Assessment of established patient reported outcomes (PROs) instruments measuring toxicities and quality of life (QOL) for patients (pts) with head and neck cancer (HNC) treated on ECOG 1308 and 2399 studies.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6074-6074 ◽  
Author(s):  
Anthony Cmelak ◽  
Yael Flamand ◽  
Shuli Li ◽  
Shanthi Marur ◽  
Barbara A. Murphy ◽  
...  
Keyword(s):  
Head And Neck ◽  
Low Dose ◽  
Standard Dose ◽  
Cure Rate ◽  
Neck Symptom ◽  
Katz Index ◽  
Patient Reported ◽  
The Impact ◽  
Clinical Trial Information

6074 Background: HPV HNC pts are younger and have a higher cure rate than smoking-related pts, and therefore carry treatment toxicities longer. Dose deintensification and conformal RT may result in decreased toxicity. We report the impact of these techniques on patient outcomes in E2399 and E1308 as measured through PROs. Methods: Longitudinal data on acute and late toxicities were recorded prospectively at baseline, post-treatment, and at 6, 12, 24 and 30 months in HPV+ pts on E1308 and HIV+/- pts on E2399 using the following measures: E1308: FACT-HN, KATZ Index of Independence (ADL), Brief Fatigue Index (BFI), Instrumental Activities of Daily Living (IADL), and the Vanderbilt Head and Neck Symptom Survey Version 2 (VHNSS V2); on E2399: FACT-HN. We correlated acute and late toxicities with de-escalation of RT dose (69.3Gy to 54Gy) on E1308, and with IMRT (E1308) vs. conformal RT (E2399). Results: 38 pts on E1308 completed 12 mo VHNSS V2; 32 received low dose IMRT and 6 standard dose, and 56 E2399 pts completed 12 mo FACT-HN. Items from the VHNSS V2 showed that difficulty eating solids (40% vs. 89%, p = 0.011) and improved nutrition (10% vs 44%, p = 0.025) were statistically improved at 12 months by lowering IMRT dose from 69.3Gy to 54Gy. The FACT-HN showed an improvement in eating solids at 12 mo when comparing low dose IMRT vs. 3DRT (65% vs. 33% had no or minimal solid food problems, p = 0.057). No other statistically significant reductions in toxicity were noted on any of the other PRO instruments. Conclusions: Both FACT-HN and VHNSS V2 demonstrated an improvement in eating solids by reducing IMRT dose. FACT-HN demonstrated that IMRT is associated with an improvement in eating solids when compared to 3DRT. Analyses are exploratory and need to be validated using randomized data.Future studies should stress accurate and complete PRO data. The KATZ, BFI, and IADL were not sensitive to detecting differences in toxicities from IMRT dose reduction on E1308. The VHNSS V2 and FACT-HN instruments corroborated specific toxicities both by RT technique as well as IMRT dose, and will therefore be utilized in future ECOG-ACRIN HNC studies. Clinical trial information: NCT01084083.

A health-related quality-of-life (HRQoL) analysis of pomalidomide + low-dose dexamethasone + daratumumab in relapsed refractory multiple myeloma (RRMM) after lenalidomide treatment.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8025-8025
Author(s):  
Donna Ellen Reece ◽  
Nizar J. Bahlis ◽  
Christy Joy Samaras ◽  
Michael Sebag ◽  
Jesus G. Berdeja ◽  
...  
Keyword(s):  
Low Dose ◽  
Completion Rates ◽  
Health Score ◽  
Related Quality ◽  
Health Related ◽  
Anxiety Depression ◽  
The Impact ◽  
Ongoing Phase ◽  
Clinical Trial Information

