The association of patient fatigue and outcomes in advanced cancer: An analysis of four SWOG treatment trials.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 140-140
Author(s):  
Julia Mo ◽  
Amy Darke ◽  
Katherine A Guthrie ◽  
Jeff A. Sloan ◽  
Joseph M. Unger ◽  
...  
Keyword(s):  
Adverse Events ◽  
Advanced Cancer ◽  
Regression Models ◽  
Cox Regression ◽  
P Value ◽  
Advanced Cancer Patients ◽  
Survey Question ◽  
Treatment Trials ◽  
Lower Baseline ◽  
Patient Reported

140 Background: Prior studies have suggested that patient-reported outcomes may be associated with cancer outcomes. We evaluated the association between clinically significant fatigue (CSF) and adverse events (AEs), quality of life (QOL), and overall survival (OS) during cancer treatment. Methods: Four phase II or III chemotherapy trials, two each in advanced non-small cell lung cancer (NSCLC) and advanced hormone-refractory prostate cancer (HRPC), were used to compare patients with or without baseline CSF. Baseline CSF was defined as a rating of 2 or greater on the FACT fatigue survey question or an EORTC QLQ-C30 fatigue symptom score of 50% or greater. Change in QOL from baseline, AE rates, and survival were compared according to baseline CSF with linear regression models, equality of proportions chi-squared tests, and Kaplan-Meier survival estimates and Cox regression models, respectively, separately for each trial. Results: Of 1,994 participants, 1,907 had complete baseline QOL survey data, with 52% reporting CSF at baseline. Baseline CSF was associated with an increased incidence of grade 3-5 constitutional (16.5% vs 9.4%, p = 0.002 and 13.9% vs 6.3%, p = 0.002) and neurological (11.7% vs 6.1%, p = 0.006 and 9.0% vs 3.9%, p = 0.01) AEs, respectively, in two studies of advanced HRPC. Overall, patients with baseline CSF had significantly lower baseline QOL across all four domains (p < 0.01). Across all four studies, baseline CSF was associated with higher mortality rates, with adjusted hazard ratios (95% confidence interval, p-value): 1.34 (1.14, 1.57, p < .001) and 1.30 (1.02, 1.66, p = 0.03) in NSCLC studies, 1.49 (0.95, 2.35, p = 0.09) and 1.53 (1.12, 2.11, p = 0.008) in HRPC studies. Conclusions: Oncology trial participants with baseline CSF had significantly lower baseline QOL, experienced more adverse events and had poorer survival compared to participants without CSF. We have confirmed previous work indicating that fatigue is an important baseline stratification factor that should be considered in all oncology treatment trials. Consistent with other research, our results indicate that fatigue should be measured and ameliorated wherever possible among advanced cancer patients.

scholarly journals Changes in fatigue, barriers, and predictors towards physical activity in advanced cancer patients over a period of 12 months—a comparative study

2021 ◽  
Author(s):  
J. Frikkel ◽  
M. Beckmann ◽  
N. De Lazzari ◽  
M. Götte ◽  
S. Kasper ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Physical Functioning ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Advanced Cancer Patients ◽  
Psychological Conditions ◽  
Patient Reported

Abstract Purpose Physical activity (PA) is recommended to improve advanced cancer patients’ (ACP) physical functioning, fatigue, and quality of life. Yet, little is known about ACPs’ attitude towards PA and its influence on fatigue and depressiveness over a longer period. This prospective, non-interventional cohort study examined ACPs’ fatigue, depression, motivation, and barriers towards PA before and after 12 months of treatment among ACP Methods Outpatients with incurable cancer receiving treatment at a German Comprehensive Cancer Center reporting moderate/severe weakness/tiredness during self-assessment via MIDOS II were enrolled. Fatigue (FACT-F), depression (PHQ-8), cancer-related parameters, self-assessed PA behavior, motivation for and barriers against PA were evaluated (T0). Follow-up data was acquired after 12 months (T1) using the same questionnaire. Results At follow-up, fatigue (p=0.017) and depressiveness (p=0.015) had increased in clinical relevant extent. Physically active ACP did not show significant progress of FACT-F (p=0.836) or PHQ-8 (p=0.799). Patient-reported barriers towards PA remained stable. Logistic regression analyses identified motivation as a positive predictor for PA at both time points (T0, β=2.152, p=0.017; T1, β =2.264, p=0.009). Clinically relevant depression was a negative predictor for PA at T0 and T1 (T0, β=−3.187, p=0.044; T1, β=−3.521, p=0.041). Conclusion Our findings emphasize the importance of psychological conditions in physical activity behavior of ACP. Since psychological conditions seem to worsen over time, early integration of treatment is necessary. By combining therapy approaches of cognitive behavioral therapy and exercise in interdisciplinary care programs, the two treatment options might reinforce each other and sustainably improve ACPs’ fatigue, physical functioning, and QoL. Trial registration German Register of Clinical Trials, DRKS00012514, registration date: 30.05.2017

scholarly journals LB743 Cutaneous immune-related adverse events are undertreated in advanced cancer patients

