Effects of a Self-Monitoring Quality of Life Intervention for Patients with Cancer Receiving Palliative Care in Japan: Study Protocol for a Randomized Controlled Trial

Background: Previous studies suggest the use of patient-reported outcome measures in routine clinical practice hasimportant benefits for patients with cancer, particularly as feedback regarding patients’ quality of life (QOL) improvesdoctor-patient communication and clinical decision making. This study aimed to examine the effect of using the CareNotebook as a routine self-monitoring QOL intervention in clinical practice for patients with cancer receiving palliativecare. The results are expected to clarify the practical use of the Care Notebook in this population. Methods: Thisprospective randomized study is being undertaken at Toshima Hospital, Japan. Participating patients who are randomlyassigned to the intervention group will be asked to complete the shortened Care Notebook booklet for patients withcancer in palliative care once each day. A control group will receive usual care. The primary outcome is global healthstatus/QOL (Global QOL), as assessed by the European Organization for Research and Treatment of Cancer Quality ofLife Questionnaire Core 15 Palliative. Data will be collected at baseline (after allocation), and at 1 week and 3 weeksin both the control and intervention groups. The effects of the intervention will be evaluated with a mixed randomeffects model. The required sample size is 200 patients. We obtained approval from Toshima Hospital (No 26-11) andthe Tokyo Medical and Dental University Ethics Committee (No 1756). The findings will be disseminated throughpublications in peer-reviewed journals and attendance at domestic and international conferences. The trial was registeredwith the UMIN clinical trials registry (Trial registration number: UMIN000025322). Conclusions: This study willprovide evidence on whether medical staff can use the Care Notebook as a routine self-monitoring QOL intervention inclinical practice for patients with cancer receiving palliative care. We expect that a routine Care Notebook interventionfor patients with cancer will be recommended in healthcare facilities.     

Correlation of quality of life with tumor response in patients receiving palliative chemotherapy for advanced gastrointestinal tumors

We prospectively evaluated the association of tumor response with change of quality of life (QOL) in patients with advanced gastrointestinal tumors receiving palliative chemotherapy. Out of 133 eligible patients, 90 (68%) completed the European Organization for Research and Treatment Quality of Life Questionnaire C-30 (EORTC QLQ C-30) at baseline and at regular intervals during palliative chemotherapy. Among the 90 available patients, 88 patients could be evaluated for response, and 32 (36%) responded. Taking into account 32 patients who had stable disease, 64 (73%) achieved a clinical benefit, defined as an objective response or stable disease. Improvement in the emotional functioning or global QOL was observed before the fourth cycle of chemotherapy in responders (P = 0.039) and patients with clinical benefit (P = 0.026). Grade 3 or 4 toxic effects occurred in 39% of patients; however, this did not adversely affect the global or other domains of QOL. Therefore, change of QOL during the chemotherapy was closely related with clinical outcomes. We should apply the QOL assessment to all patients who received palliative chemotherapy for their gastrointestinal tumors.     

Effects of a Self-Monitoring Quality of Life Intervention in Outpatients with Breast Cancer: A Preliminary Report of A Randomized Controlled Trial

Objective: This preliminary report used data from a randomized controlled clinical trial to investigate the beneficial effects of a self-monitoring quality of life (SMQOL) intervention on communication, medical care and patient outcomes in Japanese women with breast cancer. Methods: This study compared a SMQOL intervention group with a control group that received usual care after 4 months on self-efficacy aspects of patient–physician communication among outpatients with breast cancer in Japan using the Perceived Efficacy in Patient–Physician Interactions (PEPPI) questionnaire. Patients were randomly assigned to the intervention and control groups using permuted-block randomization. The intervention groups were asked to complete a paper-based quality-of-life (QOL) questionnaire in addition to the usual care provided in the control group. Analysis of covariance was used to assess the difference in PEPPI scores between the intervention and control groups. Additionally, subgroup analyses were performed for outpatients with breast cancer accompanied by depression or anxiety. Results: In total, 232 patients were eligible for this study and randomized. Seven patients did not answer the PEPPI questionnaire at baseline after group allocation, leaving 225 patients for inclusion in the analyses. The modified intention-to-treat ITT analysis showed the SMQOL intervention had no significant effect on PEPPI total score (P = 0.226). We found a significant between-group difference in PEPPI total score in the anxiety group (P = 0.045), namely, the self-efficacy aspects of patient–physician communication of those with anxiety in the intervention group were better than for those in the control group after 4 months. Conclusion: Use of the SMQOL had beneficial effects on communication self-efficacy between patients and physicians for outpatients with breast cancer, those with anxiety.     