8025 Background: Treatment (Tx) of RRMM is complex and requires evaluation of disease and patient (pt) factors to maximize efficacy and minimize toxicity. HRQoL has become an important aspect of MM Tx, as survival has improved with therapeutic advances. Results of the ongoing phase 2 MM-014 trial (NCT01946477) have demonstrated that pomalidomide (POM) + low-dose dexamethasone (LoDEX) + daratumumab (DARA) is safe and effective in RRMM pts after first- or second-line lenalidomide (LEN)-based Tx failure. Here we report the impact of this regimen on HRQoL. Methods: RRMM pts with 1 to 2 prior Tx lines, LEN-based Tx as their most recent regimen, and progressive disease during or after their last Tx line received POM + LoDEX + DARA in 28-day cycles (MM-014 cohort B). HRQoL, an exploratory endpoint for cohort B, was assessed via EuroQol’s EQ-5D. Results: As of October 15, 2018, 108 pts were evaluable for HRQoL. Baseline characteristics were similar to those of the ITT population (N = 112). EQ-5D completion rates for each cycle (1-6) were ≥ 88%. Mean change from baseline in the EQ-5D index and VAS health score was stable through 6 Tx cycles. At cycle 6, 28.8% and 39.0% of pts achieved minimum clinically important improvement in the EQ-5D index (≥ 0.1) and VAS health score (≥ 6), respectively. EQ-5D index values were stable, with a trend toward improvement in usual activities, pain/discomfort, and anxiety/depression (Table). Conclusions: In RRMM pts with early-line LEN Tx failure, HRQoL was maintained or trended toward improvement with POM + LoDEX + DARA, despite the combination of 3 drugs with distinct toxicities. These findings further support the earlier use of POM-based Tx in RRMM immediately after LEN failure. Clinical trial information: NCT01946477. [Table: see text]

Parotid sparing adaptive radiotherapy in head and neck cancer patients: A study evaluating resource intensiveness and impact on quality of life.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24037-e24037
Author(s):  
Shaurav Maulik ◽  
Indranil Mallick ◽  
Moses Arunsingh ◽  
Sriram Prasath ◽  
B Arun ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Post Treatment ◽  
Patient Reported ◽  
Adaptive Replanning ◽  
Parotid Sparing ◽  
The Impact

e24037 Background: Anatomical changes during the course of parotid sparing IMRT for head and neck cancer can lead to an increase in the actual dose absorbed by the parotid glands, which may be controlled with the use of interval adaptive replanning. In this prospective assessment of adaptive replanning for parotid dose changes, we explored the feasibility of carrying out adaptive replanning based on predefined objective dosimetric criteria at specified time points. We sought to assess the impact of this measure using a clinically meaningful endpoint of patient reported quality of life outcomes. Methods: 90 patients with head and neck radiotherapy indicated for definitive management or adjuvant therapy who had at least one parotid gland receiving a mean dose (MD) of between 25-30Gy were accrued in the study. The index parotid was delineated on the images acquired on 14th and 19th day and the MD was determined by overlaying the verification image on the planned CT. If the MD had increased by 2% of the initial intended dose, an adaptive plan was attempted with an aim to reduce MD by 2% without compromising PTV coverage; this plan was then used to deliver the remaining treatment. Patients were invited to complete QoL questionnaires: EORTC-QLQC30 with HN35 module, and XeQoL score at baseline, at 3 and 9 months after completion of treatment. Results: 46 out of 90 patients met the threshold for adaptive replanning and were switched to the new plan during treatment. Adaptive replanning was triggered at D14 for 31 patients and D19 for the remaining 15. Need for adaptive replanning was associated with receipt of concurrent chemotherapy and weight loss in the first two weeks of RT. QoL was evaluable for 50 patients at 3 months post treatment. In patients who required adaptive replanning per protocol, Mean XeQoL scores at 3 months showed significantly worse scores for overall scores (1.1 vs 2.3, p 0.001) and for the component individual physical, pain, psychological, and social domains. EORTC QLQ-C30 and HN35 questionnaires at 3 months also demonstrated significantly worse mean symptom scores of the relevant domains of mouth dryness (39 vs 60), stickiness (32 vs 54) and swallowing (39 vs 60) in patients who required adaptive replanning versus those who did not. No significant QoL trends were observable in the 31 patients who were evaluable at 9 months post treatment. The average time required for each step in the planning process was comparable for both the initial planning workflow and adaptive replanning process. Conclusions: The trigger criteria for replanning identified a population of patients who have significantly worsened quality of life due to radiation induced xerostomia. The benefits of adaptive replanning strategies based on weekly evaluation, binary thresholds and standard planning procedures is doubtful Clinical trial information: CTRI/2017/11/010683.

scholarly journals Depression, anxiety, fatigue, and quality of life in a large sample of patients suffering from head and neck cancer in comparison with the general population

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
C. Hammermüller ◽  
A. Hinz ◽  
A. Dietz ◽  
G. Wichmann ◽  
M. Pirlich ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck Cancer ◽  
General Population ◽  
Head And Neck ◽  
Neck Cancer ◽  
Daily Routine ◽  
Large Sample ◽  
Patient Reported ◽  
The Impact