2021 ◽  
Vol 141 (9) ◽  
pp. B10
Author(s):  
M. Chang ◽  
T. Otto ◽  
T. Jacoby ◽  
L. Thompson ◽  
K. Reynolds ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Advanced Cancer Patients

scholarly journals Revisiting the association between skin toxicity and better response in advanced cancer patients treated with immune checkpoint inhibitors

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Nicholas Gulati ◽  
Douglas Donnelly ◽  
Yingzhi Qian ◽  
Una Moran ◽  
Paul Johannet ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Immune Checkpoint ◽  
Skin Toxicity ◽  
Institutional Review Board ◽  
Advanced Cancer Patients ◽  
Institutional Review ◽  
Immunosuppressive Medications ◽  
Multivariable Analyses

Abstract Background Immune checkpoint inhibition (ICI) improves survival outcomes for patients with several types of cancer including metastatic melanoma (MM), but serious immune-related adverse events requiring intervention with immunosuppressive medications occur in a subset of patients. Skin toxicity (ST) has been reported to be associated with better response to ICI. However, understudied factors, such as ST severity and potential survivor bias, may influence the strength of these observed associations. Methods To examine the potential confounding impact of such variables, we analyzed advanced cancer patients enrolled prospectively in a clinicopathological database with protocol-driven follow up and treated with ICI. We tested the associations between developing ST, stratified as no (n = 617), mild (n = 191), and severe (n = 63), and progression-free survival (PFS) and overall survival (OS) in univariable and multivariable analyses. We defined severe ST as a skin event that required treatment with systemic corticosteroids. To account for the possibility of longer survival associating with adverse events instead of the reverse, we treated ST as a time-dependent covariate in an adjusted model. Results Both mild and severe ST were significantly associated with improved PFS and OS (all P < 0.001). However, when adjusting for the time from treatment initiation to time of skin event, severe ST was not associated with PFS benefit both in univariable and multivariable analyses (P = 0.729 and P = 0.711, respectively). Receiving systemic steroids for ST did not lead to significant differences in PFS or OS compared to patients who did not receive systemic steroids. Conclusions Our data reveal the influence of time to event and its severity as covariates in analyzing the relationship between ST and ICI outcomes. These differences in outcomes cannot be solely explained by the use of immunosuppressive medications, and thus highlight the importance of host- and disease-intrinsic factors in determining ICI response and toxicity. Trial registration: The patient data used in this manuscript come from patients who were prospectively enrolled in two institutional review board-approved databases at NYU Langone Health (institutional review board #10362 and #S16-00122).

Predictive value of the patient reported outcome “living with cancer” instrument on overall survival in advanced cancer patients: A tool for guiding timing of palliative care consultations.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10025-10025
Author(s):  
Stuart L. Goldberg ◽  
Dhakshila Paramanathan ◽  
Srikesh Arunajadai ◽  
Victoria DeVincenzo ◽  
Ruth Pe Benito ◽  
...  
Keyword(s):  
Palliative Care ◽  
Overall Survival ◽  
Advanced Cancer ◽  
Cox Model ◽  
Performance Status ◽  
Patient Reported Outcome ◽  
Cancer Type ◽  
Advanced Cancer Patients ◽  
Patient Reported ◽  
Living With Cancer

10025 Background: The Living with Cancer (LWC) patient reported outcome (PRO) instrument evaluates distress from the point of view of the advanced cancer pt. The 7-item Likert survey measures 4 personhood domains (performance status, pain, burden [financial and family], depression) with scores ranging 0-112. In a pilot study of 433 cancer pts at a single center a score of >28 was associated with an increased likelihood of physician’s (blinded) opinion of need for end-of-life care discussions ( J Palliative Med 2016). Methods: The LWC instrument is a statistically validated PRO (ASCO Palliative Care Symposium 2016). LWC was administered to 1024 cancer pts receiving non-curative therapy at 7 centers (Regional Cancer Care Associates, NJ) from Sept 2015 - Oct 2016. LWC surveys were linked to the Cota database, which extracts and enriches data from EHRs. Date of survey was used as the start point in time-to-event analysis. Results: 290 (28%) pts expired during the study (median f/u 9.9 months). 267 (26%) pts exceeded the threshold score of 28 defined in the pilot set (28 was also independently this study’s optimal cut point). Pts with an LWC score >28 had inferior 6 and 12 mo overall survival (69% and 54%) vs pts with scores <29 (88% and 73%) (log rank p<0.001). A Cox model demonstrated that LWC score and cancer type were significant (LWC: p<0.001, cancer types (compared to B): GI p<0.001, GU: p=0.013, T: p<0.001, M: p=0.334) A one point score increase in LWC resulted in a 1.8% increase in expected hazard. Among solid tumor pts with LWC >28, 20% died within the next 3 mo and 35% died within the next 6 mo, indicating appropriate timing for hospice and palliative care consults, respectively. Conclusions: Pt responses to the LWC instrument predict survival among advanced cancer pts and may be useful in guiding timing of palliative care consultations. [Table: see text]

