Baseline Quality of Life is a Strong and Independent Prognostic Factor for Overall Survival in Metastatic Colorectal Cancer.

BACKGROUND: Previous studies have established that higher baseline quality of life (QOL) scores are associated with improved survival in patients with metastatic colorectal cancer (mCRC). We examined the relationship between overall survival (OS) and baseline QOL. PATIENTS AND METHODS: A total of 1 247 patients with mCRC participating in N9741 (comparing bolus 5-FU/LV, irinotecan [IFL] vs infusional 5-FU/leucovorin [LV]/oxaliplatin [FOLFOX] vs. irinotecan/oxaliplatin [IROX]) provided data at baseline on overall QOL using a single-item linear analogue self-assessment (LASA) 0-100 point scale. The association of OS according to clinically deficient (defined as CD-QOL, score 0-50) vs not clinically deficient (nCD-QOL, score 51-100) baseline QOL scores was tested. A multivariable analysis using Cox proportional hazards modeling was performed to adjust for the effects of multiple baseline factors. An exploratory analysis was performed evaluating OS according to baseline QOL status among patients who did or did not receive second-line therapy. RESULTS: Baseline QOL was a strong predictor of OS for the whole cohort (CD-QOL vs nCD-QOL: 11.2 months vs 18.4 months, P < .0001), and in each arm IFL 12.4 vs 15.1 months, FOLFOX 11.1 months vs 20.6 months, and IROX 8.9 months vs 18.1 months. Baseline QOL was associated with baseline performance status (PS) (P < .0001). After adjusting for PS and treatment arm, baseline QOL was still associated with OS (P = .017). CONCLUSIONS: Baseline QOL is an independent prognostic factor for OS in patients with mCRC. The demonstration that patient-assessed QOL and PS are independent prognostic indicators suggests that these assessments provide important complementary prognostic information.

A feasibility study of virtual group therapy to improve quality of life of cancer caregivers.

BACKGROUND: Cancer caregiving can negatively impact the quality of life (QOL) of the caregiver. In-person interventions for improving coping skills have been shown to be effective in improving QOL for caregivers. OBJECTIVES: This pilot project explored the feasibility and acceptability of a virtual group therapy intervention to improve short-term cancer caregiver QOL. METHODS: Caregivers of cancer patients were enrolled in a structured multidisciplinary intervention of eight virtual group therapy sessions provided over four weeks between September 9, 2013 and November 17, 2014. Group sessions were led by trained facilitators and included components of physical therapy, occupational therapy, psychosocial education, cognitive-behavioral intervention, supportive discussion, spiritual reflection, and mindfulness therapy. Feasibility was based on acceptable number of recruited participants per session; acceptability was defined using attendance and 80% QOL completion rates. QOL domains and symptom burden were assessed using validated single items. RESULTS: The 20 cancer caregivers who enrolled were mostly older (80% were ≥ 65 years), female (76.5%), married to the patient (88.2%), Caucasian (100%), and highly educated (100%). 60% attended one to five sessions, 15% attended six to eight sessions, and 25% attended no sessions. Thirty percent completed pre- and post- intervention ratings of QOL items. SIGNIFICANCE OF RESULTS: Findings suggested that a virtual group therapy intervention is feasible for the cancer caregivers in this study. Although not statistically significant, the caregivers reported higher QOL and less symptom burden in multiple domains after participating in the virtual group therapy intervention.

Impact of Massage Therapy on the Quality of Life of Hospice Patients and Their Caregivers: A Pilot Study.

