"Ariadne's Thread": Psycho-educational Empowerment Intervention for Patients with Metastatic Breast Cancer.

"Ariadne's thread" is a psycho-educational intervention designed by the Breast Unit and the Clinical Psychology Unit of an Italian Comprehensive Cancer Center and aims to promote empowerment in patients with metastatic breast cancer. It consists of 8 online meetings led by a psycho-oncologist in which informative sessions by patients' referring physicians alternate with moments of stress management techniques. This study aims to investigate (1) the feasibility of the "Ariadne's thread" pilot intervention and (2) the satisfaction and perceived benefits of the pilot intervention. We used a mixed method approach in which (1) it was detected: the number of acceptance to the single session of the intervention by both patients and professionals, the number of help requests by patients, and the number of change of date requests by professionals; (2) semi-structured interviews were conducted with the professionals who participated in the intervention; (3) 2 focus groups were conducted with patients, and (4) a questionnaire was submitted to each of them. The intervention is sustainable from the perspective of the organization, professionals, and patients. In particular, the patients declared perceiving benefits in many aspects: improved relationships with doctors, acceptance of their illness, learning of a relaxation technique, possibility to look at the world with trust and hope, etc. The questionnaires show an improvement in empowerment and satisfaction as a result of the intervention. "Ariadne's thread" is a psycho-educational intervention that effectively addresses the needs of patients with MBC. It can be applied to other contexts (1) if it has been confirmed that similar needs exist or (2) if it can be modified to accommodate other needs.

The Long-Term Benefit of Liver Transplantation for Hepatic Metastases From Neuroendocrine Tumors.

Selection criteria and benefit of liver transplantation for hepatic metastases from neuroendocrine tumors (NETs) remain uncertain. Eighty-eight consecutive patients with metastatic NETs eligible for liver transplantation according to Milan-NET criteria were offered transplant (n = 42) versus nontransplant options (n = 46) depending on list dynamics, patient disposition, and age. Tumor burden between groups did not differ. Transplant patients were younger (40.5 vs. 55.5 years; p < 0.001). Long-term outcomes were compared after matching between groups made on multiple Cox models adjusted for propensity score built on logistic models. Survival benefit was the difference in mean survival between transplant versus nontransplant options. No patients were lost or died without recurrence. Median follow-up was 122 months. The transplant group showed a significant advantage over nontransplant strategies at 5 and 10 years in survival (97.2% and 88.8% vs. 50.9% and 22.4%, respectively; p < 0.001) and time-to-progression (13.1% and 13.1% vs. 83.5% and 89%; p < 0.001). After adjustment for propensity score, survival advantage of the transplant group was significant (hazard ratio = 7.4; 95% confidence interval (CI): 2.4-23.0; p = 0.001). Adjusted transplant-related survival benefit was 6.82 months (95% CI: 1.10-12.54; p = 0.019) and 38.43 months (95% CI: 21.41-55.45; p < 0.001) at 5 and 10 years, respectively. Liver transplantation for metastatic NETs under restrictive criteria provides excellent long-term outcome. Transplant-related survival benefit increases over time and maximizes after 10 years.

Making patient centered care a reality: a survey of patient educational programs in Italian Cancer Research and Care Institutes.

