the Departments of Psychiatry and Psychology and Oncology, Health Sciences Research, Women's Cancer Program, Chaplain Services, Physical Medicine and Rehabilitation, Mayo Clinic Cancer Center, and Medical Social Services, Mayo Clinic, Rochester MN

    ABSTRACT

    PURPOSE: The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer.

    PATIENTS AND METHODS: Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4 (end of multidisciplinary intervention), week 8, and week 27.

    RESULTS: Of the 103 participants, overall QOL at week 4 was maintained by the patients in the intervention (n = 49), whereas QOL at week 4 significantly decreased for patients in the control group (n = 54). This change reflected a 3-point increase from baseline in the intervention group and a 9-point decrease from baseline in the control group (P = .009). Intervention participants maintained their QOL, and controls gradually returned to baseline by the end of the 6-month follow-up period.

    CONCLUSION: Although intervention participants maintained and actually improved their QOL during radiation therapy, control participants experienced a significant decrease in their QOL. Thus, a structured multidisciplinary intervention can help maintain or even improve QOL in patients with advanced cancer who are undergoing cancer treatment.

    INTRODUCTION

    Quality of life (QOL) and psychosocial functioning have been the focus of extensive research in oncology populations over the last few years.1-4 Although these two areas share common characteristics, they are different. QOL is more comprehensive in that QOL encompasses all domains of functioning, including cognitive, physical, and spiritual functioning, and not just the psychosocial domains.

    It has been well demonstrated that impairment in psychosocial functioning leads to psychosocial distress. Distress, as defined by the National Comprehensive Cancer Network, is an unpleasant emotional experience of a psychosocial and/or social nature that interferes with one’s ability to cope with cancer.5,6 This inability to cope, in turn, can reduce the cancer patient’s QOL.

    QOL is a broad, multifaceted concept.7-9 It encompasses the cognitive, physical, and spiritual domains of an individual’s life, in addition to the emotional and social domains. QOL is influenced by a person’s individual experiences, beliefs, expectations, and perceptions.10-12 Consequently, QOL cannot be explained entirely by one or two components or dimensions, such as the emotional and social domains.1,13,14

    Clearly, psychosocial functioning and QOL are inter-related. It has been reported that, in general, the adverse effect of psychosocial distress on QOL is between 30% and 45% (but not 100%).15-18 Many efficacious psychosocial interventions have been shown to decrease distress and improve the psychosocial domains of QOL.6,16-26 These interventions have used a range of approaches, including psychoeducational, individual, and group supportive psychotherapy and individual and group cognitive-behavioral therapy. However, not all psychosocial interventions have improved QOL.27

    Few published studies have evaluated the feasibility and efficacy of interventions designed to directly impact overall QOL.28 Those that have are limited to populations of terminally ill hospice patients29 or have focused on the effects of a QOL assessment and not a QOL intervention.30 These QOL assessments are used to improve communication between the patient and the physician, but have not been designed to specifically improve the cancer patient’s QOL. To date, there have been no multidisciplinary, randomized, controlled trials targeting the maintenance or improvement in overall QOL of individuals with advanced cancer who are undergoing treatment.

    It is our premise that interventions designed to impact QOL, including the cognitive, emotional, physical, social, and spiritual domains, may be more efficacious than interventions targeting only one or two domains. More often than not, advanced cancer patients experience problems in all of these areas as they are receiving cancer treatment. Providing an intervention that is comprehensive has a better likelihood of maximizing the patient’s QOL, especially when they are undergoing cancer treatment. This randomized controlled trial was designed to evaluate this premise. This study sought to maintain overall QOL with a structured, multidimensional, multidisciplinary intervention addressing all elements of QOL in patients undergoing radiation therapy. This comprehensive approach adds complexity to both the intervention design and the study logistics of working with cancer patients undergoing treatment. Therefore, the goal of this study was three-fold. First, we investigated whether such an intervention would be feasible. Second, the efficacy of maintaining advanced cancer patients’ QOL during radiation therapy was assessed. Third, we assessed whether the patients’ QOL was maintained during the next 6 months after the intervention.

