Spiritual well-being, dignity-related distress and demoralisation at the end of life-effects of dignity therapy: a randomised controlled trial.

OBJECTIVES: This single-centre prospective randomised controlled study aimed to investigate the effectiveness of dignity therapy on spiritual well-being, demoralisation and dignity-related distress compared with standard palliative care. METHODS: A total of 111 terminally ill hospice patients were randomly allocated to one of two groups: dignity therapy plus standard palliative care (intervention group) or standard palliative care alone (control group). The main outcomes were meaning, peace, faith, loss of meaning and purpose, distress and coping ability, existential distress, psychological distress and physical distress. Assessments were conducted at baseline, 7-10 and 15-20 days. RESULTS: Following randomisation, 11 dropped out before baseline assessment and 33 after post-treatment assessment. A total of 67 patients completed the study, 35 in the experimental group and 32 in the control group. Repeated measures general linear model showed significant differences between groups on peace and psychological distress over time, but not on existential distress, physical distress, meaning and purpose, distress and coping ability, meaning and faith. Specifically, patients in the dignity therapy intervention maintained similar levels of peace from baseline to follow-up, whereas patients in the control group significantly declined in peace during the same time period. Moreover, psychological distress significantly decreased from pretreatment to post-treatment in the intervention group and increased in the control group. CONCLUSIONS: Dignity therapy may be an effective intervention in maintaining sense of peace for terminally ill patients. The findings of our study are of relevance in palliative care and suggest the potential clinical utility of this psychological intervention.

Assessing Preferences in Patients with Head and Neck Squamous Cell Carcinoma: Phase I and II of Questionnaire Development.

Shared-decision making for head and neck squamous cell carcinoma (HNSCC) is challenged by the difficulty to integrate the patient perception of value within the framework of a multidisciplinary team approach. The aim of this study was to develop a questionnaire to assess the preferences of HNSCC patients with respect to the disease trajectory, expected treatment, and toxicities. In accordance with the standardized EORTC Quality of Life Group's methodology for the development of quality of life modules, a phase 1-2 study was envisaged. Following a systematic review of the literature, a consolidated list of 28 issues was administered through a semi-structured interview to 111 patients from 7 institutions in 5 countries. Overall, "cure of disease", "survival", and "trusting in health care professionals" were the 3 most common priorities, being chosen by 87.3%, 73.6% and 59.1% of patients, respectively. When assessing the correlation with the treatment subgroup, the issue of "being thoroughly and sincerely informed about treatments' efficacy and survival expectation" was highly prevalent in an independent manner (71.4%, 75% and 90% of patients in the follow-up, palliative and curative subgroups, respectively). Based on prespecified scoring criteria, a 24-item list was generated. Pending clinical applicability, further testing and validation of the questionnaire are warranted.

Dignity Therapy Helps Terminally Ill Patients Maintain a Sense of Peace: Early Results of a Randomized Controlled Trial.

Introduction: Dignity Therapy (DT) is a brief, individualized, narrative psychotherapy developed to reduce psychosocial and existential distress, and promote dignity, meaning, and hope in end of life patients. Previous studies have shown that DT was effective in reducing anxiety and depression, and improving dignity-related distress. However, less is known about its efficacy on spiritual well-being. The aim of this study is to contribute to the existing literature by investigating the effects of DT on specific dimensions of spiritual well-being, demoralization and dignity-related distress in a sample of terminally ill patients. Methods: A randomized, controlled trial was conducted with 64 terminally ill patients who were randomly assigned to the intervention group (DT + standard palliative care) or the control group (standard palliative care alone). The primary outcome measures were Meaning, Peace, and Faith whereas the secondary outcome measures were (loss of) Meaning and purpose, Distress and coping ability, Existential distress, Psychological distress, and Physical distress. All measures were assessed at baseline (before the intervention), 7-10 and 15-20 days after the baseline assessment. The trial was registered with ClinicalTrials.gov (Protocol Record NCT04256239). Results: The MANOVA yielded a significant effect for the Group X Time interaction. ANOVA with repeated measures showed a significant effect of time on peace and a significant Group X Time interaction effect on peace. Post hoc comparisons revealed that, while there was a decrease in peace from pre-treatment to follow-up and from post-treatment to follow-up in the control group, there was no such trend in the intervention group. Discussion: This study provides initial evidence that patients in the DT intervention maintained similar levels of peace from pre-test to follow-up, whereas patients in the control group showed a decrease in peace during the same time period. We did not find significant longitudinal changes in measures of meaning, faith, loss of meaning and purpose, distress and coping ability, existential, psychological and physical distress. The findings of our study are of relevance in palliative care and suggest the potential clinical utility of DT, since they offer evidence for the importance of this intervention in maintaining peace of mind for terminally ill patients.

