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© 2001 American Society for Clinical Oncology Randomized Trial of Coordinated Psychosocial Interventions Based on Patient Self-Assessments Versus Standard Care to Improve the Psychosocial Functioning of Patients With CancerByFrom the Peter MacCallum Cancer Institute, Melbourne; St Vincent’s Hospital, Fitzroy; and Centre for Palliative Care, Kew, Australia. Address reprint requests to Sue-Anne McLachlan, MB BS, Familial Cancer Centre, Peter MacCallum Cancer Institute, Locked Bag 1, A’Beckett St PO, Melbourne, Victoria 8006, Australia; email: mclachsa{at}svhm.org.au
PURPOSE: To determine whether making patient-reported cancer needs, quality-of-life (QOL), and psychosocial information available to the health care team, allowing coordinated specifically targeted psychosocial interventions, resulted in reduced cancer needs, improved QOL, and increased satisfaction with care received. METHODS: Self-reported cancer needs, QOL, and psychosocial information was collected from 450 people with cancer, using standardized questionnaires via a touch-screen computer. For a randomly chosen two thirds, this information was made available to the health care team who coordinated targeted psychosocial interventions. Information from the remaining one third was not seen. Patients were assessed 2 and 6 months after randomization for changes in their cancer needs, QOL, and psychosocial functioning and satisfaction with overall care received. RESULTS: There were no significant differences between the two arms with respect to changes in cancer needs, QOL, or psychosocial functioning between the baseline and follow-up assessments, nor with respect to satisfaction with care. However, for the subgroup of patients who were moderately or severely depressed at baseline, there was a significant reduction in depression for the intervention arm relative to the control arm at the 6-month assessment (P = .001). CONCLUSION: Making patient-reported cancer needs, QOL, and psychosocial data available to the health care team at a single consultation together with coordinated psychosocial interventions does not seem to reduce cancer needs nor improve QOL, psychosocial functioning, or satisfaction with the care received. However, identification of patients with moderate or severe levels of depression may be valuable in reducing subsequent levels of depression.
CANCER IS A MAJOR cause of mortality and morbidity. Although treatments have the potential to cure or prolong life in many individuals, both the disease and its treatment can cause substantial suffering, impairment in quality of life (QOL), and disturbance of psychosocial functioning. The maintenance of patients’ well-being is a fundamental goal of medical practice. Assessment of the impact of illness on physical, mental, and social functioning is an essential element of clinical diagnosis, a major determinant of therapeutic choices and efficacy, and a guide to longer-term care. The traditional history and physical examination obtained by the doctor may not be sufficient for assessing the full range of health-related problems of patients with cancer. Although patients want physicians to ask them about their daily functioning and well-being, physicians infrequently do so, and their perceptions may not accurately reflect patients’ reported physical and psychosocial experience.1 Physicians vary widely in their ability to elicit relevant information from their patients, and patients vary in their ability to articulate their problems and concerns.2-5 Physicians frequently underestimate patients’ level of psychosocial functioning, QOL, level of depression, and the severity of important symptoms.6,7 Additionally, patients with cancer report unmet needs in relation to information, psychologic, patient care, and support domains.8 It would seem then that there is a need for improvement in the communication skills of individual health care providers and the multidisciplinary health care team. Increasing attention has been paid to the formal assessment of QOL and psychosocial issues. Several cancer-specific, self-reported measures of QOL have been developed and carefully validated. They are being included more frequently as outcome measures, alongside biomedical measures, in cancer clinical trials.9,10 These measures may also have a part to play in the care and management of individual patients. When surveyed, most oncologists believe an assessment of QOL should be made in most circumstances, regardless of whether treatment is considered curative or palliative.11 However, less than 50% of these oncologists formally assessed and recorded QOL information in everyday clinical practice. The main reasons given for not collecting QOL information include a belief that a doctor’s subjective assessment is sufficient, lack of an appropriate instrument, and time and resource constraints. Until recently, quantitative QOL and psychosocial data have been collected through questionnaires printed on paper. There is mounting evidence, however, that electronic methods of data collection are easy, quick, reliable, and acceptable to patients, all of which are important components for integration into routine oncologic practice.12-15 A number of studies have reported positive effects of standardized health status information on physicians perceived awareness of their patients’ problems and concerns.16-18 It remains to be seen, however, whether obtaining quantitative self-reported QOL and psychosocial information in everyday clinical practice translates into better outcomes for patients. This is a testable hypothesis and the subject of this study. The specific aim of this study was to determine whether making patient-reported cancer needs, QOL, and psychosocial information available to the health care team, allowing coordinated specifically targeted psychosocial interventions, results in reduced cancer needs, improved QOL, and increased satisfaction with care received. A randomized controlled trial design was used to address this question.