Impact of coping skills intervention with family caregivers of hospice patients with cancer: a randomized clinical trial

BACKGROUND: Family caregivers for cancer patients experience high levels of stress and burden and diminished quality of life (QOL). Interventions to improve coping skills of caregivers have been shown to be effective with other populations, but their impact has not been assessed in the difficult context of hospice care. The purpose of this study was to determine whether hospice plus a coping skill training intervention improved family caregivers' QOL, burden, coping, and mastery, compared with hospice plus emotional support, and usual hospice care. METHODS: A three group randomized controlled trial was conducted including baseline, 16 day, and 30 day assessments conducted from March 1999 to May 2003. The sample consisted of 354 family caregivers of community dwelling hospice patients with advanced cancer. Patient/caregiver dyads were randomly divided into three groups, including a control group (n = 109) who received standard hospice care, a group (n = 109) who received standard hospice care plus three supportive visits, and a group (n = 111) who received standard care plus three visits to teach a coping skills intervention. Primary outcomes included caregiver QOL, caregiver burden due to patient symptoms, caregiver burden due to tasks, and caregiver mastery. RESULTS: At the 30-day follow-up, the coping skills intervention led to significantly greater improvement in caregiver QOL (estimate = -0.16, standard error [SE] = 0.07, P = 0.03), burden of patient symptoms (estimate = 0.28, SE = 0.07, P < 0.001), and caregiving task burden (estimate = -0.01, SE = 0.01, P = 0.038) than did the other two conditions. None of the groups showed significant change in overall caregiving mastery, caregiver mastery specific to caregiving tasks, problem-focused or emotion-focused coping. CONCLUSIONS: The coping skills intervention was effective in improving caregiver QOL, reducing burden related to patients' symptoms, and caregiving tasks compared with hospice care alone or hospice plus emotional support. Structured caregiver skill-training interventions for caregivers are promising even in the difficult environment of end-of-life care and for families already receiving benefits of hospice care.     

Effects on quality of life of combined trastuzumab and chemotherapy in women with metastatic breast cancer.

PURPOSE: The study was designed to compare the effects of treatment with a combination of trastuzumab (Herceptin; Genentech, Inc, South San Francisco, CA) and chemotherapy versus chemotherapy alone on health-related quality of life (HRQL) in patients with HER-2/neu overexpressing, metastatic breast cancer. PATIENTS AND METHODS: A sample of 400 patients, not previously treated for metastatic disease and randomized to receive either trastuzumab plus chemotherapy (208 patients) or chemotherapy alone (192 patients), completed the European Organization for Research and Treatment Care Quality of Life Questionnaire at baseline and on at least one subsequent occasion at 8, 20, 32, 44, and 56 weeks. HRQL improvement or worsening was defined as a >or= 10-point change (range, 0 to 100 points) in the scores of six preselected domains (global quality of life [QOL], physical, role, social, and emotional functioning, and fatigue). Stable HRQL was defined as a change of less than 10. A Bonferroni correction was applied for multiple testing. RESULTS: After completion of chemotherapy, patients treated with trastuzumab and chemotherapy reported significant improvement in fatigue (P <.05) as compared with their baseline scores. Higher proportions of patients receiving the combined therapy achieved improvement in global QOL (P <.05) than did patients treated with chemotherapy alone. Higher proportions of the combined therapy group also achieved improvement in physical and role functioning and in fatigue as compared with the chemotherapy group, but the differences were not statistically significant. There were no differences in the proportions of patients in the two groups that reported worsening. CONCLUSION: Statistically significantly higher proportions of patients treated with a combination of trastuzumab and chemotherapy reported improved global QOL than did patients treated by chemotherapy alone.     

