Weathering the seasons of cancer survivorship: mind-body therapy use and reported reasons and outcomes by stages of cancer survivorship

Purpose

Mind-body therapies (MBTs), a subset of complementary and alternative medicine (CAM), are used by cancer survivors to manage symptoms related to their cancer experience. MBT use may differ by cancer survivorship stage (i.e., acute, short-term, long-term) because each stage presents varying intensities of medical activities, associated emotions, and treatment effects. We examined the relationship between MBT use and survivorship stage (acute <1 year; short-term 1 to 5 years; long-term >5 years since diagnosis) using the CAM supplement of the 2012 National Health Interview Survey. We also examined reported reasons for and outcomes of MBT use and frequency of MBT types.

Methods

The sample included cancer survivors (N?=?3076) and non-cancer controls (N?=?31,387). Logistic regression tested the relationship of MBT use and survivorship stage. Weighted percentages were calculated by survivorship stage for reported reasons and outcomes of use and frequency of MBT types.

Results

MBT use varied by cancer survivorship stage (p?=?0.02): acute (8.3 %), short-term (15.4 %), long-term (11.7 %) survivorship and non-cancer controls (13.2 %). In the adjusted model, short-term survivors had 35 % greater odds of MBT use than did controls (95 % CI 1.00, 1.83). Reasons for and outcomes of MBT use varied among the survivorship stages, with more acute survivors reporting medical-related reasons and more short-term survivors reporting to manage symptoms.

Conclusions

MBT may fulfill different symptom management needs at varying stages of survivorship. These findings can help inform supportive care services of survivors’ use of MBT for symptom burden at each stage and the allocation of these services.

     

The relationship between mindfulness,pain intensity,pain catastrophizing,depression, and quality of life among cancer survivors living with chronic neuropathic pain

Purpose

This study aims to examine if mindfulness is associated with pain catastrophizing, depression, disability, and health-related quality of life (HRQOL) in cancer survivors with chronic neuropathic pain (CNP).

Method

We conducted a cross-sectional survey with cancer survivors experiencing CNP. Participants (n?=?76) were men (24 %) and women (76 %) with an average age of 56.5 years (SD?=?9.4). Participants were at least 1 year post-treatment, with no evidence of cancer, and with symptoms of neuropathic pain for more than three months. Participants completed the Five Facets Mindfulness Questionnaire (FFMQ), along with measures of pain intensity, pain catastrophizing, pain interference, depression, and HRQOL.

Results

Mindfulness was negatively correlated with pain intensity, pain catastrophizing, pain interference, and depression, and it was positively correlated with mental health-related HRQOL. Regression analyses demonstrated that mindfulness was a negative predictor of pain intensity and depression and a positive predictor of mental HRQOL after controlling for pain catastrophizing, age, and gender. The two mindfulness facets that were most consistently associated with better outcomes were non-judging and acting with awareness. Mindfulness significantly moderated the relationships between pain intensity and pain catastrophizing and between pain intensity and pain interference.

Conclusion

It appears that mindfulness mitigates the impact of pain experiences in cancer survivors experiencing CNP post-treatment.

Implications for cancer survivors

This study suggests that mindfulness is associated with better adjustment to CNP. This provides the foundation to explore whether mindfulness-based interventions improve quality of life among cancer survivors living with CNP.

     

Thyroid cancer survivors’ perceptions of survivorship care follow-up options: a cross-sectional,mixed-methods survey

Purpose

This study investigated thyroid cancer (TC) survivors’ perceived satisfaction with and perceptions of survivorship care follow-up options.

Methods

Well-differentiated TC (WDTC) patients receiving follow-up care at an academic cancer centre completed a questionnaire assessing perceived satisfaction with follow-up care involving different clinicians and mediated by the Internet (email or videoconference) and their perceptions of these follow-up options. We examined associations between patient characteristics and perceived satisfaction with follow-up care options. Qualitative responses were analysed using conventional content analysis.

Results

Two hundred and two respondents completed the questionnaire (80 % response rate). The majority strongly agreed or agreed that they would be satisfied with specialist (surgeon, oncologist, or endocrinologist) follow-up (90.6 %) or a shared-care model that integrates specialists with primary care (67.5 %). One third (32 %) would be satisfied with video-based and 26 % with email-based specialist follow-up, 15 % with primary care alone. Longer time since diagnosis and health-related Internet use were associated with higher perceived satisfaction with Internet-based follow-up. Younger age was associated with higher perceived satisfaction with primary care follow-up. Qualitative responses (n?=?145) revealed that survivors need reassurance they are receiving adequate care, regardless of the model or medium. Enablers to primary care and Internet-based follow-up are discussed.