Participants Four hundred fifty eligible patients, predominantly attending the ambulatory clinics at Peter MacCallum Cancer Institute between March 1999 and February 2000, agreed to participate in the study. Inclusion criteria were (1) diagnosis of lung, head and neck, genitourinary, skin, or other cancers managed in the medical oncology clinic, of any clinical stage, (2) not attending for the very first consultation, (3) adequate proficiency in English language, (4) Eastern Cooperative Oncology Group performance status  2, (5) age  18 years, (6) adequate follow-up scheduled at the institute, (7) written informed consent, and (8) completion of 90% of questionnaire items on prestudy assessment. Patients receiving treatment for a major psychiatric or cognitive disorder were excluded, as were patients with breast cancer, because there were competing QOL studies for these patients.
Procedures
Patients allocated to the control group underwent a conventional clinical encounter, and the self-reported information was not made available to the health care professionals at any time. For ethical reasons, however, if a control group patient reported a serious concern (eg, suicidal ideation), then the care coordination nurse was permitted to inform the appropriate health professionals. Both groups received treatment for cancer and other treatment as considered appropriate by the treating physician. Clinical and demographic data were collected at baseline. Patients completed the same computer-based questionnaires 2 and 6 months after randomization to determine changes in their cancer needs, QOL, and depression scores. At 6 months, their satisfaction with overall care received was also assessed.
Measures The CNQ contains 32 items designed to measure patients’ perceived needs within five domains: psychologic, health information, physical and daily living, patient care and support, and interpersonal communication needs.21 For each item, patients indicate whether they are experiencing no need for help or a low, moderate, or high need for help. Preliminary studies support the instrument’s face and content validity.22 A factor analysis demonstrated five domains accounting for most of the total variance, and internal reliability coefficients were satisfactory. For this study, two further questions addressing sexual and spiritual needs were added at the end of the questionnaire using the same format. The EORTC QLQ-C30 (version 2) is a 30-item, self-reported, cancer-specific, previously validated questionnaire.23 It includes five domains pertaining to functioning; physical, role, emotional, social, and cognitive function, as well as a separate global QOL domain. In addition, there are three symptom scales measuring fatigue, pain, and emesis and six single items measuring dyspnea, sleep disturbance, appetite, diarrhea, constipation, and financial impact. The BDI Short Form has been specifically designed to measure depression.24 It comprises 13 items and measures a range of symptoms and attitudes, including sadness, pessimism, level of functioning, and physical effects. The BDI Short Form measures depressive symptoms in a unidimensional, global fashion, relying predominantly on cognitive-affective factors rather than somatic complaints.25 Numerical values for each item indicate severity between 0 and 3. It is established that clinical levels of depression occur when the overall score for the questionnaire is higher than eight. The following categories of severity were used in this report: none or minimal depression, 0 to 4; mild depression, 5 to 7; moderate depression, 8 to 15; severe depression, 16+. Patient satisfaction was measured 6 months after randomization. Patients indicated their level of satisfaction with medical and nursing staff, information provision, and overall satisfaction using a study-specific pen-and-paper survey with a four-point scale: "not at all," "a little," "quite a bit," or "very much."
