TIRED: A randomised controlled trial evaluating efficacy of cognitive behavior therapy and graded exercise therapy in severely fatigue patients with advanced cancer.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 183-183
Author(s):  
Hanneke Poort ◽  
Marlies Peters ◽  
Winette T.A. Van Der Graaf ◽  
Pythia Nieuwkerk ◽  
Agnes W Van de Wouw ◽  
...  

183 Background: Patients with advanced, metastatic cancer frequently suffer from severe fatigue. We assessed the effect of cognitive behavioral therapy (CBT) and graded exercise therapy (GET) on fatigue during cancer treatment with palliative intent. Methods: This randomized study took place between Jan 1, 2013 and Sep 1, 2017 at Radboud University Medical Center (Nijmegen, Netherlands). We enrolled adult patients from nine medical oncology clinics. Eligible patients had advanced cancer and reported severe fatigue (Checklist Individual Strength, subscale fatigue severity [CIS fatigue] ≥ 35) during cancer treatment. Participants were randomized to CBT, GET, or usual care (1:1:1 ratio, using a computer-generated sequence, stratified by study site and minimized for sex). We measured fatigue (CIS fatigue and European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 [EORTC-QLQ-C30] fatigue), quality of life, emotional functioning, physical functioning (all by EORTC-QLQ-C30), and functional impairments (Sickness Impact Profile [SIP8]) at baseline, 14, 18, and 26 weeks. The primary outcome was CIS fatigue at 14 weeks; secondary outcomes included scores for the aforementioned scales. We registered the trial with TrialRegister.nl (NTR3812). Results: 134 participants completed baseline measures (46 CBT, 42 GET, 46 usual care); 126 completed assessment at 14 weeks. There was a significant difference in CIS fatigue scores between CBT and usual care (-7.22, 97.5% CI -12.73 to -1.72; p = .003, d= 0.72), but no significant difference between GET and usual care (-4.70, -10.24 to 0.85, p = .057, d= 0.44). Secondary outcomes showed significant differences for EORTC-QLQ-C30 fatigue (-13.05 [95% CI -22.12 to -3.97]; p = 0.005), quality of life (10.15 [2.37 to 17.93]; p = 0.11), and physical functioning (7.10 [0.48 to 13.72]; p = 0.036), but not for emotional functioning or SIP8 functional impairments (p's > 0.05). There were no significant differences in secondary outcomes between GET and usual care. Conclusions: The findings support CBT for severe fatigue in patients with advanced cancer during treatment. Clinical trial information: NTR3812.

Author(s):  
Albert Tuca Rodríguez ◽  
Miguel Núñez Viejo ◽  
Pablo Maradey ◽  
Jaume Canal-Sotelo ◽  
Plácido Guardia Mancilla ◽  
...  

Abstract Purpose The main aim of the study was to assess the impact of individualized management of breakthrough cancer pain (BTcP) on quality of life (QoL) of patients with advanced cancer in clinical practice. Methods A prospective, observational, multicenter study was conducted in patients with advanced cancer that were assisted by palliative care units. QoL was assessed with the EORTC QLQ-C30 questionnaire at baseline (V0) and after 28 days (V28) of individualized BTcP therapy. Data on background pain, BTcP, comorbidities, and frailty were also recorded. Results Ninety-three patients completed the study. Intensity, duration, and number of BTcP episodes were reduced (p < 0.001) at V28 with individualized therapy. Transmucosal fentanyl was used in 93.8% of patients, mainly by sublingual route. Fentanyl titration was initiated at low doses (78.3% of patients received doses of 67 μg, 100 μg, or 133 μg) according to physician evaluation. At V28, mean perception of global health status had increased from 31.1 to 53.1 (p < 0.001). All scales of EORTC QLQ-C30 significantly improved (p < 0.001) except physical functioning, diarrhea, and financial difficulties. Pain scale improved from 73.6 ± 22.6 to 35.7 ± 22.3 (p < 0.001). Moreover, 85.9% of patients reported pain improvement. Probability of no ≥ 25% improvement in QoL was significantly higher in patients ≥ 65 years old (OR 1.39; 95% CI 1.001–1.079) and patients hospitalized at baseline (OR 4.126; 95% CI 1.227–13.873). Conclusion Individualized BTcP therapy improved QoL of patients with advanced cancer. Transmucosal fentanyl at low doses was the most used drug. Trial registration This study was registered at ClinicalTrials.gov database (NCT02840500) on July 19, 2016.