BACKGROUND: Educational intervention represents an essential element of care for cancer patients; while several single institutions develop their own patient education (PE) programs on cancer, little information is available on the effective existence of PE programs at the level of research and care institutes. In Italy such institutes--Istituti di Ricovero e Cura a Carattere Scientifico--are appointed by the Ministry of Health, and 11 (Cancer Research & Care Istitute-CRCI) of the 48 are specific for cancer on the basis of specific requirements regarding cancer care, research and education. Therefore, they represent an ideal and homogeneous model through which to investigate PE policies and activities throughout the country. The objective of this study was to assess PE activities in Italian CRCI. METHODS: We carried out a survey on PE strategies and services through a questionnaire. Four key points were investigated: a) PE as a cancer care priority, b) activities that are routinely part of PE, c) real involvement of the patients, and d) involvement of healthcare workers in PE activities. RESULTS: Most CRCI (85%) completed the survey. All reported having ongoing PE activities, and 4 of the 11 considered PE an institutional activity. More than 90% of CRCI organize classes and prepare PE handouts, while other PE activities (e.g., Cancer Information Services, mutual support groups) are less frequently part of institutional PE programs. Patients are frequently involved in the organization and preparation of educational activities on the basis of their own needs. Various PE activities are carried out for caregivers in 8 (73%) out of 11 institutes. Finally, health care workers have an active role in the organization of PE programs, although nurses take part in these activities in only half of CRCI and pharmacists are seldom included. CONCLUSIONS: The information arising from our research constitutes a necessary framework to identify areas of development and to design new strategies and standards to disseminate the culture of PE. This may ultimately help and stimulate the establishment of institutional integrated PE programs, including policies and interventions that can benefit a significant proportion of cancer patients.

Italian validation of the Purpose In Life (PIL) test and the Seeking Of Noetic Goals (SONG) test in a population of cancer patients.

OBJECTIVE: The first instruments developed to evaluate specific logotherapeutic dimensions were the Purpose In Life (PIL) and the Seeking Of Noetic Goals (SONG) tests, designed to reflect Frankl's concepts of, respectively, meaning in life attainment and will to meaning. This study aims to perform the Italian cultural adaptation and the psychometric validation of the PIL and SONG questionnaires. METHODS: We administered the PIL and SONG, culturally adapted into the Italian language, to 266 cancer patients. The psychometric validation appraised construct validity, internal consistency, test-retest reliability, known-group validity, and convergent validity of the two questionnaires with respect to one another. RESULTS: The factorial analysis indicates that the original single-factor solution can be maintained for both instruments (proportion of variance explained by the first factor 77% and 71% for the PIL and SONG, respectively). The results show excellent internal consistency (Cronbach's alpha of 0.91 for the PIL and 0.90 for the SONG) and test-retest reliability (intraclass correlation coefficient of 0.92 for the PIL and 0.81 for the SONG). As expected, males, believers, patients nearer to the diagnosis, and patients not undergoing psychological therapy have higher PIL and lower SONG scores, while expectations for age were not confirmed. The average level for the PIL was 107.3, while for the SONG, it was 66.1, and a negative correlation (-0.47) between PIL and SONG scores indicates good convergent validity of the two instruments. CONCLUSION: Italian versions of the PIL and SONG are adequate and reliable self-report instruments for evaluating purpose in life and the motivation to find purpose for cancer patient populations.

Re-activating life skills in cancer patients through expressive-creative workshops: A qualitative exploratory study.

BACKGROUND: Cancer strongly impacts on patients' lives, undermining their life skills. This research aimed to explore the perception of efficacy of participants in a series of expressive-creative workshops (ArtLab) designed to reactivate life skills in cancer patients. METHODS: Quotations of two semi-structured focus groups with ten participants in ArtLab (Mean Age = 59; SD = 11.19) enrolled at [Fondazione IRCCS Istituto Nazionale dei Tumori] have been analyzed through a priori (top-down) thematic analysis which allowed us to identify life skills provided by WHO 1948: Emotional, Relational and Cognitive. RESULTS: Thematic analysis showed ArtLab program's effectiveness, especially regarding Emotional and Relational life skills. Cognitive skills, instead, seemed to be only partially expressed. Sub-themes articulation for each life skill has been discussed. CONCLUSION: This study provides encouraging results with respect to the effectiveness of expressive-creative group workshops among cancer patients.

Development of the Functional Assessment of Chronic Illness Therapy - Liver Transplant (FACT-LT) Scale.