Statistics Two primary outcome variables were specified a priori, namely the difference between the two arms with respect to changes from baseline in psychologic needs and the difference with respect to changes from baseline in information needs, measured by the CNQ, at the 2-month assessment. To maintain the overall significance level of .05 for the primary end points, the difference between the arms with respect to each of these factors was tested for significance using a significance level of .025. Patients were randomized in a 2:1 ratio to increase the amount of data available on the intervention patients. Only 12.5% more patients in total were required to provide the same power as a trial using a 1:1 randomization ratio. The sample size of 450 patients (approximately 150 control and 300 intervention patients) was chosen for pragmatic reasons but ensured a power of at least 80% to detect a difference of 7.4 in the change in the psychologic needs scores between the randomization arms using a two-sided test at a significance level of .025 and assuming that (1) the SD of the change in scores (within each randomization arm) was no greater than 20 and (2) at least 70% of randomized patients would be assessed at 2 months. The same power applied to the difference in the changes in information needs. Because each increasing level of need in the CNQ corresponds to an increase of 33 in the cancer needs score, a difference of 7.4 in the change of needs score can be considered to correspond to approximately 20% of patients in one arm decreasing their level of need by an average of one category more than they would have done if they had been randomized to the other arm. Secondary outcomes were the other domains of the CNQ, QOL as measured by the EORTC QLQ-C30, and depression as measured by the BDI Short Form. Each primary outcome variable was analyzed using a linear model for the change from baseline, where the model also included the baseline value as a factor. Other changes from baseline were analyzed in the same way. These analyses were carried out using S-Plus statistical software(MathSoft Inc, Seattle, WA). The significance of differences between the two arms with respect to the percentage of patients assessed at 2 and 6 months was calculated using Fisher’s exact test, and the difference between arms with respect to satisfaction scores was assessed using the Cochran-Armitage test for trend. These analyses were carried out using StatXact software (Cytel Software Corp, Cambridge, MA). All reported P values are based on two-sided tests, with no adjustment for multiple comparisons. Ninety-five percent confidence intervals (CI) have been given for the main results.
Selection of Patients In an attempt to obtain a representative sample, the records of 3,520 patients were screened before their clinic attendance for potential recruitment to the trial. Of these 2,759 (78% of 3,520) did not meet prespecified eligibility criteria, predominantly because of inadequate scheduled follow-up at the institute (n = 1,284 patients), ineligible diagnosis (n = 521), first visit (n = 475), and inadequate proficiency in English language (n = 258). Only one patient was ineligible because less than 90% of the questions were answered via the computer. Of the remaining 761 patients, 309 were potentially eligible but were not randomized because of care coordination nurse workload (n = 189), nonattendance at scheduled outpatient appointment (n = 50), insufficient recruitment time before the consultation (n = 36), doctor refusal (n = 22), and technical problems (n = 12). A further two patients were eligible but excluded, one in error and one because of a computer failure. Overall, 450 (59%) of the 761 eligible or potentially eligible patients were randomized. Ninety-nine percent of patients found the touch-screen easy to use. Although 55% of patients had no prior computer use, the median time to complete all three questionnaires was 15 minutes (range, 6 to 54 minutes), with median times of 8, 4, and 3 minutes for the CNQ, EORTC QLQ-C30, and BDI Short Form, respectively.
Participant Characteristics
Patients in the intervention arm tended to have more psychologic needs, physical and daily living needs, and patient care and support needs as measured by the CNQ, but a similar proportion were moderately or severely depressed on the BDI (Table 3). Both groups had very similar functional scores and global health status/QOL scores on the QLQ-C30 (data not shown).