2013 ◽  
Vol 14 (1) ◽  
pp. 139-146 ◽  
Author(s):  
Gemma Cramarossa ◽  
Liang Zeng ◽  
Liying Zhang ◽  
Ling-Ming Tseng ◽  
Ming-Feng Hou ◽  
...  

2021 ◽  
Vol 7 (3) ◽  
Author(s):  
Cohen MV ◽  
◽  
de Fátima Teixeira P ◽  
Vaisman M ◽  
Vaisman F ◽  
...  

Background: Low risk thyroid cancer can be treated with lobectomy or total thyroidectomy. Studies have shown that the risk of recurrence does not differ between the two surgeries, although there are higher rates of complications with total thyroidectomy. Our study aimed to find if there were differences in quality of life and thyroid function in the two treatments. Methods: Low risk DTC survivors answered three QoL questionnaires (EQ5D3L, SF36, and EORTC QLQ C30) and had their thyroid function evaluated. Results: Twenty-six lobectomy patients and 101 total thyroidectomy were included. Hypoparathyroidism occurred more in the total thyroidectomy, and TSH was more likely to be on target (0.5-2.0) in lobectomy. There was no difference between groups regarding QoL, but there was a significant difference regarding thyroid function. In SF36 form, TSH off target led to more physical limitations, pain, less vitality, and worse social aspects. Abnormal total T3 level was associated with pain, less vitality, and worse mental health. In the EORTC QLQ C30, off target TSH led to worse role functioning, fatigue, and nausea. EQ5D form showed that worse utility index was found when TT3 was not in normal range. Conclusion: This study showed there was a difference among thyroid function, specially TSH depending on type of surgery. When uncontrolled, TSH was associated with worse aspects of the quality of life. Therefore, lobectomy patients have a better thyroid function control and less surgical complications which might have an impact in some aspects of the quality of life when compared to total thyroidectomy.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5030-5030
Author(s):  
Amarnath Challapalli ◽  
Susan Masson ◽  
Paul White ◽  
Narges Dailami ◽  
Sylvia Pearson ◽  
...  

