9 research outputs found
Patient satisfaction while enrolled in clinical trials: A literature review
Patient satisfaction surveys may not adequately reflect organizations that conduct research in patients who enroll in clinical trials. The purpose of this systematic literature review was to summarize the current state of knowledge of patient satisfaction while enrolled in clinical trials utilizing a widely used, validated patient satisfaction instrument. A comprehensive literature search was conducted using CINAHL, EMBASE, PsycInfo, PubMed and Web of Science. Studies were evaluated in terms of clinical trial participation; assessment conducted during or after participation; utilization of a validated instrument; a pharmacological intervention; and the paper was published in English. Only nine studies met this review’s inclusion criteria. Eight studies utilized investigator-developed patient satisfaction instruments and only one study used a widely-used, validated patient satisfaction instrument. Two studies evaluated patient satisfaction during the development of the instrument. Of the nine studies identified, only five patient satisfaction domains were common across the studies and only study evaluated the associations of patient satisfaction responses with clinical outcomes. Given the importance of patient satisfaction surveys, future studies need to focus on this subset of patients enrolled in clinical trials to evaluate a patient’s experience and its impact on protocol compliance and protocol outcomes. Future studies need to focus on domains associated with clinical trial participation and look beyond the current patients’ general expectations about healthcare accessibility, facilities, healthcare team clinical skills, and their ability to focus and listen to the patients’ concerns.
Experience Framework
This article is associated with the Policy & Measurement lens of The Beryl Institute Experience Framework. (https://www.theberylinstitute.org/ExperienceFramework). Access other PXJ articles related to this lens. Access other resources related to this lens
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A Review of the Literature on Multiple Co-occurring Symptoms in Patients With Colorectal Cancer Who Received Chemotherapy Alone or Chemotherapy With Targeted Therapies.
BackgroundPatients with colorectal cancer (CRC) rarely experience a single symptom associated with their disease and its treatment.ObjectivePurpose of this literature review was to summarize the current state of knowledge of multiple co-occurring symptoms in CRC patients who received chemotherapy (CTX) alone or CTX with targeted therapies.MethodsComprehensive literature search was conducted from 1990 to 2014. These studies were evaluated in terms of the occurrence of multiple co-occurring symptoms in CRC patients who received CTX alone or CTX with targeted therapies; the most common symptom assessment and quality of life (QOL) instruments used; and the associations identified between select demographic and treatment characteristics, QOL, and multiple co-occurring symptoms.ResultsOnly 5 studies met this review's inclusion criteria. Two studies compared symptoms in patients who received CTX alone or CTX with targeted therapies, and only 1 study reported on symptom occurrence. Of the 5 studies identified, only 2 used the same instrument to assess symptoms, and only 2 studies evaluated for associations between demographic and treatment characteristics and symptom burden, as well as QOL outcomes.ConclusionsGiven the larger number of patients with CRC, as well as the increased number of CRC patients who will receive targeted therapies with or without CTX, future studies need to describe the occurrence, severity, and distress of multiple co-occurring symptoms and their impact on CRC patients' QOL.Implications for practiceTo deliver effective symptom management interventions, the most common, severe, and distressing symptoms that CRC patients experience need to be identified
A Review of the Literature on Multiple Co-occurring Symptoms in Patients With Colorectal Cancer Who Received Chemotherapy Alone or Chemotherapy With Targeted Therapies.
BackgroundPatients with colorectal cancer (CRC) rarely experience a single symptom associated with their disease and its treatment.ObjectivePurpose of this literature review was to summarize the current state of knowledge of multiple co-occurring symptoms in CRC patients who received chemotherapy (CTX) alone or CTX with targeted therapies.MethodsComprehensive literature search was conducted from 1990 to 2014. These studies were evaluated in terms of the occurrence of multiple co-occurring symptoms in CRC patients who received CTX alone or CTX with targeted therapies; the most common symptom assessment and quality of life (QOL) instruments used; and the associations identified between select demographic and treatment characteristics, QOL, and multiple co-occurring symptoms.ResultsOnly 5 studies met this review's inclusion criteria. Two studies compared symptoms in patients who received CTX alone or CTX with targeted therapies, and only 1 study reported on symptom occurrence. Of the 5 studies identified, only 2 used the same instrument to assess symptoms, and only 2 studies evaluated for associations between demographic and treatment characteristics and symptom burden, as well as QOL outcomes.ConclusionsGiven the larger number of patients with CRC, as well as the increased number of CRC patients who will receive targeted therapies with or without CTX, future studies need to describe the occurrence, severity, and distress of multiple co-occurring symptoms and their impact on CRC patients' QOL.Implications for practiceTo deliver effective symptom management interventions, the most common, severe, and distressing symptoms that CRC patients experience need to be identified
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Quality of life of patients with gastrointestinal cancers undergoing chemotherapy.
