Effect of activity monitoring on quality of life in patients with gastrointestinal cancer undergoing chemoradiation.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18671-e18671
Author(s):  
Kristine N Kim ◽  
Nishant Shah ◽  
Amardeep S. Grewal ◽  
Elissa Klinger ◽  
Edgar Ben-Josef ◽  
...  

e18671 Background: Patients undergoing concurrent radiation therapy and systemic therapy often experience significant toxicities, which can adversely affect their quality of life. We sought to determine if activity monitoring and early outpatient intervention could lead to improved quality of life (QoL) in patients with gastrointestinal malignancies undergoing chemoradiotherapy. Methods: In this prospective randomized trial, patients with gastrointestinal malignancies undergoing concurrent chemoradiotherapy were randomized to activity monitoring versus standard of care (observation). Each group was provided a commercially available fitness tracker but only the intervention group was actively monitored. If a patient in the intervention arm had a 20% decrease in step count or 20% increase in heart rate from their baseline, a triage visit was triggered to further evaluate and manage symptoms. In the observation group, step count and heart rate were recorded but no triage visit was triggered. All patients had weekly on treatment visits and access to standard communication methods for symptom management during and after-hour business hours. The primary endpoint was the rate of completed triage visits. QoL was a secondary endpoint and was collected from both arms at radiation simulation (baseline) and weekly during treatment using the EORTC QLQ-C30 (v.3). The mixed model for repeated measures was used for longitudinal analysis of global health status (GHS) and overall QoL scores (range 1-7) to determine the impact of intervention and time on QoL. Results: A total of 40 patients were evaluable in this study: 22 in the intervention group and 18 in the observation group. The primary endpoint was met with an increased rate of triage visits in the active monitoring group compared to the observation group (86.4% vs 39.9%, OR 9.95, 95% CI 2.12 -46.56, p = 0.015). EORTC QLQ-C30 questionnaires were completed by 97.5% of patients. The baseline QoL scores were similar in both arms (mean GHS 5.06 vs 5.50, p = 0.28 and mean QoL 4.98 vs 5.73, p = 0.09 in observation vs intervention group, respectively). There was a trend towards improved mean GHS, and QoL scores in the intervention group at all timepoints, although it did not reach statistical significance. Overall, GHS and QoL scores deteriorated from week 1 to week 6 during treatment in both groups (mean QoL 5.06 to 4.46, p = 0.16 in observation; mean QoL 5.55 to 5.03, p = 0.16 in intervention group). Conclusions: This study supports the feasibility of using activity monitor to actively track step count and heart rate to successfully trigger triage visits for patients at high risk for toxicity. Early outpatient intervention with the use of activity monitoring may improve quality of life in patients undergoing chemoradiotherapy.

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.


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.


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.


2021 ◽  
pp. 0272989X2110035
Author(s):  
Dennis A. Revicki ◽  
Madeleine T. King ◽  
Rosalie Viney ◽  
A. Simon Pickard ◽  
Rebecca Mercieca-Bebber ◽  
...  

Background The EORTC QLU-C10D is a multiattribute utility measure derived from the cancer-specific quality-of-life questionnaire, the EORTC QLQ-C30. The QLU-C10D contains 10 dimensions (physical, role, social and emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems). The objective of this study was to develop a United States value set for the QLU-C10D. Methods A US online panel was quota recruited to achieve a representative sample for sex, age (≥18 y), race, and ethnicity. Respondents undertook a discrete choice experiment, each completing 16 choice-pairs, randomly assigned from a total of 960 choice-pairs. Each pair included 2 QLU-C10D health states and duration. Data were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life-year framework. Utility weights were calculated as the ratio of each dimension-level coefficient to the coefficient for life expectancy. Results A total of 2480 panel members opted in, 2333 (94%) completed at least 1 choice-pair, and 2273 (92%) completed all choice-pairs. Within dimensions, weights were generally monotonic. Physical functioning, role functioning, and pain were associated with the largest utility weights. Cancer-specific dimensions, such as nausea and bowel problems, were associated with moderate utility decrements, as were general issues such as problems with emotional functioning and social functioning. Sleep problems and fatigue were associated with smaller utility decrements. The value of the worst health state was 0.032, which was slightly greater than 0 (equivalent to being dead). Conclusions This study provides the US-specific value set for the QLU-C10D. These estimated health state scores, based on responses to the EORTC QLQ-C30 questionnaire, can be used to evaluate the cost-utility of oncology treatments.


2004 ◽  
Vol 22 (2) ◽  
pp. 354-360 ◽  
Author(s):  
Philippe Rauch ◽  
Joelle Miny ◽  
Thierry Conroy ◽  
Lionel Neyton ◽  
Francis Guillemin

Purpose To identify factors affecting the quality of life (QoL) of disease-free survivors of rectal cancer. Patients and Methods One hundred twenty-one patients in complete remission more than 2 years after diagnosis were asked to complete three QoL questionnaires: the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30; its colorectal module, QLQ-CR38; and the Duke generic instrument. Results Patients reported less pain (P = .002) than did controls drawn from the general population. EORTC QLQ-C30 physical scores were also higher among rectal cancer survivors than in the general Norwegian or German population (P = .0005 and P = .002, respectively). Unexpectedly, stoma patients reported better social functioning than did nonstoma patients (P = .005), with less anxiety (P = .008) and higher self-esteem (P = .0002). In the present authors' experience, the QLQ-CR38 does not discriminate between these groups. Residual abdominal or pelvic pain and constipation had the most negative influence on QoL. Conclusion QoL is high among rectal cancer survivors, including stoma patients. Simultaneous use of several QoL questionnaires appears to have value in follow-up and in monitoring the effects of therapy. The impact of residual pain and constipation on long-term QoL should be considered when establishing a treatment regimen.