5030 Background: Neoadjuvant cisplatin-based combination chemotherapy (NAC) improves survival in muscle invasive bladder cancer (MIBC). However, response rates and survival remain suboptimal. We sought to evaluate the efficacy, safety and tolerability of cisplatin cabazitaxel combination in this patient group. Methods: A phase 2 single arm trial (Simon 2 stage), to recruit at least 26 evaluable patients was designed with 80% power to detect the primary endpoint, objective response rate (ORR) of > 35%. ORR was defined as pathological complete response (pCR) plus partial response (pathological downstaging), measured by pathologic staging (T2 or greater at diagnosis, to T1 or less at radical cystectomy). Treatment was with Cisplatin 70mg/m2 and Cabazitaxel 15mg/m2 on day 1 of a 21 day cycle, for 4 cycles prior to surgery. Toxicity was recorded using CTCAE v.4.03. Quality of Life (QoL) data were collected at baseline, prior to each cycle of chemotherapy and at 3-5 weeks after 4th cycle of chemotherapy using EQ-5D and EORTC QLQ-C30, BLM30 questionnaires. Results: Objective response was seen in 15 out of 26 evaluable patients, 57.7% and over a third of patients achieved pCR (9/26; 34.6%). 78% (21/27) of patients completed all cycles of treatment, with only 6.7% of the reported adverse events (AEs) being graded 3 or 4. There were 6 treatment related SAEs reported but no SUSARs. In patients who achieved objective response the median progression free (PFS) and overall survival (OS) were not reached (median follow up: 41.5m). In contrast, median PFS (7.2m) and OS (16.9m) were significantly worse (p = 0.001) in patients who did not respond. Response rates for EORTC QLQ-C30, BLM 30 and EQ5D questionnaires was 70.4, 70.4 & 63% respectively, at end of treatment. There was no significant difference in EORTC QLQ C30 summary, global health scores and EQ5D score with treatment. There was a significant decline in mean QLQ C30 domain scores after 1st cycle compared to baseline, but no further deterioration with subsequent cycles of chemotherapy. Conclusions: Cabazitaxel with cisplatin as NAC of MIBC can be considered a safe, well-tolerated and effective regimen with higher pCR rate of 34.6%. This compares favorably to that with Cisplatin/Gemcitabine (23-26%). Minimal changes in Global Health & EQ5D observed during NAC further demonstrates the excellent tolerability of this regimen and to our knowledge are the first data regarding QoL in NAC in MIBC. These results warrant further evaluation in a larger phase 3 study. Clinical trial information: 2011 004090 82 .


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21650-e21650
Author(s):  
Keith I. Block ◽  
Edward Carome ◽  
David E Blask ◽  
Dinah Faith Huff ◽  
Thomas Kaslausky ◽  
...  

e21650 Background: Cancer patients develop symptoms that are pathognomonic of a failing circadian organization [CO]. Our concurrent study of 84 advanced cancer patients on randomly timed chemotherapy revealed that each suffered more disrupted circadian rhythms, sleep disorders, anxiety/depression, and quality of life scores compared to healthy age-adjusted controls, as well as poor survival. Herein, we report relationships between CO of advanced cancer patients and their functioning, symptoms, mood, and quality of life during chemotherapy in a clinic that uses comprehensive integrative therapies to maintain patient CO. Methods: 30 patients with advanced cancer participated in a randomized single-blind crossover trial of whether nightly use of blue-light blocking eyeglasses improved circadian organization during chemotherapy. Chemotherapy was applied at or near times of day known to be least toxic and most effective. CO was measured serially using actigraphy and patients provided data on their sleep quality [PSQI], mood [HADS], fatigue [Piper], and quality of life [EORTC QLQ-C30 and Ferrans/Powers QLI]. Kruskal-Wallis tests were used to detect the differences between groups [p < 0.05]. Results: These cancer patients’ actigraphy data were indistinguishable from a convenience control of healthy individuals. Sleep quality, Piper Fatigue, and HADS scores were in the non-symptomatic range; and all functional and symptomatic parameters of the EORTC QLQ-C30 and three of four QLI subscales were within population-based norms. Only the EORTC health-related quality of life and the QLI health/function parameters were lower than non-cancer controls. Median overall survival was 38.4 months. Conclusions: Actigraphy-measured COs of advanced cancer patients are damped, disorganized and accompanied by a heavy symptom burden. These cancer patients reported good quality sleep, normal function, good mood, low intensity of cancer-related symptoms and extended survival while undergoing circadian timed cancer chemotherapy and integrative support. This CO maintenance among such cancer patients is unprecedented and requires attention especially as it is achievable entirely without risk. Clinical trial information: ISRCTN16219928.


2018 ◽  
Vol 64 (6) ◽  
pp. 530-536 ◽  
Author(s):  
Juliana Nishimura Bueno ◽  
Cinira Assad Simão Haddad ◽  
Samantha Karlla Lopes De Almeida Rizzi ◽  
Patricia Santolia Giron ◽  
Gil Facina ◽  
...  

