Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

The experimental group will receive the self-management program for 12 weeks.

The control group will receive an information package on a healthy diet.

The self-management group will receive the self-management program for 12 weeks, including a self-management application, a self-management manual, and Professional support.

Self-management program

The patients in this group will receive an information package on a healthy diet.

Information package

Ching-Hui Chien, PhD

Kuan-Lin Liu, MB

Objectives: This project aims to develop a self-management program for survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy and determine its effectiveness.

Methods: The investigators will develop a self-management program and conduct a pilot study on survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy. And the investigators will test the effectiveness of the self-management program. After completing a pretest, participants will be randomly assigned to the experimental or control group. The self-management group will receive the self-management program for 12 weeks, whereas the information group will receive an information package on a healthy diet. Posttests will be administered 12 and 16 weeks after the pretest. The study variables will include physical symptoms and bothers, cancer-related self-efficacy, social participation, demoralization, and resilience.

Objectives: This project aims to develop a self-management program for survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy and determine its effectiveness.

Methods: The investigators will develop a self-management program and conduct a pilot study on survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy. And the investigators will test the effectiveness of the self-management program. After completing a pretest, participants will be randomly assigned to the experimental or control group. The self-management group will receive the self-management program for 12 weeks, whereas the information group will receive an information package on a healthy diet. The self-management program is included a self-management application, a self-management manual, and professional support. The information package consists of a manual on a healthy diet and a multimedia film on a healthy diet. Posttests will be administered 12 and 16 weeks after the pretest. The study variables will include physical symptoms and bothers, cancer-related self-efficacy, social participation, demoralization, and resilience. The statistical analyses will consist of independent sample t-tests, Chi-squire, and generalized estimating equation analysis.

Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors

Development and Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors

Latest serum level of prostate-specific antigen (ng/mL)

Self-designed five items will be used to assess these outcomes.Each item is scaled from 0 (worst) to 100 (best).

The Mandarin version of the Expanded Prostate Cancer Index Composite (EPIC) will be used to measure the urinary symptoms and bother of the participants. Total 7 items and each question is linearly scaled from 0 (worst) to 100 (best).

The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy.

The Mandarin version of the Older Adults Social Participation Scale will be used to assess participants' social participation. The scale includes 12 items with a score range of 12 to 60. A higher score shows a higher degree of social participation.

The Mandarin version of the Demoralization Scale will be used to assess participants' demoralization. The scale includes 24 items, and the score range is 0-96. A higher score means higher demoralization.

The Mandarin version of the Connor-Davidson Resilience Scale will be used to measure the psychological resilience of participants. The scale has 10 items, and the score range is 0-100. A higher score reflects better resilience.

Chang Gung Memorial Hospital

National Science and Technology Council

National Taipei University of Nursing and Health Sciences

RN, PhD, Professor

Behaviors and Mental Disorders

Carcinoma

Anxiety Disorders

Mental Disorders

Psychotic Disorders

Death

Adult patients across all phases of advanced disease (UICC stage IV solid tumor) from diagnosis to terminal stages

A short-term psychodynamic therapy that focuses on the special inner and outer situation of patients with a serious physical illness, especially with regard to the importance of relationships in a limited lifetime.

Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)

Sigrun Vehling, PD, PhD

Charlotte Walbaum, MSc

Life-threatening physical illness may powerfully re-activate existential conflict. There is little evidence to date on the effectiveness of relationship-focused therapies in this patient group.The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.

Severely physically ill patients may experience existential distress symptoms including helplessness, hopelessness, death anxiety, perceived burdensomeness and a sense of pointlessness. The latter can significantly interfere with end-of-life care processes and outcomes (receipt of treatment according to preferences, expression of desire for hastened death). So far, empirically tested psychotherapeutic programs in advanced life-threatening illness have predominantly been ultra-short and applied supportive and resource-oriented techniques. Psychodynamic treatment allows to address clinically significant existential distress through its conceptualization from early relational life experiences.