Application of the Intervention Information on the services identified by the care coordination nurse to meet the self-reported needs of patients in the intervention arm was collected routinely for the last 202 (68% of 296) intervention patients entered onto the trial. Overall 533 services were identified for these patients, of which 166 (31%) were already in place. Of the remaining 367, 320 (87%) were offered to the patients. Thirteen percent of services were not offered because the nurse decided that there were other priorities and/or a preference for other formal or informal support or for patient self-management. Twenty-six percent of the 202 patients had no services offered, the remaining 74% were offered an average of two services (range, one to six services). Of the 320 services offered, only 117 (37%) were accepted. The reasons were predominantly related to timing and priorities, a preference for other forms of support or self-management, and a belief that the services offered were unnecessary or would not help. The most frequently offered services were counseling (30% of services offered) and physical symptom management (20%). Significantly more patients accepted referrals for physical symptom management than for counseling (57% v 28%, respectively; P = .0003).
Impact of Intervention on Consultation Times
Outcomes The prespecified primary outcome variables were the changes from baseline in the CNQ assessment of psychologic needs and of health information needs at the 2-month assessment. The estimated difference between the two arms with respect to changes in psychological needs at 2 months (the intervention benefit), adjusted for baseline values, was 1.6 (95% CI, -2.6 to 5.9; P = .45) (Table 4). Similarly, the esti-mated difference between the two arms with respect to changes in health information needs at 2 months adjusted for baseline values was 0.7 (95% CI, -6.8 to 8.2; P = .85) (Table 4). There was no indication of a difference between the two arms with respect to these outcomes at the 6-month assessment.
None of the secondary outcome variables showed a statistically significant change at the 2-month assessment. There was a significant difference between the arms with respect to a change in the spiritual needs at 6 months (P = .02). This could well be a chance finding, given the multiple significance tests performed, and the difference between the arms at 2 months was in the opposite direction to the difference at 6 months (Table 4). It is possible that the intervention did not have a large effect on the outcomes because of the high percentage of patients with either no needs or low needs. Thus subgroup analyses were performed for each domain studied, selecting patients with the greatest needs at baseline (the 20% or so of patients with highest CNQ needs scores) or poorest functioning (the 20% or so of patients with lowest QLQ-C30 functioning scores). Changes in BDI scores were also studied for the subgroup of patients who were classified as moderately or severely depressed at baseline. Again, there was little or no evidence of a significant benefit associated with the intervention arm for the primary outcome variables, nor for the other CNQ and QLQ-C30 domains. However, for the subgroup of patients who were classified as moderately or severely depressed at baseline, there was an estimated difference in the mean changes between baseline and follow-up scores for the intervention and control arms of 2.5 at the 2-month assessment (95% CI, -0.3 to 5.3; P = .08) and of 5.1 (95% CI, 2.3 to 7.9; P = .001) at the 6-month assessment (Fig 1). In the control arm, 73% and 90% of patients who were moderately or severely depressed at baseline were still moderately or severely depressed at the 2- and 6-month assessments, respectively, whereas in the intervention arm, these percentages were reduced to 58% and 45%, respectively. Of interest, an estimated 68% of patients in the intervention arm who were moderately or severely depressed at baseline were offered counseling, and 47% of those offered counseling accepted the offer.
Sixty-eight percent of patients in both arms completed a patient satisfaction survey. There were no significant differences between the two arms with respect to levels of satisfaction. For control versus intervention patients, respectively, the percentage of patients indicating their level of satisfaction was "quite a bit" or "very much" was 95% versus 98% for nursing care, 98% versus 98% for medical care, 91% versus 96% for information received about their illness and treatment, and 98% versus 99% for overall satisfaction with the care received.
