction therapy for multiple myeloma.

9083 Background: Multiple myeloma (MM) patients undergoing induction therapy experience both disease- and therapy-related symptoms. We investigated the association between the trajectory of symptom severity and changes in levels of inflammatory markers. Methods: MM patients (N=62) rated symptoms via the M. D. Anderson Symptom Inventory (MDASI) twice a week during induction therapy. Patients contributed serum samples before the start of every chemotherapy cycle. A panel of pro- and anti-inflammatory cytokines and markers was evaluated by Luminex. Ordinal regression analyses were used to describe the relationship between cytokines and symptom outcomes across time. These analyses were adjusted for patient and clinical factors (age, sex, diabetes diagnosis, anemia, BMI, comorbidity, staging, ECOG PS, prior treatment status, tumor response, opioid use, and chemo regimen). Results: Bortezomib-based induction therapy was received by 89% of the sample. Fatigue was persistently the most severe symptom during induction therapy, followed by disturbed sleep, muscle weakness, pain, drowsiness, and bone aches. Numbness, which is representative of chemotherapy-induced peripheral neuropathy, significantly worsened from baseline (p=0.01). We observed significant longitudinal associations between sIL-1R1 and distress and sadness (both p=0.02); between sIL-6R and disturbed sleep (p=0.001), poor appetite (p=0.04), and sore mouth (p=0.006). IL-6 was significantly associated with pain, fatigue, nausea, and sore mouth (all p&lt;.05). A negative association between sTNF-RII and pain, sleep, distress, remembering, poor appetite, and nausea (all p&lt;0.05) was also observed. MCP-1 was positively associated with numbness (p=0.04); while MIP-1α was negatively associated with sleep, numbness, constipation, poor attention (all p&lt;0.01), and bone aches (p=0.0006). IL-10 was negatively associated with mood interference (p=0.04). Conclusions: Frequent assessment can document the longitudinal course of multiple symptoms during induction and provides opportunity to evaluate systemic inflammation as a potential source of symptom burden during induction therapy for MM.

The Longitudinal Relationship Between Inflammatory Markers and Patient-Reported Symptom Severity During Induction Therapy for Multiple Myeloma

Abstract 4920 Background:Patients with multiple myeloma (MM) undergoing induction therapy experience both disease- and therapy-related symptoms. This longitudinal study investigated the association between the trajectory of symptom severity and changes in levels of inflammatory markers. Methods:Patients with MM repeatedly rated symptoms via the M. D. Anderson Symptom Inventory (MDASI) during induction therapy. Patients contributed serum samples before start of every cycle of chemotherapy. A panel of cytokines, including interleukin (IL)-6, soluble IL-6 receptor (sIL-6R), soluble IL-1 receptor type 1 (sIL-1R1), soluble tumor necrosis factor receptor type 2 (sTNF-R2), monocyte chemotactic protein-1 (MCP-1), macrophage inflammatory protein-1 alpha (MIP-1A), and IL-10, was examined by Luminex method. Ordinal regression analyses were used to describe the interaction of cytokines and symptom outcomes across time, adjusted for patient and clinical factors of age, sex, diabetes diagnosis, anemia, body mass index, co-morbidities, tumor stage, Eastern Cooperative Oncology Group performance status (ECOG PS), prior treatment status, tumor response, opioid use, and chemotherapy regimen. Results:Sixty-two patients were enrolled on study; of these, 89% received bortezomib-based induction therapy. During induction, the most severe patient-reported symptoms were (in order of severity): fatigue, muscle weakness, disturbed sleep, pain, drowsiness, bone aches, and numbness. Fatigue was persistently the most severe symptom, while therapy-induced neuropathy (MDASI numbness item) increased significantly from baseline (P=.01). We observed significant longitudinal associations between sIL-1R1 and distress and sadness (both P=.02); between sIL-6R and disturbed sleep (P=.001), poor appetite (P=.04), and sore mouth (P=.006); between IL-6 and pain, fatigue, nausea, and sore mouth (all P<.05); and negative associations between sTNF-R2 and pain, sleep, distress, difficulty remembering, lack of appetite, and nausea (all P<.05). MCP-1 was positively associated with numbness (P=.04). MIP-1A was negatively associated with disturbed sleep, numbness, constipation, difficulty paying attention (all P<.01), and bone aches (P=.0006). IL-10 was negatively associated with mood interference (P=.04). Discussion:Frequent assessment documented the longitudinal course of multiple symptoms during the induction period, providing an opportunity to evaluate potential changes in inflammation as one source of symptom distress. Our preliminary study suggests a network of pro- and anti-inflammatory cytokines relevant to symptom expression during induction. The results warrant further basic and translational studies to confirm the role of inflammation in the development of symptoms during treatment. Such information may suggest methods of effective symptom management and identify potential biomarkers for patients at high risk of symptom burden during treatment for multiple myeloma. Disclosures:No relevant conflicts of interest to declare.