    PATIENTS AND METHODS

    Design

    A randomized, stratified, two-group, controlled clinical trial was undertaken to compare the efficacy of a structured multidisciplinary intervention with standard care in maintaining overall QOL of patients with advanced cancer undergoing radiation therapy. The primary end point was overall QOL as measured by a single-item linear analog scale.31 The design was reviewed and approved by the Institutional Review Board of the Mayo Clinic (Rochester, MN). Figure 1 presents the flow diagram for participant identification, accrual, and compliance throughout the trial.

    Patient Selection

    Study participants were recruited from the Mayo Clinic Rochester’s adult advanced cancer patients who were scheduled to undergo radiation therapy. This population was chosen because these individuals, who do not qualify for hospice or palliative services and who have a low probability of long-term survival, rarely receive psychosocial or QOL research attention. Eligibility criteria included a diagnosis within the last 12 months, an expected survival time of at least 6 months, a 5-year survival probability of no more than 50% (as routinely determined by the primary radiation oncologist), and a treatment recommendation of radiation therapy of at least 2 weeks. Patients were approached within a week of starting radiation therapy, and the radiation doses and fractions for the two arms of the study were not different (P = .8068). The total dose and number of fractions of radiation therapy ranged from 30 Gy in 10 fractions to 72 Gy in 42 fractions. Exclusion criteria included previous radiation therapy, recurrent disease after a disease-free period of greater than 6 months, and a previous cancer diagnosis within 5 years. Also, individuals were excluded if they had a Mini Mental Status Examination score of less than 20,32 an Eastern Cooperative Oncology Group performance score of 3 or more,33 active alcohol or substance dependence (except nicotine), active thought disorder, or suicidal plans or were participating in another psychosocial research trial. Participants receiving psychotropic medications or counseling were not excluded.

    Procedure

    The study coordinator approached all persons meeting eligibility criteria. Written informed consent was obtained from each participant before participation in this study. A psychiatrist or psychologist screened potential participants for disqualifying psychiatric disorders and active suicidality. A physiatrist screened participants for ability to participate in the intervention’s physical therapy component. Participants were randomly assigned to either the structured intervention arm or standard medical care arm. Stratification for tumor type, age, sex, and Eastern Cooperative Oncology Group score was undertaken using a minimization procedure that balances the marginal distributions.34,35

    Participants provided demographic data at baseline along with a battery of screening and outcome measures before the intervention, which occurred before beginning radiation or before the second radiation therapy session. Because there was a rolling entry onto the intervention group, participants attended the eight intervention sessions during the first 4 weeks after enrollment but not in any particular order. The intervention was delivered 3 days per week, each week, allowing for maximal participation of eligible individuals. The number of participants in the intervention at any time ranged from one to four patients. Participants were included in the final analysis if they completed at least five of eight sessions. On completion of the intervention phase at week 4, participants provided further QOL data. Participants received the week 4 study packet questionnaires either from the study coordinator at a clinic visit or mailed to their named address. These study questionnaires were again collected at 8 and 27 weeks after enrollment via mail. The study coordinator telephoned participants every 2 weeks after the intervention and telephoned control participants at weeks 4, 8, and 27 to maintain study contact. Recruitment continued until at least 50 individuals were randomly assigned to participate in the intervention group.

    Outcome Measures

    The Spitzer QOL Uniscale and Linear Analog Scales of Assessment (LASAs) of QOL36-38 were the primary and secondary outcome measures, respectively. Overall QOL was measured by the Spitzer QOL Uniscale, and the subconstructs of QOL were assessed by a series of linear analog self-assessments that have been used in a number of oncology trials.39 The LASAs used in this study consisted of 12 items that were each rated on a scale from 0 (as bad as it can be) to 100 (as good as it can be). The items included ratings of overall QOL and cognitive, physical, emotional, social, and spiritual well-being. The social dimension included overall social well-being, social support, financial well-being, and legal concerns. Three additional physical symptoms frequently encountered by advanced cancer patients (fatigue, pain frequency, and pain severity) were also assessed.

    Additional, multiple-item, secondary outcome measures included the Symptom Distress Scale,40 the Profile of Mood States (POMS) –Short Form,41 and the Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being.42 These standardized measures were chosen for their reliability, validity, and previous application in cancer populations. It took an average of 15 minutes for patients to complete these assessments at each time point.