Background: This study aims to propose an initial development of the FACT-Liver Transplant (FACT-LT) scale to assess the major physical and emotional concerns of patients before and after Orthotopic Liver transplant (OLT) due to acute and chronic liver failure and hepatocellular carcinoma. Methods: The FACT-LT was developed in two phases. In Phase I, items were generated: 1) through interviews with 10 OLT experts and 15 candidates for or recipients of both oncological and non-oncological OLT which identified relevant topics; 2) from the FACIT item bank. In Phase II, a questionnaire to assess item frequency, applicability, and comprehension was administered to 20 OLT experts and, to assess item difficulty, embarrassment and content irrelevance, to 30 transplant recipients or candidate patients (15 oncological, 15 non-oncological). Results: In Phase I, 44 items were formulated/reviewed, and 30 items were maintained. All the healthcare professionals interviewed rejected the recommendation to develop two different modules for cancer and non-cancer patients. In Phase II, the majority of the experts and patients expressed an overall satisfaction with the questionnaire, indicating that the items were relevant, comprehensible and not embarrassing (range 75% - 99%). The first version of the FACT-LT includes 28 items defining four QOL domains: 5 items relating to Physical Well-Being, 8 to Functional Well-Being, 13 to Emotional Well-Being, and 2 to Social/Family Well-Being. Conclusion: The preliminary results obtained were promising; however further studies are needed, in order to proceed with a FACT-LT validation process.

Phenomenology and emotional impact of neuropsychiatric symptoms in orthotopic liver transplant for hepatocellular carcinoma.

BACKGROUND: Few studies have focused on neuropsychiatric symptoms like hallucinations or delusions occurring in the early posttransplant period. The aim of this study was to estimate the percentage of patients reporting neuropsychiatric symptoms in the immediate postoperative phase, to describe the phenomenology, and to evaluate the emotional impact of such disorders. METHOD: We studied 94 consecutive patients who underwent orthotopic liver transplant (OLT) for hepatocellular carcinoma at least 30 days prior. The presence of neuropsychiatric symptoms were retrospectively evaluated through a semistructured interview. RESULTS: Overall 49 patients (52%) reported various postoperative neuropsychiatric symptoms. None of the demographic and clinical variables showed significant associations, except for barbiturate administration; patients using barbiturates showed a lower percentage of neuropsychiatric symptoms. It was a time-limited phenomenon that in most cases resolved by day 7 after transplantation. Interestingly, the most frequent emotion perceived was surprise and not fear; a nontrivial amount of patients reported happiness, while many patients reported no emotion. CONCLUSIONS: The results of this study suggested the usefulness of a registry of the neurological and psychiatric complications after OLT that may help to clarify the pathogenic mechanisms of such complications and implement uniform protocols of prevention and treatment. In fact, better knowledge of the phenomenology of neuropsychiatric symptoms in OLT recipients could allow easier symptom recognition and therapy adjustments on the basis of the emotional impact of such symptoms on patients, family, and caregivers, as well as increase patients' awareness and capability to face this experience.

Italian consensus on a curriculum for volunteer training in oncology.

Volunteers' education, together with selection and organization, are fundamental for an adequate volunteer service in oncology, which is focused on patient and family needs and is fully integrated with the activity of the care team. To achieve such an aim, well-defined requirements and educational objectives are essential. A curriculum for voluntary service in oncology was developed through a consensus of experts. By comparing the work carried out by six different teams, a questionnaire was drafted, which grouped 91 educational aims. For each, the questionnaire queried whether the aim was relevant or not, and, if yes, whether it should be pursued through (a) knowledge, (b) skill, and/or (c) attitude (with a possible multiple answer). To improve comprehension, the questionnaire was divided into five sections: (a) the association; (b) the disease, therapies, and care site; (c) voluntary service in oncology; (d) psychosocial aspects of the patient and family; and (e) approach, communication, and acceptance. The questionnaire was sent to 117 delegates from 93 Italian volunteer organizations who, during a period of 8 years, had attended a course for volunteer trainers held by the Italian League Against Cancer. As indicated in the letter forwarded with the questionnaire, the final document would report only the aims considered relevant by at least 70% of the participants. Moreover, the area(s) of pursuit (knowledge, skill, and attitude) would be stated for each goal when indicated by at least one-half of the participants. Of 117 individuals questioned, 83 (71%) replied. Of the 91 aims proposed, 60 were considered relevant, and a type of approach (knowledge, skill, and/or attitude) was suggested. The formative curriculum of voluntary service in oncology represents a consensual guideline for future training programs.