An Interdisciplinary Care Approach for Integration of Palliative Care in Lung Cancer

PurposeQuality of Life (QOL) and symptom concerns are common in lung cancer. This article presents findings from 2 separate pilot studies that utilize an educational model to reduce barriers to pain and fatigue management (“barriers study”) and an interdisciplinary palliative care approach to manage QOL concerns for patients with lung cancer (“QOL pilot”).Patients and MethodsIn the barriers study, a total of 46 patients with lung cancer with a self-reported pain and/or fatigue rating of ≥ 4 were accrued, with 18 patients in the usual care group and 28 in the experimental group, using a quasi-experimental design. This study involved a 4-part educational intervention delivered by a nurse to address pain and fatigue. In the QOL study, the pilot intervention included 10 patients with lung cancer. This pilot included use of QOL assessment completed by a nurse followed by an interdisciplinary case conference intended to initiate supportive care to address QOL and symptom concerns. Patient-reported outcomes such as barriers to pain and fatigue management, fatigue intensity, other symptoms, and overall QOL were analyzed through tabulation of standard summary statistics and multivariate analysis methods. All eligible patients were recruited from the ambulatory clinic of one National Cancer Institute–designated Comprehensive Cancer Center.ResultsFor the barriers study, patients with lung cancer in the experimental group had a statistically significant decrease in patient-related barriers for both pain and fatigue. Findings from the QOL pilot revealed that patients with lung cancer have multiple QOL concerns and that an interdisciplinary palliative care approach was feasible to address these complex, multidimensional patient needs.ConclusionAttention to barriers of symptom management, early referral to supportive care services, and coordination of interdisciplinary care are essential to supporting the QOL of patients with lung cancer. The next phase of this research will test QOL/symptom interventions for patients with lung cancer.     

Randomized controlled trial of maintaining quality of life during radiotherapy for advanced cancer

BACKGROUND:

Psychosocial interventions often address only 1 domain of quality of life (QOL), are offered to patients with early‐stage cancer, do not include the caregiver, and are delivered after cancer treatment has been completed.

METHODS:

In the current randomized controlled trial, 131 patients with advanced cancer who received radiotherapy and their caregivers were randomly assigned to either a 6‐session, structured, multidisciplinary intervention arm or a standard care arm. The average age of the patients was 58 years, the majority were male (63%), and tumor types varied (gastrointestinal [37%], brain [22%], head and neck [16%], lung [13%], and other [12%]). The six 90‐minute sessions addressed the 5 domains of QOL: cognitive, physical, emotional, social, and spiritual. The in‐person intervention was followed by 10 brief telephone counseling sessions that took place over the next 6 months.

RESULTS:

Of the 117 patients who completed the study, overall QOL (assessed by Functional Assessment of Cancer Therapy‐General [FACT‐G]) at week 4 was significantly higher in the intervention group (n = 54) compared with the standard arm control group (n = 63) (75.2 vs 68.7; P = .02). The 10 brief telephone contacts did not appear to impact QOL because at week 27 the groups had identical QOL (means of 77.6 and 77.7, respectively). There was no effect of the intervention noted on caregiver QOL.

CONCLUSIONS:

Participating in a 6‐session multidisciplinary intervention was found to be effective in maintaining the QOL of patients with advanced cancer who were actively receiving radiotherapy. The QOL and symptom burden of this population is striking, making it important to identify effective QOL strategies to implement in conjunction with cancer care. Cancer 2013. © 2012 American Cancer Society.     