Conclusions

WDTC survivors want specialists involved in their follow-up. A specialist/primary care shared-care approach appears to be a suitable alternative to specialist-led follow-up for TC survivors. Internet-based visits could address some aspects of follow-up care for some WDTC survivors. Future work should examine patient and provider requirements for shared, multi-modal survivorship care.

     

Unmet needs mediate the relationship between symptoms and quality of life in breast cancer survivors

Purpose

This study aimed to compare the symptoms, unmet needs, and QoL reported by women at 6 months to <2 years and 2 to 5 years following surgery and adjuvant treatment for breast cancer. It also evaluated the relationships among symptoms, unmet needs, and QoL using structural equation modeling.

Methods

In this study, 113 and 137 survivors following breast cancer treatment 6 months to <2 years and 2 to 5 years, respectively, completed the Memorial Symptom Assessment Scale, the Supportive Care Needs Survey-34, and the Medical Outcomes Study 12-item Short Form Health Survey version 2.0 during their medical follow-up.

Results

The mean numbers of symptoms and unmet needs were 5.43 and 3.0, respectively, for survivors at <2 years, and 5.24 and 2.42, respectively, for survivors at 2 to 5 years following treatment. The most common reported symptoms were related primarily to physical domains. No significant differences were found between the two survivor groups on the MSAS scores. Survivors at <2 years reported significantly higher scores in Psychological and Health Care System/Information needs (p?<?0.01), and lower composite scores in physical and mental QoL (p?<?0.05) than those at 2 to 5 years post-treatment. Significant direct and indirect effects were found of symptom burden through unmet needs on survivors’ physical and mental QoL after adjustment for survival time, and the models showed a good fit.

Conclusions

Results suggest that breast cancer survivors continue to endure many symptoms independent of the survivorship period. The unmet needs mediate the relationship between symptom burden and survivors’ QoL.

     

Is long-term cancer survivors’ quality of life comparable to that of the general population? An italian study

Purpose

Since long-term survivorship is now a reality for an increasingly number of people with a history of cancer, understanding their quality of life (QoL) can inform health care policy as well as help supporting individual patients. This study was aimed to quantify QoL of this specific population in comparison with data provided for both the general population and cancer patients and to assess QoL association with several sociodemographic, clinical, and psychological variables.

Methods

Three hundred fourteen Italian long-term cancer survivors (people who have been free from cancer and cancer treatments for at least 5 years) completed a battery of questionnaires including the SF12 for QoL assessment.

Results

Both physical and mental functioning were higher than those among Italian cancer patients but lower than those of the Italian general population (p?<?.001). Poorer QoL (physical and mental functioning) was associated more often with psychological conditions (as anxiety and depression) than with sociodemographic and cancer-related variables.

Conclusions

These data support an ongoing specific interest in the QoL of long-term cancer survivors and suggest the need for further study of multidimensional functioning in this population.

     

The ENCOURAGE mortality risk score and analysis of long-term outcomes after VA-ECMO for acute myocardial infarction with cardiogenic shock

Purpose

This study was designed to identify factors associated with in-intensive care unit (ICU) death and develop a practical mortality risk score for venoarterial-extracorporeal membrane oxygenation (VA-ECMO)-treated acute myocardial infarction (AMI) patients. Long-term survivors’ health-related quality of life (HRQOL), anxiety, depression, and post-traumatic stress disorder (PTSD) frequencies were also assessed.

Methods

Data from 138 ECMO-treated AMI patients admitted to two French ICUs (2008–2013) were analyzed. ICU survivors contacted >6 months post-ICU discharge were assessed for HRQOL, psychological and PTSD status.

