scholarly journals Response Rates for Patient-Reported Outcomes Using Web-Based Versus Paper Questionnaires: Comparison of Two Invitational Methods in Older Colorectal Cancer Patients

2015 ◽  
Vol 17 (5) ◽  
pp. e111 ◽  
Author(s):  
Nicole JE Horevoorts ◽  
Pauline AJ Vissers ◽  
Floortje Mols ◽  
Melissa SY Thong ◽  
Lonneke V van de Poll-Franse
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
Response Rates ◽  
Web Based ◽  
Patient Reported ◽  
Colorectal Cancer Patients

Defining mild, moderate, and severe fatigue in cancer patients and survivors: E2Z02, a trial of the Eastern Cooperative Oncology Group.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9099-9099
Author(s):  
Xin Shelley Wang ◽  
Fengmin Zhao ◽  
Michael Fisch ◽  
Tito R. Mendoza ◽  
Ann M. O'Mara ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Survivors ◽  
Cancer Patients ◽  
Rating Scale ◽  
Performance Status ◽  
Fatigue Management ◽  
Severe Fatigue ◽  
Patient Reported ◽  
Fatigue Severity ◽  
Colorectal Cancer Patients

9099 Background: Although mild, moderate and severe categories have been used in clinical guidelines for fatigue management in cancer patients, the optimal cutpoints on a 0-10 scale for delineating these categories have not been replicated. Methods: A multicenter ECOG study (E2Z02) enrolled breast, lung, prostate, or colorectal cancer patients with any treatment status. Fatigue and symptom interference were measured on the 0-10 numerical rating scale of the M. D. Anderson Symptom Inventory (MDASI). The optimal boundaries for categorizing fatigue severity were determined by the largest F ratios from MANOVA (Serlin’s criteria, 1995). Logistic regression with robust standard errors was used to identify risk factors for moderate/severe fatigue for cancer survivors (defined as patients with no evidence of disease and receiving no cancer treatment). Results: The optimal cutpoints that identified 3 distinct levels of fatigue severity for the 2341 patients were: ratings of 1-3 as mild, 4-6 as moderate, and 7-10 as severe. Known-group validity for these cutpoints was established by significant differences of fatigue severity by ECOG performance status and patient-reported quality of life (all P<0.001). Using these cutpoints, 45% (983/2177) of patients undergoing active therapy had moderate/severe fatigue, with significant more mild fatigue in breast and colorectal cancer patients, while more severe fatigue in lung cancer patients (p<.001). Among cancer survivors, 29% (150/515) had moderate/severe fatigue (breast 31%, colorectal 27%, prostate 22%, lung 33%). Younger age (OR=0.97, 95% CI=0.95-0.99) and poor performance status (OR=4.21, 95% CI=2.36-7.51) were associated with more moderate/severe fatigue in cancer survivors. Survivor time was also associated with moderate/severe fatigue in breast and colorectal cancer survivors (>=5yrs vs. <5yrs: OR=0.23, P<0.01 for breast, OR=9.3, P=0.03 for colorectal). Conclusions: This multicenter study confirmed the standard cutpoints for fatigue severity used in NCCN fatigue management guidelines. It also provides a profile of moderate to severe fatigue prevalence for actively treated cancer patients and for cancer survivors.

Efficacy and feasibility of OncoSmart, a tool for remote detection and monitoring chemoterapy-related adverse events in metastatic colorectal cancer patients: a pilot retrospective study. (Preprint)

2020 ◽  
Author(s):  
Teresa Troiani ◽  
Stefania Napolitano ◽  
Marinella Terminiello ◽  
Pietro Paolo Vitiello ◽  
Fortunato Ciardiello ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
Wearable Device ◽  
Strong Impact ◽  
Care Providers ◽  
Symptom Intensity ◽  
Patient Reported