The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.The inverstigators will

1. analyse the feasibility of the treatment, and
2. investigate changes in process- and patient-relevant outcomes over the course of the treatment

The inverstigators will conduct a single-group pre-post study with five assessment points in which 50 adult patients diagnosed with advanced cancer will receive a manualized psychodynamic short-term therapy. Target parameters are assessed by diagnostic interviews, focus interviews, self-assessment questionnaires as well as electronic patient records. For research objective b) the investigators will compare the intervention group with a matched comparison group of a longitudinal cohort sample (NCT04600206). Matching will be based on stress level, demographic, and medical parameters across the 5 assessment points.

Short-term Psychodynamic Psychotherapy in Serious Physical Illness

ORPHYS - Short-term Psychodynamic Psychotherapy in Serious Physical Illness

Will be assessed using the short form of the Schedule of Attitudes Toward Hastened Death (SAHD-A, Kolva et al., 2017).

Will be assessed using the Beck Scale for Suicidal Ideation (BSS, Kliem \& Brähler, 2015).

Will be assessed using the a) Structured Interview for Psychological Adjustment and Demoralisation (Bobevski \& Kissane, 2019) and b) Demoralisation Scale-II (DS-II, Robinson et al., 2016).

Will be assessed according to International Classification of Diseases (ICD-11) using the Adjustment Disorder Module of the CIDI (Composite International Diagnostic Interview, (Perkonigg et al., 2018).

Will be assessed according to the criteria by Earle et al., 2003: receipt of chemotherapy in the last two weeks of life, emergency hospital admissions or intensive-care treatment during the last month of life. Will be obtained from medical chart reviews for deceased patients.

Will be assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019).

Will be assessed using the Death Anxiety and Distress Scale (DADDS, Krause etal., 2015).

Will be assessed using Subscales (Dependence, Relatedness) of the Depressive Experience Questionnaire (DEQ, Blatt, D'Afflitti \& Quinlan, 1976; Blatt et al., 1982).

Will be assessed using the Revised Loss Orientation and Life Engagement in Advanced Cancer Scale (LOLES, Vehling et al., 2018).

Will be assessed using the Sense of Dignity Item (SDI, Chochinov et al., 2002) and the Patient Dignity Inventory (PDI, Chochinov, 2008).

Will be assessed using the Sources of Meaning and Meaning in Life Questionnaire (SoMe, Schnell, 2009).

Will be assessed using a subscale (Life completion) of the Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire (Qual-EC-P).

Will be assessed using subscales (coping competence, adaptability) of the questionnaire for patient competence in coping with cancer (PCQ, Aderhold et al., 2019).

Will be assessed using the Structured questionnaire of psychosocial support needs for existential distress.

Will be assessed via Inventory for the Balanced Assessment of Negative Effects of Psychotherapy (INEP, Ladwig, Rief \& Nestoriuc, 2014).

Will be assessed via drop-out rates (number of patients not completing at least 12 sessions) and treatment compliance (number of sessions missed).

Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings.

Will be assessed via qualitative analysis of supervision protocols.

Will be assessed via semi-structured qualitative interviews.

Will be assessed via California Psychotherapy Alliance Scales (CALPAS, Marmar \& Gaston, 1989) for patients and therapists.

Will be assessed via inventory for assessment of interpersonal problems (IIP-D-32, Thomas, Brähler \& Strauß, 2011).

Will be assessed via Helping Alliance Questionnaire (HAQ, Luborsky et al., 1996) (IIP-D-32, Thomas, Brähler \& Strauß, 2011) for patients and therapists.