Managing cancer and living meaningfully (CALM) as an intervention for severe fatigue in gastrointestinal cancer survivors

This study aimed to evaluate the effectiveness and feasibility of CALM (managing cancer and living meaningfully), which is a psychotherapeutic intervention used to reduce cancer-related fatigue (CRF) and improve quality of life (QOL) in Chinese gastrointestinal cancer survivors (GCs). A total of 115 GCs were enrolled in this study. All patients were randomly assigned to either the CALM group or the usual care (UC) group. All patients were evaluated using the Piper Fatigue Scale (PFS) and Quality of Life Assessment Scale before and after 2, 4, and 6 CALM or UC sessions with GCs presenting with severe fatigue. We compared the differences in these scores between the CALM group and the UC group and analyzed the correlations between CRF and QOL scores. Compared with the UC group, the CALM group showed significant differences in total CRF, behavioral/daily life CRF, emotional/affective CRF, sensory/physical CRF, cognitive CRF and QOL scores before and after 2, 4, and 6 CALM sessions (F=3106.434, F=1113.831, F=1159.919, F=1502.266, F=820.275, F=606.513, respectively; P<0.001). Finally, negative correlations were found between CRF and QOL scores in the GCs in the CALM group (before treatment: r=-0.46, P=0.0002; after 2 sessions: r=-0.46, P=0.0002; after 4 sessions: r=-0.51, P<0.0001; after 6 sessions: r =-0.44, P=0.0004). The CALM intervention effectively reduced fatigue in cancer patients and improved their QOL. This study suggests that CALM as a psychotherapeutic intervention may be an effective way to reduce CRF.     

Quality of life in lung cancer patients: impact of baseline clinical profile and respiratory status

As cure is attainable in very few cases of lung cancer, the imperative issue is to make quality of life (QOL) as good as possible as part of the palliative care package. The aim of this paper was to evaluate the baseline QOL of lung cancer patients and observe its association with various clinical parameters and overall respiratory status. A total of 101 patients were administered the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30, version 3) questionnaire. Clinical profile and measures of respiratory status, including spirometry, measures of dyspnoea, and 6-min walk test, were recorded. Higher Karnofsky Performance Status (KPS) significantly correlated with better global health status (P < 0.001) and healthy level of functioning (P < 0.001). The cumulative symptom burden was significantly associated with global QOL (P = 0.01) and physical, role and cognitive function scales (P < 0.05). All dyspnoea measures negatively correlated with global QOL and functioning scales. Spirometric indices showed a positive correlation with all functional scales (P < 0.05) except social. In conclusion, lung cancer patients have unsatisfactory QOL, with the global health status and physical functions being most affected. Number of symptoms, KPS, dyspnoea and spirometry significantly affect QOL.     

Prospective assessment of emotional distress, cognitive function, and quality of life in patients with cancer treated with chemotherapy

BACKGROUND: The current study sought to delineate prospectively the rates and clinical course of emotional distress, cognitive impairment, and quality of life (QOL) in chemotherapy-naive patients with cancer and to consider the determinants of global QOL. METHODS: Patients who consented to participate were administered the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire, the Mini-Mental State Examination (MMSE), and the Hospital Anxiety and Depression Scale before and at the end of treatment (EOT). RESULTS: Of the 102 patients initially assessed, 80 (78.4%) completed the study. Most aspects of QOL did not change considerably over time. At EOT, patients reported only significant increases in fatigue and significant decreases in sleep disturbance. Although no significant changes emerged in the rates of anxiety or depression throughout chemotherapy, nearly one-third of the patients experienced severe emotional distress at both points in time. In addition, the authors observed neither significant alteration in the cognitive performance over time nor reliable associations between scores on the MMSE and subjective cognitive function, emotional distress, or QOL. Finally, depression proved to be the leading predictor of global QOL at baseline and at EOT. CONCLUSIONS: The results indicated that a significant proportion of Greek patients with cancer experienced intense anxiety and depression throughout chemotherapy and confirmed the importance of depression as a strong predictor of global QOL. Routine screening of emotional distress across all phases of cancer is mandatory because it will contribute to the identification of patients who are in need of pharmaceutical and/or psychologic intervention.     

Age and Gender Moderate the Impact of Early Palliative Care in Metastatic Non‐Small Cell Lung Cancer

Background.

