scholarly journals Phase III Randomized Controlled Trial of eRAPID: eHealth Intervention During Chemotherapy

2021 ◽  
pp. JCO.20.02015
Author(s):  
Kate Absolom ◽  
Lorraine Warrington ◽  
Eleanor Hudson ◽  
Jenny Hewison ◽  
Carolyn Morris ◽  
...  

PURPOSE Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online eHealth system for patients to self-report symptoms during cancer treatment. It provides automated severity-dependent patient advice guiding self-management or medical contact and displays the reports in electronic patient records. This trial evaluated the impact of eRAPID on symptom control, healthcare use, patient self-efficacy, and quality of life (QOL) in a patient population treated predominantly with curative intent. METHODS Patients with colorectal, breast, or gynecological cancers commencing chemotherapy were randomly assigned to usual care (UC) or the addition of eRAPID (weekly online symptom reporting for 18 weeks). Primary outcome was symptom control (Functional Assessment of Cancer Therapy-General, Physical Well-Being subscale [FACT-PWB]) assessed at 6, 12, and 18 weeks. Secondary outcomes were processes of care (admissions or chemotherapy delivery), patient self-efficacy, and global quality of life (Functional Assessment of Cancer Therapy–General, EQ5D-VAS, and EORTC QLQ-C30 summary score). Multivariable mixed-effects repeated-measures models were used for analyses. Trial registration: ISRCTN88520246. RESULTS Participants were 508 consenting patients (73.6% of 690 eligible) and 55 health professionals. eRAPID compared to UC showed improved physical well-being at 6 ( P = .028) and 12 ( P = .039) weeks and no difference at 18 weeks (primary end point) ( P = .69). Fewer eRAPID patients (47%) had clinically meaningful physical well-being deterioration than UC (56%) at 12 weeks. Subgroup analysis found benefit in the nonmetastatic group at 6 weeks ( P = .0426), but not in metastatic disease. There were no differences for admissions or chemotherapy delivery. At 18 weeks, patients using eRAPID reported better self-efficacy ( P = .007) and better health on EQ5D-VAS ( P = .009). Average patient compliance with weekly symptom reporting was 64.7%. Patient adherence was associated with clinician's data use and improved FACT-PWB at 12 weeks. CONCLUSION Real-time monitoring with electronic patient-reported outcomes improved physical well-being (6 and 12 weeks) and self-efficacy (18 weeks) in a patient population predominantly treated with curative intent, without increasing hospital workload.

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18140-18140
Author(s):  
V. Alberola ◽  
O. Gallego ◽  
G. López-Vivanco ◽  
C. Mesía ◽  
J. Oramas ◽  
...  

18140 Background: Erlotinib is an EGFR TKI that is effective in the treatment of advanced NSCLC, in terms of longer survival, better quality of life and delayed symptom progression.We present here the outcome of a group of p from the TargeT study, whose QoL was assessed by the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire and the Lung Cancer Subscale (LCS). Methods: TargeT study was a multicenter, single-arm phase II study evaluating efficacy, safety, and tolerability of erlotinib (150 m/day) in p with stage IIIB or IV NSCLC, in 1st, 2nd and 3rd line treatment. Primary end-point was time to progression. QoL was a secondary end point as assessed monthly by the Functional Assessment of Cancer Therapy-Lung questionnaire (FACT- L) and its Lung Cancer Subscale. Physical and functional aspects of the QoL were measured by the Trial Outcome Index (TOI), which is the sum of the physical well being, functional well-being and LCS scores from the FACT-L questionnaire. Results: Data from 91 pts were available. QoL analysis showed that 53% of the p (95% IC 37–58%) had improvement in FACT-L or TOI. Similarly, 45% (95% IC35–56%) of improved their symptoms from baseline. Improvement was observed for each individual LCS item and specifically in the pulmonary items. In symptomatic p, shortened of breath was 17,6% at baseline vs 2.2% after treatment (p<0.001) and cough was 24.7% vs 8.8 % (p<0.001) after treatment. Those improvements in symptoms were rapid and, 73% of the patients who improved showed that recovery in the first cycle of treatment. In terms of association between efficacy of erlotinib and QoL, there is a statistically significative relationship between objective response and improvement in TOI or FACT-L (p<0.02). Conclusions: This QoL analysis confirms that erlotinib improves both symptoms and functional aspect of patients with NSCLC. The improvement in QoL is related with objective response. No significant financial relationships to disclose.