Universitätsklinikum Hamburg-Eppendorf

Adult patients across all phases of advanced disease (UICC stage IV solid tumor or stage III lung or ovarian tumor) from diagnosis to terminal stages

Adult informal caregivers of patients who are diagnosed with stage IV solid tumors or stage III lung or ovarian tumors

In this longitudinal cohort study, patients and caregivers will not receive an intervention. In addition to the outcomes named in the section "Outcome Measures" patients and caregivers will complete self-report questionnaires for

Existential distress (Demoralization Scale-II, Death and Dying Distress Scale, Depressive Experiences Questionnaire, Revised Loss Orientation and Life Engagement in Advanced Cancer Scale, Sense of Dignity Item, Patient Dignity Inventory, Marwit-Meuser Caregiver Grief Inventory, Caregiver Guilt Questionnaire)

Need for and utilization of psychosocial support

Resources (Sources of Meaning and Meaning in Life Questionnaire, Questionnaire on the Defiant Power of the Human Spirit) and

Control variables (Memorial Symptom Assessment Scale, PHQ-9 and GAD-7)

Self-report questionnaires

Sigrun Vehling, PhD

Despite the potential for alleviation of existential distress through psychosocial interventions, existential concerns and their impact on health care outcomes of patients and caregivers have not yet been systematically studied. The aim of this longitudinal cohort study is to investigate the frequency, longitudinal trajectory and predictive impact of existential distress on patient- and caregiver-relevant end-of-life outcomes. Further, it aims to determine the need for and utilization of psychosocial support in patients and caregivers with regard to existential concerns.

Due to medical progress and an aging population, the number of patients and caregivers who face the profound existential challenges of advanced incurable cancer is constantly growing. Clinically significant existential distress may result from a fear of suffering and perceived lack of control, fear and uncertainty about the end of life, feelings of burdensomeness or insufficiency, grief about missed opportunities, and profound loneliness. Such distress may have a unique and independent contribution to health care outcomes at the end of life. Despite an increasing interest in existential and palliative care interventions that discuss such issues openly, a lack of systematic quantitative data on existential distress and specific support needs hampers clinicians to consequently detect and address existential needs. This longitudinal study aims to 1) systematically investigate the frequency, longitudinal trajectory and predictive impact of existential distress on patient- and caregiver-relevant end-of-life outcomes and 2) determine patients' and caregivers' specific need for and utilization of psychosocial support with respect to existential concerns.

Adult patients diagnosed with advanced cancer and caregivers will be consecutively recruited from outpatient and inpatient treatment facilities of the Univer-sity Cancer Center Hamburg and affiliated clinics. Existential distress, end-of-life outcomes, and mental disorders in 1,000 participants (500 patients, 500 care-givers) will be assessed using self-report questionnaires at five points of assessment over a period of 12 months and diagnostic interviews (at baseline, after six months). To determine the prevalence of existential distress, mental disorders and palliative care outcomes descriptive statistics will be calculated. Descriptive analyses will also be used to examine the need for and utilization of psychosocial support. To investigate the predictive impact of existential distress and patient- and caregiver-relevant end-of-life outcomes multiple linear and logistic regression will be conducted. To analyze longitudinal trajectory of existential distress growth mixture models will be used.

Shaping a clear and systematic knowledge about frequent and persistent existential concerns that are most relevant to the risk for unfavorable end-of-life outcomes, results will significantly contribute to the recognition and manage-ment of existential distress and provide a valuable basis for the development of targeted interventions.

Existential Distress in Patients With Advanced Cancer and Their Caregivers

Existential Distress in Patients With Advanced Cancer and Their Caregivers: A Longitudinal Cohort Study

Will be assessed for patients according to the criteria by Earle et al., 2003: receipt of chemotherapy in the last two weeks of life, emergency hospital admissions or intensive-care treatment during the last month of life. Will be obtained from medical chart reviews for deceased patients.

Will be assessed for patients and caregivers using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019).

Will be assessed according to International Classification of Diseases (ICD-11) for patients and caregivers using the Adjustment Disorder Module of the CIDI (Composite International Diagnostic Interview, (Perkonigg et al., 2018).

Will be assessed for patients and caregivers using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019).