Evidence for massage therapy (MT) in hospice patients remains limited. We conducted a prospective pilot study on MTs impact on quality of life of hospice patients and caregivers. Patient-caregiver dyads were enrolled if patients scored ≥5 on pain, depression, anxiety, or well-being using the revised Edmonton Symptom Assessment System Revised (ESAS-r). The patient received MT weekly for up to 3 massages with assessments completed at baseline, after each massage, and 1 week after the final massage for patients and at baseline and 1 week after final massage for caregivers. A satisfaction survey was completed at study completion. A pro-rated area under the curve (AUC) was utilized to assess the primary endpoints of change in ESAS-r for patient ratings of pain, depression and anxiety as well as the Linear Analogue Self-Assessment (LASA). Median difference scores (end of study value)-(baseline value) for each participant and caregiver were calculated. Of 27 patients and caregivers enrolled, 25 patients received MT. Fifteen patients completed all 3 MT sessions and were given the final symptom assessment and satisfaction survey and their caregivers completed final assessments. The proportion of patients considered success (AUC > baseline) in the primary endpoints were the following: pain 40.9%, depression 40.9%, anxiety 54.5%, LASA 54.5%. Median difference scores were largely zero indicating no significant temporal change in symptoms. Patients were highly satisfied with MT. This pilot study indicated that MT was a feasible and well-received intervention in our population of patients with inadequately controlled symptoms.

Spirituality and Emotional Distress Among Lung Cancer Survivors.

BACKGROUND: Emerging research is highlighting the importance of spirituality in cancer survivorship as well as the importance of early distress screening. The purpose of this study was to prospectively examine the relationships among spirituality, emotional distress, and sociodemographic variables during the early period of lung cancer survivorship. PATIENTS AND METHODS: Eight hundred sixty-four lung cancer survivors completed the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being, and the Short-Form-8 for emotional distress within the first year after lung cancer diagnosis, and 474 of these survivors completed the survey again 1 year later. RESULTS: At baseline, spirituality was associated with lower prevalence of emotional distress, being married, fewer years of cigarette smoking, and better Eastern Cooperative Oncology Group performance status. Additionally, high baseline spirituality was associated with lower rates of high emotional distress at 1-year follow-up. CONCLUSION: These findings suggest that spirituality might serve as a protective factor for emotional distress among lung cancer survivors. Further research is warranted to explore the role of spirituality in promoting distress management among lung cancer survivors.

A Case Management System for Integrating Patient-reported Outcome Assessment in Clinical Practice: The Beacon Tool.

INTRODUCTION: What if you could only ask one question of the patient during a clinic visit? Further, suppose the patient's biggest concern can pragmatically be incorporated into routine clinical care and clinical pathways that can address the patient's single biggest concern can be identified. If the principal concern can be dealt with efficiently at each visit through key stakeholder case management, positive outcomes should result. Therefore, motivated by the need for patient-centered health care visits, the Beacon electronic patient-reported outcomes (PRO) quality of life (QOL) tool was developed. METHODS: Central to the tool is that at each health care visit, the patient's biggest concern is electronically communicated to the health care team. Therefore, the tool can help catalyze important discussions between the health care team and the patient, perhaps on topics that would not have been discussed otherwise at a routine visit. In recognition of the community of resources needed to provide comprehensive care, the tool generates clinical pathways or actions that can be pursued to address the patient's biggest concern. The concern is efficiently triaged such that members of the health care community with appropriate expertise and resources are identified to address and manage that single biggest concern signaled by the patient. A report, which can be uploaded into the patient's medical chart, is created and provides a list of resources for a case manager to assist the patient and contains graphical presentations of the patient's QOL and a history of prior concerns. The report also labels potentially significant changes in QOL. DISCUSSION: The tool, which has been applied successfully in several health conditions, acts as a beacon to health care providers so that a patient's self-reported concern can be consistently and effectively integrated into their care. KEY POINTS: It is impractical to try to deal with every patient concern in every visit. The key to the Beacon tool is that at each visit the patient's biggest concern is identified, clinical pathways indicated, and resources efficiently matched to address the patient's biggest concern.

Longitudinal adverse event assessment in oncology clinical trials: the Toxicity over Time (ToxT) analysis of Alliance trials NCCTG N9741 and 979254.