    Intervention

    The structured, multidisciplinary intervention focused on specific strategies designed to improve participants’ QOL (Table 1). The content of these sessions was derived from existing patient education materials available through our cancer education center and from a review of written manuals used in controlled trials for coping with cancer, as well as specific materials developed by each of the study specialists representing one of the QOL domains.43-46 Each session was designed to stand alone to accommodate enrollment of participants on an ongoing basis. Participants on the intervention arm attended eight 90-minute sessions over 3 weeks. Participants received a 200-page manual containing written materials covered in each of the eight sessions for their review. Structured sessions began with 20 minutes of conditioning exercises conducted by a physical therapist followed by educational information, cognitive-behavioral strategies for coping with cancer, open discussion with group leaders and other participants, and support from the overall experience with group leaders and other participants.

    Each session had a theme incorporating the specific domains of QOL and concluded with a 10- to 20-minute guided relaxation exercise. A psychiatrist or psychologist led each session; depending on the theme, an advanced practice nurse, a certified hospital chaplain, or a licensed social worker cofacilitated the session. Each of the leaders and coleaders participated in every step of the development of this intervention and used structured, manualized materials, including structured and specific overheads that were developed before beginning the intervention. Each leader or coleader had a single back-up person who was trained to use the manual and who was required to observe that specialty’s one specified study person in the treatment intervention before participation. At the end of each session, participants rated the overall quality of the session on a 0 to 10 scale, and participants were asked to comment on the specific quality of the three main themes of the session. Session ratings were varied but, in general, were all rated from 8 to 10. Additionally, all forms indicated that all participants received information or discussion on the three main themes for each session. This ensured fidelity and reproducibility of the interventions over the course of the study.47 The sessions were balanced with didactic material, a question and answer period, sharing, reflecting, relaxation, and physical activity.

    Control Group

    The control group received standard medical care as recommended by their radiation oncologist. This included interactions with their oncologist, referrals to specialists when indicated, and opportunities for receiving support through a range of outside agencies such as the American Cancer Society support group (which does not have professional leaders). Inquiries into all resources used by patients both in the intervention and control groups occurred, and this information was recorded.

    Statistical Methods

    The primary end point was the participants’ overall QOL as reported on the single-item Spitzer Uniscale at week 4 after random assignment. The primary analysis was a comparison of week 4 overall QOL in the two groups via a two-sample t test. A sample of 50 patients per group provided 80% power to detect a difference in overall QOL scores of 0.55 times the standard deviation, using a two-tailed t test with a 5% type I error rate.48 This moderate effect size has been identified as a conservative estimate of a clinically meaningful difference for QOL end points.39,49,50 The comparison of the proportion of patients reporting a clinically meaningful improvement had 80% power to detect differences of 20% between the proportions if the lesser result was no more than 10% (presumably, the standard care group). Power considerations for the various secondary end points were comparable.

    Supplementary analysis of the primary end point involved comparison of average change from baseline across groups via a t test. All scales were converted to a 0 to 100 score for comparison purposes, where a higher number indicates better QOL. Assuming a standard deviation of roughly 17% of the range, this translates into a detectable difference of at least 8 points (range, 8 to 10 points) on a scale of 0 to 100 points. Hence, we defined a priori that a difference between groups in overall QOL of at least 8 points would be considered clinically significant. This has been demonstrated to be a reasonable cutoff for clinical significance across a variety of settings for QOL end points.11,51 Comparison of the proportion of patients reporting a clinically significant change across groups was performed using Fisher’s exact test. Note that we refer to change here rather than an improvement because it was expected that the intervention would prevent reductions in QOL secondary to receiving radiotherapy rather than necessarily impart an improvement from baseline QOL.

    Secondary analysis included constructing a general linear model involving a repeated-measures design to ascertain the impact of potential confounding covariates on the primary outcome. Each of the secondary end points was analyzed in a manner similar to that of the primary end point. Correlation coefficients were used to assess the degree of redundancy and amount of shared variance among the QOL end points.