Will only be assessed for patients and caregivers who were recruited at location no.4 (Specialized Outpatient Clinic for Autoimmune Liver Disease and for Liver and Bile Duct Tumors, University Medical Center Hamburg-Eppendorf).

Will be assessed for patients using the short form of the Schedule of Attitudes Toward Hastened Death (SAHD-A, Kolva et al., 2017). Items are scored with either being true (1) or false (0). The total score is the number of endorsed items, ranging from 0 to 6, with high scores indicating high levels of desire for hastened death.

Will be assessed for patients and caregivers using the Beck Scale for Suicidal Ideation (BSS, Kliem \& Brähler, 2015). Items are scored from 0 to 2 (e.g., 0 = I have a moderate to strong wish to live, 1 = I have a weak wish to live, 2 = I have no wish to live). The sum score ranges from 0 to 38 for the total scale, with higher scores indicating stronger suicidal tendencies.

Will be assessed for patients and caregivers using the Structured Interview for Psychological Adjustment and Demoralisation (Bobevski \& Kissane, 2019). Participants may answer most of the questions with yes or no.

Will be assessed for caregivers after the patient's death using the Inventory of Complicated Grief (ICG; Lumbeck et al., 2012). Items are scored from 0 (never) to 4 (always). The sum score ranges from 0 to 76, with scores ≥ 25 indicating experiences of complicated grief.

Will be assessed from the caregivers' perspective using a shot version of the Quality of Dying and Death Questionnaire (QODD, Mah et al., 2020). Caregivers indicate how they would rate each experience for the patient on a scale from 0 (terrible experience) to 10 (almost perfect experience). The total score ranges between 0 and 100, with higher scores indicating a better quality of the dying experience.

Depressive Disorder

Depression

Behavioral Symptoms

Quality of Life

Patients in the experimental group will receive the brief, individual, manualized CALM intervention, a semi-structured psychotherapy designed for patients with advanced cancer. CALM was developed based on empirical results, clinical observation and the theoretical foundations of supportive-expressive and existential approaches, as well psychodynamic and attachment theories. The sessions are delivered bimonthly over a period of 6 months. Sessions are reviewed to ensure treatment fidelity.

Supportive psycho-oncology intervention (SPI) includes counseling, psychoeducation and crisis intervention, which is the usual care intervention provided in our centres.

CALM intervention covers four domains, namely: 1) Symptom management and communication with health care providers; 2) Changes in self and relations with close others, 3) Spiritual well-being, sense of meaning and purpose, 4) Preparing for the future, sustaining hope and facing mortality

CALM

Active Comparator: Supportive psycho-oncology intervention Supportive psycho-oncology intervention (SPI) includes counseling, psychoeducation and crisis intervention, which is the usual care intervention provided in our centres.

Luigi Grassi, M.D.

Rosangela Caruso, M.D., PhD

Luigi Grassi, MD

Background: Patients with advanced cancer suffer from a variety of psycho-social symptoms that impair quality of life and may benefit from psychotherapeutic treatment. We describe here the methodology of a randomized controlled trial to test the effectiveness of a novel and brief semi-structured psychotherapeutic intervention, called Managing Cancer and Living Meaningfully (CALM), originally developed in Canada and now cross-culturally tested in Italy.

Methods/Design: The study is a single-blinded randomized controlled trial with 2 conditions: CALM intervention versus nonspecific supportive intervention (SPI) and assessments at baseline, 3 and 6 months. The coordinating site is the Program on Psycho-Oncology and Psychiatry in Palliative Care, University of Ferrara and Integrated Department of Mental Health, S. Anna University Hospital, in Ferrara, Italy. Another centre from northern and southern Italy will collaborate. Eligibility criteria include: ≥ 18 years of age; Italian fluency; no cognitive impairment; and diagnosis of advanced cancer. The intervention consists of 12 sessions , following the CALM manual and allowing for flexibility to meet individual patients' needs. It is delivered over a 6-month period and provides reflective space for patients (and their primary caregivers) to address 4 main domains: symptom management and communication with health care providers; changes in self and relations with close others; sense of meaning and purpose; and the future and mortality. The primary outcome is depression and the primary endpoint is at 6 months. Secondary outcomes include demoralization, generalized anxiety, death anxiety, spiritual well-being, quality of life, attachment security, posttraumatic growth, communication with partners, and satisfaction with clinical interactions.