BACKGROUND In metastatic colorectal cancer (mCRC) treatment-related health symptoms may have a strong impact on patient’s quality of life (QoL). It has been shown that a considerable number of health care providers underestimates symptom intensity. In this context, the systematic collection of electronic patient-reported outcomes (ePROs) has been demonstrated to be a valid, reliable, feasible and precise approach to tabulating symptomatic toxicities and to detect symptoms missed by clinicians. OBJECTIVE We aimed to evaluate feasibility as well as patients’ acceptance of remote technology system to detect and monitoring chemotherapy-related adverse events in metastatic colorectal cancer outpatients. METHODS We enrolled 8 mCRC outpatients who received an oncological treatment. A wearable device (smart watch) allowing automatic vitals measurement (blood pressure, heart rate, oxygen saturation, respiratory rate, pedometer and sleeping monitor) has been provided to all patients. Moreover, two mobile applications have been developed: the first one to monitor vital measurements recorded by the wearable device, the second one to identify treatment-related toxicities and QoL parameters using a 30-items questionnaire (some taken from EORTCQLQ-C30 and others composed by the investigators). Clinicians filled the electronic health records (EHR) at each visit with symptoms reported by patients, physical examination and any treatment modifications. RESULTS a total of 8 patients were enrolled, 2 women (25%) and 6 men (75%); median age was 54 years (range 35-69). Compliance was 77%. Overall concordance between ePRO and symptoms detected by clinicians was 80%; in 15% of cases of electronic patient-reported outcomes (ePROs) included symptoms missed during the visit, while in 5% of cases clinicians reported toxicities not recorded by patients. Regarding the symptoms that led to treatment modifications and/or suspension, the concordance between ePROs and clinician’s evaluation during the visit was 100%. CONCLUSIONS In our pilot experience this type of ePROs is feasible and well tolerated, showing high compliance (80%), and allowing identification of toxicities missed by clinicians in 15% of cases. These data suggest that the integration of ePROs with EHR may improve the management of cancer patients. These strategies should be prioritized to optimize active oncological treatments and supportive care in order to improve patient’s QoL and reduce inappropriate hospitalization.

PD-1 blockade combined with COX inhibitor in patients with MSI-H/dMMR or high TMB, advanced or metastatic colorectal cancer (PCOX study).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 111-111
Author(s):  
Zehua Wu ◽  
Huabin Hu ◽  
Jianwei Zhang ◽  
Yue Cai ◽  
Xiaoyu Xie ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Cancer Patients ◽  
Survival Rates ◽  
Response Rates ◽  
T Cell Infiltration ◽  
Cox Inhibitor ◽  
Secondary Endpoints ◽  
One Year ◽  
Colorectal Cancer Patients

111 Background: MSI-H/dMMR and POLE mutation had been proven to be predictive of response to PD-1 blockade in metastatic colorectal cancer. However, reported response rates are often < 50%. Several preclinical studies reported COX inhibitor improve antigen presentation and T-cell infiltration in tumors. We investigated the efficacy of PD-1 blockade combined with COX inhibitor in colorectal cancer patients with MSI-H/dMMR or POLE mutation. Methods: PCOX was a prospective, single arm, phase II study. Patients with MSI-H/dMMR or POLE mutation advanced or metastatic colorectal cancer received PD-1 blockade (pembrolizumab 200mg, q3w; or BAT 1306 100mg, q3w; or nivolumab 3mg per kilogram, q2w) plus COX inhibitor (celebrex 400mg or aspirin 200mg, p.o. qd). The primary endpoint was ORR, secondary endpoints included PFS, OS and safety. Results: Totally 24 patients were enrolled. 14(58.3%) patients were female. Median age was 41.5-years-old. Among 24 patients, 5(20.8%) patients were chemotherapy-naïve, 11(45.8%) patients had first line chemotherapy failed and 8(33.3%) patients had at least second lines chemotherapy failed. 22 patients were MSI-H/dMMR and 2 patients were with POLE mutation. At a median follow-up of 14.5 months, the ORR was 83.3% (20/24), including 5 patients achieved CR (3 pCR and 2 cCR). 3 patients achieved SD and 1 patient was PD. Median PFS and OS was not yet reached. One-year PFS rates was 80.7% (95%CI, 63.5%-97.9%). One-year survival rates was 91.3% (95%CI, 79.7%-100%). The reported treatment-related adverse events were listed in table below. Conclusions: The combination of PD-1 blockade plus COX inhibitor was associated with higher response rates in advanced or metastatic colorectal cancer patients with MSI-H/dMMR or POLE mutation than anti-PD-1 alone as historical controls. Clinical trial information: NCT03638297. [Table: see text][Table: see text]

scholarly journals Patient Reported Outcome Measures (PROMs) for quality of care assessment: a pilot study protocol

