Economic evaluation of a combined screening and stepped-care treatment program targeting psychological distress in patients with metastatic colorectal cancer: A cluster randomized controlled trial.

BACKGROUND: Psychological distress is highly prevalent among patients with metastatic colorectal cancer. AIMS: To perform an economic evaluation of a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer in comparison with usual care. DESIGN: Societal costs were collected alongside a cluster randomized controlled trial for 48 weeks. A total of 349 participants were included. SETTING: Participants were recruited from oncology departments at 16 participating hospitals in the Netherlands. METHODS: Outcome measures were the Hospital Anxiety and Depression Scale and quality-adjusted life-years. Missing data were imputed using multiple imputation. Uncertainty was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty surrounding the cost-effectiveness estimates. Sensitivity analyses were performed to check robustness of results. RESULTS: Between treatment arms, no significant differences were found in Hospital Anxiety and Depression Scale score (mean difference: -0.058; 95% confidence interval: -0.13 to 0.011), quality-adjusted life-years (mean difference: 0.042; 95% confidence interval: -0.015 to 0.099), and societal costs (mean difference: -1152; 95% confidence interval: -5058 to 2214). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was 0.64 and 0.74 at willingness-to-pay values of €0 and €10,000 per point improvement on the Hospital Anxiety and Depression Scale, respectively. The probability that the intervention was cost-effective compared to usual care for quality-adjusted life-years was 0.64 and 0.79 at willingness-to-pay values of €0 and €20,000 per quality-adjusted life-year, respectively. CONCLUSION: The intervention is dominant over usual care, primarily due to lower costs in the intervention group. However, there were no statistically significant differences in clinical effects and the uptake of the intervention was quite low. Therefore, widespread implementation cannot be recommended.

Screening and Stepped Care Targeting Psychological Distress in Patients With Metastatic Colorectal Cancer: The TES Cluster Randomized Trial.

BACKGROUND: This study evaluated the effectiveness of a screening and stepped care program (the TES program) in reducing psychological distress compared with care as usual (CAU) in patients with metastatic colorectal cancer starting with first-line systemic palliative treatment. PATIENTS AND METHODS: In this cluster randomized trial, 16 hospitals were assigned to the TES program or CAU. Patients in the TES arm were screened for psychological distress with the Hospital Anxiety and Depression Scale and the Distress Thermometer/Problem List (at baseline and 10 and 18 weeks). Stepped care was offered to patients with distress or expressed needs, and it consisted of watchful waiting, guided self-help, face-to-face problem-solving therapy, or referral to specialized mental healthcare. The primary outcome was change in psychological distress over time, and secondary outcomes were quality of life, satisfaction with care, and recognition and referral of distressed patients by clinicians. Linear mixed models and effect sizes were used to evaluate differences. RESULTS: A total of 349 patients were randomized; 184 received the TES program and 165 received CAU. In the TES arm, 60.3% of the patients screened positive for psychological distress, 26.1% of which entered the stepped care program (14.7% used only watchful waiting and 11.4% used at least one of the other treatment steps). The observed low use of the TES program led us to pursue a futility analysis, which showed a small conditional power and therefore resulted in halted recruitment for this study. No difference was seen in change in psychological distress over time between the 2 groups (effect size, -0.16; 95% CI, -0.35 to 0.03; P>.05). The TES group reported higher satisfaction with the received treatment and better cognitive quality of life (all P<.05). CONCLUSIONS: As a result of the low use of stepped care, a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer did not improve psychological distress. Our results suggest that enhanced evaluation of psychosocial concerns may improve aspects of patient well-being.

Screening and treatment of psychological distress in patients with metastatic colorectal cancer: study protocol of the TES trial.