Tailored Sailing Experience to Reduce Psychological Distress and Improve the Quality of Life of Breast Cancer Survivors: A Survey-Based Pilot Study.

Background: Growing evidence indicates that physical/sporting activities may improve the health outcomes and quality of life (QoL) of breast cancer (BC) survivors. Since recent reports have suggested that sailing can improve the psychophysical well-being and QoL of people with disabilities, this pilot study evaluated the effectiveness of a tailored sailing experience on the QoL and psychological distress (PD) of BC survivors. Methods: A group of 19 breast cancer survivors, who were attending the Cancer Rehabilitation Center in Florence, were invited to participate in a sailing school and completed a survey based on a structured online questionnaire assessing QoL and PD both on departure (baseline) and one week after returning (follow-up). The survey comprised a first part (i.e., sociodemographic characteristics and the practice of physical/sporting activities at baseline; sailing experience satisfaction at follow-up) and a second part (i.e., Short Form-12 (SF-12), State/Trait-Anxiety Inventory form Y (STAI-Y), distress thermometer questionnaires). A paired Student's t-test was used to compare the baseline versus follow-up QoL and PD scores. Results: A statistically significant improvement in SF-12 mental component scores and a reduction in both STAI-Y state/trait components and distress thermometer scores were found after the sailing experience. Conclusions: We conclude that sailing practice could be a feasible intervention to increase the psychophysical well-being of BC survivors.

Construction of new personal meanings by cancer patients: a qualitative analysis in an Italian patient population.

PURPOSE: The goal of this study is to investigate the meaning that cancer patients in active therapy and/or rehabilitation give to their illness and resources they rely on to build new experiences of meaning and a future perspective. METHODS: The present study consisted in a summative content analysis of answers to open questions of the Purpose In Life (PIL) Questionnaire administered to 158 consecutive patients with non-advanced cancer (no metastases). The PIL is an attitude scale that indicates the degree of attainment of meaning and purpose in life and is divided into three sections: a first 20-item quantitative section, with statements rated on a 7-point verbal scale with two anchoring phrases (part A); a qualitative section with 13 open-end items and paragraph composition section addressing the future goals (part B) and past meaningful experience (part C). For the present study, we analyzed the answers to open questions, most interesting in a therapeutic contest related to the meanings associated with life, illness, and suffering to understand the experienced of the cancer patients. RESULTS: The main recurring themes in PIL section B analyzed associated to the sense of life, disease, and death are as follows: meaning (positive/negative), personal dimension, religiousness; physical health, family, normal life; negative sense of death, the end, natural transition, religious belief, consolation, mystery, rejection; opportunity, negativity. Whereas main themes emerging from section C were associated to life goals of the interviewed patients: the desire of realization in the future perspective; the value of life; physical health and healing; guiding values; plus three more themes, distinguishable, but with a minor recurrence: legacy responsibility, religiousness, lack of purpose/resignation. CONCLUSION: The use of summative content analysis evidenced the recurrence of a strong sense of positivity, present in the majority of the interviews. In particular, this positivity is shown by the use of words associated frequently to self-consciousness and self-evaluation, desire of happiness, and desire of contributing to the good of significant others and of taking care of your own life in order to give a positive contribution.

Sexual satisfaction assessment in 194 nonmetastatic cancer patients on treatment or in follow-up.

