Special psycho-oncological training for nursing staff to acquire basic knowledge about the experience of mental stress as well as diagnostics of psychosocial stress

OptiScreen training

Tanja Zimmermann, Prof.

Tanja Zimmermann

Adequate, needs-oriented psycho-oncological care contributes to reducing the burden on cancer patients and their relatives and to improving the quality of life. There is still a need for clarification regarding the need and the determination of psychosocial needs. This multi-center study (3 centers: Hanover, Leipzig and Dresden) aims at a professionalization of psychosocial screening, in order to enable thus an exact and need-based allocation to psycho-oncological support. The optimization and professionalization of the psychosocial screening process shall be achieved by a training of oncological nursing and development of an interdisciplinary care algorithm. The aim is to examine whether "OptiScreen" increases the targeted and needs-based allocation to psycho-oncology.

Adequate, needs-oriented psycho-oncological care contributes to reducing the burden on cancer patients and their families and to improving the quality of life of all those affected. In order to ensure patient-oriented psycho-oncological care, it is necessary to allocate psychologically burdened patients and patients in need of care to psycho-oncology by means of screening.

Within the framework of this multicenter study (Hannover, Leipzig and Dresden), a newly designed training of nursing staff ("OptiScreen training") on mental stress and psycho-oncological care is intended to increase the precise identification of mentally stressed patients in need of treatment, to increase the allocation of these patients to psycho-oncology and to improve interdisciplinary cooperation.

Aims of the study:

1. targeted, needs-based allocation to psycho-oncology
2. increasing the acceptance of psycho-oncological screening by patients\* and treatment team
3. increase of patient competence and satisfaction
4. increasing the acceptance of psycho-oncological treatment by patients and treatment team In summary, the findings of this multi-center study should contribute to the improvement of interdisciplinary cooperation, improve the demand-oriented and targeted allocation of psychologically burdened patients to psycho-oncological care and thus develop a "best practice model" of an interdisciplinary care algorithm.

Methodology

The study will include inpatients from the visceral oncology centers at the three sites who have the necessary cognitive, physical and linguistic abilities. The study is divided into 2 phases:

Phase 1: Survey of the current status For this purpose, N = 300 patients\* in the visceral oncology centers are interviewed with a questionnaire during the inpatient stay (t0) and three months later (t1).

The data collected will include psychological stress, disease management/treatment, quality of life and treatment satisfaction of persons with oncological diseases. In addition, the needs for information and support, the practicability as well as the allocation to psycho-oncological care and its utilization will be surveyed.

Execution of the "OptiScreen training": special psycho-oncological training of the nursing staff for basic knowledge about the experience of psychological stress as well as diagnostics of psychosocial stress will take place after the completion of phase 1.

Phase 2: survey after the OptiScreen training Analogous to phase 1, N = 600 patients\* in the visceral oncology centers are interviewed during the inpatient stay (t0) and three months later (t1).

Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm

Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm: From Screening to Intervention

Distress Thermometer (NCCN Distress Thermometer)

Supportive Care Needs Survey Short Form German (SCNS-SF34-G)

Progredienangstfragebogen (PA-F; Fear of Progression Questionnaire)

Patient Activation Measure (PAM 13D; German version of the Patient Measure

Scales for social support during illness (SSUK Skalen zur sozialen Unterstützung bei Krankheit) zur sozialen Unterstützung bei Krankheit-8 (SSUK-8; llness-specific Social Support Scale)

Universitätsklinikum Leipzig

UniversitätsKrebsCentrum Dresden

Hannover Medical School

Prof. Dr. Tanja Zimmermann

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

In-person meeting with the patient in the out-patient department. The patient is free to bring up to four\* relatives or other persons of their own choice to the in-person meeting.

(\* Restriction due to space limitation).

Telephone call with the patient. The patient is free to turn on loudspeaker to include relatives or other persons in the telephone conversation, alternatively to ask the physician to call and inform one relative or other person after the patient-doctor telephone call

All patients are informed that they will receive a telephone call between 08 AM and 5 PM on workdays, as soon as the results of invasive workup are available. This is expectedly 3 to 5 days after invasive workup. At the telephone call, patients are free to ask for a later call, to summon relatives, to turn on the loud speaker, and/or ask the physician to call one relative of choice to share the information.

Regardless of group, all patients are informed on the possibility of malignancy at every patient-physician encounter.

Telephone call

All patients are provided a written and verbal appointment date 5 workdays after invasive workup, and that they will receive a telephone call if 1) results are not available at the time of the meeting, and/or 2) if results need urgent action (such as small-cell lung cancer).