BACKGROUND: Traditional methods of reporting adverse events in clinical trials are inadequate for modern cancer treatments with chronic administration. Conventional analysis and display of maximum grade adverse events do not capture toxicity profiles that evolve over time or longer lasting, lower grade toxic effects; we aimed to address this shortcoming in this study. METHODS: We developed an analytic approach and standardised, comprehensive format, the Toxicity over Time (ToxT) approach, which combines graphs and adverse event tabular displays with multiple longitudinal statistical techniques into a readily applicable method to study toxic effects. Plots visualising summary statistics or individual patient data over discrete timepoints were combined with statistical methods including the following longitudinal techniques: repeated measures models that describe the changes in adverse events across all cycles of treatment; time-to-event analyses of first and worst grade toxicity; and area under the curve (AUC) analyses summarising adverse event profiles over the entire course of a study, including chronic low-grade events. We applied ToxT analysis to adverse event data from two completed North Central Cancer Treatment Group (NCCTG/Alliance) trials: N9741 (NCT00003594), in which different combinations of oxaliplatin, 5-fluorouracil, and irinotecan were investigated for metastatic colorectal cancer, and 979254, in which survivors of breast cancer were given venlafaxine or placebo for control of hot flashes. FINDINGS: In trial NCCTG 979254 there was a higher incidence of late-occurring dry mouth in patients who were given venlafaxine than in those given placebo (week 1 [baseline]: 13% [six incidence in 48 patients, SD 5] vs 22% [11/49, SD 6]; p=0·20; week 5: 49% [24/49, 7] vs 2% [1/46, 2]; p<0·0001). In trial NCCTG N9741 there was an increased incidence of early nausea for patients given irinotecan plus oxaliplatin (IROX) compared with those given 5-fluorouracil plus oxaliplatin (FOLFOX; cycle 1 mean grade nausea 1·1 [SD 1·0] vs 0·6 [0·7]; p<0·0001). Event charts showed earlier occurrences of higher grades of diarrhoea for patients given IROX compared with those given FOLFOX, and the AUC analysis shows a higher magnitude of diarrhoea consistently over time throughout the study in patients given IROX versus those given FOLFOX (mean AUC 4·2 [SD 5·2] vs 2·9 [4·2]; p<0·0001). INTERPRETATION: The ToxT analytical approach incorporates the dimension of time into adverse event assessment and offers a more comprehensive depiction of toxic effects than present methods. With new, continuously administered targeted agents, immunotherapy, and maintenance regimens, these improved longitudinal analyses are directly relevant to patients and are crucial in cancer clinical trials. FUNDING: National Cancer Institute of the National Institutes of Health and the Mayo Comprehensive Cancer Center.

Cancer caregiver quality of life: need for targeted intervention.

OBJECTIVES: Caregiving can negatively impact well-being. Cancer caregivers face unique challenges given the intense nature of cancer and treatment, which increases their risk for burden, poor quality of life (QOL), and burnout. Studies to reduce caregiver burden demonstrate QOL improvement and distress reduction in the short term. However, few studies exist to address long-term benefits. We assessed changes in various QOL domains after participation in a QOL intervention for caregivers of patients having newly diagnosed advanced cancer. METHODS: Our institutional review board-approved study randomized patient-caregiver dyads to either usual care or an in-person group intervention composed of six 90-min sessions of structured multidisciplinary QOL components delivered over 4 weeks, with 10 follow-up phone calls within 20 weeks. Caregivers attended four of the six sessions attended by patients. Sessions included physical therapy, coping and communication strategies, mental health education, spirituality, and social needs. Caregiver QOL (Caregiver Quality of Life Index-Cancer Scale [CQOLC] and Linear Analogue Self-Assessment [LASA]) and mood (Profile of Mood States-Brief [POMS-B]) were measured at baseline and 4, 27, and 52 weeks. Wilcoxon tests and effect sizes were used to compare the caregiver groups. RESULTS: Of the 131 caregivers (65 intervention and 66 usual care), 116 completed the study. Caregivers post-intervention (at 4 weeks) had improved scores on LASA Spiritual Well-being; POMS-B total score, Vigor/Activity, and Fatigue/Inertia; and CQOLC Adaptation. At long term (at 27 weeks), caregivers retained improvement in POMS-B Fatigue/Inertia and gained improvements in CQOLC Disruptiveness and Financial Concerns. CONCLUSIONS: Caregivers who received the intervention had higher QOL ratings for specific QOL domains but not for overall QOL. Although a comprehensive intervention was helpful, more specific, targeted interventions tailored for individual needs are recommended. Copyright © 2015 John Wiley & Sons, Ltd.