Studies demonstrate that early palliative care (EPC) improves advanced cancer patients’ quality of life (QOL) and mood. However, it remains unclear whether the role of palliative care differs based upon patients’ demographic characteristics. We explored whether age and gender moderate the improvements in QOL and mood seen with EPC.

Methods.

We performed a secondary analysis of data from a randomized controlled trial of patients with metastatic non-small cell lung cancer. Patients received either EPC integrated with oncology care or oncology care alone. We assessed the degree to which QOL (Trial Outcome Index [TOI]) and mood (Hospital Anxiety and Depression Scale [HADS] and Patient Health Questionnaire 9 [PHQ-9]) outcomes at week 12 varied by patient age (<65) and gender. The week 12 data of 107 patients are included in this analysis.

Results.

At 12 weeks, younger patients receiving EPC reported better QOL (TOI mean = 62.04 vs. 49.43, p = .001) and lower rates of depression (HADS–Depression = 4.0% vs. 52.4%, p < .001; PHQ-9 = 0.0% vs. 28.6%, p = .006) than younger patients receiving oncology care alone. Males receiving EPC reported better QOL (TOI mean = 58.81 vs. 48.30, p = .001) and lower rates of depression (HADS–Depression = 18.5% vs. 60.9%, p = .002; PHQ-9 = 3.8% vs. 34.8%, p = .008) than males receiving oncology care alone. At 12 weeks, QOL and mood did not differ between study groups for females and older patients.

Conclusion.

Males and younger patients who received EPC had better QOL and mood than those who received oncology care alone. However, these outcomes did not differ significantly between treatment groups for females or older patients.

Implications for Practice:

This study found that early palliative care improves patients’ quality of life and mood differentially based on their age and gender. Specifically, males and younger patients receiving early palliative care experienced better quality of life and mood than those receiving oncology care alone. Conversely, females and older patients did not experience this treatment effect. Thus, palliative care interventions may need to be tailored to patients’ age- and gender-specific care needs. Studying how patients’ demographic characteristics affect their experience with palliative care will enable the development of interventions targeted to the distinct supportive care needs of patients with cancer.     

Improving cancer patients' pain: the impact of the hospital specialist palliative care team

Pain is reported to occur in the majority of patients with advanced cancer and is one of the main reasons for referral to a hospital specialist palliative care team. Yet despite this, there is a paucity of research into the impact the hospital specialist palliative care team has on pain control in patients. A non-equivalent control group design using a quota sample investigated 100 cancer patients who had been admitted to hospital for symptom control. Fifty patients received specialist hospital palliative care team intervention compared with 50 patients receiving traditional care. Outcome was assessed using the Palliative Care Assessment (PACA) tool on three occasions. There was no difference between the groups on the initial assessment and the results indicated that all cancer patients admitted to hospital had a significant improvement in their pain control. However, the patients who had the additional input of the palliative care team demonstrated a statistically significant greater improvement than the control group (P<0.001). Potential explanations are made for the results including the enhanced knowledge and skills of the hospital specialist palliative care team.     

Effectiveness of Symptom Management Intervention for Improving the QOL of Cancer Patients

Background: Managing the symptoms of cancer patients is challenging for health care providers and interventions individually designed are required to improve the quality of life (QOL) of cancer patients. Objective: to assess the efficacy of symptom management intervention on symptom reduction and the QOL of cancer patients. Methods: A Quasi-experimental study using pre and post-test design was conducted among 200 cancer patients selected by a convenient sampling technique from the selected cancer hospitals. The intervention group received symptom management intervention and the control group received routine clinical care. The data were collected from individuals who had been diagnosed with breast/head and neck cancer and were in the third or fourth stages of cancer, using symptom assessment and Functional Assessment of Cancer Therapy (FACT) QOL tool. After the pre-test, symptom management intervention was provided, and a post-test was conducted at one month and three months after the intervention. Results: The mean age was 50.93 years among the participants. Fifty-two percent and 68% of them were in stage IV cancer in the intervention group and control group respectively. The mean QOL score of head and Neck cancers in the intervention group increased from 20.76 (1.82) to 97.03 (3.33) and the mean scores of QOL of breast cancer patients in the intervention group increased from 22.44 (2.92) to 94.39 (8.30). Repeated measure ANOVA showed that the intervention program was effective in enhancing symptom reduction and QOL among cancer patients (Head and Neck cancers F(1.3, 114) =391.62, p< 0.001 and Breast cancer F (1, 75) =177.41.41, p=.001). Conclusion: Nurses play a vital role in providing care to cancer patients and improving their quality of life since nurses are more involved in care.     