Discussion: This trial is being conducted to determine the effectiveness of CALM in an Italian cancer setting. The intervention has potential cross-national relevance and, if shown to be effective, has the potential to be disseminated as a new approach in oncology to relieve distress and promote psychological well-being in patients with advanced cancer.

The study is coordinated by the Program on Psycho-Oncology and Palliative Care, University of Ferrara Northern Italy. Another centre from northern Italy will collaborate. The study is designed as a single-blinded randomized-controlled trial with two arms. Participants in the experimental group will receive the CALM intervention, while those in Control Group will receive a supportive intervention, which is usual psycho-oncology care in our settings.The primary outcome is depression. The primary endpoint is 6 months. Secondary outcomes include demoralization, generalized anxiety, death anxiety, spiritual well-being, quality of life, attachment security, posttraumatic growth, communication with partners, and satisfaction with clinical interactions.The study has received approval from Ethical Committees.

Interventions:Patients in the experimental group will receive the CALM intervention, a semi-structured psychotherapy designed for patients with advanced cancer. In this Italian adaptation, CALM consists of 12 individual sessions (45-60 minutes each), instead of the original 6 sessions. The sessions are delivered bimonthly over a period of 6 months.

The intervention covers four domains: 1) Symptom management and communication with health care providers; 2) Changes in self and relations with close others; 3) Spiritual well-being, sense of meaning and purpose; 4) Preparing for the future, sustaining hope and facing mortality.

Non-manualized supportive psycho-oncology intervention (SPI):The Control group intervention includes counseling, information, crisis intervention, which is the usual care intervention provided in our center. As with CALM patients, SPI patients receive up to twelve sessions of individual therapy during a period of 6 months.

Inclusion criteria are:18 years of age or more;fluency in Italian language; absence of cognitive deficit documented in the clinical records;diagnosis of "wet" stage IIIB or IV lung cancer; any stage of pancreatic cancer, stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancer; and stage IV breast, genitourinary, gastrointestinal, melanoma, sarcoma, or endocrine cancers (all with an expected survival of 12-18 months); a score ≥10 at the Patient Health Questionnaire and/or ≥ 20 at the Death and Dying Distress Scale. Exclusion criteria are: language barriers hindering psychotherapy;inability to commit to the required 12 sessions; concomitant psychotherapy.

Randomization procedure:Study participants are randomly assigned to receive either CALM or SPI. After obtaining informed consent , a research assistant includes patient's data on the random allocation list and informs the PI's about treatment allocation (CALM or SPI). The patient is not informed about treatment condition (CaLM or SPI).