BACKGROUND/INTRODUCTION: Psychological distress occurs frequently in patients with cancer. Psychological distress includes mild and severe forms of both anxious and depressive mood states. Literature indicates that effective management of psychological distress seems to require targeted selection of patients (T), followed by enhanced care (E), and the application of evidence based interventions. Besides, it is hypothesized that delivering care according to the stepped care (S) approach results in an affordable program. The aim of the current study is to evaluate the (cost)-effectiveness of the TES program compared to usual care in reducing psychological distress in patients with metastatic colorectal cancer (mCRC). METHODS: This study is designed as a cluster randomized trial with 2 treatment arms: TES program for screening and treatment of psychological distress versus usual care. Sixteen hospitals participate in this study, recruiting patients with mCRC. Outcomes are evaluated at the beginning of chemotherapy and after 3, 10, 24, and 48 weeks. Primary outcome is the difference in treatment effect over time in psychological distress, assessed with the Hospital Anxiety and Depression Scale. Secondary outcomes include quality of life, patient evaluation of care, recognition and management of psychological distress, and societal costs. DISCUSSION: We created optimal conditions for an effective screening and treatment program for psychological distress in patients with mCRC. This involves targeted selection of patients, followed by enhanced and stepped care. Our approach will be thoroughly evaluated in this study. We expect that our results will contribute to the continuing debate on the (cost-) effectiveness of screening for and treatment of psychological distress in patients with cancer. TRIAL REGISTRATION: This trial is registered in the Netherlands Trial Register NTR4034.

Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial).

BACKGROUND: Breast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local recurrence, whereas the cosmetic outcome has been considered less important. Large studies have reported poor cosmetic outcomes in 20-40% of patients after breast-conserving surgery, with the volume of the resected breast tissue being the major determinant. There is clear evidence for the efficacy of ultrasonography in the resection of nonpalpable tumours. Surgical resection of palpable breast cancer is performed with guidance by intra-operative palpation. These palpation-guided excisions often result in an unnecessarily wide resection of adjacent healthy breast tissue, while the rate of tumour-involved resection margins is still high. It is hypothesised that the use of intra-operative ultrasonography in the excision of palpable breast cancer will improve the ability to spare healthy breast tissue while maintaining or even improving the oncological margin status. The aim of this study is to compare ultrasound-guided surgery for palpable tumours with the standard palpation-guided surgery in terms of the extent of healthy breast tissue resection, the percentage of tumour-free margins, cosmetic outcomes and quality of life. METHODS/DESIGN: In this prospective multicentre randomised controlled clinical trial, 120 women who have been diagnosed with palpable early-stage (T1-2N0-1) primary invasive breast cancer and deemed suitable for breast-conserving surgery will be randomised between ultrasound-guided surgery and palpation-guided surgery. With this sample size, an expected 20% reduction of resected breast tissue and an 18% difference in tumour-free margins can be detected with a power of 80%. Secondary endpoints include cosmetic outcomes and quality of life. The rationale, study design and planned analyses are described. CONCLUSION: The COBALT trial is a prospective, multicentre, randomised controlled study to assess the efficacy of ultrasound-guided breast-conserving surgery in patients with palpable early-stage primary invasive breast cancer in terms of the sparing of breast tissue, oncological margin status, cosmetic outcomes and quality of life. TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NTR): NTR2579.

Evaluation of quality-of-life measures for use in palliative care: a systematic review.

PURPOSE: In this literature review we evaluated the feasibility and clinimetric quality of quality-of-life (QoL) measurement instruments suitable for use in palliative care. METHODS: We conducted a systematic literature review to identify instruments measuring (at least one domain of) QoL. We selected articles that present data on patients receiving palliative care and at least one measurement property. A checklist was used to describe the characteristics of the instruments, and a widely accepted rating list was used to evaluate the clinimetric aspects. RESULTS: 29 instruments were identified and evaluated, most of which were targeted at palliative patients in general. None of the instruments demonstrated satisfactory results for all measurement properties. Fourteen instruments received positive ratings for construct validity. Thirteen instruments were tested for reliability, but only two were tested adequately and had positive results (ICC>0.70). Responsiveness was not tested adequately for any of the instruments. Very few of the studies provided information on the interpretation of the scores. Overall, the MQOL, followed by the QUAL-E and the QODD, received the best ratings for their measurement properties. CONCLUSIONS: Many measurement instruments were identified, but most had not yet been adequately evaluated. The evaluation of existing instruments with good content validity should have priority over the development of new instruments.

Podiatric Adverse Events and Foot Care in Cancer Patients and Survivors Awareness, Education, and Literature Review.