AIMS AND BACKGROUND: Sexuality is an important aspect of quality of life, but health care professionals still avoid discussing sexual issues with cancer patients. METHODS AND STUDY DESIGN: We present a secondary analysis of sexuality issues according to the results of a survey on 266 patients with early-stage cancer. The aim of the survey was to ascertain the feasibility and clinical usefulness of questionnaires (Patient Dignity Inventory, PDI; Hospital Anxiety and Depression Scale, HADS; Edmonton Symptom Assesssment Scale, ESAS; FACIT-spiritual well-being scale, FACIT-SP; System of Belief Inventory, SBI-15R) investigating aspects such as dignity, hope and research of meaning in life. The present study is an ancillary analysis of the full sample, and we have focused on the results of FACIT-SP about the correlation between sexual satisfaction and clinical characteristics in 108 patients having solid tumors and 86 having hematological malignancies with no metastases who were on active cancer treatment or in follow-up in four different cancer treatment settings during the first half of 2011. RESULTS: The median age of the 194 patients was 65 years, 112 were women, 155 were undergoing treatment and 39 were in follow-up. Eighty-three patients were above the cutoff score for HADS. Among the 171 believers, 80 were churchgoers and 91 were nonchurchgoers, whereas the nonbelievers among the patients were 23. Thirty-five percent of the patients did not respond to the sexuality item of the questionnaire. Among the responders (n = 126), 36% reported having no sexual satisfaction (score = 0). Sexual dissatisfaction was greater in older patients (47% vs 31%, not significant [NS]), women (43% vs 27%, NS), patients on treatment (38% vs 25%, NS), patients who requested psychological support (53% vs 25%, P = 0.001), patients with high levels of anxiety and depression, i.e., HADS scores >10 (44% vs 30%, NS), nonbelievers (61% vs 34% among churchgoers, 29% among believers but nonchurchgoers, P = 0.046). CONCLUSIONS: One out of 3 patients did not respond to the item on sexuality. Among the responders, 1 out of 3 reported having no sexual satisfaction. Half of the patients receiving psychological support considered their sexual life not satisfying. Clinical interviews and specific questionnaires on sexuality should be used to investigate this particular aspect.

The Edmonton Symptom Assessment System (ESAS) as a screening tool for depression and anxiety in non-advanced patients with solid or haematological malignancies on cure or follow-up.

BACKGROUND: Symptoms' assessment should be considered a clinical practice routine in all cancer stages. The Edmonton Symptom Assessment System (ESAS) is a ten-item patient-rated symptom assessment developed and validated for population affected by cancer in different languages and cultures. The main objective of this study was to assess the performance of ESAS items on anxiety and depression when detecting Hospital Anxiety Depression Scale (HADS) 'cases'. METHODS: A cross-sectional study was carried out on 194 non-advanced patients with solid (108) or hematologic malignancies on cure or follow up, Karnofsky Performance Status ≥ 70, life expectancy > 6 months and no metastases. Patients were assessed by means of ESAS and by HADS. Receiving operator characteristic (ROC) analysis of ESAS anxiety and depression items versus cases of severe (cutoff 11) anxiety and depression according to HADS-specific subscales was performed. RESULTS: Depression and anxiety ESAS items correlated strongly (0.707, Spearman). Area under the curve ranged between 0.84 and 0.96 for the two ESAS items when detecting severe anxiety or depression HADS cases (cutoff = 11). ESAS anxiety or depression scores >3 detected quite well the severe depression HADS cases (Sensibility = 75-Specificity = 84, Sensibility = 87-Specificity = 90, respectively). CONCLUSIONS: Anxiety or depression ESAS items score >3 can be applied as a useful, easy and not time consuming screening tool for assessing anxiety and depression in non-advanced patients with solid or haematological malignancies.

Impact of a psycho-oncological rehabilitation intervention on psychological distress: the experience of CeRiOn (Oncological Rehabilitation Centre) Florence 2007-2010.

BACKGROUND: Combining medical and psychological knowledge and accompanying patients in an individualised path, the Oncological Rehabilitation Centre of Florence (CeRiOn) aims at offering effective integrated rehabilitation interventions and at reducing psychological distress in cancer patients. In the present observational study, we measured the psychological distress at baseline and at the end of the completed rehabilitation processes. METHODS: A total number of 627 cancer patients were treated by the psycho-oncological service at CeRiOn in 2007-2010. Among them, 99 (all women) participated in more than or equal to three sessions, were followed up for clinical and life status for at least 1 year and had a formal conclusion of their psychological rehabilitation process. For 98 cases, both a baseline and a follow-up measure of distress, by the Psychological Distress Inventory (PDI) and the Distress Thermometer (DT), were available. RESULTS: Relevant before-after amelioration in this selected group of psychologically, highly suffering cancer patients has been shown. Almost all the patients (except 20%) received both group and individual psychological support. The average rehabilitation process lasted 1.7 years. Average distress evaluation decreased from a baseline of 34.7 to 26.4 (P < 0.001) according to PDI and from 5.9 to 2.2 according to DT (P < 0.001). CONCLUSIONS: On average, quite a long psychological support time was necessary to complete the rehabilitation process. During this period, patients who had a formal conclusion of the psychological support received at CeRiOn showed a significant reduction of their distress.