At the in-person meeting, patients are free to invite family and relatives (up to 4 persons, restriction due to space available).

Regardless of group, all patients are informed on the possibility of malignancy at every patient-physician encounter.

In-person meeting

Uffe Bodtger, PhD

John Brodersen, PhD

Disclosure of bad news is challenging for patients, relatives and healthcare providers. Current protocols for breaking bad news assume a single, in-person meeting for breaking bad news, however cancer workup is not a single event but a consecutive process with several contacts between patient and physician. Furthermore, an increasing number of patients receive their cancer diagnosis by telephone.

The investigators want to examine whether having the result of lung cancer workup by telephone results in worse psychosocial consequences than having the result in-person. Both groups receive information on possibility of cancer at every patient-physician contact.

Lung cancer is the most common cause of cancer death worldwide. Patient-friendly delivery of results of lung cancer workup is mandatory in an era of personalized medicine. The possibility of delivering health care using telephone has been acknowledged for various medical interactions such as genetic counselling, delivery of screening results, smoking cessation programmes, palliative interventions, and disclosing result of breast cancer workup. However, Retrospective observational studies have identified higher patients' satisfaction scores when the cancer diagnosis is conveyed by a physician with high communicative skills, in personal rather than in impersonal settings, in-person rather than by telephone, when the patients had a perception of opportunity to ask questions, and when conversations lasted more than10 minutes and included discussion of treatment options.

All current models for breaking bad news (SPIKES, Kayes' 10 step-model, PACIENTE, BREAK) all focus on a single patient-physician encounter, which is in contrast to the organization of contemporary cancer workup as a flow of examinations and thus multiple encounters.

The study aims to examine the effects on psychosocial consequences of receiving the final diagnosis of workup of suspected cancer in lung, pleura or mediastinum by telephone versus in-person when patients receive information on possible malignancy at every patient-physician encounter.

HYPOTHESES:

The main hypothesis of this study is that having the final diagnosis of cancer workup delivered by telephone (intervention group) is associated with worse psychosocial consequences than when delivered in-person (control group). More specifically, the hypothesis is:

1) Receiving the result of cancer workup results in decreased scores of the disease-specific questionnaire Consequences of Screening: Lung Cancer (COS-LC) compared to patients receiving their results in-person.

Potential moderators and mediators:

During the study potential mediating and moderating factors will be explored, e.g. including socio-demography, comorbidity, and disease-specific factors, will be investigated. Most importantly, results on patients with confirmed cancer are explored separately as will data on patients without a final diagnosis of malignancy.

METHODS:

Study design:

The study is a non-pharmacological two-armed randomized controlled trial with intervention group receiving the result of cancer workup by telephone (telephone group) and active control group receiving result of cancer workup in-person ("gold standard"; in-person group). Both groups will otherwise receive the same information and in the same way, thus regardless of group, all patients are informed on the possibility of malignancy at every patient-physician encounter.

Primary endpoint is a patient-reported outcome. Statistician were blinded to intervention until all statistical analyses were conducted

Breaking Potentially Bad News in Lung Cancer Workup: Telephone Versus In-person Breaking of Final Diagnosis

Psychosocial Consequences of Receiving Results of Lung Cancer Workup by Telephone or In-person

Troubles concerning Danish data protection regulations in sharing outside Denmark

Questionnaire COS-LC (Consequences of Screening - Lung Cancer) part 1. COS-LC part 1 consists of nine psychosocial scales (four core and five lung-cancer-screening-specific scales). Each scale is constructed from an individual number of items (see below), and each item has four response categories ordered on a continuum: "not at all", "a bit", "quite a bit" and "a lot": The minimum score of each item is 0 with a maximum of 3. The higher the scale score, the more negative the psychosocial consequences The four core scales measure "Anxiety" (7 items; scale score 0-21), "Behaviour" (7 items; scale score 0-21), "Dejection" (6 items; scale score 0-18), and "Sleep" (4 items; scale score 0-12).

The five lung-cancer-screening-specific scales measure "Self-blame" (5 items; scale score 0-15), "Focus on Airway Symptoms" (2 items; scale score 0-6), "Stigmatisation" (4 items; scale score 0-12), "Introvert" (4 items; scale score 0-12), and "Harm of Smoking" (2 items; scale score 0-6).