Measures:The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression. It is composed by nine items, reflecting DSM-IV criteria for major depression. A four-point Likert scale scores from 0 (not at all) to 3 (nearly every day), with a cut-off score of ≥10 suggesting depression. For study purposes, two additional items assessing self-harm intention and rating how difficult these symptoms have made it to do lead one's life, have been included.The Demoralization Scale (DS) is a 24-item self-report tool assessing demoralization components of loss of meaning and purpose, dysphoria, disheartenment and helplessness. Items are scored on a five-point Likert scale ranging from 0 (never) to 4 (all the time). Low levels of demoralization were indicated by a score 10, moderate demoralization by a score 11-36, and high demoralization by a score \> 37.The Generalized Anxiety Disorder Questionnaire (GAD-7) is a 7-item self-report instrument screening the severity of GAD symptoms. Items are scored on a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Scores ≤4 indicate absence of anxiety, scores from 5 to 9 suggest that mild anxiety is present, and scores from 10 to 15 indicate moderate levels of anxiety. An eighth item rating how difficult these symptoms have made it to lead one's daily life has been included. The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-SP)\[v\] is a 12-item self-report tool, exploring spiritual well-being, in terms of sense of meaning, faith and inner peace. Items are scored on a five-point Likert scale from 0 (not at all) to 4 (very much), with higher scores indicating a greater spiritual wellbeing.The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of positive psychological changes after traumatic events. It consists of four subscales: New Possibilities, Appreciation of Life, Relating to Others and Spiritual Change. Items are scored on a three-point Likert scale ranging from 0 (not at all) to 2 (very much) with higher scores indicating greater post-traumatic growth.The Quality of Life at the End of Life-Cancer Scale (QUAL-EC) is a self- report measure of quality of life in patients near the end of life. It originally consists of four subscales: Symptom Control, Relationship with Health Care Providers, Preparation for End of Life and Life Completion. For this study purposes, the symptom control subscale is not included, thus only items 4-17 are used. Items are scored on a five-point Likert scale ranging from 1 (not at all) to 5 (completely), with higher scores indicating higher quality of life.The Death and Dying Distress Scale (DADDS), is a 15-item self-report measure assessing specific concerns of advanced cancer patients about end of life, feeling a burden to others and wasted opportunities. It is scored on a six-point Likert scale from 0 (no distress) to 5 (very much distress), with higher scores indicating higher death anxiety and distress.The Experiences in Close Relationships Inventory Modified Short Form Version (ECR-M16), is used in its 16-item self-report form to measure the attachment style. The scale yields scores on two dimensions of attachment: avoidance and anxiety. Items are scored on a seven-point Likert scale ranging from 1 (disagree) to 7 (agree), with a total sum score on each subscale ranging from 16 to 56. Higher scores on both subscales indicate higher attachment insecurity.The Memorial Symptom Assessment Scale (MSAS) \[x\]assesses the disease symptom severity. The scale, in its shortened version (MSAS- short form), measures the presence and severity of 28 common physical symptoms of cancer. Items are scored on a five-point Likert scale ranging from 0 (not at all) to 4 (very much).

The Couple Communication Scale (CCS) is used for participants who have a partner. The 10-item CCS taken from the PREPARE/ENRICH Inventory is concerned with an individual's feelings, beliefs, and attitudes about the communication in his/her romantic relationship. Each item is scored from 1 (strongly disagree) to 5 (strongly agree).

Intervention and control participants will complete the Clinical Evaluation Questionnaire (CEQ) at 3 and 6-months. The CEQ is a seven-item self-report questionnaire which assesses the amount of clinical benefit patients have experienced by from therapy at the time of the assessment. Items are rated from 0 to 4, with 0 (no clinical benefit) and 4 (a great clinical benefit).Satisfaction of patients will also be qualitatively assessed by inviting them to share comments in a written form after completing CEQ questionnaire.

Assessment:At baseline (T0), participants provide demographics and medical and treatment data using a standardized questionnaire and will complete all outcome measures, with the exception of the CEQ. The PHQ-9 and DADDS are first administered to assess eligibility prior to study entry, followed by the remaining baseline outcomes. Follow-up assessments on all outcomes are collected at three months (T1) and six months (T2). The CEQ is administered only at three months (T1) and six months (T2) as it is an evaluation of the intervention received to date. At T2, participants will also be queried about their having remained blind (or not) to randomization.