Patient dignity inventory (PDI) questionnaire: the validation study in Italian patients with solid and hematological cancers on active oncological treatments.

BACKGROUNDS: In Oncology, little is known about dignity-related distress and the issues that influence the sense of dignity for patients. We validated the Patient Dignity Inventory (PDI) questionnaire in Italian patients on oncological active treatments. METHODS: After the translation procedures, the PDI was administered to 266 patients along with other questionnaires to assess the psychometric properties of the Italian version of PDI. Factor structure was tested by both explorative and confirmatory factor analyses. Concurrent validity was tested through convergent and divergent validity with validated questionnaires inquiring about physical and psychological symptoms, and religiosity. The test/retest reliability was assessed through the concordance coefficient of Linn (two-week interval, 80 patients). RESULTS: The explorative analysis suggested one factor only loading highly on all the 25 items (>.45) and explaining the 48% variance; confirmative analysis and Cronbach alpha (0.96) confirmed the adequacy of the one-factor model. In the 2-week test-retest study, a concordance coefficient of 0.73 (95% CI, 0.64-0.83) was found. High correlations of problems with dignity were found with both physical and psychological symptoms (0.52 and 0.64 rho coefficient, respectively), and a moderate inverse correlation with spiritual well being (-.40). The dignity construct, as measured by PDI, proved to be orthogonal to that of religiosity (-.02). CONCLUSIONS: The Italian version of PDI is a valid and reliable tool to evaluate the dignity related-distress in out-patients with solid and hematological cancers, on active oncological treatments, in non advanced stages of the disease.

Hope Herth Index (HHI): a validation study in Italian patients with solid and hematological malignancies on active cancer treatment.

AIMS AND BACKGROUND: Although hope is a widely used term, the experience of hope in patients with chronic or even life-threatening diseases is often disregarded due to the scarcity of carefully designed and validated assessment tools. The aim of this study was to validate the Hope Herth Index (HHI) questionnaire in the Italian population of patients with solid or hematological malignancies during active cancer treatment. METHODS: After the translation procedures, the psychometric properties of the Italian version of HHI were evaluated in 266 patients with non-advanced cancer cared for in four different settings. Summative scores ranged from 12-48, with a higher score denoting greater hope. Confirmative factorial analysis was performed to assess dimensionality. The test-retest reliability was assessed by means of the Lin concordance coefficient (two weeks' interval, 80 patients). Concurrent validity was assessed through the following questionnaires: Hospital Anxiety and Depression Scale (HADS), Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp), Edmonton Symptom Assessment Scale (ESAS), and System Belief Inventory (SBI-15R). RESULTS: A total of 266 patients were enrolled. Confirmative factor analysis did not confirm the original three-factor solution, whereas a one-factor solution did perform well. Cronbach's alpha was 0.84 and the test-retest reliability was 0.64 (95% CI 0.51; 0.76). Large convergence was found with spiritual well-being as measured by the FACIT-Sp (0.69) and with anxiety-depression as measured by the HADS (inverse correlation: -0.51). Physical symptoms and religiousness were only slightly correlated, as expected. CONCLUSIONS: The Italian version of HHI is a valid and reliable assessment tool - useful to initiate conversation with someone who is troubled but finds it difficult to talk - in patients with either solid or hematological malignancies on active cancer treatment during the non-advanced stages of the disease.

Is the spiritual life of cancer patients a resource to be taken into account by professional caregivers from the time of diagnosis?

BACKGROUND AND AIM: Spiritual life can be defined as the search for personal contact with the transcendent. Careful assessment of spiritual life can help to value its importance to cancer patients from the moment of their diagnosis. METHODS: This is a cross-sectional study. Two hundred fifty-seven patients undergoing cancer treatment filled in the validated Italian version of the Systems of Belief Inventory (SBI-15R). Patients were also asked to attribute themselves to one of the following, mutually exclusive categories: believer and churchgoer, believer but no churchgoer, and non-believer. RESULTS: Five patients did not report their religious stance and were therefore excluded from the analysis. Of the remaining 252 patients, 49% declared to be believers and churchgoers, 43% believers but not churchgoers, and 8% non-believers. Of the 20 cancer patients who declared not to have a religious faith, 7 patients agreed with the statement that they felt certain that God exists in some form, and 4 had experienced peace of mind through prayer and meditation. Almost all of the patients who declared to have a religious faith and to be churchgoers explicitly affirmed to have been helped by prayer and meditation in coping with their illness. Among believer churchgoers, only 30% declared to seek out the religious or spiritual community when they needed help. CONCLUSIONS: A large proportion of cancer patients find themselves involved with the search for a personal contact with the transcendent, also beyond any specific religious affiliation. These spiritual issues may be important even when they are not expressed as participation in religious rituals or adherence to specific religious beliefs. On the other hand, participation in religious rituals often implies the need for a personal spiritual life, both through those rituals and beyond them, as through personal prayer and meditation. These results ask for more attention on the part of professionals towards spiritual resources among cancer patients. It might be appropriate to look systematically for these resources from the moment of the diagnosis, through the sensitive administration of an easy and valid assessment tool like the SBI-15R.