COS-LC part 2 encompasses six scales (24 items) focusing on patient-perceived changes at the time of follow-up (4 weeks after the final screening result) compared to baseline: "Calm/Relaxed" (2 items), "Social Relations" (3 items), "Existential Values" (6 items), "Impulsivity" (6 items), "Empathy" (3 items), and "Regretful of still Smoking" (4 items). All items in COS-LC part 2 have five response categories scored laterally reversed: "much less" 2, "less" 1, "the same as before" 0, "more" 1, and "much more" 2: Part 2 was designed and validated to measure changes, both positive and negative, and high scores denote more change

University of Copenhagen

Naestved Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

The WINGS smartphone application is being tested on prostate cancer patients for the first time in this pilot study. It provides easy access to prostate cancer-related information and simplifies networking with supporters, such as family and friends. The WINGS smartphone application can be easily downloaded to a personal smartphone via Google Play or the App Store and can be used at any time from home or on the go.

In addition, the WINGS smartphone application also provides supporters, such as family members and friends of prostate cancer patients with easy access to prostate cancer-related information. Moreover, it helps them to support prostate cancer patients by facilitating joint activities, tailored to the needs of the patient.

The technology-based SSIP ("WINGS") offers disease-related information and builds up social inner circles between patients, their friends, and family members while facilitating to organize, perform, and enjoy activities and content.

WINGS-IP1 Smartphone Application

Noa Roemmel, M.Sc.

Noa Roemmel, MSc.

Gunther Meinlschmidt, Prof. Dr.

Rainer Schaefert, Prof. Dr.

The goal of this pilot study is to assess the perceived usability of a smartphone application called WINGS targeting psychosocial distress and well-being in prostate cancer patients and their social network. The main questions it aims to answer are:

* How do prostate cancer patients and their social network rate the usability of the technology-based social-support intervention program smartphone application?
* Do symptoms of prostate cancer patients improve after using the WINGS smartphone application?
* Does the burden of prostate cancer patients social network decrease after using the WINGS smartphone application? Participants will be asked to use the WINGS smartphone application over the period of eight to twelve weeks and fill in questionnaires before, during, and after this time.

There is still little knowledge about how smartphone apps can improve the quality of life in prostate cancer patients. Hence, the investigators are interested in finding out whether the simplified access to information and planning of activities increases the perceived social support in prostate cancer patients and ultimately improves their quality of life.

The duration of the study is approximately three months per participant. The WINGS smartphone application can be used from home and questionnaires can be completed online. Participants are therefore not required to be present at the University Hospital Basel during the entire course of the present study.

The investigators plan to recruit a total of 30 prostate cancer patients at the University Hospital Basel and 0-10 supporters (family members and friends) per prostate cancer patient. All study participants will have access to the regular treatment services of the University Hospital Basel.

Feasibility of Technology-Based SSIP in Prostate Cancer Patients

Technology-Based Social-Support Intervention Program for Reducing Psychosocial Burden in Prostate Cancer Patients: A Proof-of-Feasibility Pilot Study

In order to measure patients' beliefs in their capabilities to use the German version of the Internet and Internet-based programs the investigators will use the 'Internet Self-efficacy Scale' (ISS, \[Eastin \& LaRose, 2006\]). The ISS is a self-report measure, including 10 items rated on a seven-point Likert-scale ranging from 1 = "strongly disagree" to 7 = "strongly agree". For the purpose of this study, the investigators will translate the ISS into German. This scale will be completed by prostate cancer patients and their supporters.

The investigators will ask patients and their supporters to declare how often they have used the WINGS Smartphone Application during the eight-week intervention phase (e.g., daily, every other day, three times a week, twice a week, once a week, less than once a week).

The investigators will ask patients to declare how many supporters they have contacted via WINGS Smartphone Application.

The investigators will extract the number of supporters per individual patient directly from the WINGS Smartphone Application.

The investigators will ask prostate cancer patients if they had taken up psycho-oncological consultation before or after their prostatectomy.

The investigators will consult hospital records to check whether patients have had any psycho-oncological consultations.

The investigators will ask prostate cancer patients and their supporters to report any Adverse Events (AEs) in free text format.

The investigators will ask prostate cancer patients and their supporters to report any Device Deficiencies (DDs) in free text format.

The investigators will ask prostate cancer patients and their supporters to provide general feedback on the WINGS Smartphone Application.

The investigators will adequately assess any undesired side effects of the intervention and document the rate of adverse events in general, considering reports of adverse events or device deficiency by prostate cancer patients and supporters. The investigators will also monitor (severe) Adverse Events (AEs) relating to participants' disease progression, including (but not limited to) death and hospitalization. AEs will be designated and managed according to ICH-GCP E6 (International Conference on Harmonization (ICH), 2016). All AEs that occur during the study will be monitored.