Abstract Background Treatment of head and neck cancer (HNC) often leads to visible and severe functional impairments. In addition, patients often suffer from a variety of psychosocial problems, significantly associated with a decreased quality of life. We aimed to compare depression, anxiety, fatigue and quality of life (QoL) between HNC patients and a large sample of the general population in Germany and to examine the impact of sociodemographic, behavioral and clinical factors on these symptoms. Methods We assessed data of HNC patients during the aftercare consultation at the Leipzig University Medical Center with a patient reported outcome (PRO) tool named “OncoFunction”. Depression, anxiety, fatigue and QoL were assessed using validated outcome measures including the PHQ-9, the GAD-2, and the EORTC QLQ-C30 questionnaire. Results A total of 817 HNC patients were included in our study and compared to a sample of 5018 individuals of the general German population. HNC patients showed significantly higher levels of impairment in all dimensions assessed. Examination of association between depression, anxiety, fatigue and QoL and clinical as well as sociodemographic variables showed significant relationships between occupational status, ECOG-state, body mass index and time since diagnosis. Conclusions HNC patients suffer significantly from psychological distress. The used questionnaires are suitable for the use in daily routine practice and can be helpful to increase the detection of depression, anxiety and fatigue and therefore can improve HNC aftercare.

The effect of surgery in tenosynovial giant cell tumours as measured by patient-reported outcomes on quality of life and joint function

2019 ◽  
Vol 101-B (3) ◽  
pp. 272-280 ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
W. T. A. van der Graaf ◽  
M. A. J. van de Sande ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Giant Cell ◽  
Diffuse Type ◽  
Joint Function ◽  
Population Means ◽  
Sf 36 ◽  
Patient Reported ◽  
The Impact

Aims The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. Patients and Methods This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. Results A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years’ follow-up. Conclusion Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients’ daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272–280.

Patients With a History of Oronasal Fistula Repair Exhibit Lower Oral Health Measured With Patient-Centric Outcomes Measures

2020 ◽  
pp. 105566562098133
Author(s):  
Alyssa Fritz ◽  
Diana S. Jodeh ◽  
Fatima Qamar ◽  
James J. Cray ◽  
S. Alex Rottgers
Keyword(s):  
Quality Of Life ◽  
Oral Health ◽  
Cleft Palate ◽  
Fistula Repair ◽  
Old Patients ◽  
Oronasal Fistula ◽  
Patient Reported ◽  
History Of ◽  
The Impact

Introduction: Oronasal fistulae following palatoplasty may affect patients’ quality of life by impacting their ability to eat, speak, and maintain oral hygiene. We aimed to quantify the impact of previous oronasal fistula repair on patients’ quality of life using patient-reported outcome psychometric tools. Methods: A cross-sectional study of 8- to 9-year-old patients with cleft palate and/or lip was completed. Patients who had a cleft team clinic between September 2018 and August 2019 were recruited. Participants were divided into 2 groups (no fistula, prior fistula repair). Differences in the individual CLEFT-Q and Child Oral Health Impact Profile-Short Form 19 (COHIP-SF 19) Oral Health scores between the 2 groups were evaluated using a multivariate analysis controlling for Veau classification and syndromic diagnosis. Results: Sixty patients with a history of cleft palate were included. Forty-two (70%) patients had an associated cleft lip. Thirty-two (53.3%) patients had no history of fistula and 28 (46.7%) patients had undergone a fistula repair. CLEFT-Q Dental, Jaw, and Speech Function were all higher in patients without a history of a fistula repair; however, none of these differences were statistically significant. The COHIP-SF 19 Oral Health score demonstrated a significantly lower score in the fistula group, indicating poorer oral health ( P = .05). Conclusions: One would expect that successful repair of a fistula would result in improved function and patient satisfaction, but the consistent trend toward lower CLEFT-Q scores and significantly increased COHIP-SF 19 Oral Health scores in our study group suggests that residual effects linger and that the morbidity of a fistula may not be completely treated with a secondary correction.

scholarly journals Randomized Trial Assessing the Impact of Routine Assessment of Health-Related Quality of Life in Patients with Head and Neck Cancer

Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3826
Author(s):  
Oumar Billa ◽  
Franck Bonnetain ◽  
Jérôme Chamois ◽  
Angeline Ligey ◽  
Valérie Ganansia ◽  
...  
Keyword(s):  
Head And Neck ◽  
Satisfaction With Care ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
The Impact ◽  
Routine Assessment ◽  
Eq Vas