Psychosocial adaptation after liver transplantation with particular reference to recipients aware of their cancer.

This study investigated the Psychosocial adjustment in 40 patients who received orthotopic liver transplantation (OLT) for several endstage liver diseases. Twenty patients were grafted because they suffered from liver Cancer as well as cirrhosis. Particular attention was paid to evaluating whether cancer could affect recipients' coping with transplant. Each patient underwent a semi-structured interview to obtain information on their psychosocial life, relationship with the donor, organ acceptance and life expectancy. Interview was performed I year after transplantation. A psychodiagnostic evaluation was also performed using a Minnesota Multiphasic Personality Inventory (MMPI) and a Human Figure Test. Psychosocial adaptation in everyday life following liver transplantation seemed good in most of the patients, whatever the indication for transplantation might be. It can he seen that by replacing the diseased organ a high percentage of oncological patients overcame their fear of cancer.

Prevalence of sexual dysfunction in male cancer patients treated with rectal excision and coloanal anastomosis.

Impotency due to parasympathetic nerve injury is one of the most feared consequences of rectal cancer surgery. Sexual relationships make a significant contribution to the quality of life for almost everybody. Rectal excision and coloanal anastomosis (CAA) is a new surgical procedure for low rectal tumor with little data regarding the prevalence of sexual impairment as yet. We have examined the sexual life of 21 male patients who have undergone CAA by means a self-administered questionnaire. Only two patients reported reactive impotency. On the other hand 17 out of 21 patients had no ejaculation after undergoing surgery. According to our data it appears that CAA results in surgery a low degree of sexual impairment (impotency). Both sexual dysfunction and quality of life investigations should be integrated with oncological results when reporting data about colorectal surgery.

Genetic counselling: communication and psychosocial aspects.

The results of genetic research have a remarkable role in medicine progress. At the same time the issues of prevention, individual attitudes and behaviour have acquired more importance, not only in relation to the illness but also regarding one's health. For these reasons is important to consider this field of study and intervention as an area to face, not only from the medical point of view but also from ethical and psychological ones. If we agree on the importance of a global approach to this problem, psychosocial support, which is often considered a parallel intervention, becomes a component of genetic counselling: the focal point of the intervention becomes the person, and not only the problem. The literature of the last years is rich of studies that have deepened these themes. Some studies have been analysed and reported but it is not easy to individualise a common patrimony of knowledge. Some aspects as information, communication, risk perception and psychological consequences are presented and discussed in this paper.

Evaluation of quality of life in patients with malignant dysphagia.

BACKGROUND: In the last 10 years of clinical research there has been increasing interest in the evaluation of quality of life. Several generic and specific instruments have been developed for this purpose. EORTC QLQ C-30 is a cancer-specific questionnaire translated into various languages and validated in several European countries including Italy, where the impact of malignant disease on different areas of quality of life is poorly documented. METHODS: The EORTC QLQ C-30 was administered to 109 patients referred to the endoscopy division of the Istituto Nazionale Tumori, Milan, for endoscopic palliative treatment of malignant dysphagia to test its characteristics in terms of acceptability and clinical validity. RESULTS: In this group of patients the impact of advanced esophageal cancer was highly evident for Emotional and Physical Functioning, Fatigue and Global QoL scales. Dysphagia is a serious problem for many patients; there is a correlation between grade of dysphagia and four QoL dimensions. CONCLUSIONS: QoL assessment is an important tool to evaluate the adequate management of patients with esophageal cancer. The EORTC QLQ-C30 questionnaire proved to be valid and reliable also in this population.