Improving Spiritual Well-Being in Patients with Lung Cancers.

Patients with lung cancer report more disease burden and lower spiritual well-being (SWB) compared with other cancer patients. Understanding variables that lessen disease burden and improve SWB is essential. The aim of this study was to explore the relationship between motivational level for physical activity and SWB in patients with lung cancer. Linear regression showed increased SWB as stage of change for physical activity increased (p < 0.0001), even after adjusting for multiple demographic variables.

Improving Adherence to Cancer Treatment by Addressing Quality of Life in Patients With Advanced Gastrointestinal Cancers.

CONTEXT: Many patients with potentially curable cancer do not complete their prescribed treatment regimens because of the toxicity. There is evidence that the common endpoints of many of these toxicities are amenable to quality of life (QOL)-directed interventions. OBJECTIVES: This study was conducted to determine the effect of a multidisciplinary QOL-directed intervention on patients' adherence to planned chemoradiation (CR) regimens. METHODS: The results of two randomized controlled trials that used the same QOL intervention were pooled to form a cohort of 61 patients with advanced localized gastrointestinal cancer. Of these 61 subjects, 29 participated in six to eight bi- to triweekly sessions that included exercise, education, and relaxation, and 32 received usual medical care. The primary endpoint was completion of their prescribed CR regimens. Secondary outcomes included hospitalization during CR, rates of adverse postoperative events, and complete pathological response in those undergoing neoadjuvant therapy. RESULTS: Significantly, more members of the intervention than the control group completed their planned CR regimens (77.8 vs. 38.2%, P = 0.003). More participants in the control (n = 14) than the intervention (n = 5) group (P = 0.063) required hospitalization. Among those undergoing neoadjuvant CR, those in the intervention group were significantly more likely to complete CR as planned (81.0% vs. 37.5%, P = 0.005) and less likely to be hospitalized (14.3% vs. 50.0%, P = 0.011). CONCLUSION: A structured multidisciplinary QOL-directed intervention delivered to patients undergoing CR may increase the proportion of patients who complete CR as planned and reduce unplanned hospitalizations. Utilization is an important outcome in QOL-directed intervention trials.

5-year follow-up of a randomized controlled trial of immediate versus delayed zoledronic acid for the prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen: N03CC (Alliance) trial.

BACKGROUND: Postmenopausal women with breast cancer receiving aromatase inhibitors are at an increased risk of bone loss. The current study was undertaken to determine whether upfront versus delayed treatment with zoledronic acid (ZA) impacted bone loss. This report described the 5-year follow-up results. METHODS: A total of 551 postmenopausal women with breast cancer who completed tamoxifen treatment and were undergoing daily letrozole treatment were randomized to either upfront (274 patients) or delayed (277 patients) ZA at a dose of 4 mg intravenously every 6 months. In the patients on the delayed treatment arm, ZA was initiated for a postbaseline bone mineral density T-score of <-2.0 or fracture. RESULTS: The incidence of a 5% decrease in the total lumbar spine bone mineral density at 5 years was 10.2% in the upfront treatment arm versus 41.2% in the delayed treatment arm (P<.0001). A total of 41 patients in the delayed treatment arm were eventually started on ZA. With the exception of increased NCI Common Toxicity Criteria (CTC) grade 1/2 elevated creatinine and fever in the patients treated on the upfront arm and cerebrovascular ischemia among those in the delayed treatment arm, there were no significant differences observed between arms with respect to the most common adverse events of arthralgia and back pain. Osteoporosis occurred less frequently in the upfront treatment arm (2 vs 8 cumulative cases), although this difference was not found to be statistically significant. Bone fractures occurred in 24 patients in the upfront treatment arm versus 25 patients in the delayed treatment arm. CONCLUSIONS: Immediate treatment with ZA prevented bone loss compared with delayed treatment in postmenopausal women receiving letrozole and these differences were maintained at 5 years. The incidence of osteoporosis or fractures was not found to be significantly different between treatment arms.

Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis.

PURPOSE: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. METHODS AND MATERIALS: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). RESULTS: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. CONCLUSIONS: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation.

Application of therapeutic harp sounds for quality of life among hospitalized patients.

CONTEXT: Hospitalized patients experience symptoms including pain and anxiety that may negatively affect their well-being and overall quality of life (QOL), even when medical interventions are deemed successful. OBJECTIVES: The objective of the study was to assess the efficacy of prescriptive live therapeutic harp sounds on patient symptoms and QOL. METHODS: The study was a two-period, two-treatment arm crossover, randomized clinical trial. Individuals were randomized to harp music and standard care for the first 24 hours of the hospital stay, followed by 24 hours of only standard care, or vice versa. The harp intervention was 30-40 minutes of prescriptive live therapeutic harp sounds in the form of solo harp pieces and improvisations. Patients recorded well-being and symptom scores on linear analogue scales. Entry criteria included at least 18 years and a score of 3 or below on a 1-5 linear analogue scale indicating compromised overall QOL. RESULTS: Ninety-two eligible patients participated in the clinical trial. All the QOL variables had significantly higher percentages of patients with improvements during the harp treatment than during standard care. Five symptoms--fatigue, anxiety, sadness, relaxation, and pain--were significantly improved following therapeutic harp treatment. Approximately 30% to 50% of patients showed a significant increase in the QOL measures after harp treatment. CONCLUSION: There is evidence of strong positive effects on the QOL of hospitalized patients who received therapeutic harp sound treatment along with standard care.

American ginseng (Panax quinquefolius) administration does not affect performance of the Roche COBAS Ampliprep/Taqman HIV-1 RNA assay.

BACKGROUND: Previous data indicate that purified components of ginseng can inhibit HIV reverse transcriptase in vitro, suggesting that ginseng components in plasma may interfere with HIV-1 RNA detection assays. METHODS: Pre- and post-dose plasma from three volunteers dosed with 3000 mg American ginseng was spiked with HIV and analyzed by the Roche COBAS Ampliprep/Taqman v2.0 HIV-1 RNA assay. RESULTS: Presence of American ginseng had no significant effect on measured HIV-1 RNA concentration. Variation within pre- and post-dose plasma pair was insignificant and within assay performance limits. CONCLUSION: Plasma from subjects dosed with 3000 mg American ginseng does not interfere with the Roche COBAS Ampliprep/Taqman v2.0 HIV-1 RNA assay. This implies that in vitro inhibition of HIV reverse transcriptase by American ginseng components is unlikely to be clinically relevant.

Do age and quality of life of patients with cancer influence quality of life of the caregiver?