    Missing data were dealt with in a number of ways. Simple imputation of missing data for the primary and QOL-related secondary end points was undertaken as a sensitivity analysis.52,53 None of the results for the imputed analyses differed from the raw results; thus, our results are not affected by the missing data. If a participant failed to report an improvement of at least 8 points on the scale of 0 to 100 points, they were declared to have experienced treatment failure.54

    RESULTS

    One hundred fifteen of the possible 418 participants were enrolled over a 1.5-year period. The most common reasons for refusal, in order of frequency, included the following: excessive travel distance to the treatment center (n = 121), lack of interest in research participation (n = 50), too many competing demands (n = 37), and not feeling well enough to participate (n = 34). Less common reasons included dislike of the group intervention design (n = 27), family member exclusion (n = 13), working (n = 10), burden of completing forms (n = 5), less than 3 weeks of radiation therapy (n = 4), and did not want to commit (n = 2). Only one participant was excluded as a result of cognitive impairment (scoring < 20 on the Mini Mental Status Examination). Eight patients were excluded as a result of not attending at least five of eight intervention sessions because of illness. Of the 115 participants, 103 (49 patients in the active treatment group and 54 patients in the control group) actually completed the week 4 assessments and were evaluated for the primary end point of overall QOL at week 4. A potential confounding factor on the study results would be a between-group difference in the number of patients still receiving radiation therapy at the week 4 assessment. Of the 49 intervention participants, 45 (92%) were still receiving radiation therapy at the week 4 assessment, and of the 54 control participants, 47 (87%) were still receiving radiation therapy at the week 4 assessment. A 2 analysis yielded a nonsignificant difference between the groups (P = .43).

    Baseline characteristics were balanced across treatment arms (Table 2). The average age of the participants was 59.5 years (range, 31 to 85 years). Sixty-six patients were male, and 37 were female. Most patients were married and high school graduates. Patients who expressed a religious affiliation were Christian. Half of the patients were actively employed. Of the 103 participants, 38% had colorectal cancer, 17% had primary head and neck cancer, 15% had lung cancer, 12% had primary brain tumors, and 18% had other cancers. There were no significant differences in distribution of tumor types between intervention and control groups. Hence, the treatment groups were well balanced at baseline for potentially confounding concomitant variables.

    QOL Outcomes

    Baseline QOL end points were comparable between treatment groups. None of the differences between groups at baseline in terms of QOL end points was more than 5.5 points on the scale of 0 to 100 points, and none of the differences was statistically significant. At baseline, average overall QOL as measured by the LASA was 73 in the control group and 70 in the intervention group (P = .48; Table 3). Attrition in the two groups was 3% at week 4, 7% at week 8%, and 20% at week 27. Sensitivity analyses using various imputation methods indicated that the missing data had no impact on the initial results.

    The primary end point analysis of overall QOL at week 4 averaged approximately 9 points higher in the intervention group than in the control group (72.8 v 64.1, respectively; P = .047; Fig 2). Supplementary analysis of the primary end point indicated that QOL in the intervention group actually increased by 3 points from baseline, whereas QOL declined 9 points in the control group (P = .009). Furthermore, the number of participants reporting this significant increase of 8 points was two times higher in the intervention group compared with the control group (43% v 22%, respectively; P = .025). The proportion of participants reporting a significant decline in QOL at week 4, as measured by an 8-point decrease from baseline scores, was only 33% for the intervention group, whereas it was 54% for the control group (P = .0312). Note that overall spiritual well-being was also statistically significant between the intervention and control groups (92.9 v 83.9, respectively; P = .003). Supplementary linear modeling of the overall QOL end point, including all time points and various demographic covariates, produced comparable results. The repeated-measures analysis indicated that a difference between treatments was observed only at the week 4 time point (P = .037), which is comparable to our end point. No differences occurred at weeks 8 or 27.

    Over the next 5 months, QOL was maintained or increased from baseline for patients in the intervention group, whereas the QOL of patients in the control group slowly returned to the baseline level. The statistical difference in QOL between the control and intervention groups by weeks 8 and 27 was no longer statistically significant (Table 3 and Fig 3).