Statistical methods:To calculate the required sample size, we used a validated, manualized online power and sample size calculator that is ideal for longitudinal multilevel designs, GLIMMPSE \[ \]. A total sample size estimate for our primary hypothesis, that the treatment group (CALM) will demonstrate a greater higher improvement ind depressive symptoms (PHQ-9) at follow-up periods, as compared to the control group (SPI), was derived with a target power of 80% and alpha of .05 and with estimated mean scores, with variability, and cross-time correlations entered. For the primary hypothesis, the calculated total sample size is 124 patients (62 patients per treatment arm). To account for anticipated attrition while maintaining the targeted power, we used the following equation to calculated an adjusted sample size: N = N0 \* (1 + DRP), where N0 = original estimated sample size required at baseline; DRP = anticipated dropout rate across participants. For an anticipated completion rate of 70% rate (30% dropout rate), the adjusted sample size for this attrition rate is N = 124 \* (1 + .30) = 161.2. The adjusted sample size at baseline will therefore be 162, with 81 patients per treatment arm.

Statistical analyses will be carried out by using SPSS Statistics program. For the final analyses we will use an intention-to-treat approach (ITT) and compare patients in the assigned treatment arms. To test the pPrimary hypothesis : we hypothesize that mean depression scores in the intervention arm will be lower than in the control arm at 3 and 6 months, . We will use multilevel modeling (MLM) with maximum likelihood estimation to conduct the intent-to-treat analysis in testing hypotheses. MLM includes all participants, including those with missing data, in model estimation and also accounts for both inter-center and intra-center variability.To test for treatment-arm differences, we will compare the CALM and SPI groups on the primary outcome of PHQ-9 scores and on the secondary outcomes at the follow-up periods. This will entail the following set of MLM analyses:i)We will first test the level-1 predictor of Time, coded for the primary hypothesis as a categorical variable representing baseline and the 6-month follow-up period (primary endpoint). To code time for tests of secondary hypotheses, the categorical time variable will include baseline and the 3-month (secondary endpoint) and 6-month follow-up periods. ii)Next, we will add the level-2 treatment-group main effect and the cross-level treatment group x time interactions to test the hypothesized treatment-group differences at follow-up periods. Pairwise comparisons will evaluate the treatment-group difference at each follow-up period.iii)We will finally test whether the fixed effects in step ii change when any identified covariates are added to control for their effects. As a sensitivity analysis, we will use multiple imputation to examine the influence of missing values. Lastly, prior trial results suggest that there may be arm differences in the processing of death-related distress such that individuals with moderate death anxiety tend to be more responsive to the intervention than either those with low death anxiety (approximately the lower third of the distribution) or those with high death anxiety (the upper third). We will conduct a sub-analysis to confirm this effect, by examining the effect of removing individuals with low and high death anxiety scores at baseline (i.e., DADDS \< 15), following the Canadian protocol.

We will also qualitatively analyze the participants' comments about CALM and SPI on the CEQ. NVivo Plus software package will be used for the qualitative analysis of data.

Managing Cancer and Living Meaningfully (CALM) Adapted to Italian Cancer Care Setting

Effectiveness of a Brief Manualized Intervention Managing Cancer and Living Meaningfully (CALM) Adapted to the Italian Cancer Care Setting. Study Protocol for a Randomized Controlled Trial

The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression. It is composed by nine items, reflecting Diagnostic and Statistical Manual-IV criteria for major depression. A four-point Likert scale scores from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. A cut-off point of ≥10 is used as recommended for the screening of depression,but further analysis will be done according to other cut-off scores recommended to classify the type of depression, specifically, no depression/minimal (score 0-4), mild depression (score 5-9), moderate depression (score10-14), moderately severe depression (score 15-19), severe depression (score 20-27). For study purposes, two additional items assessing intent to cause self-harm and rating how difficult these symptoms have made it to do work, take care of things at home, or get along with other people, have been included.

The Generalized Anxiety Disorder Questionnaire (GAD-7)is a 7-item self-report measure designed to screen the severity of GAD symptoms. Items are scored on a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day) with a total score ranging from 0 to 21. Scores up to 4 indicate absence of anxiety, scores from 5 to 9 indicate the presence of mild anxiety, scores from 10 to 15 indicate moderate anxiety. An eighth item rating how difficult these symptoms have made it to do work, take care of choirs at home, or get along with other people, has been included.