SUMMARY Breast cancer is one of the most common types of tumor in the world and the most common among women. There are several treatments for breast cancer; however, the condition often can be accompanied by severe complications in a woman's life. OBJECTIVE: o evaluate and compare body image perception, quality of life, tenderness, and pain in women with breast cancer during preoperative and postoperative periods of 30, 60 and 90 days. MATERIALS AND METHODS: We conducted a prospective longitudinal study. The patients answered the questionnaire “How I relate to my own body”, EORTC QLQ-C30 and EORTC QLQ-BR23. We assessed upper limb and breast sensitivity with an esthesiometer. Patients were questioned about the presence and level of pain on a scale of 0 to 10. RESULTS: For body image, it was possible to observe a significant difference between pre and postoperative at 30 days. There were changes in some areas of the EORTC QLQ C30 and EORTC QLQ BR23 questionnaires, such as arm and breast symptoms, social function, constipation, sexual function and satisfaction, among others. For evaluation of breast and axilla sensitivity and assessment of pain, all postoperative periods showed significant differences when compared to the preoperative period. The sensitivity of the inner region of the arm presented no significant change. CONCLUSION: The difference found in the study shows that evaluations on all scales should be done in several periods, using a proper treatment for the changes and individuality of each patient.


2021 ◽  
Author(s):  
Seon-Hye Won ◽  
Yusuke Hiratsuka ◽  
Sang-Yeon Suh ◽  
Hayoung Bae ◽  
Sung-Eun Choi ◽  
...  

Abstract Purpose Mid-upper arm circumference (MUAC) has been used to assess malnutrition and health status across various disease groups. However, it is unclear whether MUAC is associated with quality of life (QOL) of patients with advanced cancer. Our goal was to investigate the relationship between MUAC and QOL in ambulatory out-patients with advanced cancer. Method This was a cross-sectional study conducted in a tertiary cancer center in South Korea. A total of 200 patients with advanced cancer at oncology clinics of Seoul National University Bundang Hospital from March 2016 to January 2019 were enrolled. Out-patients with advanced cancer whose survival was expected to be less than one year by their oncologists were enrolled. QOL of patients was evaluated using the European Organization for Research and Treatment of Cancer quality of life questionnaire core 30 (EORTC QLQ-C30). Associations of QOL with MUAC and nutritional parameters were examined with generalized linear models. Results The most common cancer sites were the lung, colon or rectum, and genitourinary tract. In univariate analyses, significant factors associated with higher summary score of EORTC QLQ-C30 were higher MUAC (≥ 26.5 cm, p < 0.001), higher body mass index (BMI) (≥ 22 kg/m2, p < 0.001), higher serum albumin (≥ 3.7 g/dL, p = 0.004), higher creatinine (≥ 0.8 mg/dL, p = 0.023), and higher uric acid (≥ 5 mg/dL, p = 0.001). In multivariate analysis, higher serum albumin (≥ 3.7 g/dL, p < 0.01) and higher MUAC (≥ 26.5 cm, p = 0.03) were independently associated with better summary score of EORTC QLQ-C-30. Conclusion MUAC was highly associated with QOL in terms of summary score and overall health status. Thus, MUAC, with its simplicity, can be a useful tool to reflect QOL in patients with advanced cancer.


2012 ◽  
Vol 30 (12) ◽  
pp. 1296-1303 ◽  
Author(s):  
Young Ho Yun ◽  
Keun Seok Lee ◽  
Young-Woo Kim ◽  
Sang Yoon Park ◽  
Eun Sook Lee ◽  
...  