    Further analysis of trends in assessment scores indicated four areas where the intervention group improved, while the standard treatment group declined, from baseline to week 4 (Fig 4). The mean scores of the intervention versus control groups were statistically significantly different and occurred in regard to physical symptom reduction (0.4 v –10.0, respectively; P = .022), emotional well-being (2.8 v –5.4, respectively; P = .046), social well-being (financial issues: 7.0 v –3.6, respectively; P = .025; and legal concerns: 6.7 v –4.7, respectively; P = .048), and spiritual well-being (5.4 v –2.1, respectively; P = .06).

    Reviewing the multiple-item assessment tools at week 4, the tension/anxiety (P = .042) and confusion/bewilderment (P = .014) subscales of the POMS reflected higher emotional distress in the control group. These differences did not result in the total POMS score being statistically different. Additional measures of physical symptoms with the Symptom Distress Scale and spiritual well-being with the Functional Assessment of Chronic Illness Therapy scale did not reveal significant differences between the two groups at week 4.

    Pearson correlations were computed to compare overall QOL with the five main QOL domains as measured by the LASAs (Table 4). Strong correlations existed with baseline cognitive, baseline social, week 4 emotional, week 4 social, and week 4 physical well-being (coefficients of at least 0.75). Moderate correlations existed with baseline physical, baseline emotional, baseline spiritual, week 4 cognitive, and week 4 spiritual well-being (coefficients ranging from 0.66 to 0.73). This is indicative of measurement constructs that are related but not redundant, sharing less than half of their variability.55

    DISCUSSION

    Most randomized psychosocial interventions have included cancer education, coping strategies, and emotional support in a cognitive-behavioral framework to help manage the distress associated with receiving a cancer diagnosis and then undergoing cancer treatment.19 However, these interventions have typically addressed only one or two of the domains of QOL.56-58 To our knowledge, this is the first published randomized controlled trial that developed and implemented a truly multidimensional, multidisciplinary, integrated intervention specifically designed to directly address QOL as a whole, with the goal of maintaining overall QOL in advanced-stage cancer patients undergoing cancer treatment. This study demonstrates that a comprehensive, coordinated approach among specialists can maintain overall QOL for patients during cancer treatment.

    The impact of our intervention on overall QOL is clinically important. Several previous studies have cited a lack of comprehensiveness in the design of their interventions, which may have contributed to their failure to demonstrate an impact on overall QOL.59-61 These previous studies showed that symptomatology can be reduced in a variety of areas in advanced cancer patients without greatly impacting overall QOL.59-61 Hence, it is notable that our comprehensive intervention imparted significant benefit to our cancer patients by eliminating the decline in QOL experienced by the person undergoing cancer treatment.

    Intervention participants reported changes in many, but not all, of the individual domains of QOL. These domains included emotional well-being, social well-being (especially in dealing with financial and legal concerns), and spiritual well-being. However, maintaining overall QOL was independent of the individual domains of QOL, so we were able to demonstrate that these areas were related but not the same. The overall QOL measure achieved both statistical and clinical significance (unlike the individual domains of QOL), thus demonstrating that our global approach to addressing cancer patients’ needs had greater potential for impacting overall well-being than focusing on a discrete domain of concern.11

    Although the difference in QOL between the intervention and control patients was significant at week 4, this difference slowly narrowed to nonsignificance over the next 5 months. Intervention participants maintained their QOL, whereas control participants, who collectively experienced a significant decrease in QOL during radiation therapy, slowly returned to their QOL baseline levels before radiation therapy. The major benefit for patients participating in the intervention group was not experiencing this significant and meaningful decrease in their QOL during cancer treatment.

    Despite the contributions of this study, it, like so many studies addressing components of QOL, had limitations. Our sample population was primarily white and Christian and from the Midwest. Some specialists involved in this intervention, although commonly found in tertiary care centers, may not always be available in rural areas. The number of eligible patients agreeing to participate in the study was only 25%, but this is similar to participation rates of many psychosocial interventions. The cost and availability of a multidisciplinary team providing this level of care may also limit the application of this approach to being implemented as a standard of care, except in large academic health centers. However, the cost effectiveness of QOL intervention has received limited investigation.17 The cost of the intervention was approximately $2,000 per participant for the entire eight-session intervention. However, the larger number of individuals participating, the more this cost can be divided among the participants, and thus, the costs per participant can be reduced. In considering the cost of participating in a multidisciplinary intervention, it may be that the potential benefit obtained in the quality of the advanced cancer patient’s limited life span is well worth the expense of the intervention. Finally, the results need to be explored in other cancer populations who might be receiving only surgery or chemotherapy.