Prevalence and trajectory of disease- and treatment-related symptom burden in patients with multiple myeloma undergoing induction therapy.

e19627 Background: Patients with multiple myeloma (MM) undergoing induction therapy experience both disease- and therapy-related symptoms. This study selectively focused on the trajectory of pain, fatigue, numbness and bone aches from patient-reported outcome. Methods: MM patients (N=62) repeatedly rated symptoms via the M. D. Anderson Symptom Inventory (MDASI) (twice a week for 12 weeks, then weekly for 6 weeks). Ordinal regression analysis was used to describe symptom trajectories across time. Group-based trajectory modeling was used 1) to estimate the proportion of MM patients belonging to high, medium or low group by symptom severity; and 2) to examine the patterns of each group derived for each symptom. Results: During induction period, fatigue was persistently the most severe symptom, while therapy-induced neuropathy (MDASI numbness item) increased significantly from baseline (P=.0008). Group-based trajectory modeling resulted in 3 groups as the best model fit for 4 symptoms. The proportions of patients categorized as having high, medium or low symptom severity, respectively, were: for pain, 27%, 41% and 32%; for bone ache, 22%, 43% and 35%; for numbness, 22%, 48% and 30%; for fatigue, 28%, 58% and 14%. For pain, we observed a significant linear increased trend in the medium group (P<.001). For fatigue, bone ache and numbness, the medium and low groups exhibited only a slight change in slope, while the high symptom group showed a significant initial increase followed by a decrease trend (all quadratic trends, P<.001). Other than baseline performance status (P<.01), no clinical or patient factor was related to group membership. Conclusions: The majority of patients reported moderate or greater fatigue, pain and bone aches throughout the induction treatment, with little evidence of reduction, while numbness/tingling dramatically increased over time. We also observed that some MM patients persistently reported low symptom burden compared to others, despite similar disease burden and therapy. These results warrant further translational studies to identify biomarker(s) related to high symptom burden, so as to guide personalized patient care during standard induction therapy.

Including Patient Input In Patient-Reported Outcome Instrument Development: Examples From the MDASI-CML

AbstractAbstract 2573 Introduction:The United States Food and Drug Administration (FDA) recognizes patient-reported outcomes (PROs) as acceptable measures of treatment benefit and risk in medical product clinical trials. The FDA requires that patient input be included in the development and testing of PRO instruments. We have adopted a three-step process for the development of multi-symptom PROs that includes patient input in each step. This method is being used for the development of the M. D. Anderson Symptom Inventory (MDASI) for Philadelphia-chromosome-positive chronic myeloid leukemia (CML). The MDASI is a PRO measure of symptom burden, defined as the combined impact of all disease-related and therapy-related symptoms on one's ability to function as one did before the onset of disease or therapy, in patients with cancer. The core MDASI includes 13 symptom severity items and 6 interference items rated at their worst in the last 24 hours on a 0–10 scale, with 0 meaning no symptom or interference and 10 meaning as bad as can be imagined or complete interference. Patients and Methods:The first step in the process was qualitative interviews with 35 patients with CML about their symptom experiences. Symptoms were extracted by descriptive exploratory analysis from interview transcripts. Step 2 was grading of the relevance of the symptoms (0 to 4 scale) from Step 1 by an expert panel that included professional care providers as well as patients with CML and their family caregivers. Symptoms that received a mean relevance rating of ≥ 3 were added to the 13 symptom items and 6 interference items of the core MDASI for validation in Step 3. One hundred and sixty patients with CML are completing the experimental MDASI-CML, which will undergo psychometric validation and item reduction. The first 30 patients in Step 3 completed a cognitive debriefing interview about their experience of completing the MDASI-CML. Results:Patient characteristics are in Table 1. No personal information was collected on the expert panel members.Thirty-nine symptoms (13 core and 26 CML-specific) were extracted from the Step 1 qualitative interviews and rated by the expert panel. Four physicians, 5 nurses, 3 patients, and 3 family caregivers returned ratings. Six of the 26 CML-specific items had mean relevance ratings of ≥ 3. The experimental MDASI-CML includes the 13 core symptoms, 6 CML-specific symptoms, and 6 core interference items (Table 2).Table 2MDASI-CML ItemsCORE SYMPTOM ITEMSCML-SPECIFIC SYMPTOM ITEMSINTERFERENCE ITEMSPainDiarrheaGeneral activitiesFatigueSwellingMoodNauseaRash or skin changesWork (including around the house)Disturbed sleepMuscle soreness or crampingRelations with othersDistressEasy bruising or bleedingWalkingShortness of breathMalaise (not feeling well)Enjoyment of lifeTrouble rememberingLack of appetiteDrowsiness (sleepiness)Dry mouthSadnessVomitingNumbness or tinglingDuring the cognitive debriefing, over 80% of patients reported that the MDASI-CML items were not at all difficult to complete or understand, were completely comfortable to answer, and were not repetitive, and that the 0–10 scoring system for rating severity of symptoms and interference with daily activities was very easy to use. Nine patients listed 12 additional symptoms that should be included, but each symptom was only mentioned by 1 patient and had already been eliminated because of low relevance ratings by the expert panel. Conclusions:Inclusion of patient input at each step of PRO development ensures that the instrument measures what is important to patients and enhances content validity. It further ensures that the measure is easy to understand and complete. Psychometric validation of the MDASI-CML is proceeding. Disclosure:No relevant conflicts of interest to declare.