Purpose To determine whether an Internet-based tailored education program is effective for disease-free cancer survivors with cancer-related fatigue (CRF). Patients and Methods We randomly assigned patients who had completed primary cancer treatment within the past 24 months in any of four Korean hospitals and had reported moderate to severe fatigue for at least 1 week to participate in a 12-week, Internet-based, individually tailored CRF education program or to receive routine care. We based the program on the CRF guidelines of the National Comprehensive Cancer Network (NCCN) and incorporated the transtheoretic model (TTM). At baseline and 12 weeks, we used the Brief Fatigue Inventory (BFI) and Fatigue Severity Scale (FSS) as primary outcomes and the Hospital Anxiety and Depression Scale (HADS) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) for secondary outcomes. Results We recruited 273 participants and randomly assigned 136 to the intervention group. Compared with the control group, the intervention group had an improvement in fatigue as shown by a significantly greater decrease in BFI global score (−0.66 points; 95% CI −1.04 to −0.27) and FSS total score (−0.49; 95% CI, −0.78 to −0.21). In secondary outcomes, the intervention group experienced a significantly greater decrease in HADS anxiety score (−0.90; 95% CI, −1.51 to −0.29) as well as global quality of life (5.22; 95% CI, 0.93 to 9.50) and several functioning scores of the EORTC QLQ-C30. Conclusion An Internet-based education program based on NCCN guidelines and TTM may help patients manage CRF.


2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Mette Falk Brekke ◽  
Karen la Cour ◽  
Åse Brandt ◽  
Hanne Peoples ◽  
Eva Ejlersen Wæhrens

Background. Occupational therapy and occupational science are founded on the theoretical core assumption that occupation and quality of life (QoL) are closely related. However, such theoretical core assumptions must be supported through empirically based research. Objective. To investigate the association between QoL and occupation, here self-reported and observed ADL abilities as a part of occupation, among people with advanced cancer, including determining whether self-reported or observed ADL ability had the stronger association with QoL. Methods. The study was nested in a cross-sectional study. The association between ADL ability and QoL among 108 people with advanced cancer was investigated using the ADL Interview (ADL-I), the Assessment of Motor and Process Skills (AMPS), and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Results and Conclusions. Results showed that high observed ADL motor ability was associated with high QoL. In contrast, observed ADL process ability and self-reported ADL ability were not significantly associated with QoL. Oppositely expected, observed ADL ability had a stronger association with QoL than self-reported ADL ability. Thereby, the study to some extent contributes knowledge confirming the theoretical core assumptions about the relation between occupation, here performance of ADL, and QoL.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yacir El Alami ◽  
Hajar Essangri ◽  
Mohammed Anass Majbar ◽  
Saber Boutayeb ◽  
Said Benamr ◽  
...  

Abstract Background Health-related quality of life is mainly impacted by colorectal cancer which justified the major importance addressed to the development and validation of assessment questionnaires. We aimed to assess the validity and reliability of the Moroccan Arabic Dialectal version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) in patients with colorectal cancer. Methods We conducted a cross-sectional study using the Moroccan version of the EORTC QLQ-C30 on colorectal cancer patients from the National Oncology Institute of Rabat, in the period from February 2015 to June 2017. The QLQ-C30 was administered to 120 patients. Statistical analysis included reliability, convergent, and discriminant validity as well as known-groups comparisons. Results In total, 120 patients with colorectal cancer were included in the study with 38 (32%) patients diagnosed with colon cancers. Eighty-two patients (68%) had rectal cancer, among which 29 (24%) patients with a stoma. The mean age of diagnosis was 54 years (+/− 13.3). The reliability and validity of the Arabic dialectal Moroccan version of the EORTC QLQ-C30 were satisfactory. [Cronbach’s alpha (α =0.74)]. All items accomplished the criteria for convergent and discriminant validity except for question number 5, which did not complete the minimum required correlation with its own scale (physical functioning). Patients with rectal cancer presented with bad Global health status and quality of life (GHS/QOL), emotional functioning as well as higher fatigue symptoms compared to patients with colon cancer. The difference between patients with and without stoma was significant for diarrhea and financial difficulty. Conclusions The Moroccan Arabic Dialectal version of the QLQ-C30 is a valid and reliable measure of health-related quality of life (HRQOL) in patients with colorectal cancer.


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