OBJECTIVE: There are significant burdens associated with providing care for loved ones with cancer. However, caregiver quality of life (QOL) is often overlooked. With the increasing number of older adults with cancer, it is important to determine whether a patient's age and QOL have any association with the caregiver's QOL. The objective of our study was to describe caregiver QOL and explore whether patient age and other psychosocial factors impact caregiver QOL. MATERIALS AND METHODS: Baseline information from patients with advanced cancer undergoing radiation and their caregivers, who were enrolled in a randomized, controlled clinical trial to test the effectiveness of a structured, multidisciplinary QOL intervention, was analyzed for this study. Caregivers completed the Caregiver Quality of Life Index-Cancer (CQOLC) Scale. Both patients and caregivers completed the Linear Analogue Self-Assessment (LASA) to measure QOL, and Profile of Mood States (POMS) to measure mood states. RESULTS: Overall, 131 patient-caregiver pairs participated in the study. At baseline, caregivers of older adults (≥65years) had higher mental (P=0.01), emotional (P=0.003), spiritual (P<0.01), and social support (P=0.03) LASA QOL scores. Caregivers of older adults also had higher baseline QOL (CQOLC, P=0.003) and mood (POMS, P=0.04) than caregivers of younger adults. Caregivers of patients with higher LASA QOL scores had higher overall (P=0.02), mental (P=0.006), physical (P=0.02), emotional (P=0.002), and spiritual LASA QOL scores (P=0.047). CONCLUSIONS: Caregivers of older adults with advanced cancer demonstrated better QOL and fewer mood disturbances compared to caregivers of younger patients. When patients have good QOL, caregivers also had good QOL.

Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial.

IMPORTANCE Despite the documented prevalence and clinical ramifications of physician distress, few rigorous studies have tested interventions to address the problem. OBJECTIVE To test the hypothesis that an intervention involving a facilitated physician small-group curriculum would result in improvement in well-being. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of 74 practicing physicians in the Department of Medicine at the Mayo Clinic in Rochester, Minnesota, conducted between September 2010 and June 2012. Additional data were collected on 350 nontrial participants responding to annual surveys timed to coincide with the trial surveys. INTERVENTIONS The intervention involved 19 biweekly facilitated physician discussion groups incorporating elements of mindfulness, reflection, shared experience, and small-group learning for 9 months. Protected time (1 hour of paid time every other week) for participants was provided by the institution. MAIN OUTCOMES AND MEASURES Meaning in work, empowerment and engagement in work, burnout, symptoms of depression, quality of life, and job satisfaction assessed using validated metrics. RESULTS Empowerment and engagement at work increased by 5.3 points in the intervention arm vs a 0.5-point decline in the control arm by 3 months after the study (P = .04), an improvement sustained at 12 months (+5.5 vs +1.3 points; P = .03). Rates of high depersonalization at 3 months had decreased by 15.5% in the intervention arm vs a 0.8% increase in the control arm (P = .004). This difference was also sustained at 12 months (9.6% vs 1.5% decrease; P = .02). No statistically significant differences in stress, symptoms of depression, overall quality of life, or job satisfaction were seen. In additional comparisons including the nontrial physician cohort, the proportion of participants strongly agreeing that their work was meaningful increased 6.3% in the study intervention arm but decreased 6.3% in the study control arm and 13.4% in the nonstudy cohort (P = .04). Rates of depersonalization, emotional exhaustion, and overall burnout decreased substantially in the trial intervention arm, decreased slightly in the trial control arm, and increased in the nontrial cohort (P = .03, .007, and .002 for each outcome, respectively). CONCLUSIONS AND RELEVANCE An intervention for physicians based on a facilitated small-group curriculum improved meaning and engagement in work and reduced depersonalization, with sustained results at 12 months after the study. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01159977.

Spiritual quality of life in advanced cancer patients receiving radiation therapy.