The relevance of the Spanish society for medical oncology (SEOM)’s clinical oncology guidelines

In this issue of Clinical and Translational Oncology, the Spanish Society for Medical Oncology (SEOM) publishes a group of the Clinical Guidelines that are the result of an ambitious educational programme. The main objective of this programme was to periodically create and actualise a set of clinical guidelines mainly focused on the medical treatment for the majority of solid tumours and cancerrelated or therapy-related symptoms. Clinical guidelines have increasingly become a common part of clinical practice during the past decade. They are defi ned by the Institute of Medicine as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specifi c clinical circumstances” [1]. Appropriate care involves assessing the balance between the sum of the benefi ts and the sum of the risks [2]. There are several factors that have stimulated increased interest in the development of clinical guidelines. Among the most relevant reasons are the exponential increment of medical publications, rising healthcare costs, the use of more expensive technologies, variations in service delivery among providers even within the same city or geographic region and the aspiration of healthcare physicians to offer the best possible care to their cancer patients. In this scenario, clinical guidelines are considered as a tool for giving the patients the best care based on the most consistent scientifi c evidence. Therapy based on guidelines has been shown to lead to better clinical outcomes compared with locally adapted therapeutic strategies and this would also lead to improved quality of care for the patients. Several objectives can be assigned to clinical guidelines. The main aim is usually to improve the quality of the medical care. However, other important objectives to consider are to facilitate the decision-making process for the treating physician, to promote effi cient use of the health system resources and to set the basis for performing an evaluation of the quality of medical care. Clinical guidelines’ highest quality probably lies in the methodology for constructing them based on the comprehensive review of the literature and the most convincing evidence-based medicine available. Nowadays, there are many clinical guidelines in oncology, produced by different institutions, governments, scientifi c societies and cooperative groups. So why has SEOM launched a new group of clinical guidelines? This initiative is the result of the intent to adapt the best evidence-based knowledge in medical oncology to the specifi c scenario of the Spanish health care system and to actively cooperate with the health authorities in the homogenisation of medical oncology care among the different communities in Spain. For this purpose, the board of SEOM created a working group in 2008 with the aim of coordinating this project. The clinical guidelines working group established the methodology and the basis for building each guideline. They defi ned some common characteristics for each guideline with special emphasis on being clear and concise but complete at the same time, and the use of tables or algorithms for facilitating comprehension. It should be highlighted that the recommendations made by the clinical guidelines should be in accordance with the approvals obtained by the different therapies in Spain at the moment of writing the guideline. Regarding the authors, a fi rst panel of experts was nominated in order to write the fi rst draft of the guideline. Then, a second panel of experts also nomiD. Isla Casado SEOM Clinical Guidelines Coordinator Servicio de Oncologia Medica Hospital Clinico Universitario Lozano Blesa Zaragoza, Spain

Immediate versus delayed self-reporting of symptoms and side effects during chemotherapy: Does timing matter?

PurposeThe aim of this study was to examine how patients recall symptoms at a delayed self-report. Accurate insight into toxicity symptoms during chemotherapy is essential so that nurses and doctors can assess therapeutic tolerance and adjust supportive care accordingly. MethodA non-experimental, longitudinal design was employed. Using the Therapy-Related Symptoms Checklist (TRSC), respondents (n = 142) reported their initial symptoms during the first 7 days of the chemotherapy cycle at two different times: (1) each day of the first seven days after the chemotherapy administration (immediate self-report), and (2) at their next hospital visit for chemotherapy (delayed self-report). We compared the number and severity of symptoms and side effects reported in the immediate and delayed self-reports. ResultsRespondents reported significantly fewer symptoms and fewer severe symptoms in the delayed self-report. For 22 out of 25 symptoms the delayed-reported grade was significantly lower than the immediate-reported maximum grade. Compared to the immediate-reported median grade, significant differences occurred in only 10 out of the 25 symptoms. In all cases, except fatigue, the delayed-reported grade was significantly higher than the immediate-reported median grade. ConclusionsThis study indicates that delayed self-report of chemotherapy side effects is not an appropriate measure of actual symptoms and side effects experienced by patients. Delayed self-report gives a weaker insight into actual symptom burden. Fatigue is at particular risk to be minimized at the delayed self-report. Therefore it is recommended to assess chemotherapy-related symptoms and side effects by means of immediate self-report.