Standardized QOL and psychosocial assessments are increasingly being included in clinical trials, but their use in clinical practice is still uncommon and of unproven value. The objective of this randomized clinical trial was to investigate the effectiveness of collecting standardized, self-reported QOL, psychosocial, and cancer needs information via a touch-screen computer in the ambulatory setting. In the intervention group, the information was then made available for the clinical encounter as a brief report form and if problems were reported, coordinated psychosocial interventions were implemented. The results of the trial indicate that there was no meaningful difference in the changes from baseline in cancer needs or QOL between the intervention and standard care groups as measured at 2 and 6 months. Acceptability of the touch-screen process as a means of self-reporting and satisfaction with care received were highly endorsed in both study groups. The lack of an overall effect deserves comment. The entry criteria for the study were broad and included ambulatory patients with a variety of cancer types of any disease stage at virtually any time in their disease process. However, some restrictions were imposed. Patients needed to be functioning relatively well according to the performance status index. Possibly as a consequence, the selected patients reported relatively low levels of cancer needs and relatively high levels of psychosocial functioning and QOL. Additionally more than one third were in follow-up, not receiving active treatment. The QOL profiles of the group, as measured by the EORTC QLQ-C30, however, are similar to those reported by other cancer patients in a population-based survey, but the group as a whole had lower functional status than individuals without any illness.26 The small percentage of patients reporting high levels of cancer needs may have limited the ability to effect clinically meaningful changes in the intervention group. When the subgroup of patients with moderate or severe levels of depression were selected for analysis, there was a trend toward a significant benefit associated with the intervention at 2 months (P = .08), which had become clearly significant at 6 months (P = .001). No similar trend was seen in patients with high cancer needs as measured by the CNQ or poor functioning as measured by the EORTC QLQ-C30. It is possible that there is a future role for the routine screening of cancer patients for depression before medical appointments. Our results support previous work suggesting that computers are an acceptable way for patients to provide information in an ambulatory clinical setting. In this trial, the collection and use of the self-reported information in the consultation occurred on one occasion, at one clinic visit. The impact of one essentially randomly timed application may have been inadequate to effect meaningful changes in a high proportion of patients. Previous studies have reported patients’ willingness to complete health-related surveys each time they visited the doctor.15 Similarly, other studies in a range of treatment settings including primary care, academic and community practice indicate that the introduction of standardized psychosocial and health status assessments is feasible and seems to facilitate communication between patients and their physicians.27-29 Truly incorporating this process into everyday clinical practice would require patients to report on their QOL and cancer needs at every visit. This would allow health professionals to have a better understanding of measurement principles and an appreciation of the value and meaning of patient-reported data. It would also provide an opportunity for patients to develop a trusting relationship with their treating health care team and to choose the most appropriate time to take up services that had been offered. In this study, an estimated 63% of services offered to the patients by the care coordination nurses were not accepted, predominantly because of timing of the offer and other priorities. The diagnostic and therapeutic components of the program implemented in this trial may not have been optimal. The CNQ was chosen because it is self-administered and has previously been used to screen for cancer needs in an Australian population. This seemed appropriate, because it is documented that patients with cancer report high levels of unmet needs in several domains. Testing of the CNQ’s psychometric properties is encouraging but preliminary. The responsiveness of this instrument was presumed; however, formal evaluation is required before we can be certain that it is sensitive enough to detect changes in needs over time. The EORTC QLQ-C30 and BDI Short Form are well-established and validated measures of QOL and depression, respectively. No differences in change scores were found between arms for any of the domains or symptom subscales measured by these questionnaires. This suggests that it is likely that the groups did not differ with respect to the amount of change that occurred over time in cancer needs, QOL, nor depression. When deficits in QOL and psychosocial functioning occurred or when high levels of cancer needs were identified, prespecified care pathways were in place to assist the multidisciplinary team in responding to the concerns raised. Detection of the problem is only the first step toward adequate treatment. Providing appropriate support services and interventions in response to these concerns is the other important component. A large body of evidence indicates that psychosocial interventions can benefit the