The Death and Dying Distress Scale (DADDS) is a 15-item self-report measure assessing specific concerns of advanced cancer patients about end of life, feeling a burden to others and wasted opportunities. It is scored on a six-point Likert scale from 0 (no distress) to 5 (very much distress), with a total score ranging from 0 to 75, a greater score indicating higher death anxiety and distress.

The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-SP) is a 12-item self-report measure of spiritual well-being, assessing patients' sense of meaning, peace and faith. Items are scored on a five-point Likert scale from 0 (not at all) to 4 (very much), with a total score ranging from 0 to 48, with higher scores indicating higher spiritual wellbeing.

The Quality of Life at the End of Life-Cancer Scale (QUAL-EC)is a self- report measure of quality of life in patients near the end of life. It originally consists of five subscales: symptom control, relationship with health care providers, preparation for end of life and life completion. For this study purposes, the symptom control subscale is not included, thus only items 4-17 are used assessing the remaining subscales. Items are scored on a five-point Likert scale ranging from 1 (not at all) to 5 (completely), with a total score ranging from 14 to 70 and higher scores indicating higher quality of life.

The Experiences in Close Relationships Inventory Modified Short Form Version (ECR-M16), is used in its 16-item self-report form to measure the attachment style (i.e. style in relationships perceived to be important for felt security). The scale yields scores on two dimensions: avoidance and anxiety. Items are scored on a seven-point Likert scale ranging from 1 (disagree) to 7 (agree), with a total sum score ranging from 16 to 56 on each subscale. Higher scores on one or both subscale indicate higher attachment insecurity.

The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report scale which measures positive psychological changes after trauma. It consists of four subscales: new possibilities, appreciation of life, relating to others and spiritual change. Items are scored on a three-point Likert scale ranging from 0 (not at all) to 2 (very much) with a total score ranging from 0 to 42. High scores indicate greater post-traumatic growth.

The Couple Communication Scale (CCS) is used for participants who are married, common-law, or in a long-term relationship. The CCS is taken from the PREPARE/ENRICH Inventory, of which we used ten items concerning romantic relationship, with each item scored from 1 (strongly disagree) to 5 (strongly agree).

Intervention and control participants complete respectively the Clinical Evaluation Questionnaire (CEQ) \[19\] - CALM and SPI at 3 and 6-months; a seven-item self-report questionnaire which assesses the level of mastery and insight patients have gained in time and the extent to which therapeutic sessions were perceived as helpful for patients. Experimental group patients' satisfaction will also be qualitatively assessed by inviting participants to share comments in a written form after completing CEQ questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors	NCT05335967	Prostatic Neopl... Self-Management	Self-management... Information pac...	20 Years - 80 Years	National Taipei University of Nursing and Health Sciences
Short-term Psychodynamic Psychotherapy in Serious Physical Illness	NCT05520281	Malignant Neopl... Carcinoma Palliative Care	Short-term psyc...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors	NCT05335967	Prostatic Neopl... Self-Management	Self-management... Information pac...	20 Years - 80 Years	National Taipei University of Nursing and Health Sciences
Existential Distress in Patients With Advanced Cancer and Their Caregivers	NCT04600206	Neoplasms Malig... Carcinoma Palliative Care	Self-report que...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Managing Cancer and Living Meaningfully (CALM) Adapted to Italian Cancer Care Setting	NCT03068013	Depression Anxiety Quality of Life	CALM SPI	18 Years -	Università degli Studi di Ferrara
Existential Distress in Patients With Advanced Cancer and Their Caregivers	NCT04600206	Neoplasms Malig... Carcinoma Palliative Care	Self-report que...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Short-term Psychodynamic Psychotherapy in Serious Physical Illness	NCT05520281	Malignant Neopl... Carcinoma Palliative Care	Short-term psyc...	18 Years -	Universitätsklinikum Hamburg-Eppendorf

Spots Global Cancer Trial Database for demoralization