Results

Sixty-five patients (47 %) survived to ICU discharge. On the basis of multivariable logistic regression analyses, the ENCOURAGE score was constructed with seven pre-ECMO parameters: age >60, female sex, body mass index >25 kg/m², Glasgow coma score <6, creatinine >150 μmol/L, lactate (<2, 2–8, or >8 mmol/L), and prothrombin activity <50 %. Six months after ECMO, probabilities of survival were 80, 58, 25, 20, and 7 % for ENCOURAGE score classes 0–12, 13–18, 19–22, 23–27, and ≥28, respectively. The ENCOURAGE score ROC AUC [0.84 (95 % CI 0.77–0.91)] was significantly better than those of the SAVE, SAPS II, and SOFA scores. Survivors’ HRQOL evaluated after median follow-up of 32 months revealed satisfactory mental health but persistent physical and emotional-related difficulties, with 34 % (95 % CI 20–49 %) anxiety, 20 % (95 % CI 8–32 %) depression, and 5 % (95 % CI 0–12 %) PTSD symptoms reported.

Conclusions

The ENCOURAGE score might be a useful tool to predict mortality of severe cardiogenic shock AMI patients who received VA-ECMO. However, it now needs prospective validation on other populations of AMI patients.

     

The prognostic association of health-related quality of life scores with survival in breast cancer

Goals of work

There is extensive data showing that health-related quality of life (HRQOL) tools measuring the activities of daily life provide prognostic information in cancer. However, similar information on HRQOL tools measuring patient satisfaction with their life is sparse. The Ferrans and Powers quality of life index (QLI) is one such instrument. This study evaluated the association between HRQOL, as measured by the QLI, and survival in breast cancer.

Materials and methods

We examined a consecutive case series of 251 histologically confirmed breast cancer patients treated at Cancer Treatment Centers of America® between April 2001 and November 2004. QLI measures overall HRQOL and the HRQOL in four major subscales: health and physical functioning, social and economic, psychological and spiritual, and family. All scores range from 0 to 30 with higher scores indicating a better HRQOL. Study patients were dichotomized into two groups based on the median scores for all QLI subscales. Kaplan–Meier method was used to calculate survival. Log-rank test was used to study the equality of survival distributions. Multivariate Cox regression analyses were then performed to evaluate the joint prognostic significance of HRQOL and clinical factors.

Results

Patient satisfaction with health and physical subscale was significantly associated with survival (p?=?0.0006), with the median survival for low and high scores being 17.8 and 35.3 months, respectively. Similarly, patient satisfaction with overall HRQOL was significantly associated with survival (p?=?0.0006), with the median survival for low and high scores being 17.8 and 34.6 months, respectively. Patient satisfaction with health and physical subscale and overall HRQOL were found to be predictive of survival independent of the effects of stage at presentation.

Conclusions

This study suggests that baseline patient satisfaction with health and physical functioning and overall HRQOL, as measured by QLI, provides useful prognostic information in patients with breast cancer independent of stage at presentation.

     

Risk of chemotherapy-induced febrile neutropenia with early discontinuation of pegfilgrastim prophylaxis in US clinical practice

Purpose

Accumulating evidence suggests that not all cancer chemotherapy patients who receive first-cycle pegfilgrastim prophylaxis continue to receive it in subsequent cycles and that these patients may be subsequently at higher risk of febrile neutropenia (FN). Additional evidence from US clinical practice is warranted.

Methods

Data from two US private healthcare claims repositories were employed. The source population comprised adults who received “intermediate-risk” or “high-risk” chemotherapy regimens for solid cancers or non-Hodgkin’s lymphoma and first-cycle pegfilgrastim prophylaxis. From the source population, all patients who did not receive second-cycle pegfilgrastim prophylaxis ("comparison patients”) were matched (1:1) to those who received it (“pegfilgrastim patients”) based on cancer, regimen, and propensity score. Odds ratios (OR) for FN—broad and narrow definitions—during the second chemotherapy cycle were estimated for comparison patients versus pegfilgrastim patients using generalized estimating equations.

Results

A total of 2245 comparison patients (5.3 % of source population) were matched to pegfilgrastim patients; cohorts were well-balanced on baseline characteristics. Second-cycle FN incidence proportions for comparison and pegfilgrastim patients were 3.8 versus 2.2 % based on broad definition and 2.6 versus 0.8 % based on narrow definition; corresponding OR were 1.7 (95 % CI 1.2–2.5, p?=?0.002) and 3.5 (95 % CI 2.0–6.0, p?<?0.001). Results were similar within cancer/regimen-subgroups and were robust when using alternative methods for confounding adjustment.

Conclusions

In this retrospective evaluation of cancer chemotherapy patients who received first-cycle pegfilgrastim prophylaxis in US clinical practice, a clinically relevant minority did not receive second-cycle prophylaxis. Second-cycle FN odds among this subset were significantly higher than they were among those who continued prophylaxis.