PurposeFindings regarding changes in the quality of life (QOL) of patients with gastrointestinal cancers (GI) undergoing chemotherapy (CTX) are inconclusive. Purpose was to evaluate for changes in QOL scores of patients with GI cancers over two cycles of CTX.MethodsPatients (n = 397) completed disease-specific [i.e., Quality of Life-Scale-Patient Version (QOL-PV)] and generic [12-item Medical Outcomes Study Short Form Survey (SF-12)] measures of QOL a total of six times over two cycles of CTX. Changes in these QOL scores were evaluated using bootstrapped multilevel regression with full information maximum likelihood estimation. Treatment group (i.e., with or without targeted therapy), age, number of metastatic sites, time from cancer diagnosis, number of prior cancer treatments, GI cancer diagnosis (i.e., colon/rectum/anal vs. other), and CTX regimen were evaluated as covariates in the conditional models for each of the QOL scores.ResultsDuring the second cycle of CTX, QOL-PV scores decreased in the week following CTX administration, and then increased the following week. For both cycles of CTX, the physical component summary and mental component summary scores of the SF-12 decreased in the week following CTX administration and then increased the following week. Increased time from cancer diagnosis and a higher number of prior cancer treatments resulted in worse QOL-PV and SF-12 scores at enrollment.ConclusionsWhile changes in QOL scores over the two CTX cycles were statistically significant, the differences were not clinically meaningful. Future studies need to determine the optimal timing of QOL assessments to assess changes associated with cancer treatments
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Quality of life of patients with gastrointestinal cancers undergoing chemotherapy.
PurposeFindings regarding changes in the quality of life (QOL) of patients with gastrointestinal cancers (GI) undergoing chemotherapy (CTX) are inconclusive. Purpose was to evaluate for changes in QOL scores of patients with GI cancers over two cycles of CTX.MethodsPatients (n = 397) completed disease-specific [i.e., Quality of Life-Scale-Patient Version (QOL-PV)] and generic [12-item Medical Outcomes Study Short Form Survey (SF-12)] measures of QOL a total of six times over two cycles of CTX. Changes in these QOL scores were evaluated using bootstrapped multilevel regression with full information maximum likelihood estimation. Treatment group (i.e., with or without targeted therapy), age, number of metastatic sites, time from cancer diagnosis, number of prior cancer treatments, GI cancer diagnosis (i.e., colon/rectum/anal vs. other), and CTX regimen were evaluated as covariates in the conditional models for each of the QOL scores.ResultsDuring the second cycle of CTX, QOL-PV scores decreased in the week following CTX administration, and then increased the following week. For both cycles of CTX, the physical component summary and mental component summary scores of the SF-12 decreased in the week following CTX administration and then increased the following week. Increased time from cancer diagnosis and a higher number of prior cancer treatments resulted in worse QOL-PV and SF-12 scores at enrollment.ConclusionsWhile changes in QOL scores over the two CTX cycles were statistically significant, the differences were not clinically meaningful. Future studies need to determine the optimal timing of QOL assessments to assess changes associated with cancer treatments
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Differences in symptom occurrence, severity, and distress ratings between patients with gastrointestinal cancers who received chemotherapy alone or chemotherapy with targeted therapy.