Cancer is one of the leading causes of mortality and morbidity worldwide. Recent improved therapies have resulted in more patients surviving cancer and living longer. Despite these advances, the majority of patients will develop adverse events from anticancer therapies. Foot alterations, including nail toxicities, hand-foot syndrome, edema, xerosis, hyperkeratosis, and neuropathy, are frequent among cancer patients. These untoward conditions may negatively impact quality of life, and in some cases may result in the interruption or discontinuation of cancer treatments. Appropriate prevention, diagnosis, and management of podiatric adverse events are essential to maintain foot function and health-related quality of life, both of which are critical for the care of cancer patients and survivors. This article shows results related to complaint and impact on quality of life of the Oncology Foot Care program and reviews publications specific to podiatric adverse events related to cancer treatments.

Distress in spouses and patients after treatment for head and neck cancer.

BACKGROUND: The objective of this study is to obtain insight into distress in spouses and patients treated for head and neck cancer. METHODS: Forty-one patient-spouse pairs completed the Hospital Anxiety and Depression Scale (HADS). Inclusion criteria included curative treatment for head and neck cancer. Exclusion criteria were visiting the clinic without a spouse, bad news at the routine follow-up examination, diseases causing cognitive dysfunction, and poor understanding of the Dutch language. Next to the HADS, the assessment protocol included age, gender, health status, coping strategy, time since cancer treatment, tumor stage and site, treatment modality, functional and social impairment, and caregiving burden. RESULTS: A clinical level of distress was noted in 20% of the spouses and in 27% of the patients. Distress in spouses was related to the presence of a feeding tube in patients, a passive coping style, less vitality, and a disrupted daily life schedule resulting from caregiving. Distress in patients was related to the presence of a feeding tube, speech and swallowing problems, less social contacts, a passive style of coping, and nonexpression of emotions. CONCLUSION: Distress is often present in spouses and patients treated for head and neck cancer. Routine screening for psychologic distress is recommended.

Content and spiritual items of quality-of-life instruments appropriate for use in palliative care: a review.

Despite the importance of palliative care and quality of life (QoL) as an outcome measure, little research evaluated the QoL instruments that are used in end-of-life situations. We evaluated the content of and domains measured by QoL instruments that are suitable for use in palliative care and how the domain of spirituality was operationalized in these instruments. We conducted two literature reviews. One identified the domains that are most important for the QoL of incurably ill patients and resulted in a framework of QoL domains. The other review identified 29 instruments measuring (at least one domain of) QoL that are appropriate for use in palliative care. Most of the instruments covered only one or two QoL domains, and none of the instruments covered all QoL domains included in the framework. Among the 29 instruments, 15 included items on spirituality. We also categorized the spirituality items contained in the instruments into the spirituality aspects in the framework. Most spirituality items concerned the meaning or purpose of life. This study provides information about the domains included in QoL instruments that are suitable for use in palliative care and provides insights into the differences in content, which can be helpful when choosing an instrument for use in palliative care.

Computerized prospective screening for high levels of emotional distress in head and neck cancer patients and referral rate to psychosocial care.

To investigate prospectively the prevalence of high levels of emotional distress and referral rate to psychosocial care in head and neck cancer (HNSCC) patients. Fifty-five consecutive newly diagnosed HNSCC patients were asked to complete the hospital anxiety and depression scale (HADS) and the EORTC QLQ-C30 and H&N35 quality of life questionnaires on a touch screen computer-assisted data collection system on their first visit and during follow-up visit. Sociodemographic, clinical, and quality of life parameters were compared to a high level of distress (HADS score >15). Number of patients with a high level of distress were compared to referral rates to psychosocial care as retrieved from patient hospital files. At time of diagnosis, 18% (10/55) of the patients had a high level of distress (related to tumor stage and site, and global quality of life and social eating) versus 25% (14/55) at follow-up (related to a variety of quality of life parameters). Low levels of distress at baseline or follow-up was noted in 64%; 18% had normal scores at baseline and developed distress at follow-up; 11% had high levels at baseline and returned to normal scores at follow-up, and 7% had persistent distress from baseline to follow-up. No patients were referred to psychosocial care at time of diagnosis. At follow-up visit 21% (3/14) were referred, all patients who developed a high level of distress after initial diagnosis. High level of emotional distress is common and few patients are referred to psychosocial care. Development of a stepped care model (including careful monitoring by using a touch screen computer system) may meet the potentially unmet needs of HNC patients and contribute improving cancer care.