OBJECTIVE: The aim of this randomized controlled trial for patients with advanced cancer receiving radiation therapy was to determine the effect of a multidisciplinary intervention on spiritual quality of life (QOL) at the end of the intervention (week 4) and at two follow-up time points (weeks 26 and 52). METHODS: One hundred thirty-one persons were randomized to either the intervention or control (forms only) groups. The intervention included six 90-min in-person sessions based on the physical, emotion, social, and spiritual domains of QOL. Three sessions included the spiritual component. Caregivers were present for four sessions, one which included a spiritual component. Ten follow-up phone calls were made to the patients in the intervention group during the 6-month follow-up period. Patients completed the Functional Assessment of Cancer Therapy: General Scale, the Linear Analog Self-Assessment which includes an assessment of spiritual QOL, and the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp) at enrollment, and weeks 4, 27, and 52. RESULTS: Following the intervention, the intervention group demonstrated improved spiritual QOL on the FACIT-Sp, whereas the spiritual QOL of the control group decreased, resulting in significant mean changes between groups (total score: 1.7 vs. -2.9; p < 0.01; meaning/peace subscale: 1.0 vs. -3.5; p < 0.01; faith subscale: 3.1 vs. -1.7; p = 0.04). CONCLUSIONS: The results indicate that a multidisciplinary intervention which includes a spiritual component can maintain the spiritual QOL of patients with advanced cancer during radiation therapy.

Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2.

BACKGROUND: Safe, effective interventions to improve cancer-related fatigue (CRF) are needed because it remains a prevalent, distressing, and activity-limiting symptom. Based on pilot data, a phase III trial was developed to evaluate the efficacy of American ginseng on CRF. METHODS: A multisite, double-blind trial randomized fatigued cancer survivors to 2000mg of American ginseng vs a placebo for 8 weeks. The primary endpoint was the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) at 4 weeks. Changes from baseline at 4 and 8 weeks were evaluated between arms by a two-sided, two-sample t test. Toxicities were evaluated by self-report and the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) provider grading. RESULTS: Three hundred sixty-four participants were enrolled from 40 institutions. Changes from baseline in the general subscale of the MFSI-SF were 14.4 (standard deviation [SD] = 27.1) in the ginseng arm vs 8.2 (SD = 24.8) in the placebo arm at 4 weeks (P = .07). A statistically significant difference was seen at 8 weeks with a change score of 20 (SD = 27) for the ginseng group and 10.3 (SD = 26.1) for the placebo group (P = .003). Greater benefit was reported in patients receiving active cancer treatment vs those who had completed treatment. Toxicities per self-report and CTCAE grading did not differ statistically significantly between arms. CONCLUSIONS: Data support the benefit of American ginseng, 2000mg daily, on CRF over an 8-week period. There were no discernible toxicities associated with the treatment. Studies to increase knowledge to guide the role of ginseng to improve CRF are needed.

Spiritual well-being in lung cancer survivors.

PURPOSE: Spiritual well-being (SWB) among lung cancer survivors has not been well-delineated. Additionally, little is known about how SWB is affected over the trajectory of the disease process. The aims of this study were to examine the SWB of individuals with a diagnosis of lung cancer, to assess the stability of SWB over time, and to identify the factors associated with SWB. METHODS: A prospective cohort of patients with lung cancer first seen at the Mayo Clinic over a 10-year period of time was included in this study. Study entry was at the time of diagnosis or referral to the Mayo Clinic, and participation involved annual survey using the Functional Assessment in Chronic Illness Therapy-Spiritual Well-being, Medical Outcome Short Form 8, and Quality of Life (QOL) Linear Analog Scale Assessment. Associations were explored using Fisher's exact test, chi-squared test, Kruskal-Wallis test, and Spearman correlations. Linear regression was used to explore multivariate relationships. RESULTS: There were 1,578 participants over a 10-year period of time. Group SWB scores were relatively high and stable over a 10-year period of time ([Formula: see text], standard deviation = 14.47-18.46, possible scale of 0-100). However, individual scores varied widely across almost the entire scale (2.1-100) and revealed a chaotic trajectory for SWB. Males, current smokers, and those with higher pack-years experienced lower SWB compared to females, nonsmokers, and those with lower pack-years (p < 0.0001, 0.0455, and 0.0004, respectively). SWB was strongly associated with overall QOL. CONCLUSIONS: SWB is an individualistic experience that can change dramatically over time for cancer survivors. Ongoing assessments are important.

