scholarly journals Association Between Music Therapy Techniques and Patient-Reported Moderate to Severe Fatigue in Hospitalized Adults With Cancer

2020 ◽  
Vol 16 (12) ◽  
pp. e1553-e1557 ◽  
Author(s):  
Thomas M. Atkinson ◽  
Kevin T. Liou ◽  
Michael A. Borten ◽  
Qing S. Li ◽  
Karen Popkin ◽  
...  
Keyword(s):  
Music Therapy ◽  
Positive Affect ◽  
Care Utilization ◽  
Inpatient Setting ◽  
Free Text ◽  
Cross Sectional ◽  
Cancer Disease ◽  
Cancer Related Fatigue ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale

PURPOSE: Cancer-related fatigue is a prevalent, debilitating symptom that contributes to increased health care utilization among hospitalized patients. Music therapy is a nonpharmacological intervention that uses active (eg, singing, selecting songs) and passive (eg, listening) techniques. Preliminary evidence from small trials suggests a potential benefit for cancer-related fatigue in the inpatient setting; however, it remains unclear which techniques are most effective. METHODS: A cross-sectional mixed-methods study was performed to compare cancer-related fatigue before and after active or passive music therapy. Cancer-related fatigue was captured via the Edmonton Symptom Assessment Scale fatigue item. Patients were asked to provide postsession free-text comments. RESULTS: A total of 436 patients (mean [standard deviation] age, 62.2 [13.4] years; n = 284 [65.1%] women; n = 294 [67.4%] white; active music therapy n = 360 [82.6%]; passive music therapy n = 76 [17.4%]) with a range of primary malignancies participated. Active music therapy was associated with a 0.88-point greater reduction in cancer-related fatigue (95% CI, 0.26 to 1.51; P = .006; Cohen’s D, 0.52) at postsession as compared with passive music therapy when restricting the analysis to patients who rated their baseline cancer-related fatigue as moderate to severe (ie, ≥ 4; n = 236 [54.1%]). Free-text responses confirmed higher frequencies of words describing positive affect/emotion among active music therapy participants. CONCLUSIONS: In a large sample of inpatient adults with diverse cancer disease types, active music therapy was associated with greater reduction in cancer-related fatigue and increased reporting of positive affect/emotions compared with passive music therapy. Additional research is warranted to determine the specific efficacy and underlying mechanisms of music therapy on cancer-related fatigue.

scholarly journals Patient-Reported Use of the After Visit Summary in a Primary Care Internal Medicine Practice

2019 ◽  
Vol 7 (5) ◽  
pp. 703-707
Author(s):  
Sarita Pathak ◽  
Gregory Summerville ◽  
Celia P Kaplan ◽  
Sarah S Nouri ◽  
Leah S Karliner
Keyword(s):  
Primary Care ◽  
Multivariable Analysis ◽  
Free Text ◽  
Primary Care Visit ◽  
Communication Tool ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Care Visit ◽  
Patient Reported ◽  
Communication Errors

Participants completed a cross-sectional survey about their use of the after visit summary (AVS) at a previous primary care visit. Of 355 participants, 294 (82.8%) recalled receiving it, 67.4% consulted it, 45.9% consulted it more than once, and 31.6% shared the AVS. In multivariable analysis, higher education and older age were associated with AVS consultation. Among the subset of 133 patients recalling personalized free-text instructions, 96% found them easy to understand and 94.4% found them useful. Our findings suggest that the AVS is a useful communication tool and improvement efforts should emphasize clarity for those most vulnerable to communication errors.

scholarly journals Vitamin D Levels: Associations with Acute Pain Events and Self-Reported Pain in Children with Sickle Cell Disease