The impact of routine assessment of health-related quality of life (HRQoL) on satisfaction with care and the HRQoL of patients with head and neck cancer (HNC) treated with radiotherapy was assessed. Patients with HNC were randomly assigned to two arms, with stratification on sex, cancer localization, and stage of the disease. In the intervention arm, the patients completed the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires first before randomization, then before each medical appointment during radiotherapy (7 weeks), and then every 3 months until 1 year and at 2 years thereafter. In the control arm, the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires were completed before randomization and at 1 year and 2 years thereafter. The primary endpoint was mean change in HRQoL at score at 2 years from baseline assessed by EQ VAS from the EuroQol questionnaire. The secondary endpoint was mean change in satisfaction with care at 2 years from baseline assessed by QLQ-SAT32. Two hundred patients with head and neck cancers were involved in this study (mean age, 58.83 years (range, 36.56–87.89)), of whom 100 were assigned to the intervention arm and 100 to the control arm. Patients in the intervention arm were reported to have a statistically significant increase in EQ VAS at 2 years (p < 0.0001) and exceeded the minimal clinically important difference (mean change at 2 years from baseline = 10.46). In the two arms, mean differences between arms were not statistically significant, but minimal clinically important differences in favor of the intervention arm were found for EQ VAS (mean change difference (MD) = 5.84), satisfaction with care, in particular waiting times (MD = 10.85) and satisfaction with accessibility (MD = 6.52). Routine assessment of HRQoL improves HRQoL and satisfaction with care for patients with HNC treated with radiotherapy.

scholarly journals Vision-related quality of life in adults with severe peripheral vision loss: a qualitative interview study

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Ryan Lange ◽  
Abigail Kumagai ◽  
Sara Weiss ◽  
Katherine B. Zaffke ◽  
Sherry Day ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Contrast Sensitivity ◽  
Qualitative Interviews ◽  
Well Being ◽  
Vision Impairment ◽  
Qualitative Interview Study ◽  
Patient Reported ◽  
Related Quality ◽  
The Impact

Abstract Background Existing patient-reported outcome (PRO) measures may not be relevant to the full range of functional and vision-related quality of life (VR-QOL) concerns of individuals with vision impairment due to severe peripheral field loss (PFL). Measurement of VR-QOL in severe PFL is important in order to determine the effectiveness of vision rehabilitation interventions for this population. The purpose of this study was to characterize the impact of severe PFL due to retinitis pigmentosa (RP) and glaucoma on VR-QOL as the initial phase in the development of a novel PRO measure. Methods Individuals with severe PFL due to RP or glaucoma were recruited from the Kellogg Eye Center and the Association for the Blind and Visually Impaired. Participants completed semi-structured qualitative interviews, the Impact of Vision Impairment (IVI) questionnaire and the RAND 36-Item Health Survey. Interviews were analyzed by two coders using thematic analysis. A matrix analysis was conducted to compare VR-QOL by cause of severe PFL. Sample size was determined by thematic saturation. Results The study included 37 participants (19 RP, 18 glaucoma). Median best-corrected visual acuity for those with RP and glaucoma was 20/40 and 20/27.5, while Pelli-Robson contrast sensitivity was 1.2 log contrast sensitivity (logCS) and 1.1 logCS, respectively. Median domain scores on the IVI (reading, mobility, well-being) ranged from a low of − 0.2 to a high of 0.7 logits in those with RP and from 0.5 to 1.2 logits in those with glaucoma. Qualitative interviews identified six VR-QOL themes relevant across participants with both RP and glaucoma, including activity limitations, driving, emotional well-being, reading, mobility, and social function. VR-QOL concerns were largely consistent among those with severe PFL due to RP and glaucoma. These overarching themes contained content relevant to specific challenges related to severe PFL. Conclusions There are commonly occurring VR-QOL concerns among individuals with severe PFL due to RP and glaucoma. The outlined themes will serve as the basis for development of the Low Vision Severely Constricted Peripheral Eyesight (LV-SCOPE) Questionnaire.

scholarly journals Patient-reported quality-of-life outcomes in relation to provider-assessed adverse events during head and neck radiotherapy

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Joshua R. Niska ◽  
Cameron S. Thorpe ◽  
Michele Y. Halyard ◽  
Angelina D. Tan ◽  
Pamela J. Atherton ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Head And Neck ◽  
Life Outcomes ◽  
Quality Of Life Outcomes ◽  
Patient Reported ◽  
Head And Neck Radiotherapy

scholarly journals Quality of life assessments in clinical practice using either the EORTC-QLQ-C30 or the SEIOQL-DW: a randomized study