     

Evaluating the efficacy of a self-guided Web-based CBT intervention for reducing cancer-distress: a randomised controlled trial

Purpose

This study evaluated the efficacy of a self-guided Web-based cognitive behaviour therapy (CBT) intervention compared to an attention control in improving cancer-related distress, health-related quality of life (HRQOL), and maladaptive coping, among people recently diagnosed with cancer.

Methods

Sixty individuals with cancer diagnosed in the previous 6 months and receiving treatment with curative intent were randomised to receive either the 6-week intervention Cancer Coping Online (CCO: n = 30) or the 6-week Web-based attention control (n = 30). Outcome measures, including cancer distress (the Posttraumatic Stress Scale—Self-Report), general distress (Depression Anxiety Stress Scale), quality of life (EORTC QLQ-C30), and coping (mini-MAC), were administered at baseline, immediately post-intervention, and at 3 and 6 months post-intervention.

Results

Significant main effects for time were found for cancer distress, global QOL, physical function, role function, social function, and anxious preoccupation. Post hoc between-group comparisons showed CCO participants had statistically significantly higher physical functioning compared to controls at 3 months of follow-up (d = ?0.52, p = 0.02). Furthermore, compared to controls, post hoc comparisons found moderate between-group effect sizes favouring CCO post-intervention for cancer distress (d = 0.43) and anxious preoccupation (d = 0.38), and at 6 months of follow-up for global QOL (d = ?0.43).

Conclusions

These results provide preliminary support for the potential efficacy of a self-guided Web-based CBT programme in improving aspects of HRQOL, cancer-related distress, and anxious preoccupation after cancer diagnosis. This paper provides justification for, and will help inform the development of, subsequent larger multi-site studies.

     

Breast cancer survivors suffer from persistent postmastectomy pain syndrome and posttraumatic stress disorder (ORTHUS study): a study of the palliative care working committee of the Turkish Oncology Group (TOG)

Purpose

Persistent postmastectomy pain syndrome (PMPS) is one of the most important disturbing symptoms. Posttraumatic stress disorder (PTSD) is an anxiety disorder which is characterized by reactions to reminders of the trauma that has been experienced. The purpose of this study is to evaluate the predictors of PMPS and PTSD in Turkish breast cancer survivors and the correlation between PMPS and PTSD.

Method

The study is designed as a multicenter survey study. Breast cancer patients in remission were evaluated. Patients were evaluated with structured questionnaires to assess the PMPS and clinical parameters associated with it. The Turkish version of the posttraumatic stress disorder checklist—civilian version (PCL-C) was used.

Results

Between February 2015 and October 2015, 614 breast cancer survivors in outpatient clinics were evaluated. The incidence of PMPS documented is 45.1 %. In the multivariate analysis low income, presence of PTSD and <46 months after surgery were associated with increased risk of PMPS. PTSD was documented in 75 %, and the mean PCL-C score was 32.4?±?11.1. PMPS and being married at the time of the evaluation were linked with PTSD.

Conclusions

It is the first data about the association between PMPS and PTSD. The clinicians should be aware of PMPS and PTSD in breast cancer survivors.

     

Benefits of 24 versus 12 weeks of exercise and wellness programming for women undergoing treatment for breast cancer

Purpose

Community exercise programs can help maintain or improve health in cancer survivors. However, the most effective and feasible duration of a community exercise program for breast cancer survivors who are undergoing treatment is not known. This pre-post-design study evaluated the effects of the “Breast cancer patients Engaging in Activity while Undergoing Treatment” (BEAUTY) program on physical and psychosocial outcomes after 12 and 24 weeks.

Methods

BEAUTY is an ongoing community exercise and wellness program for breast cancer patients who are undergoing, or within 3 months of completing chemotherapy and radiation. Participants completed assessments at baseline, 12 weeks, and 24 weeks to measure body composition, hand-grip dynamometry, aerobic fitness, and flexibility. Self-report questionnaires assessed fatigue (FACIT-fatigue), cognitive function (FACT-cog), quality of life (QOL) (FACT-B), and depressive symptoms (CES-D). Main analyses were repeated measures general linear model for all outcomes.