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3089-3089
Author(s):  
Latika Puri ◽  
Nicole M Alberts ◽  
Guolian Kang ◽  
Juan Ding ◽  
Jane S Hankins ◽  
...  
Keyword(s):  
Vitamin D ◽  
Sickle Cell Disease ◽  
Vitamin D Deficiency ◽  
Sickle Cell ◽  
Care Utilization ◽  
Cell Disease ◽  
Cross Sectional ◽  
Vitamin D Levels ◽  
Patient Reported ◽  
Deficient Group

Abstract Background/Aims: Individuals with sickle cell disease (SCD) are at high risk for vitamin D deficiency due to dark skin color, limited physical activity, poor nutrition, and renal dysfunction. In smaller retrospective studies, vitamin D deficiency in SCD was associated with increased frequency of acute pain events and higher opioid use, however the impact of vitamin D deficiency on pain related patient reported outcomes has not been described . Supplementation with high dose vitamin D is shown to be associated with fewer pain days per week and higher physical activity scores in patients with chronic pain. Thus, the objective of our study was to evaluate relationship between vitamin D levels, acute health care utilization and self-reported pain among children with SCD. We hypothesized that vitamin D deficiency is associated with increase health care utilization for pain and patient-reported outcomes for pain. Methods: Patients with SCD (1 to 18 years of age), enrolled in Sickle Cell Clinical Research and Intervention Program (SCCRIP), at St. Jude Children's Research Hospital were included in the study (Hankins et.al., Pediatric Blood and Cancer, 2018). Demographic, clinical and laboratory data were extracted from SCCRIP database. Prospective pain event leading to a hospital visit was analyzed. We analyzed pain-related hospitalizations in two ways: the number of pain-related hospitalizations within 2 years prior to and after vitamin D measurement in a cross-sectional design and longitudinally. Generalized linear regression model was used to examine associations between vitamin D and cross-sectional pain events with adjusting for hydroxyurea use. Generalized linear mixed effect model was used to assess the associations between vitamin D and longitudinal pain events, with adjusting for SCD genotype, sex, age, hydroxyurea use and interaction between age and hydroxyurea use. Pediatric Quality of Life Inventory™ Sickle Cell Disease Module (PedsQL™ SCD) was used to measure pain and pain interference using 1) Pain and Hurt and 2) Pain Impact scales. PedsQL™ SCD assessments include a Likert response scale. Items are reverse -scored and transformed to a 0-100 scale where higher scores indicate better health related quality of life in that scale. Two sample t-test or Wilcoxon rank sum test was used to compare mean scores between the two groups. Results: A total of 799 patients (females, n=398; males, n=401) were included in the study. Mean age (Standard Deviation [SD]), range at time of first vitamin D measurement for entire cohort was 8.7 (4.7), (0.8-18 years). Mean (SD) initial vitamin D level for entire cohort was 19.0 (9.4) ng/dl. Mean (SD) number of pain-related hospitalizations within two years of first vitamin D measurement was higher in the vitamin D deficient group as compared to non deficient group [0.81(1.97) vs 0.66 (1.2), (p=0.0034)]. Longitudinal data analyses showed vitamin D deficiency was associated with increased number of pain related hospitalizations (p=0.0091), after adjusting for covariates listed above (Figure 1a). Mean (SD) scores for Pain and Hurt in vitamin D deficient versus non deficient group were [74.5.7(18.2) versus 83.5(15.6), p < 0.001]. Mean (SD) scores for Pain Impact in vitamin D deficient group as compared to non deficient group were [(66.7 (22.7) versus 75.5 (22.3), p <0.001] (Figure 1b) Conclusion: Results indicated that low vitamin D levels predicted higher frequency of painful events leading to a hospital visit and were associated with higher prevalence of self-reported pain and pain interference. Further studies evaluating mechanisms by which vitamin D influences sickle cell pain are warranted and larger controlled trials can help evaluate the therapeutic efficacy of vitamin D for sickle cell pain. Figure 1 Figure 1. Disclosures Hankins: UpToDate: Consultancy; Bluebird Bio: Consultancy; Vindico Medical Education: Consultancy; Global Blood Therapeutics: Consultancy.