BackgroundApproximately 28% of patients with gastrointestinal (GI) cancers will receive targeted therapy (TT) because of the associated increases in survival. Only four studies have examined the symptom experience of these patients. To date, no studies have evaluated for differences in symptom occurrence, severity, and distress between patients who received chemotherapy (CTX) alone (n=304) or CTX with TT (n=93).MethodsPatients completed self-report questionnaires, approximately one week after they received CTX. A modified version of the Memorial Symptom Assessment Scale (MSAS) was used to obtain data on symptom occurrence, severity, and distress. Binary logistic regression analyses were used to test for differences in symptom occurrence rates between the two treatment groups. Ordinal logistic regression analyses were used to test for differences in severity and distress ratings between the two treatment groups.ResultsPatients who received CTX with TT were significantly younger (P=0.009); were diagnosed with cancer longer (P=0.004); had a higher number of prior treatments (P=0.024); had metastatic disease, specifically to the liver (P<0.001); had a diagnosis of anal, colon, rectum, or colorectal cancer (CRC) (P<0.001); and were positive for detection of B-Raf proto-oncogene, serine/threonine kinase (BRAF) and Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations (both P<0.001). In addition, CTX treatment regimens were significantly different between the two groups (P<0.001). After controlling for significant covariates, patients who received TT reported lower occurrence rates for lack of energy, cough, feeling drowsy, and difficulty sleeping (all, P<0.05). Patients who received TT reported lower severity scores for dry mouth (P=0.034) and change in the way food tastes (P=0.035). However, they reported higher severity scores for "I don't look like myself" (P=0.026). No differences in symptom distress scores were found between the two treatment groups.ConclusionsThis study is the first to evaluate for differences in the symptom experience of GI cancer patients who received CTX alone or CTX with TT using a multidimensional symptom assessment scale. While between group differences in patients' symptom experiences were identified, both treatment groups warrant ongoing assessments to optimally manage their symptoms
Changes in the Occurrence, Severity, and Distress of Symptoms in Patients With Gastrointestinal Cancers Receiving Chemotherapy.
ContextStudies on multiple dimensions of the symptom experience of patients with gastrointestinal cancers are extremely limited.ObjectivePurpose was to evaluate for changes over time in the occurrence, severity, and distress of seven common symptoms in these patients.MethodsPatients completed Memorial Symptom Assessment Scale, six times over two cycles of chemotherapy (CTX). Changes over time in occurrence, severity, and distress of pain, lack of energy, nausea, feeling drowsy, difficulty sleeping, and change in the way food tastes were evaluated using multilevel regression analyses. In the conditional models, effects of treatment group (i.e., with or without targeted therapy), age, number of metastatic sites, time from cancer diagnosis, number of prior cancer treatments, cancer diagnosis, and CTX regimen on enrollment levels, as well as the trajectories of symptom occurrence, severity, and distress were evaluated.ResultsAlthough the occurrence rates for pain, lack of energy, feeling drowsy, difficulty sleeping, and change in the way food tastes declined over the two cycles of CTX, nausea and numbness/tingling in hands/feet had more complex patterns of occurrence. Severity and distress ratings for the seven symptoms varied across the two cycles of CTX.ConclusionsDemographic and clinical characteristics associated with differences in enrollment levels as well as changes over time in occurrence, severity, and distress of these seven common symptoms were highly variable. These findings can be used to identify patients who are at higher risk for more severe and distressing symptoms during CTX and to enable the initiation of preemptive symptom management interventions
Differences in symptom occurrence, severity, and distress ratings between patients with gastrointestinal cancers who received chemotherapy alone or chemotherapy with targeted therapy.
BackgroundApproximately 28% of patients with gastrointestinal (GI) cancers will receive targeted therapy (TT) because of the associated increases in survival. Only four studies have examined the symptom experience of these patients. To date, no studies have evaluated for differences in symptom occurrence, severity, and distress between patients who received chemotherapy (CTX) alone (n=304) or CTX with TT (n=93).MethodsPatients completed self-report questionnaires, approximately one week after they received CTX. A modified version of the Memorial Symptom Assessment Scale (MSAS) was used to obtain data on symptom occurrence, severity, and distress. Binary logistic regression analyses were used to test for differences in symptom occurrence rates between the two treatment groups. Ordinal logistic regression analyses were used to test for differences in severity and distress ratings between the two treatment groups.ResultsPatients who received CTX with TT were significantly younger (P=0.009); were diagnosed with cancer longer (P=0.004); had a higher number of prior treatments (P=0.024); had metastatic disease, specifically to the liver (P<0.001); had a diagnosis of anal, colon, rectum, or colorectal cancer (CRC) (P<0.001); and were positive for detection of B-Raf proto-oncogene, serine/threonine kinase (BRAF) and Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations (both P<0.001). In addition, CTX treatment regimens were significantly different between the two groups (P<0.001). After controlling for significant covariates, patients who received TT reported lower occurrence rates for lack of energy, cough, feeling drowsy, and difficulty sleeping (all, P<0.05). Patients who received TT reported lower severity scores for dry mouth (P=0.034) and change in the way food tastes (P=0.035). However, they reported higher severity scores for "I don't look like myself" (P=0.026). No differences in symptom distress scores were found between the two treatment groups.ConclusionsThis study is the first to evaluate for differences in the symptom experience of GI cancer patients who received CTX alone or CTX with TT using a multidimensional symptom assessment scale. While between group differences in patients' symptom experiences were identified, both treatment groups warrant ongoing assessments to optimally manage their symptoms