System of belief inventory (SBI-15R): a validation study in Italian cancer patients on oncological, rehabilitation, psychological and supportive care settings.

AIMS AND BACKGROUND: Spiritual and religious needs are part of a patient's clinical history. The aim of the study was to validate the System of Belief Inventory (SBI-15R) in Italy. It is a feasible way to collect useful information on spiritual needs and resources of patients at any stage of the disease. METHODS: After the translation procedure, the psychometric properties of the Italian version of SBI-15R were evaluated in patients with non-advanced cancer cared for in four care settings. All patients were administered the Italian version of SBI-15R together with an hoc item inquiring about spirituality--"I believe I am a spiritual person", which was supposed to be correlated with the SBI-15R score. RESULTS: A total of 257 patients were enrolled (mean age, 53.6 years; 191 females, 50% breast cancers, 12% had mestastases). As regards spirituality and religious beliefs, 47.9% were churchgoers; 42% believers but not churchgoers, and 7.8% non-believers; 86.7% of the patients were catholic. The construct validity was high both for the Belief Scale (Cronbach alpha = 0.946) and for the Support Scale (Cronbach alpha = 0.897). The mean (+/- SD) SBI-15R scores of the different groups of patients (known-groups validity) for the "Support" scale was 9.7 (+/- 3.4) for churchgoers, 4.9 (+/- 3.2) for believers non-churchgoers, and 0.8 (+/- 1.4) for non-believers (P < 0.0001, F test). For the "beliefs" scale, it was 25.4 (+/- 4.8) for churchgoers, 18.1 (+/- 6.3) for believers non-churchgoers, and 3.4 (+/- 3.5) for non-believers (P < 0.0001, F test). Regarding the test-retest reliability (n = 68), Lin's concordance correlation for the "Support" scale was 0.890 (0.841; 0.939 95% CI) and for the "Belief" scale was 0.969 (0.955; 0.984 95% CI). The correlation between the statement "I believe I am a spiritual person" and the SBI-15R scores was 0.475 for the "Support" scale and 0.473 for the "Belief" scale." CONCLUSIONS: The Italian version of SBI-15R is a valid and reliable assessment tool to evaluate religiousness and spirituality in cancer patients.

The measure of psychological distress in cancer patients: the use of Distress Thermometer in the Oncological Rehabilitation Center of Florence.

GOALS OF WORK: Distress in cancer patients is common. In the last years, several studies have used the single-item Distress Thermometer (DT) as a screening tool for psychological distress in cancer patients. The primary objective of this study was to determine the optimal cutoff score on the DT for detecting psychological distress in cancer patients attending a rehabilitation center, by comparing the DT's scores with those of the Psychological Distress Inventory (PDI). The second aim was to explore the effectiveness of the DT as a screening tool for psychological distress in rehabilitative oncological setting. PATIENTS AND METHODS: The sample study totaled 290 patients who were recruited from patients attending the Oncological Rehabilitation Center of Florence for the first time between January and December 2007. Patients were administered the DT along with the Problem List (PL) and the PDI as the gold standard against which the DT was compared. MAIN RESULTS: The area under the receiver operating characteristics curve was 0.84 [95%CI 0.80-0.89]. The optimal DT cutoff score for identifying distressed cancer patients would be at or above 7 (sensitivity = 0.73; specificity = 0.82). Patients whose DT score was 7 or above were more likely to report problems in all issues on the PL. CONCLUSIONS: The combination of DT and PL could be a practicable screening instrument for assessing the extent and the kind of distress also in rehabilitative oncological patients. On the other hand, the choice of the DT should be evaluated by clinicians.