    Appendix: Specific Thematic Components

    Cognitive component. Each session included specific oral and written information for meeting needs of cancer patients and dealing with treatment adverse effects.

    Physical component. Physical component goals included maximizing range of motion, increasing flexibility, and enhancing endurance through gradually increased intensity in conditioning exercises. A physical therapist with extensive experience with cancer patients led this portion of each session.

    Emotional component. The emotional component sought to identify and address psychological distress. Emphasizing a cognitive-behavioral approach, facilitators provided strategies for goal setting, prioritization, assertiveness, communication, stress management, problem solving, and support utilization. Each session ended with relaxation exercises including progressive relaxation, guided imagery, and deep breathing.

    Spiritual component. The goal of the spiritual component was to address the spiritual concerns of those facing life-threatening cancer. The chaplain discussed topics frequently raised by cancer patients including those on grief, guilt, hope, meaning, and purpose. The chaplain individualized the discussion to the patients present that day. Discussing religious beliefs, death, and beliefs regarding afterlife occurred in the context of the discussion on spiritual aspects of one’s life.

    Social component. The social component identified areas of need and discovered ways to maximize social supports. The social worker provided information on dealing with finances, living wills, advanced directives, and other legal concerns. Helping the participants plan for their future medical care, home care, and additional supports was part of the component.

    Authors' Disclosures of Potential Conflicts of Interest

    The authors indicated no potential conflicts of interest.

    Author Contributions

    Conception and design: Teresa A. Rummans, Matthew M. Clark, Jeff A. Sloan, Marlene H. Frost, John Michael Bostwick, Pamela J. Atherton, Mary E. Johnson, Gail Gamble, James Martensen, Janis Miller, Katherine Piderman, Mashele Huschka, Jean Girardi

    Financial support: Teresa A. Rummans, Matthew M. Clark

    Administrative support: Teresa A. Rummans, Matthew M. Clark, Jean Hanson

    Provision of study materials or patients: Teresa A. Rummans, Matthew M. Clark, Marlene H. Frost, Gail Gamble, Jarrett Richardson, Paul Brown, James Martensen, Janis Miller, Katherine Piderman, Jean Hanson

    Collection and assembly of data: Teresa A. Rummans, Matthew M. Clark, Jeff A. Sloan, Michael Bostwick, Pamela J. Atherton, Jarrett Richardson, James Martensen, Janis Miller, Mashele Huschka, Jean Girardi, Jean Hanson

    Data analysis and interpretation: Teresa A. Rummans, Matthew M. Clark, Jeff A. Sloan, Marlene H. Frost, John Michael Bostwick, Pamela J. Atherton, James Martensen, Janis Miller, Mashele Huschka, Jean Hanson

    Manuscript writing: Teresa A. Rummans, Matthew M. Clark, Jeff A. Sloan, Marlene H. Frost, John Michael Bostwick, Pamela J. Atherton, Mary E. Johnson, Gail Gamble, Paul Brown, James Martensen, Janis Miller, Mashele Huschka, Jean Girardi, Jean Hanson

    Final approval of manuscript: Teresa A. Rummans, Matthew M. Clark, Jeff A. Sloan, Marlene H. Frost, John Michael Bostwick, Pamela J. Atherton, Gail Gamble, Paul Brown, James Martensen, Janis Miller, Katherine Piderman, Mashele Huschka, Jean Girardi, Jean Hanson

    Other: Gail Gamble (Administered neuromuscular exams), Jarrett Richardson, Janis Miller, Jean Girardi (Conducting intervention with study subjects)

    NOTES

    Supported by a grant from the Linse Bock Foundation and the Saint Marys Hospital Sponsorship Board.

    Authors' disclosures of potential conflicts of interest and authors contribution are found at the end of this article.

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《临床肿瘤学医学期刊》2006年2月第24卷第2期