Digitally captured step counts for evaluating performance status in advanced cancer patients: A single cohort, prospective trial (Digi-STEPS).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6651-TPS6651
Author(s):  
Gillian Gresham ◽  
Andrew Eugene Hendifar ◽  
Jun Gong ◽  
Arash Asher ◽  
Christine S. Walsh ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Performance Status ◽  
Advanced Cancer Patients ◽  
Step Counts ◽  
Wide Range ◽  
Ecog Ps ◽  
Single Cohort

TPS6651 Background: Advanced cancer patients undergo dynamic changes in their functionality and physical activity over the course of their treatment. Monitoring patient function is important because it can inform treatment decisions and allow for timely and appropriate intervention. Current scales that assess patient function, such as the ECOG Performance Status (PS), are limited in their ability to capture the wide range in activity that cancer patients can experience on a daily basis outside of the clinic setting. Given recent technological advances in wearable activity monitors, we can collect real-time, objective information about a patient’s daily activity including steps, stairs, heart rate, sleep, and activity intensity. Thus, the primary objective of this study is to determine whether longitudinal changes in objectively-assessed activity are associated with change in physician-rated ECOG PS. Methods: This is a prospective, single cohort trial being conducted at Cedars-Sinai Medical Center. Stage 3/4 cancer patients who are English or Spanish-speaking, ambulatory (assistive walking devices are allowed) and expected to be seen for treatment or follow-up with their oncologist at least every 8 weeks are eligible for study. Consenting patients will be asked to wear a Fitbit Charge HR continuously for 8 weeks during the study period and for one week prior to the 6 month and 1 year follow-up visits. Primary outcomes are change in average daily step counts and ECOG PS at 8 weeks from baseline. Secondary outcomes include: 1) Change in NIH PROMIS patient-reported outcomes (physical function, pain, sleep, emotional distress, and fatigue), 2) Change in frailty status at 8 weeks, 3) Occurrence of adverse events, and 4) 6-month and 1-year survival outcomes. Baseline assessments include a physical exam, medical history, and frailty assessment. The attending oncologist will rate the patient's ECOG PS at baseline and at the end-of-study visit. Weekly NIH PROMIS questionnaires will be administered online over the 8-week study and again at 6 months and 1 year follow-up. The occurrence of serious cancer-related adverse events, chemotherapy-associated toxicities, and hospitalizations will be documented up to 12 weeks from baseline. Survival will be assessed at 6 months and 1 year. Accrual is ongoing with 20 patients currently enrolled of a target sample size of 60 patients. Clinical trial information: NCT03757182.

Patient-reported KPS and other measures as predictors of survival in patients with advanced cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19606-e19606
Author(s):  
Victor T Chang ◽  
Charles B. Scott ◽  
Melanie L. Gonzalez ◽  
Houling Yan ◽  
Jan Einhorn ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Cox Regression ◽  
Cox Model ◽  
Karnofsky Performance Status ◽  
Metastatic Cancer ◽  
Performance Status ◽  
Risk Of Death ◽  
Increased Risk ◽  
Patient Reported ◽  
Patient Responses

e19606 Background: Understanding determinants of survival remains a challenge in patients(pts) with advanced cancer. Prognostic factors of interest include pts rating of their own performance status, and patient responses from the EQ-5D. Methods: This prospective study was approved by the VA New Jersey HCS IRB. Pts with metastatic cancer whose cancer had already been treated with standard or experimental chemotherapy with KPS < 80%, or who did not wish to receive systemic chemotherapy, were recruited in a specified manner. At entry, Karnofsky performance status (KPS) was estimated, pts rated their own KPS, and answered a modified version of the EQ-5D. Cox regression survival analyses were performed. Results: Of 242 pts enrolled, 237 pts were analyzable. Median (M) age was 67 years (range 44-88), with 56% white, 41% black and 3% other; lung (26%) and prostate (18%) were the 2 most common primary sites and M KPS was 60% (range 30-100%). The majority (97%) of pts have died, with M survival of 95 days, range 4-2032 days. Higher KPS is associated with decreased risk of death (p<.0001). Both patient KPS (p<0.0319) and physician rated KPS were predictive of survival (p<0.004). Discrepancy between physician and pt KPS was noted, with upstaging by pts 48%, same for 27%, and downstaging in 25%, with no effect on survival. Physician KPS was a better predictor than pt KPS at each level. The EQ-5D pain item showed an increased risk of death with increasing pain (p<0.0001). The pain item was associated with KPS: pts with no pain had average KPS 75; moderate pain average KPS 63; extreme pain average KPS 48. The patient’s EQ-5D health rating was positively correlated with survival (p=0.0054), and with KPS (r=0.36). The other items in the EQ-5D did not predict survival. When all the factors (physician KPS, pt KPS, pain, health) were incorporated into a Cox model, only physician KPS was statistically significant (p=0.0033). Conclusions: Pts ratings of health and pain are significantly associated with KPS. Pts have a more positive outlook on their performance status. Physician KPS may be a better predictor because physicians have a wider frame of reference. Physician KPS can contribute to determination of hospice eligibility. Supported by VA HSRD IIR 2-103

Sign in / Sign up

Export Citation Format

Share Document