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
A J Fauci ◽  
A Acampora ◽  
C Cadeddu ◽  
C Angioletti ◽  
A G De Belvis ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Performance Evaluation ◽  
Cancer Patients ◽  
Outcome Measures ◽  
Healthcare Providers ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Centered ◽  
Patient Reported ◽  
Colorectal Cancer Patients

Abstract Background There is emerging interest in integrating Patient Reported Outcome Measures (PROMs) into the assessment of care quality. This study protocol aims at testing the collection and use of PROMs for evaluating and comparing health outcomes by patients with colorectal cancer. This is part of a project of the Istituto Superiore di Sanità and Gruppo Italiano di Reti Oncologiche (GIRO) aimed at promoting Value-Based Healthcare (VBHC) for performance evaluation of oncological healthcare providers. Methods A multicentric prospective observational study will be conducted at the seven GIRO oncological hospitals. For each hospital, 40 colorectal cancer patients undergoing either surgery or surgery plus neoadjuvant therapy, will be recruited (20 colon; 20 rectum) over 12 months. The data will be collected twice (before and after surgery) or three times for patients undergoing neoadjuvant therapy, by using EORTC-C30, a generic module for cancer patients and EORTC-CR29, a specific module for colorectal cancer patients. Collected data will be analyzed descriptively and the scores of each hospital will be compared to the overall scores of all the centers. Additional medical information will be used to adjust for the center casemix. Feedback from health professionals and patients will be collected through structured questionnaires and focus groups. Results The results will be interpreted to assess and compare the health outcomes reported by the patients among the GIRO hospitals. Feedback from health professionals and patients will help identify barriers and facilitators of implementation of PROs collection. Conclusions PROMs have the potential to systematically incorporate the patient perspective into the health outcome measurements for performance evaluation and benchmarking, which is essential to delivering high-value patient-centered care. The PROMs collected in this study will be integrated in a set of process and outcome indicators previously defined within same project. Key messages Patient-Reported Outcome Measures (PROMs) have the potential to systematically incorporate the patient perspective, which is essential to delivering high-value patient-centered care. It is critical to integrate PROMs in performance evaluation and comparison among oncological healthcare providers for improving the quality of care in a Value-Based Healthcare perspective.

Colorectal cancer patient utilization of an internet based clinical trials matching system

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3624-3624
Author(s):  
C. Bui ◽  
M. Hampshire ◽  
C. Vachani ◽  
J. Metz
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Cancer Patient ◽  
Cancer Patients ◽  
Call Center ◽  
Colorectal Cancer Patient ◽  
The Internet ◽  
Specific Information ◽  
Web Based ◽  
Colorectal Cancer Patients

3624 Background: Colorectal cancer patients are increasingly looking to the Internet for information on clinical trials; however, services offering clinical trials recruitment have not been well defined. This study describes one of the first web-based cancer clinical trials matching resources and the demographics of the colorectal cancer patient user base. Methods: Oncolink ( http://www.oncolink.org ) is the web-based educational resource at the University of Pennsylvania and serves between 1.5–2 million pages per month to over 385,000 unique IP addresses. Oncolink, in conjunction with EmergingMed (New York, NY), launched one of the first clinical trials matching resources on the Internet. Patients input demographic and tumor-specific information via secure Internet-only registration or via the Internet with assistance from a call center, to match to trials. As of 12/2005, there were 112 total colorectal trials in the database. Results: Between 12/2000 and 9/2005 a total of 41,970 individual profiles were created, with 3289 (7.8%) by colorectal cancer patients. Other GI tumors accounted for 15% of profiles. Of the 3289 patients, 54% were male and 46% were female, and the median age was 55 (range 19–96). Most patients reported their disease as having spread to another organ (62%) or to lymph nodes (15.4%). Most patients were previously treated with surgery (81%), radiation (26%), chemotherapy (74%), and/or biological therapies (21%) (bevacizumab, cetuximab, interferon or interleukin). Patients who used the call center with the Internet were more likely to apply for enrollment in a clinical trial after review of the matches (77% vs. 10%, p<0.001). The median number of trial matches in the system was 7 per patient. Of the 3289 colorectal patients, 681 patients (21%) went on to apply for enrollment to trials based on their matches. Conclusions: This report demonstrates that a significant percentage of colorectal cancer patients are willing to use the Internet to match to clinical trials. Contact with a call center greatly increases the likelihood of application to trials. Internet based clinical trials resources should maintain options for personal communication to increase the likelihood of enrollment to clinical trials. No significant financial relationships to disclose.