1997 ◽  
Vol 15 (3) ◽  
pp. 974-986 ◽  
Author(s):  
M J Brady ◽  
D F Cella ◽  
F Mo ◽  
A E Bonomi ◽  
D S Tulsky ◽  
...  

PURPOSE This is the first published report on the validation of the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer. The FACT-B consists of the FACT-General (FACT-G) plus the Breast Cancer Subscale (BCS), which complements the general scale with items specific to QL in breast cancer. The FACT-B was developed with an emphasis on patients' values and brevity and is available in nine languages. METHODS AND RESULTS Two validation samples were used for this report. The first (n = 47) was tested twice over a 2-month period to assess sensitivity to change. Significant sensitivity to change in performance status rating (PSR) was demonstrated for the FACT-B total score, the Physical Well-Being (PWB) subscale, the Functional Well-Being (FWB) subscale, and the BCS. Sensitivity to change in QL as measured by the Functional Living Index-Cancer (FLIC) was documented in the FACT-B total score, PWB, FWB, and Emotional Well-Being (EWB). Additional validity and reliability data were obtained from a larger sample (n = 295). The alpha coefficient (internal consistency) for the FACT-B total score was high (alpha = .90), with subscale alpha coefficients ranging from .63 to .86. Evidence supported test-retest reliability, as well as convergent, divergent, and known groups validity. CONCLUSION The FACT-B is appropriate for use in oncology clinical trials, as well as in clinical practice. It demonstrates ease of administration, brevity, reliability, validity, and sensitivity to change.


2018 ◽  
Vol 4 (3) ◽  
Author(s):  
Nasira Hayat ◽  
Suhaib Bin Bilal Hafi ◽  
Farhana Badar ◽  
Irfan Ahmed

Purpose: Radical cystectomy is carried out for muscle invasive bladder (BL) cancer, which greatly affects the quality of life. The objective of our study was to assess the health-related quality of life (HRQoL) in patients following radicalcystectomy.Methods: A retrospective review was done in patients that underwent radical cystectomy between July 2009 and November 2014 at Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan. HRQoLassessments of 34 patients done during clinical psychology review were included in this study. HRQoL was assessed using functional assessment of cancer therapy-BL questionnaire.Results: Low scores were observed in physical well-being and emotional well-being domains with mean scores of 7.32 and 7.97, respectively. Patients scored high on social and family well-being, functional well-being and additionalconcerns, with mean scores of 24.9, 17.24 and 21.73, respectively.Conclusions: Psychological evaluation and rehabilitation should be an integral part of surveillance after radical cystectomy.Key words: Bladder cancer, functional assessment of cancer therapy-bladder, health-related quality of life, radicalcystectomy, South Asian


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1311-1311
Author(s):  
Lathi A Nina ◽  
Pierre Isogai ◽  
Nicole Mittmann ◽  
Carlo DeAngelis ◽  
Matthew Cheung ◽  
...  