营养干预对宫颈癌患者同步放化疗耐受性及生活质量的影响

目的:探讨营养干预对宫颈癌患者同步放化疗耐受性及生活质量(QOL)的影响。方法:将86例宫颈癌患者随机分为营养干预组和对照组,观察两组患者的放疗中断率、化疗完成次数及放疗剂量达40Gy时生活质量评分情况。结果:营养干预组的放疗中断率为2.3%（1/43）,对照组为18.6%（8/43）,P=0.03;营养干预组完成化疗周期数为4.0±0.98,对照组为3.3±1.28,P=0.005;放射剂量达40Gy时两组患者QOL评分的差异有统计学意义（P＜0.01）。结论:营养干预能有效提高宫颈癌患者同步放化疗的耐受性,提高其生活质量。     

Interdisciplinary Palliative Care Intervention in Metastatic Non–Small-Cell Lung Cancer

ObjectiveChallenges and barriers continue to hinder the integration of palliative care models into comprehensive, ambulatory oncology care. This article aims to describe how symptoms, distress, and quality of life (QOL) data from the usual care phase of a National Cancer Institute–supported Program Project informed the development of an interdisciplinary, tailored palliative care intervention for patients with metastatic non–small-cell lung cancer (NSCLC).MethodsPatients receiving usual care for metastatic NSCLC were recruited into this prospective longitudinal study over a 1-year period. A total of 130 patients with stage IV NSCLC were accrued, and 114 patients had evaluable data. Research nurses assisted patients in completing the clinical section of the data forms, and patients completed surveys and self-reports at baseline and 6, 12, and 24 weeks.ResultsPatients ranged in age from 40 to 84 years, and 61% were Caucasian non-Hispanic. Sixty-six former (N = 59) and current smokers had an average of 38 pack-year history of smoking. The Karnofsky Performance Status, Instrumental Activities of Daily Living, and Cognitive scores deteriorated significantly (P = .001, .009, and .042, respectively). Social Activity was stable, whereas Social Support increased significantly. Overall symptom distress score and Total symptom score both significantly increased at 24 weeks (P = .003 and .017, respectively). Physical Well-Being decreased significantly (P = .036), whereas the Functional Assessment of Cancer Therapy-Lung, Functional Assessment of Chronic Illness Therapy-Spirituality Subscale, and Distress scores remained statistically stable over time.ConclusionsPatients with metastatic NSCLC continue to experience high symptom burden and diminished physical well-being over time while receiving cancer treatments. An interdisciplinary palliative care intervention is currently being tested to improve symptom burden and overall QOL.     

Role of a Medical Social Worker in Improving Quality of Life for Patients with Advanced Cancer with a Structured Multidisciplinary Intervention

Abstract

Background: Patients with advanced cancer face multiple challenges to their quality of life (QOL). The goal of this study was to investigate the impact of participation in a multidisciplinary intervention, including a social service component, on improving the QOL of patients with advanced cancer undergoing radiation therapy.

Design: A total of 115 participants with newly diagnosed advanced stage cancer, who were receiving radiation therapy, were randomly assigned to either participate in an 8-session structured multidisciplinary intervention or to receive standard care. Each 90-minute session was led by either a psychologist or psychiatrist and co-led with a nurse, physical therapist, chaplain, and/or social worker. The sessions were designed to address the domains that impact QOL: emotional, spiritual, physical, and social domains (support, community resources, financial and legal issues, and advance directives). QOL was assessed, at baseline, 4 (end of treatment), 8 and 27 weeks. The primary endpoint was overall QOL assessed on a 0–100 scale at Week 4.