Pretreatment levels of serum lactate dehydrogenase (LDH) and clinical outcome in metastatic colorectal cancer patients receiving first-line chemotherapy and bevacizumab.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 514-514 ◽  
Author(s):  
Elena Maccaroni ◽  
Riccardo Giampieri ◽  
Mario Scartozzi ◽  
Michela Del Prete ◽  
Luca Faloppi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Cancer Patients ◽  
Response Rates ◽  
Serum Lactate Dehydrogenase ◽  
Control Group ◽  
First Line ◽  
Potential Marker ◽  
Low Levels ◽  
Colorectal Cancer Patients

514 Background: No predictive marker for efficacy of a Bevacizumab-based therapy has been identified in metastatic colorectal cancer. Soluble LDH levels seem to be related to increased angiogenesis. The focus of this analysis is whether high levels of LDH can be related to higher benefit of bevacizumab-based therapy in this setting. Methods: Eligible patients were metastatic colorectal cancer patients treated in 1st line setting with a chemotherapy doublet and bevacizumab in the last year. A historical control group was also formed by collecting data of patients treated with only a chemotherapy doublet. Pre-treatment LDH serum levels were collected for all patients. Cut-off level for soluble LDH was determined via ROC curve. Primary end-point was difference in progression free survival between the two groups. Secondary end-points were overall survival and response rates. Results: 82 patients treated with first line containing bevacizumab were eligible for our analysis. 138 patients were identified as control group. The two groups were comparable for major clinical characteristics. LDH cut-off level was stated at 588 mg/dl. In the control group PFS of 4.2 and 8 months were observed for LDH high and low levels (p=0.0003,HR:0.2973,95%CI:0.0318 to 0.3543). OS were 19.6 and 34.9 months (p=0.0014,HR:0.2484,95%CI: 0.0188 to 0.3884). No significant differences were seen for response rates (with 20% vs 39% partial responses, p=0.1671). In the group of patients treated with Bevacizumab, PFS of 8.5 and 7.3 months were observed respectively for LDH high and low levels (p=0.2,HR:0.6360,95%CI:0.2528 to 1.4185). OS were 26.6 and 22 months (p=0.7,HR:0.8480,95%CI:0.2307 to 2.9563). Improved response rate for LDH high patients could be seen (58% vs 14% partial responses, p=0.0243). Conclusions: These data confirm the role of soluble LDH as marker of worse outcome for unselected patients and also suggest a role as potential marker of increased effectiveness of Bevacizumab based therapy.

Why focus on patient-reported outcome measures in older colorectal cancer patients?

2020 ◽  
Vol 46 (3) ◽  
pp. 394-401 ◽  
Author(s):  
James W. Doolin ◽  
Meredith Halpin ◽  
Jonathan L. Berry ◽  
Tammy Hshieh ◽  
Jessica A. Zerillo
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Colorectal Cancer Patients

scholarly journals Patient‐reported distress and age‐related stress biomarkers among colorectal cancer patients

2021 ◽  
Author(s):  
Hyrum S. Eddington ◽  
Megan McLeod ◽  
Amber W. Trickey ◽  
Nicolas Barreto ◽  
Katherine Maturen ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Stress Biomarkers ◽  
Age Related ◽  
Patient Reported ◽  
Related Stress ◽  
Colorectal Cancer Patients
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