scholarly journals Computer-assisted textual analysis of free-text comments in the Swiss Cancer Patient Experiences (SCAPE) survey

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Chantal Arditi ◽  
Diana Walther ◽  
Ingrid Gilles ◽  
Saphir Lesage ◽  
Anne-Claude Griesser ◽  
...  
Keyword(s):  
Cancer Patient ◽  
Cancer Care ◽  
Textual Analysis ◽  
Questionnaire Development ◽  
Patient Experiences ◽  
Computer Assisted ◽  
Free Text ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Patient Reported

Abstract Background Patient experience surveys are increasingly conducted in cancer care as they provide important results to consider in future development of cancer care and health policymaking. These surveys usually include closed-ended questions (patient-reported experience measures (PREMs)) and space for free-text comments, but published results are mostly based on PREMs. We aimed to identify the underlying themes of patients’ experiences as shared in their own words in the Swiss Cancer Patient Experiences (SCAPE) survey and compare these themes with those assessed with PREMs to investigate how the textual analysis of free-text comments contributes to the understanding of patients’ experiences of care. Methods SCAPE is a multicenter cross-sectional survey that was conducted between October 2018 and March 2019 in French-speaking parts of Switzerland. Patients were invited to rate their care in 65 closed-ended questions (PREMs) and to add free-text comments regarding their cancer-related experiences at the end of the survey. We conducted computer-assisted textual analysis using the IRaMuTeQ software on the comments provided by 31% (n = 844) of SCAPE survey respondents (n = 2755). Results We identified five main thematic classes, two of which consisting of a detailed description of ‘cancer care pathways’. The remaining three classes were related to ‘medical care’, ‘gratitude and praise’, and the way patients lived with cancer (‘cancer and me’). Further analysis of this last class showed that patients’ comments related to the following themes: ‘initial shock’, ‘loneliness’, ‘understanding and acceptance’, ‘cancer repercussions’, and ‘information and communication’. While closed-ended questions related mainly to factual aspects of experiences of care, free-text comments related primarily to the personal and emotional experiences and consequences of having cancer and receiving care. Conclusions A computer-assisted textual analysis of free-text in our patient survey allowed a time-efficient classification of free-text data that provided insights on the personal experience of living with cancer and additional information on patient experiences that had not been collected with the closed-ended questions, underlining the importance of offering space for comments. Such results can be useful to inform questionnaire development, provide feedback to professional teams, and guide patient-centered initiatives to improve the quality and safety of cancer care.

scholarly journals Remote Mentoring Optimizes Virtual Collection of Patient-Reported Data: A Prospective Cohort Study with Adaptive Design Conducted in COVID-19 Era.

2021 ◽  
Author(s):  
Karineh Kazazian ◽  
Jessica Bogach ◽  
Wendy Johnston ◽  
Deanna Ng ◽  
Carol J. Swallow
Keyword(s):  
Cohort Study ◽  
Adaptive Design ◽  
Negative Impact ◽  
Surgical Oncology ◽  
Active Management ◽  
Hard Copy ◽  
Study Cohort ◽  
Cross Sectional ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale

Abstract Prior to the COVID-19 pandemic, patients attending ambulatory clinics at cancer centers in Ontario completed the Edmonton Symptom Assessment Scale (ESAS) at each visit. At our center, completion was via touch pad, with assistance by clinic volunteers. As of March 2020, clinic appointments were conducted virtually when possible and touch pads removed. We anticipated a negative impact on the collection of patient-reported outcomes (PROs), and the recognition of severe symptoms. Methods: We performed a prospective cross-sectional cohort study to test the feasibility of remote ESAS completion by patients with appointments at a weekly surgical oncology clinic. Patients in the initial study cohort were asked to complete and return the ESAS virtually(V). Given low completion rates, the ensuing cohort was asked to complete a hard-copy(HC) ESAS. For the final cohort, we used an adaptive approach, providing remote, personal mentorship by a member of the care team to support virtual electronic ESAS completion (virtual-mentored(VM) cohort). Results: Between May-July 2020, a total of 174 patient encounters were included in the study. For the V cohort, 20/46 patients (44%) successfully completed and returned the electronic ESAS, compared to 49/50 (98%) for the HC cohort. For the VM cohort (n=78), the completion rate was 74%. Questionnaire completion was not predicted by age, sex or tumor site, although patients who completed the ESAS were more likely to be in active management rather than surveillance(p=0.04). Of all completed forms, 42% revealed a depression score ³2, and 27% an anxiety score ³4. Conclusions: We identified significant barriers to the virtual completion of ESAS forms, with a lack of predictive variables. The severe degree of psychological distress reported by ~50% of respondents demonstrates the need for ongoing regular collection/review of these data. Innovative solutions are required to overcome barriers to virtual collection of PROs.

Implementation of virtual mentoring to optimize collection of patient-reported data in the COVID-19 era: A prospective cohort study with adaptive design.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24091-e24091
Author(s):  
Karineh Kazazian ◽  
Jessica Bogach ◽  
Wendy Johnston ◽  
Carol Jane Swallow
Keyword(s):  
Cohort Study ◽  
Adaptive Design ◽  
Completion Rate ◽  
Hard Copy ◽  
Cancer Center ◽  
Study Cohort ◽  
Tumor Site ◽  
Cross Sectional ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale

e24091 Background: Prior to the COVID-19 pandemic, all patients attending ambulatory clinic at cancer centers in Ontario, Canada completed the Edmonton Symptom Assessment Scale (ESAS), as per governmental cancer agency mandate. At our center, completion was via touch pad, with assistance by clinic volunteers. As of mid-March 2020, clinic appointments were conducted virtually whenever possible, and touch pads removed from clinic. Our purpose here was to explore how these changes impacted the collection of patient-reported outcomes, in particular the recognition of severe symptoms. Methods: We performed a prospective cross-sectional cohort study to test the feasibility of remote completion of the ESAS by patients scheduled for appointments at a weekly surgical oncology clinic at a major cancer center. Patients were identified serially based on date of clinic appointment. Patients in the initial study cohort were asked to complete and return the ESAS virtually (V). Given low completion rates, the ensuing study cohort was asked to complete a hard-copy (HC) ESAS. For the final cohort, we used an adaptive approach, providing remote, personal mentoring by a member of the health care team to support virtual ESAS completion (virtual-mentored, VM). Results: Between May-July 2020, a total of 174 patients were included in the study: 53% were female, and median age was 62 (19-90) yrs. Age, gender and tumor site did not differ between the three cohorts. For the V cohort, 20/43 patients successfully completed and returned the ESAS electronically (completion rate 44%). For the HC cohort, 49/50 completed the form (98%). For the VM cohort (n=78), the completion rate was 74%. Questionnaire completion was not predicted by age, gender or tumor site, although patients who completed the ESAS were more likely to be under active investigation/treatment vs. surveillance (p=.04). Of the 127 ESAS forms completed in all patient cohorts, 117 reported at least 1 symptom score ≥1. There were no significant differences in individual symptom scores (e.g. tiredness, wellbeing-see Table) reported between cohorts. Of all completed forms, 42% had a depression score ≥2 and 27% an anxiety score ≥4, indicating significant psychosocial distress. Conclusions: We have identified significant barriers to the virtual completion of ESAS forms, with lack of predictive variables. The severe degree of psychological distress reported by ̃50% of respondents demonstrates the need for ongoing regular collection and review of these data.[Table: see text]

Patient-reported symptoms obtained through telephonic nursing services in an oncology disease management program.