Abstract Neutropenia is a serious hematologic consequence of cancer chemotherapy that can lead to further complications such as febrile neutropenia (FN). FN is potentially life threatening and often requires hospitalization. Few studies have evaluated the impact of neutropenia on quality of life (QoL). This study quantified QoL using two nonneutropenia-specific instruments, the EQ-5D questionnaire, a generic tool used to measure health-related QoL, and the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, and a neutropenia-specific instrument, the Functional Assessment of Cancer Therapy - Neutropenia (FACT-N) questionnaire. The FACT-G is a 27-item questionnaire that examines QoL in patients with cancer using four subscales. A neutropenia-specific subscale (NSS) has been developed for use with the FACT-G; this combined questionnaire is the FACT-N. Data were collected from patients, who provided informed consent, and who were admitted to Sunnybrook Health Sciences Centre, Toronto, Canada, for the treatment of chemotherapy-induced FN. Linear regression models were fitted to examine the relationship of scores from the neutropenia-specific instrument with those obtained from the other instruments. Two models were fitted using the NSS as the response variable. Predictors for the regression models were the FACT-G scores for each of the subscales (physical, emotional, social and functional wellbeing) and the five domains of the EQ-5D (mobility, self-care, usual activity, pain/discomfort and anxiety/depression) along with the visual analog scale (VAS) component of this tool. The physical and emotional wellbeing subscales of the FACT-G had a strong relationship to the NSS (p &lt; 0.05); the social and functional well-being subscales had a much weaker relationship (p &gt; 0.5). For the EQ-5D, the pain/discomfort domain had the strongest relationship to the NSS (p=0.18); the remaining domains, with or without the VAS, all demonstrated a weaker relationship (p &gt; 0.5). Model fit was assessed by the adjusted R2 statistic; it was 0.54 when FACT-G subscales were used as the predictors compared to −0.04 for the EQ-5D domains indicating that the FACT-G was a better predictor of neutropenia-related concerns. Neutropenia concerns appear to be more closely related to cancer specific QoL compared to general quality of life as demonstrated by the stronger relationship of the NSS to the FACT-G than to the EQ-5D. This may be due to the comprehensiveness of the FACT-G questionnaire where a possible score anywhere from 0 to 24 or 28 can be obtained in each of the subscales, compared to three-point descriptive system for each of the domains of the EQ-5D.


2018 ◽  
Vol 26 ◽  
pp. e17948
Author(s):  
Laís De Andrade Martins Cordeiro ◽  
Denismar Alves Nogueira ◽  
Clícia Valim Côrtes Gradim

Objetivo: avaliar a qualidade de vida de mulheres com neoplasia mamária e em quimioterapia adjuvante. Método: estudo descritivo, transversal e quantitativo desenvolvido com 25 mulheres em tratamento em uma Unidade de Assistência de Alta Complexidade em Oncologia de uma cidade do Brasil, por meio do questionário Functional Assessment of Cancer Therapy – Breast plus Arm Morbidity (FACTB +4). Pesquisa aprovada no Comitê de Ética em Pesquisa da Universidade Federal de Alfenas (UNIFAL-MG), por meio do Protocolo: 208/2011. Resultados: verificaram- se, em âmbito geral, bons resultados de qualidade de vida nos domínios e para o FACT B Total. Encontraram-se menores médias de escores nos domínios preocupações adicionais com o câncer de mama (22,68±4,96/36) e bem-estar funcional (16,92±4,60/28). Conclusão: destaca-se a necessidade de cuidados referentes às modificações da imagem corporal, ao estresse sobre a doença e anseios de um familiar vir a ter câncer.ABSTRACTObjective: to evaluate the quality of life of women with breast cancer in adjuvant chemotherapy. Method: this descriptive, quantitative, cross-sectional study examined 25 women undergoing treatment at a High Complexity Oncology Unit in a Brazilian city, in 2012, using the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT B +4) questionnaire. The study was approved by the research ethics committee of Alfenas Federal University (UNIFAL-MG), under Protocol 208/2011. Results: by and large, good quality of life was found in the domains and for Total FACT B. Lower mean scores were observed in the additional concerns with breast cancer (22.68 ± 4.96/36) and functional well-being (16.92 ± 4.60/28) domains. Conclusion: the findings highlighted the need for care relating to changes in body image, disease-related stress and anxiety that a family member may come to have cancer.RESUMENObjetivo: evaluar la calidad de vida de mujeres con neoplasia mamaria y en quimioterapia adyuvante. Método: estudio descriptivo, transversal y cuantitativo desarrollado junto a 25 mujeres en tratamiento en una Unidad de Asistencia de Alta Complejidad en Oncología de una ciudad de Brasil, en 2012; por medio del cuestionario Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACTB +4). Investigación aprobada en el Comité de Ética en Investigación de la Universidad Federal de Alfenas (UNIFAL-MG), a través del Protocolo: 208/2011. Resultados: se verificaron, en general, buenos resultados de calidad de vida en los dominios y para el FACT B Total. Se encontraron menores promedios de escores en los dominios ‘preocupaciones adicionales con el cáncer de mama (22,68/36) y bienestar funcional (16,92/28)’. Conclusión: se destaca la necesidad de cuidados referentes a las modificaciones de la imagen corporal, al estrés sobre la enfermedad y preocupaciones con la posibilidad de que un familiar vaya a tener cáncer.