Two simple indexes used to evaluate the impact of therapy on the quality of life of patients receiving primary chemotherapy for operable breast cancer.

The psychometric characteristics of two indexes used to evaluate the subjective morbidity of chemotherapy regimens were analyzed. Both indexes assessed the duration of discomfort as perceived by the patient throughout therapy. The first index asked patients to state the number of days spent with 'discomfort', and the second index asked them which days they would like to eliminate altogether because of the unbearable symptoms experienced on those days. While the first index gives some idea of the duration of suffering, without defining it, the second highlights a specific time when the quality of her life was unacceptable to the patient. We studied these indexes in the form of a questionnaire completed by 168 women who had entered a cancer clinical trial. This trial evaluated the efficacy of primary chemotherapy in rendering conservative surgery feasible in women with operable breast cancer, but whose tumor size was greater than 3 cm. Four different treatment regimens were used: CMF, FAC, FEC, FNC (C = cyclophosphamide, M = methotrexate, F = fluorouracil, A = adriamycin, E = epirubicin, N = mitoxantrone). Seventy-nine patients were interviewed during chemotherapy and 89 during follow-up visits. Initial assessment of the reliability, discriminant and concurrent validity of the two indexes produced satisfactory results. Finally, we analyzed the responses given by 168 patients for a total of 600 treatment cycles. The average value of 'discomfort' was 3 days, whereas the average value of days 'to be eliminated' was 1. The range of subjective morbidity (for every cycle of treatment: 'discomfort = 0-30 days; 'to be eliminated' = 0-20 days) was very broad.(ABSTRACT TRUNCATED AT 250 WORDS)

Neurotoxicity of interferon-alpha in melanoma therapy: results from a randomized controlled trial.

BACKGROUND: The objective of this study was to evaluate the neurologic and quality of life impact of low dose adjuvant interferon (IFN)-alpha immunotherapy in patients with malignant melanoma metastatic to regional lymph nodes after radical surgery. METHODS: One hundred and thirteen patients were randomized to receive IFN-alpha, 3 x 10(6) IU three times weekly by subcutaneous injection for 36 months or until melanoma recurrence (IFN group), or to act as controls (CTR group). Seventy-five of these patients (66%) entered the toxicity study and underwent formal neurologic, neuropsychologic, psychologic, and quality of life assessments. Patients were assessed at baseline and after 1, 3, 6, and 12 months of follow-up. For each variable, maximum worsening of symptoms from baseline was considered as a response variable. The differences between the two groups regarding this variable were evaluated by means of the Hodges-Lehmann median unbiased point estimates and their 95% confidence interval. RESULTS: A significant degree of action tremor was found in eight patients in the IFN group and in none of the controls. No differences were found during psychiatric evaluation and for cognitive tests. There was a greater increase in anxiety in the IFN group on both trait and state anxiety. With regard to quality of life the analysis showed a significant worsening of at most one level on only three questionnaire items and on the fatigue scale. CONCLUSIONS: Neurologic dysfunction associated with IFN therapy was mild. Psychiatric symptoms and neuropsychologic impairment were not found. Levels of fatigue and anxiety were increased in the IFN group but without a sizable impact on quality of life measures.

Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system.

There is need for multilingual cross-culturally valid quality of life (QOL) instrumentation to assess the QOL endpoint in international oncology clinical trials. We therefore initiated a multilingual translation of the Functional Assessment of Cancer Therapy (FACT) Quality of Life Measurement System (Version 3) into the following languages: Dutch, French, German, Italian, Norwegian and Swedish. Prior to this project, the FACT Measurement System was available in English, Spanish and Canadian French. The FACT is a self-report instrument which measures multidimensional QOL. The FACT (Version 3) evaluation system uses a 29-49 item compilation of a generic core (29 Likert-type items) and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. The FACT-G (general version) and eight of 18 available cancer-related subscales were translated using an iterative forward-backward translation sequence. After subsequent review by 21 bilingual health professionals, all near final language versions underwent pretesting with a total of 95 patients in the native countries. Available results indicate good overall comprehensibility among native language-speakers. Equivalent foreign language versions of the FACT will permit QOL evaluation of people from diverse cultural backgrounds.