Results: A total of 115 patients were enrolled from October 2, 2000 to October 28, 2002. Overall QOL at Week 4 averaged 10 points higher in the intervention group than in the control group (80 vs. 70 points, p =0.047) which was an increase of 3% from baseline in the intervention group versus a decrease of 9% in the control group (p =0.009). Of the subscores reflecting patient's opinion regarding their QOL, there was improvement in all social domains which contributed to the overall improvement in QOL. Significant changes from baseline to Week 4 scores were seen in the areas of financial concerns (p =0.025) and legal issues (p =0.048).

Conclusions: A social work component within a structured multi-disciplinary intervention results in significant advantages in the social domain of QOL, and contributes to clinically meaningful improvements in the overall QOL for patients with advanced cancer undergoing active medical treatment. Numerous studies have documented the financial burdens and social changes that may occur with the diagnosis of cancer. However, previous research has not examined the role of a social worker in providing financial, social, and legal education, in a structured multidisciplinary intervention, and its direct impact on QOL. Outlined in this paper is the role of the medical social worker in a clinical trial, how education was provided and strategies for future interventions.     

Role of a medical social worker in improving quality of life for patients with advanced cancer with a structured multidisciplinary intervention

Background: Patients with advanced cancer face multiple challenges to their quality of life (QOL). The goal of this study was to investigate the impact of participation in a multidisciplinary intervention, including a social service component, on improving the QOL of patients with advanced cancer undergoing radiation therapy. Design: A total of 115 participants with newly diagnosed advanced stage cancer, who were receiving radiation therapy, were randomly assigned to either participate in an 8-session structured multidisciplinary intervention or to receive standard care. Each 90-minute session was led by either a psychologist or psychiatrist and co-led with a nurse, physical therapist, chaplain, and/or social worker. The sessions were designed to address the domains that impact QOL: emotional, spiritual, physical, and social domains (support, community resources, financial and legal issues, and advance directives). QOL was assessed, at baseline, 4 (end of treatment), 8 and 27 weeks. The primary endpoint was overall QOL assessed on a 0-100 scale at Week 4. Results: A total of 115 patients were enrolled from October 2, 2000 to October 28, 2002. Overall QOL at Week 4 averaged 10 points higher in the intervention group than in the control group (80 vs. 70 points, p = 0.047) which was an increase of 3% from baseline in the intervention group versus a decrease of 9% in the control group (p = 0.009). Of the subscores reflecting patient's opinion regarding their QOL, there was improvement in all social domains which contributed to the overall improvement in QOL. Significant changes from baseline to Week 4 scores were seen in the areas of financial concerns (p = 0.025) and legal issues (p = 0.048). Conclusions: A social work component within a structured multidisciplinary intervention results in significant advantages in the social domain of QOL, and contributes to clinically meaningful improvements in the overall QOL for patients with advanced cancer undergoing active medical treatment. Numerous studies have documented the financial burdens and social changes that may occur with the diagnosis of cancer. However, previous research has not examined the role of a social worker in providing financial, social, and legal education, in a structured multidisciplinary intervention, and its direct impact on QOL. Outlined in this paper is the role of the medical social worker in a clinical trial, how education was provided and strategies for future interventions. doi:10.1300/J077v25n04_07.     

Quality of life in lung cancer: does disclosure of the diagnosis have an impact?

BACKGROUND: Quality of life (QOL) is an important component of evaluation in oncology. Usually, QOL is used in phase III studies to compare two treatments. The aim of this trial was to evaluate the impact of the disclosure of the diagnosis of cancer on QOL by using the European Organisation for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ)-C30 questionnaire and the supplemental lung cancer-specific module QLQ-LC13. PATIENTS AND METHODS: Patients hospitalised for exploration of an abnormal chest X-ray, with no previous history of cancer, a performance status < or =2, and able to fulfil the questionnaire were eligible. The patients answered the questionnaire two times: before (Q1) and after (Q2) the disclosure of the diagnosis. RESULTS: Seventy patients answered at Q1 and Q2. After the disclosure, some scores deteriorated: arm pain (P=0.009), physical functioning (P=0.01), role functioning (P=0.008), emotional functioning (P=0.0001) and social functioning (P=0.012), whereas the patients' own assessment of global QOL (item global QOL in functioning scales) did not show the same evolution. CONCLUSION: Disclosure of the diagnosis had an impact on social and emotional QOL. Patients with lung cancer need psychological support at the beginning of their disease.     

Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial.

PURPOSE: To examine the effects on process of care and patient well-being, of the regular collection and use of health-related quality-of-life (HRQL) data in oncology practice. PATIENTS AND METHODS: In a prospective study with repeated measures involving 28 oncologists, 286 cancer patients were randomly assigned to either the intervention group (regular completion of European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire version 3.0, and Hospital Anxiety and Depression Scale on touch-screen computers in clinic and feedback of results to physicians); attention-control group (completion of questionnaires, but no feedback); or control group (no HRQL measurement in clinic before encounters). Primary outcomes were patient HRQL over time, measured by the Functional Assessment of Cancer Therapy-General questionnaire, physician-patient communication, and clinical management, measured by content analysis of tape-recorded encounters. Analysis employed mixed-effects modeling and multiple regression. RESULTS: Patients in the intervention and attention-control groups had better HRQL than the control group (P =.006 and P =.01, respectively), but the intervention and attention-control groups were not significantly different (P =.80). A positive effect on emotional well-being was associated with feedback of data (P =.008), but not with instrument completion (P =.12). A larger proportion of intervention patients showed clinically meaningful improvement in HRQL. More frequent discussion of chronic nonspecific symptoms (P =.03) was found in the intervention group, without prolonging encounters. There was no detectable effect on patient management (P =.60). In the intervention patients, HRQL improvement was associated with explicit use of HRQL data (P =.016), discussion of pain, and role function (P =.046). CONCLUSION: Routine assessment of cancer patients' HRQL had an impact on physician-patient communication and resulted in benefits for some patients, who had better HRQL and emotional functioning.     

Assessment of quality of life in patients with rectal cancer treated by preoperative radiotherapy: a longitudinal prospective study

PURPOSE: To assess prospectively the quality of life (QOL) of patients treated by preoperative radiotherapy (RT) and surgery for locally advanced rectal cancer. METHODS AND MATERIALS: We studied 53 patients treated with bi-fractionated RT (50 Gy in 40 fractions within 4 weeks) followed at a median interval of 45 days by abdominoperineal resection in 11 patients and low anterior resection in 42 patients. Their QOL was assessed using two self-rating questionnaires developed by the European Organization for Research and Treatment of Cancer (EORTC): one was cancer specific (EORTC QLQ-C30) and one was site specific (EORTC QLQ-C38). The questionnaires were completed before RT and 12-16 months after RT, at which time 17 patients had undergone colostomy. We hypothesized that at least some scores of the various scales would vary between the two analyses. RESULTS: Compared with the pre-RT scores, at 1 year, patients reported statistically significant improvement in their emotional state (median 75 vs. 100, p <0.0001), perspective of the future (67 vs. 100, p = 0.0004), and their global QOL (75 vs. 83, p = 0.0008), as well as a decrease in GI symptoms (13 vs. 0, p = 0.002). However, the sexual dysfunction score increased significantly, particularly in men (17 vs. 83, p = 0.0045), and a trend toward a lower body image score was observed (100 vs. 89, p = 0.068). At 1 year, patients with colostomies reported similar or significantly improved symptom scores for fatigue, pain, GI problems, and sleep disturbance, but no such improvements were observed in patients without stomas. CONCLUSION: One year after combined treatment for locally advanced rectal cancer, patients exhibited statistically significant improvement in some important QOL outcomes, including global QOL, despite a decrease in sexual function and body image. Any additional improvement in QOL outcome may require refinements in the RT and surgical techniques to reduce late sequelae, particularly sexual dysfunction. Our results suggest that QOL considerations do not justify sphincter-conserving approaches if locoregional tumor control would be compromised.