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 147-147
Author(s):  
Deb Harrison ◽  
Melissa Jameson ◽  
Janet L. Espirito ◽  
Robyn K. Harrell ◽  
Matthew Clayton ◽  
...  
Keyword(s):  
Disease Management ◽  
Acute Care ◽  
Disease Management Program ◽  
Repeated Measures ◽  
Management Program ◽  
Care Utilization ◽  
Significant Difference ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale ◽  
Acute Care Utilization

147 Background: Telephonic nursing (RN) outreach was provided as part of an oncology disease management program to provide symptom (sx) management education, assess patient-reported sxs during treatment (tx), and reduce acute care utilization. The Edmonton Symptom Assessment Scale (ESAS) was used to assess sx severity in patients (pts) receiving active chemotherapy. Methods: ESAS scores were obtained at scheduled intervals and documented in the electronic health record for eligible pts receiving chemotherapy between 6/2010-12/2012. Participation was voluntary. Pts were categorized according to cancer diagnosis (dx) and tx setting (early vs. advanced). Repeated measures logistic regression analysis was used to test for differences in ESAS scores between dx and tx settings. Results: 365 pts had 2,198 calls with ESAS scores. Mean age was 53 yrs, 67% female, 33% male. Pts were managed an average of 97 days and received on avg 6 calls/pt. The majority of pts had breast, colon, and non-small cell lung (NSCL) cancer (74%). Of these pts, the most frequent reported sx of any severity other than zero during post-tx calls were for mild/moderate tiredness, appetite, and pain. There was no evidence of a significant difference in the severity of sxs by tx setting in these cohorts; p=NS. One hundred and nine breast, colon, and NSCL pts (40%) received additional unscheduled calls based on sx scores or RN assessment. Outcomes related to acute care utilization are being evaluated. Conclusions: Pt reported sxs obtained through telephonic RN support demonstrated mild/moderate ESAS scores for mainly tiredness, appetite, and pain. This is lower than previously reported in different contexts. Regular RN contact as a supplement to clinic visits may help reduce sx severity. While the ESAS tool is traditionally used for palliative care, in this active tx setting it supported identification of sxs for referrals back to the practice with the goal to reinforce education and avoid acute care utilization. [Table: see text]

Utilizaton of patient reported outcomes measures (PROM) to characterize symptom burden and adherence associated with oral oncolytic therapy.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 210-210
Author(s):  
Emily R. Mackler ◽  
Taylor Weis ◽  
Kelly Marie Procailo ◽  
Vincent D. Marshall ◽  
Karen B. Farris
Keyword(s):  
Medication Adherence ◽  
Cancer Treatment ◽  
Symptom Burden ◽  
Symptom Assessment ◽  
Self Management ◽  
Improve Medication Adherence ◽  
Cross Sectional ◽  
Oncolytic Therapy ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale

210 Background: The use of patient reported outcome measures (PROMs) to monitor cancer treatment tolerability has been shown to positively impact outcomes. The purpose of this study was to characterize the incidence and severity of side effects, patient self-management confidence, and medication adherence in patients receiving oral oncolytic therapy. Methods: This multicenter, cross-sectional, observational study was conducted across 6 Michigan oncology practices from July 2016-December 2018. Patients were eligible to complete PROMs during the course of their treatment if they were receiving an oral oncolytic medication (excluding endocrine therapy). Results: There were a total of 2252 PROMs completed in 695 patients. Patients were 48% female, a median age of 69 years, and most commonly receiving treatment with capecitabine (18%), palbociclib (10%), and lenalidomide (9%). 54% of PROMs had at least one Edmonton Symptom Assessment Scale (ESAS) symptom rated as moderate or severe. Patients indicated the presence of a most bothersome symptom (MBS) in 35% of PROMs. Most common MBSs were fatigue (26%), pain (16%), constitutional symptoms other than fatigue (15%), and nausea/vomiting (14%). Non-adherence was reported in 20% of PROMs. ESAS symptoms rated as moderate or severe, the presence of a MBS, and lower confidence scores all correlated with medication non-adherence. Conclusions: Patients taking oral oncolytics for their cancer treatment experience a high symptom burden with more than 50% experiencing a moderate to severe symptom. Optimizing symptom management and providing patient education that increases patient confidence in self-management may improve medication adherence and patient outcomes.