The use of Ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9.

PURPOSE: Patients undergoing treatment for cancer often report problems with their cognitive function, which is an essential component of health-related quality of life. Pursuant to this, a two-arm randomized, placebo-controlled, double-blind, phase III clinical trial was conducted to evaluate Ginkgo biloba (EGB 761) for the prevention of chemotherapy-related cognitive dysfunction in patients with breast cancer. METHODS: Previously chemotherapy naïve women about to receive adjuvant chemotherapy for breast cancer were randomized to receive 60 mg of EGB 761 or a matching placebo twice daily. The study agent was to begin before their second cycle of chemotherapy and to be taken throughout chemotherapy and 1 month beyond completion. The primary measure for cognitive function was the High Sensitivity Cognitive Screen (HSCS), with a secondary measure being the Trail Making Tests (TMT) A and B. Subjective assessment of cognitive function was evaluated by the cognitive subscale of the Perceived Health Scale (PHS) and the Profile of Mood States (POMS). Data were collected at baseline and at intervals throughout and after chemotherapy, up to 24 months after completion of adjuvant treatment. The primary statistical analysis included normalized area under the curve (AUC) comparisons of the HSCS, between the arms. Secondary analyses included evaluation of the other measures of cognition as well as correlational analyses between self-report and cognitive testing. RESULTS: One hundred and sixty-six women provided evaluable data. There were no significant differences in AUC up to 12 months on the HSCS between arms at the end of chemotherapy or at any other time point after adjuvant treatment. There were also no significant differences in TMT A or B at any data point. Perceived cognitive functions, as measured by the PHS and confusion/bewilderment subscale of the POMS, were not different between arms at the end of chemotherapy. There was also little correlation between self-reported cognition and cognitive testing. No differences were observed in toxicities per Common Terminology Criteria for Adverse Events (CTCAE) assessment between Ginkgo biloba and placebo throughout the study; however, after chemotherapy, the placebo group reported worse nausea (p = .05). CONCLUSION: This study did not provide any support for the notion that Ginkgo biloba, at a dose of 60 mg twice a day, can help prevent cognitive changes from chemotherapy. These analyses do provide data to further support the low associations between patients' self-report of cognition and cognitive performance, based on more formal testing.

Spiritual well-being and quality of life of women with ovarian cancer and their spouses.

BACKGROUND: There is little research on the quality of life (QOL) and spiritual well-being (SWB) of women diagnosed with ovarian cancer and their spouses. OBJECTIVE: We compared the SWB and QOL of these women and their spouses over a 3-year period. METHODS: This is a descriptive, longitudinal study involving 70 women with ovarian cancer and 26 spouses. Questionnaires were completed postoperatively and by mail 3, 7, 12, 18, 24, and 36 months later. All participants completed the Functional Assessment of Chronic Illness Therapy (FACIT)-Spiritual Well-Being-Expanded Version, Symptom Distress Scale, and open-ended questions about changes in their lives. Diagnosed women completed the FACIT-Ovarian and spouses the Caregiver Burden Interview and Linear Analog Self-Assessment scales. RESULTS: Women reported a high level of SWB over time. Spouses' SWB was significantly worse than the women's at 1 and 3 years (P ≤ .05). Insomnia, fatigue, and outlook/worry were problematic across time, with no significant differences between women and spouses except that women experienced more insomnia through 3 months (P = .02). Emotional well-being was compromised over time for the women but not their spouses until year 3. Physical and social well-being were compromised in spouses across time, while women's social well-being remained high and physical well-being was problematic only for the first year. LIMITATIONS: Limitations include a small spouse sample and, due to the disease process, attrition over time. CONCLUSIONS: Ovarian cancer has significant, but different, effects on women and spouses. Some effects are static, while others are not, which underscores the need for continual monitoring.