emotional adjustment and social functioning of patients with cancer.30 There is also good evidence that pharmacologic therapies can improve disease and treatment-related symptoms. In the analysis of this study, it seems that a significant proportion of patients may not have received the interventions identified to meet their needs, with an estimated 13% of identified interventions not being offered to the patients and an estimated 63% of those offered not being accepted by the patients. Interestingly, patients were more likely to accept referrals for physical symptom management than for counseling. Another possible design limitation of this study was the potential for contamination between the groups. Doctors and clinic nurses were involved in seeing both intervention and control patients in the ambulatory care clinics. The health professionals’ behavior may have changed as a result of a heightened awareness of the study purposes and issues raised by patients in the intervention group. The usual care patients could then have benefited from this shift, resulting in the high levels of satisfaction in both groups. In subsequent studies, a cluster-type randomization process may be preferable, so that whole clinics are randomized to either usual care or the intervention process and patient outcomes then compared. Similarly, completion of the touch-screen questionnaires by the control group may have resulted at least partly in an intervention effect. The process may have served as a prompt for patients to raise their concerns during the consultation, even though a summary report form was not made available. As with many longitudinal studies of patients with cancer, there was attrition of participants from the point of recruitment to the completion of the trial. Although attrition reduces the statistical power of the study to detect differences, this was considered a priori and the sample size was calculated to account for the potential loss of participants. More importantly, there is the potential for bias if proportionately more patients drop out from a particular group. In our study, the attrition rate was very similar in both arms as were the reasons for dropping out. It is therefore unlikely that missing data had a significant impact on the overall results of the trial. It is possible that no difference between the control and intervention groups was apparent because the current standard of care, as provided by the health care team involved in this study, already adequately addresses patients’ needs and psychosocial functioning. We are not overly confident of this explanation. Caution is required, because medical practitioners in both medical oncology and general practice settings have been found to have difficulties identifying patients with depression.31,32 Clinical audit and prospective studies indicate that clinicians are frequently unaware of psychologic disturbance experienced by their patients.33 Similarly, patients with cancer report unmet needs in relation to information, psychologic, patient care, and support domains. A number of issues must be addressed and evaluated before health status and psychosocial measures are used routinely in clinical practice. Health professionals need to have a better understanding of measurement properties and the meaning of patient-reported data. Most clinicians have well-established responses for abnormal laboratory and imaging results, but they also need strategies and guidelines for less familiar problems highlighted by health status and psychosocial assessments. Ongoing development and refinement of disease-specific measures of QOL and psychologic function are needed to increase their relevance to clinicians and everyday clinical practice. Further trials of health status measurement as a component of everyday clinical practice are required. Measures need to be tested in more diverse populations incorporating differences in language, age, disease status, and educational level. Studies are needed to determine which measures add useful information and to which clinical situations they add most. In this study setting, it does not seem that making patient-reported cancer needs and QOL data available to the health care team at a single consultation results in overall reduced cancer needs and improved QOL or satisfaction with the care received. However, a rapid and simple means of identifying patients with moderate or severe levels of depression could be valuable in reducing the future incidence of depression in this group of patients.
APPENDIX Other Contributors Psychosocial Working Party: T. Anderson, E. Ballinger, J. Blackshaw, B. Ferguson, H. Mugg, P. Reddy, and G. White. Care Coordination Nurse Working Party: D. Austin, E. Cheng, H. Ferguson, A. Mumme, M. Oliver-Weymouth, A. Pollard, and K. Swift. General Practitioner Communication Working Party: W. Coates, J. Grogan, T. Oehr, and J. Samers. Resource Utilization Working Party: J. Brophy and A. Dalton. Clinical Collaborators: J. Ainslie, D. Ball, K. Narayan, L. Peters, M. Prince, and G. Toner.
Supported by the Commonwealth of Australia and State Government of Victoria. We thank the following for their contribution: Robert Sanson-Fisher, PhD, who contributed to the design and reviewed the protocol and results; Phyllis Butow, PhD, Sanchia Aranda, PhD, and Doreen Akkerman, who reviewed the protocol and results; the medical and nursing staff involved in the recruitment and care of patients; and the patients who participated.
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Copyright © 2001 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