scholarly journals “Can Someone as Young as You Really Feel That Much Pain?” – A Survey on How People With Fibromyalgia Experience Healthcare in Sweden

2021 ◽  
Vol 7 ◽  
pp. 237796082110261
Author(s):  
Rebecka Hasselroth ◽  
Gunilla Björling ◽  
Carina Faag ◽  
Catarina Nahlén Bose
Keyword(s):  
Health Care ◽  
Health Care Personnel ◽  
Healthcare Personnel ◽  
Free Text ◽  
Cross Sectional ◽  
Patient Reported ◽  
Poor Treatment ◽  
Cross Sectional Design ◽  
Experience Measure ◽  
Research Show

Background Research show that fibromyalgia has low credibility in healthcare, leading to poor treatment, lack of knowledge and disinterest. Therefore, people with fibromyalgia feel frustration, fear, anxiety and disappointment. Objective: The aim of this study was to explore the experiences of people with fibromyalgia in their encounters with healthcare personnel in Sweden. Method: A cross-sectional design, where 409 people with fibromyalgia answered an anonymous online patient-reported experience measure, developed specific for the study, with six closed questions and one open-ended question. Descriptive statistics were analysed by response frequencies. Correlation analysis were performed between demographic and clinical variables with the answers from the closed questions. Free-text answers were analysed with content analysis. Results: A third experienced the treatment as bad (34%) and that they were not being taken seriously (30.5%). Almost half (47%) always or mostly felt fear of seeking healthcare related to fibromyalgia and that the health care personnel did not understand their diagnosis (46%). The majority (54%) experienced that the health care personnel did not understand how fibromyalgia affected them or how they could help them. The findings were confirmed in the free-text answers that were categorized into: Scepticism and disregard, Ignorance and disinterest and Professionalism and empathy. There were positive significant correlations between age and five of the questions (ρ = .105–.181, p < .05–p < .01), indicating that lower age is correlated with a worse experience. Furthermore, the duration of fibromyalgia showed a significant correlation with feeling afraid of seeking healthcare because of fibromyalgia (ρ = .144, p < .01), the shorter duration, the greater was the fear of seeking healthcare. Conclusion: As a third of patients with fibromyalgia had bad experiences with healthcare, especially younger patients, knowledge about fibromyalgia needs to be increased and the patients should be taken seriously and treated respectfully, as well as given adequate support.

scholarly journals Assessment of Patients’ Ability to Review Electronic Health Record Information to Identify Potential Errors: Cross-sectional Web-Based Survey

10.2196/19074 ◽  
2021 ◽  
Vol 5 (2) ◽  
pp. e19074
Author(s):  
Lisa Freise ◽  
Ana Luisa Neves ◽  
Kelsey Flott ◽  
Paul Harrison ◽  
John Kelly ◽  
...  
Keyword(s):  
Information Exchange ◽  
Personal Health Information ◽  
Free Text ◽  
Patient Portal ◽  
Medical Terminology ◽  
Framework Analysis ◽  
Cross Sectional ◽  
Web Based ◽  
Patient Reported ◽  
Electronic Health