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Åsa Kettis ◽  
Hanna Fagerlind ◽  
Jan-Erik Frödin ◽  
Bengt Glimelius ◽  
Lena Ring
Keyword(s):  
Quality Of Life ◽  
Clinical Practice ◽  
Significant Difference ◽  
Patient Reported ◽  
Health Related Qol ◽  
Health Related ◽  
Secondary Outcomes ◽  
The Impact ◽  
Over Time

Abstract Background Effective patient-physician communication can improve patient understanding, agreement on treatment and adherence. This may, in turn, impact on clinical outcomes and patient quality of life (QoL). One way to improve communication is by using patient-reported outcome measures (PROMs). Heretofore, studies of the impact of using PROMs in clinical practice have mostly evaluated the use of standardized PROMs. However, there is reason to believe that individualized instruments may be more appropriate for this purpose. The aim of this study is to compare the effectiveness of the standardized QoL-instrument, the European Organization for Research and Treatment of Cancer Quality of Life C-30 (EORTC-QOL-C30) and the individualized QoL instrument, the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), in clinical practice. Methods In a prospective, open-label, controlled intervention study at two hospital out-patient clinics, 390 patients with gastrointestinal cancer were randomly assigned either to complete the EORTC-QOL-C30 or the SEIQoL-DW immediately before the consultation, with their responses being shared with their physician. This was repeated in 3–5 consultations over a period of 4–6 months. The primary outcome measure was patients’ health-related QoL, as measured by FACIT-G. Patients’ satisfaction with the consultation and survival were secondary outcomes. Results There was no significant difference between the groups with regard to study outcomes. Neither intervention instrument resulted in any significant changes in health-related QoL, or in any of the secondary outcomes, over time. This may reflect either a genuine lack of effect or sub-optimization of the intervention. Since there was no comparison to standard care an effect in terms of lack of deterioration over time cannot be excluded. Conclusions Future studies should focus on the implementation process, including the training of physicians to use the instruments and their motivation for doing so. The effects of situational use of standardized or individualized instruments should also be explored. The effectiveness of the different approaches may depend on contextual factors including physician and patient preferences.

Assessing the impact of chemotherapy-induced nausea and vomiting on patients’ quality of life: An Arabic version of the Functional Living Index-Emesis

2021 ◽  
pp. 107815522199844
Author(s):  
Abdullah M Alhammad ◽  
Nora Alkhudair ◽  
Rawan Alzaidi ◽  
Latifa S Almosabhi ◽  
Mohammad H Aljawadi
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Arabic Language ◽  
Nausea And Vomiting ◽  
Cancer Center ◽  
Arabic Version ◽  
Patient Reported ◽  
Arabic Speaking ◽  
The Impact

Introduction Chemotherapy-induced nausea and vomiting is a serious complication of cancer treatment that compromises patients’ quality of life and treatment adherence, which necessitates regular assessment. Therefore, there is a need to assess patient-reported nausea and vomiting using a validated scale among Arabic speaking cancer patient population. The objective of this study was to translate and validate the Functional Living Index-Emesis (FLIE) instrument in Arabic, a patient-reported outcome measure designed to assess the influence of chemotherapy-induced nausea and vomiting on patients’ quality of life. Methods Linguistic validation of an Arabic-language version was performed. The instrument was administered to cancer patients undergoing chemotherapy in a tertiary hospital's cancer center in Saudi Arabia. Results One-hundred cancer patients who received chemotherapy were enrolled. The participants’ mean age was 53.3 ± 14.9 years, and 50% were female. Half of the participants had a history of nausea and vomiting with previous chemotherapy. The Cronbach coefficient alpha for the FLIE was 0.9606 and 0.9736 for nausea and vomiting domains, respectively, which indicated an excellent reliability for the Arabic FLIE. The mean FLIE score was 110.9 ± 23.5, indicating no or minimal impact on daily life (NIDL). Conclusions The Arabic FLIE is a valid and reliable tool among the Arabic-speaking cancer population. Thus, the Arabic version of the FLIE will be a useful tool to assess the quality of life among Arabic speaking patients receiving chemotherapy. Additionally, the translated instrument will be a useful tool for future research studies to explore new antiemetic treatments among cancer patients.

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