Assessment of hospitalised cancer patients' needs by the Needs Evaluation Questionnaire.

BACKGROUND: Cancer disease modifies the order and the nature of needs connected with the state of health. The aim of this study was to evaluate the informative, psychological, social and practical needs of hospitalised cancer patients by means of the Needs Evaluation Questionnaire (NEQ), an instrument designed concisely for the convenience of patients and medical staff. PATIENTS AND METHODS: Different samples of consecutive hospitalised cancer patients were involved in the various phases of designing the instrument: 30 patients for items identification, 101 patients for completeness and acceptability evaluation, 423 patients for construct validity and prevalence of needs; content and reliability analysis were performed on 2 subsamples of, respectively, 60 and 88 of the patients from the last sample. RESULTS: The validation analysis showed rather good reliability, structure validity and internal consistency of the questionnaire. The prevalence analysis showed that the most common needs were: 'more information about my future conditions' (74%); 'more information about my diagnosis' (56%); 'more information about the exams I am undergoing' (52%); 'more explanations on treatments' (51%); 'to have a better dialogue with clinicians' (57%); 'better services from the hospital' (bathrooms, meals, cleaning) (56%). CONCLUSIONS: The NEQ, self-completed by patients, has proven to be a useful clinical tool for obtaining a systematic and undistorted overview of the principal needs with respect to the state of health of patients. This instrument, which can also be administered by persons not belonging to the health care system such as volunteers, and inserted into the patients' hospital charts, could be used by the medical staff to identify the real needs of patients at an early stage.

Cancer genetics service provision: a comparison of seven European centres.

OBJECTIVE: To conduct a survey in seven European cancer genetics centres to compare service provision, organisation and practices for familial breast and colon cancer consultations and testing. Information was obtained on aspects of services both nationally and locally. METHODS: A detailed survey questionnaire was adapted collaboratively to obtain the required information. Initial survey data were collected within each centre and interim results were discussed at two European Workshops. Where differences in practice existed, details were clarified to ensure accuracy and adequacy of information. Participating centres were Haifa (Israel), Hannover (Germany), Leiden (The Netherlands), Leuven (Belgium), Manchester (UK), Marseille (France) and Milan (Italy), representing countries with populations ranging from 6.5 to 80 million. RESULTS: The European countries diverged in regard to the number of cancer genetics centres nationally (from 8 in Belgium to 37 in France), and the average population served by each centre (from 0.59 million in Israel to 3.32 million in Italy). All centres offered free care at the point of access, but referral to specialist care varied according to national health care provision. At a centre level, staff roles varied due to differences in training and health care provision. The annual number of counsellees seen in each participating centre ranged from 200 to over 1,700. Access to breast surveillance or bowel screening varied between countries, again reflecting differences in medical care pathways. These countries converged in regard to the wide availability of professional bodies and published guidelines promoting aspects of service provision. Similarities between centres included provision of a multidisciplinary team, with access to psychological support, albeit with varying degrees of integration. All services were dominated (70-90%) by referrals from families with an increased risk of breast cancer despite wide variation in referral patterns. Collection of pedigree data and risk assessment strategies were broadly similar, and centres used comparable genetic testing protocols. Average consultation times ranged between 45 and 90 min. All centres had access to a laboratory offering DNA testing for breast and bowel cancer-predisposing genes, although testing rates varied, reflecting the stage of service development and the type of population. Israel offered the highest number of genetic tests for breast cancer susceptibility because of the existence of specific founder mutations, in part explaining why the cancer genetics service in Haifa differed most from the other six. CONCLUSION: Despite considerable differences in service organisation, there were broad similarities in the provision of cancer genetic services in the centres surveyed.