Background Sharing personal health information positively impacts quality of care across several domains, and particularly, safety and patient-centeredness. Patients may identify and flag up inconsistencies in their electronic health records (EHRs), leading to improved information quality and patient safety. However, in order to identify potential errors, patients need to be able to understand the information contained in their EHRs. Objective The aim of this study was to assess patients’ perceptions of their ability to understand the information contained in their EHRs and to analyze the main barriers to their understanding. Additionally, the main types of patient-reported errors were characterized. Methods A cross-sectional web-based survey was undertaken between March 2017 and September 2017. A total of 682 registered users of the Care Information Exchange, a patient portal, with at least one access during the time of the study were invited to complete the survey containing both structured (multiple choice) and unstructured (free text) questions. The survey contained questions on patients’ perceived ability to understand their EHR information and therefore, to identify errors. Free-text questions allowed respondents to expand on the reasoning for their structured responses and provide more detail about their perceptions of EHRs and identifying errors within them. Qualitative data were systematically reviewed by 2 independent researchers using the framework analysis method in order to identify emerging themes. Results A total of 210 responses were obtained. The majority of the responses (123/210, 58.6%) reported understanding of the information. The main barriers identified were information-related (medical terminology and knowledge and interpretation of test results) and technology-related (user-friendliness of the portal, information display). Inconsistencies relating to incomplete and incorrect information were reported in 12.4% (26/210) of the responses. Conclusions While the majority of the responses affirmed the understanding of the information contained within the EHRs, both technology and information-based barriers persist. There is a potential to improve the system design to better support opportunities for patients to identify errors. This is with the aim of improving the accuracy, quality, and timeliness of the information held in the EHRs and a mechanism to further engage patients in their health care.

scholarly journals Combination Therapy of Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Phase II Randomized Double-Blind Controlled Trial

2021 ◽  
pp. 1-9
Author(s):  
Sriram Yennurajalingam ◽  
Vicente Valero ◽  
Zhanni Lu ◽  
Diane D. Liu ◽  
Naifa L. Busaidy ◽  
...  
Keyword(s):  
Physical Activity ◽  
Combination Therapy ◽  
Advanced Cancer ◽  
Phase Ii ◽  
Functional Assessment ◽  
Effect Size ◽  
Controlled Trial ◽  
Cancer Related Fatigue ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale

Background: Despite the high frequency of cancer-related fatigue (CRF) and its debilitating effects on the quality of life of patients with advanced cancer, there are limited treatment options available. Treatments including physical activity (PA) or dexamethasone (Dex) improve CRF; however, they have lower adherence rates (PA) or long-term adverse effects (Dex). The aim of this study was to determine the feasibility of and preliminary results for the combination of PA and Dex in improving CRF. Methods: In this phase II randomized controlled trial, patients with advanced cancer and CRF scores of ≥4/10 on the Edmonton Symptom Assessment Scale were eligible. Patients were randomized to standardized PA for 4 weeks with either 4 mg of Dex (LoDex arm) or 8 mg of Dex (HiDex arm) twice a day for 7 days. Feasibility and change in the Functional Assessment of Cancer Illness Therapy-Fatigue subscale (FACIT-F) from baseline to day 8 and day 29 (primary outcome) were assessed. Secondary outcomes included changes in fatigue dimensions (FACIT-General, Patient-Reported Outcomes Measurement Information System [PROMIS]-Fatigue). Results: A total of 60 of 67 (90%) patients were evaluable. All patients were adherent to study medication. We found that 84% and 65% of patients in the LoDex arm and 96% and 68% of patients in the HiDex arm were adherent to aerobic and resistance exercise, respectively. The FACIT-F effect size in the LoDex arm was 0.90 (P<.001) and 0.92 (P<.001) and the effect size in the HiDex arm was 0.86 and 1.03 (P<.001 for both) at days 8 and 29, respectively. We found significant improvements in the Functional Assessment of Cancer Therapy-Physical (P≤.013) and the PROMIS-Fatigue (P≤.003) at days 8 and 29 in both arms. Mixed-model analysis showed a significant improvement in the FACIT-F scores at day 8 (P<.001), day 15 (P<.001), and day 29 (P=.002). Changes in the FACIT-F scores were not significantly different between patients in the 2 arms (P=.86). Conclusions: Our study found that the combination therapy of PA with Dex was feasible and resulted in the improvement of CRF. The improvement was seen for up to 3 weeks after the discontinuation of Dex. Further larger studies are justified. ClinicalTrials.gov identifier: NCT02491632.

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