Results

Assessments at all three time points were completed by N?=?63 participants. At 24 weeks, waist to hip ratio (p?=?.019), duration of the submaximal treadmill test (p?=?.013), and estimated VO_2max (p?=?.018) improved compared to baseline. Fatigue improved at 24 compared to 12 weeks (p?=?.002). FACT-B scores improved at 24 weeks when compared to both baseline (p?=?.002) and 12 weeks (p?=?.001). Depressive symptoms improved compared to baseline (p?=?.05) and 12 weeks (p?=?.009).

Conclusions

Additional benefits were seen after 24 versus 12 weeks, suggesting that a longer duration exercise program during, or shortly after completing treatments for breast cancer, may be necessary to see improvements in fitness and psychosocial outcomes. Findings can be applied to community exercise and rehabilitation programs for breast cancer survivors.

     

The association of psychosocial screening and service provision in pediatric oncology: the Psychosocial Assessment Tool (PAT2.0) into clinical practice

Purpose

Distress screening in oncology has been widely endorsed in recent years. However, current knowledge of the impact of screening on delivery of clinical psychosocial services is limited. This study investigated the association between screening and psychosocial services in the early period following diagnosis of childhood cancer.

Methods

The Psychosocial Assessment Tool (PAT2.0) was administered by clinical social workers in two pediatric oncology centers shortly following diagnosis. Psychosocial service activity in the first 8 weeks post diagnosis was collected via social work surveys and extraction of information from hospital databases.

Results

PAT2.0 and psychosocial service data were obtained for 89 families with a child newly diagnosed with cancer. Distribution of PAT2.0 risk categories was consistent with previous studies (57.3 % universal, 38.2 % targeted, 4.5 % clinical). Significant, weak to moderate correlations between PAT2.0 and social workers’ estimates of psychosocial risk were observed. No significant differences in the amount of psychosocial services provided to families with “universal” versus “elevated” (i.e., targeted or clinical) risk were found. Number of days in hospital was strongly and positively associated with the amount of psychosocial services families received in the first 8 weeks following diagnosis.

Conclusions

Psychosocial risk, as measured by the PAT2.0, and allocation of psychosocial services were not significantly associated in the early period following diagnosis. Further investigation is required to understand if differences emerge over time when psychosocial screening is implemented clinically. Development of clinical pathways of care needs to account for patients who may predominantly be treated in the outpatient setting.

     

Life Impact and Treatment Preferences of Individuals with Asthma and Chronic Obstructive Pulmonary Disease: Results from Qualitative Interviews and Focus Groups

Introduction

The impact of asthma and chronic obstructive pulmonary disease (COPD) on individuals’ lives may be substantial, yet clinical practice often focuses only on symptoms. We aimed to better understand the perspective of asthma or COPD patients and to identify condition-related burden, life impact, priorities, unmet needs, and treatment goals.

Methods

Individuals aged at least 18 years with asthma or COPD were identified by a recruitment panel via clinical referrals, support groups, consumer networks, and a patient database. Interviews were carried out individually (by telephone) or in focus groups (with no more than five participants per group). A semi-structured interview guide was used with prespecified topics, informed by a literature review, that were considered impactful in asthma or COPD (symptoms and daily-life impact, satisfaction with current treatment, important aspects of treatment, adherence, and ideal treatment).

Results

Overall, 72 people participated in focus groups/individual interviews (asthma n = 18/n = 21; COPD n = 15/n = 18). “Shortness of breath” was the most frequently reported symptom; however, participants discussed the life impact of their condition more than symptoms alone. Reported physical impacts included the inability to sleep and socialize, while emotional impacts included “embarrassment, stigma, and/or self-consciousness”, “fear and/or panic”, and “sadness, anxiety, and/or depression”. Coping mechanisms for normal activities included continuing at reduced pace and avoidance. Treatment preferences centered on resolving impacts; improved sleep, “speed of action”, and “length of relief” were the most frequently reported ideal treatment factors.

Conclusion

Patients with asthma or COPD experience substantial quality of life limitations and tend to focus on these in their expressions of concern, rather than symptoms per se. Life impacts of these conditions may have implications beyond those commonly appreciated in routine practice; these considerations will be applied to a future discrete choice experiment survey.

Funding

GSK funded study (H0-15-15502/204821).

     

Demographic,clinical, psychosocial,and environmental correlates of objectively assessed physical activity among breast cancer survivors

Purpose

The aim of this study was to identify demographic, clinical, psychosocial, and environmental correlates of objectively assessed physical activity among breast cancer survivors.