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

2004 ◽  
Vol 2 (2) ◽  
pp. 115-124 ◽  
Author(s):  
JÖRG DIRMAIER ◽  
SILKE ZAUN ◽  
UWE KOCH ◽  
TIMO HARFST ◽  
HOLGER SCHULZ

Objective: Recent years have shown an increase in the use of questionnaires measuring health-related quality of life to verify the quality of treatment in the field of oncology. An often used cancer-specific questionnaire is the “Quality of Life Core Questionnaire of the European Organization for the Research and Treatment of Cancer” (EORTC QLQ-C30). The purpose of this study is to analyze the psychometric properties of the EORTC QLQ-C30 (version 1) in order to determine the feasibility and appropriateness for its use in inpatient cancer rehabilitation in Germany with heterogeneous diagnoses.Methods: The questionnaire was administrated to a sample of 972 cancer patients at the beginning of treatment and to 892 patients after treatment. Besides descriptive analysis, the statistical analyses include confirmatory analysis and the multitrait/multimethod approach to test the questionnaire's postulated scale structure (factorial validity) and its reliability (internal consistencies). The analysis also includes a comparison of responsiveness indices (effect size, reliable change index) to test the sensitivity of the instrument.Results: The EORTC QLQ-C30 showed satisfactory levels of reliability and sensitivity, but the postulated scale structure could not be confirmed. The results illustrate that the varimax-rotated solution of a principal component analysis does not confirm the scale structure postulated by the authors. Correspondingly, the selected fit indices within the scope of the confirmatory factor analysis do not show satisfactory results either.Significance of results: We therefore consider version 1 of the EORTC QLQ-C30 to be only limitedly useful for the routine assessment of changes in the quality of life of cancer patients in inpatient rehabilitation in Germany, especially because of the instrument's length and possible redundancies. For this reason, a scoring procedure limited to a subset of items is suggested, revealing satisfactory to good psychometric indices. However, further psychometric tests are necessary, especially with regard to validity and sensitivity.


2000 ◽  
Vol 23 (7) ◽  
pp. 423-428 ◽  
Author(s):  
M. Majkowicz ◽  
Z. Afeltowicz ◽  
M. Lichodziejewska-Niemierko ◽  
A. Debska-Slizien ◽  
B. Rutkowski

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4097-4097
Author(s):  
Juan W. Valle ◽  
Antoine Hollebecque ◽  
Junji Furuse ◽  
Lipika Goyal ◽  
Funda Meric-Bernstam ◽  
...  

4097 Background: In FOENIX-CCA2 (NCT02052778), a pivotal phase 2 study among iCCA patients (pts) with FGFR2 fusions/rearrangements, the highly selective, irreversible FGFR1–4 inhibitor futibatinib demonstrated a confirmed objective response rate of 41.7%, with a 9.7-month median duration of response. Adverse events were manageable with dosing modifications that did not adversely impact on response. We report outcomes for the preplanned analysis of Patient-Reported Outcomes (PROs) during futibatinib treatment as a secondary objective of FOENIX-CCA2. Methods: Pts enrolled in FOENIX-CCA2 had locally advanced/metastatic unresectable iCCA with FGFR2 fusions/rearrangements, ≥1 prior line of therapy (including gemcitabine/cisplatin) and ECOG PS 0-1. Pts received oral futibatinib 20 mg continuous QD dosing per 21-day cycle. PRO measures included EORTC-QLQ-C30 (1 global health, 5 functional, 9 symptom scales), EQ-5D-3L, and EQ visual analogue scale (VAS). PROs were collected at screening, cycles 2 and 4, every 3 cycles thereafter, and end of treatment. PRO data were evaluated up to cycle 13, the last visit before data were missing for >50% of the PRO population (PRO primary assessment time point). Results: 92/103 (89.3%) pts enrolled had PRO completion data at baseline and a minimum of 1 follow-up assessment (median age 58 y, 56.5% female), with 48 pts having PRO data at cycle 13. At baseline, mean (SD) EORTC QLQ-C30 global health status score was 70.1 (19.4) and EQ VAS score 71.7 (20.3). Mean EORTC QLQ-C30 global health status scores were maintained from baseline to cycle 13, corresponding to 9.0 months on treatment, with no clinically meaningful (≥10-point) changes in individual functional measures (Table). EORTC QLQ-C30 scores across individual symptom measures were also stable from baseline through cycle 13; only constipation showed an average of 10.0-point worsening at only cycle 4. Mean EQ VAS scores were sustained from baseline to cycle 13 (mean change ranging -1.8 to +4.8 across cycles), with values maintained within the population norm range from across 20 countries. Conclusions: Quality of life data from the phase 2 FOENIX-CCA2 trial show that physical, cognitive and emotional functioning, and overall health status were maintained among pts with advanced iCCA receiving futibatinib. Clinical trial information: NCT02052778. [Table: see text]


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