2012 ◽  
Vol 30 (12) ◽  
pp. 1335-1342 ◽  
Author(s):  
Caroline J. Hoffman ◽  
Steven J. Ersser ◽  
Jane B. Hopkinson ◽  
Peter G. Nicholls ◽  
Julia E. Harrington ◽  
...  

Purpose To assess the effectiveness of mindfulness-based stress reduction (MBSR) for mood, breast- and endocrine-specific quality of life, and well-being after hospital treatment in women with stage 0 to III breast cancer. Patients and Methods A randomized, wait-listed, controlled trial was carried out in 229 women after surgery, chemotherapy, and radiotherapy for breast cancer. Patients were randomly assigned to the 8-week MBSR program or standard care. Profile of Mood States (POMS; primary outcome), Functional Assessment of Cancer Therapy–Breast (FACT-B), Functional Assessment of Cancer Therapy–Endocrine Symptoms (FACT-ES) scales and the WHO five-item well-being questionnaire (WHO-5) evaluated mood, quality of life, and well-being at weeks 0, 8, and 12. For each outcome measure, a repeated-measures analysis of variance model, which incorporated week 0 measurements as a covariate, was used to compare treatment groups at 8 and 12 weeks. Results There were statistically significant improvements in outcome in the experimental group compared with control group at both 8 and 12 weeks (except as indicated) for POMS total mood disturbance (and its subscales of anxiety, depression [8 weeks only], anger [12 weeks only], vigor, fatigue, and confusion [8 weeks only]), FACT-B, FACT-ES, (and Functional Assessment of Cancer Therapy subscales of physical, social [8 weeks only], emotional, and functional well-being), and WHO-5. Conclusion MSBR improved mood, breast- and endocrine-related quality of life, and well-being more effectively than standard care in women with stage 0 to III breast cancer, and these results persisted at three months. To our knowledge, this study provided novel evidence that MBSR can help alleviate long-term emotional and physical adverse effects of medical treatments, including endocrine treatments. MBSR is recommended to support survivors of breast cancer.


Urology ◽  
1997 ◽  
Vol 50 (6) ◽  
pp. 920-928 ◽  
Author(s):  
Peg Esper ◽  
Fei Mo ◽  
Gerald Chodak ◽  
Michael Sinner ◽  
David Cella ◽  
...  

Cancer ◽  
2020 ◽  
Vol 126 (16) ◽  
pp. 3750-3757
Author(s):  
Kenneth Mah ◽  
Nadia Swami ◽  
Lisa W. Le ◽  
Ronald Chow ◽  
Breffni L. Hannon ◽  
...  

2019 ◽  
Vol 29 (3) ◽  
pp. 655-663 ◽  
Author(s):  
Rasheeda K. Hall ◽  
Michael P. Cary ◽  
Tiffany R. Washington ◽  
Cathleen S. Colón-Emeric

Abstract Purpose Patient priorities for quality of life change with age. We conducted a qualitative study to identify quality of life themes of importance to older adults receiving dialysis and the extent to which these are represented in existing quality of life instruments. Methods We conducted semi-structured interviews with 12 adults aged ≥ 75 years receiving hemodialysis to elicit participant perspectives on what matters most to them in life. We used framework analysis methodology to process interview transcripts (coding, charting, and mapping), identify major themes, and compare these themes by participant frailty status. We examined for representation of our study’s subthemes in the Kidney Disease Quality of Life (KDQOL-36) and the World Health Organization Quality of Life for Older Adults (WHOQOL-OLD) instruments. Results Among the 12 participants, average age was 81 (4.2) years, 7 African-American, 6 women, and 6 met frailty criteria. We identified two major quality of life themes: (1) having physical well-being (subthemes: being able to do things independently, having symptom control, maintaining physical health, and being alive) and (2) having social support (subthemes: having practical social support, emotional social support, and socialization). Perspectives on the subthemes often varied by frailty status. For example, being alive meant surviving from day-to-day for frail participants, but included a desire for new life experiences for non-frail participants. The majority of the subthemes did not correspond with domains in the KDQOL-36 and WHOQOL-OLD instruments. Conclusion Novel instruments are likely needed to elicit the dominant themes of having physical well-being and having social support identified by older adults receiving dialysis.


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