Methods

Baseline data were utilized from 574 female breast cancer survivors who participated in three different intervention studies: Resistance and Endurance exercise After ChemoTherapy (REACT), Exercise and Nutrition Routine Improving Cancer Health (ENRICH), and Move More for Life (MM4L). Participants were eligible if they were aged ≥18 years and had completed primary cancer treatment. Physical activity was objectively assessed by accelerometers or pedometers. Participants completed self-reported questionnaires on demographic, psychosocial, and environmental factors. Information regarding clinical factors was obtained from medical records or patient self-report. Multivariable linear regression analyses were applied on the pooled dataset to identify factors that were significantly correlated with physical activity. In addition, the explained variance of the model was calculated.

Results

The multivariable regression model revealed that older age, (β = ?0.01, 95 %CI = ?0.02; ?0.003), higher body mass index (β = ?0.05, 95 %CI = ?0.06; ?0.03), lower self-efficacy (β = 0.2, 95 %CI = 0.08; 0.2), and less social support (β = 0.1, 95 %CI = 0.05; 0.2) were significantly correlated with lower physical activity. This model explained 15 % of the variance in physical activity.

Conclusion

Age, body mass index, self-efficacy, and social support were significantly correlated with objectively assessed physical activity in breast cancer survivors. It may therefore be recommended that physical activity intervention studies in these women target those who are older, and have a higher body mass index, and should operationalize behavior change strategies designed to enhance self-efficacy and social support.

Trial registration

The REACT study is registered at the Netherlands Trial Register [NTR2153]. The ENRICH study is registered at Australian New Zealand Clinical Trials Register [ANZCTRN12609001086257]. And the MM4L study is registered at Australian New Zealand Clinical Trials Register [ACTRN12611001061921]

     

Predictors of quality of life in head and neck cancer survivors up to 5 years after end of treatment: a cross-sectional survey

Purpose

This study aimed to assess quality of life (QoL) in head and neck cancer (HNC) survivors and determine factors predictive of poor QoL in the first 5 years after the end of treatment.

Methods

A cross-sectional survey, including the Quality of Life in Adult Cancer Survivors (QLACS) measure, was sent to HNC survivors in three Scottish health regions, with responses linked to routinely collected clinical data. Independent sample t tests, ANOVAs, Pearson correlations and multiple hierarchical regressions were used to explore associations between and to determine the contribution made by demographic, lifestyle and clinical factors to predicting ‘generic’ and ‘cancer-specific’ quality of life.

Results

Two hundred eighty patients (65 %) returned questionnaires. After adjustment, multivariate analysis showed that younger age, lower socio-economic status, unemployment and self-reported comorbidity independently contributed to poorer generic and cancer-specific quality of life. In addition to these factors, having had a feeding tube or a diagnosis of oral cavity cancer were independently predictive of poorer cancer-specific quality of life.

Conclusions

Socio-economic factors and comorbidity are important predictors of QoL in HNC survivors. These factors and the detrimental long-term effects of feeding tubes need further attention in research and practice.

     

An Observational Study of the Effect of Levodopa–Carbidopa Intestinal Gel on Activities of Daily Living and Quality of Life in Advanced Parkinson’s Disease Patients

Introduction

Continuous delivery of levodopa–carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson’s disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations (“on” and “off” states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients.

Methods

This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2–4 h of “off” time or 2 h of dyskinesia daily. Patients received LCIG via PEG-J for 16 h continuously. Effectiveness was assessed using Unified PD Rating Scale parts II and III, the Non-Motor Symptom Scale, and the PD Questionnaire-8.

Results

The mean (SD) treatment duration was 275 (157) days. Patients experienced significant improvement from baseline in activities of daily living at final visit (p < 0.05) as well as at months 3 and 6 (p < 0.0001). Patients also experienced significant improvements from baseline in quality of life and non-motor symptoms at all time points (p < 0.001 for all). Specifically, patients manifested significant improvements in mean change from baseline at every study visit in five of nine non-motor symptom score domains: sleep/fatigue, mood/cognition, gastrointestinal tract, urinary, and miscellaneous. One-third of patients (32.8%) experienced an adverse event; 21.9% experienced a serious adverse event; 11.1% discontinued because of an adverse event.

Conclusion

This study demonstrated significant and clinically relevant improvements in measures of activities of daily living, quality of life, and a specific subset of non-motor symptoms after treatment with LCIG.

Funding

AbbVie Inc.