Primary outcome is prostate cancer patients' perceived usability of the WINGS-IP1 Smartphone Application measured by the German version of the 'Intervention Usability Scale' (IUS, \[Lyon et al., 2021\]). This scale was adapted from the 'System Usability Scale' (SUS, \[Brooke, 1996\]), a widely used self-reported scale to assess usability of digital systems, mobile applications, devices, and websites (see Kaya et al., 2019; Klug, 2017; Usability.gov, 2013). The SUS is composed of 10 items, assessed on a five-point Likert-scale, ranging from 0 = "strongly disagree" to 4 = "strongly agree" (Brooke, 1996). This scale will be completed by prostate cancer patients and their supporters.

In order to assess change mental burden related to medical condition the investigators will use the German version of the 'Mental Health Component Summary Score' of the 'Short Form-36 Version 1'(SF-36, \[Ware, 2000\]). The SF-36 is a validated, self-report instrument consisting of 36 items rated on five-choice response scales. The possible score ranges from 0 to 100 points, whereby 0 points represent the greatest possible health restriction and 100 points represent no health restriction at all. This scale will only be completed by prostate cancer patients.

The investigators will use the German version of the 'Patient Health Questionnaire' with 8 items (PHQ-8) to assess the severity of depressive symptoms in prostate cancer patients (Kroenke et al., 2009; Kroenke \& Spitzer, 2002). The last criteria had been excluded as it assesses suicidal or self-injurious thoughts, which investigators will not be able to address adequately within the context of the proposed study. Prostate cancer patients and their supporters will be asked to indicate how often they experienced a depressive symptom in the past two weeks (Kroenke et al., 2009). They rate these symptoms on a four-point Likert-scale ranging from 0 = "not at all," 1 = "several days," 2 = "more than half the days," to 3 = "nearly every day". The PHQ-8 demonstrated acceptable internal consistency with Cronbach's α = 0.82 (Pressler et al., 2011).

The investigators will implement the German version of the seven item 'General Anxiety Disorder Scale' (GAD-7) to assess the presence of generalized anxiety disorder, social phobia, panic disorder, and post-traumatic stress disorder (Spitzer et al., 2006; Staples et al., 2019). Prostate cancer patients and their supporters rate items on a four-point Likert-scale ranging from 0 = "not at all," 1 = "several days," 2 = "more than half the days," to 3 = "nearly every day", based on their symptoms in the last two weeks. The GAD-7 showed acceptable discriminative validity (AUCs between 0.74 and 0.75, ps \< 0.001) and good test-retest reliability (r = 0.83) and internal consistency with Cronbach's α = 0.88 (Staples et al., 2019).

In order to measure daily fluctuations of depressive symptoms and anxiety during the eight-week intervention phase, the investigators will implement the 'Patient Health Questionnaire' (PHQ-4) which consists of the PHQ-2 (Kroenke et al., 2003) and the 'General Anxiety Disorder Scale' (GAD-2, \[Staples et al., 2019\]) as Ecological Momentary Assessment (EMA, \[Stone et al., 1999\]). Both measures will be adapted in accordance with procedures of Bauer and colleagues (2018) to adjust instructions and Likert-scales to daily assessments. This scale will only be completed by prostate cancer patients.

In the proposed study the investigators will assess prostate cancer patients perceived stigma using the German version of the 'Social Impact Scale' (SIS-D) with 24 items (Fife \& Wright, 2000). The SIS-D has been previously used to measure stigma in cancer patients and covers four dimensions, namely social rejection, internalised shame, social isolation, and financial insecurity. All items are answered on a 4-point Likert scale from 1 ("strongly disagree") to 4 ("strongly agree"). This scale will only be completed by prostate cancer patients.

To assess prostate cancer patients' perceived social support, the investigators will use the German version of the 'Oslo Social Support Scale' (OSSS-3, \[Dalgard et al., 2006; Kocalevent et al., 2018\]). The OSSS-3 is a very brief, three-item scale. In addition to pre- and post-intervention assessment, the investigators will also measure the OSSS-3 weekly, to assess fluctuations in perceived social support. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support. This scale will only be completed by prostate cancer patients.

The investigators will assess somatic symptom disorder using the 'Somatic Symptom Disorder-B Criteria Scale' (SSD-12) composed of 12 items (Toussaint et al., 2016). These subscales are divided into three psychological subscales including cognitive aspects, affective aspects, and behavioural aspects. All items are answered on a 5-point Likert scale from 1 ("never") to 4 ("very often"). This scale will only be completed by prostate cancer patients.

The investigators will assess symptoms associated with prostate cancer and its treatment with the German version of the 'Expanded Prostate Cancer Index Composite' (EPIC-26, \[Wei et al., 2000\]). The EPIC-26 is a self-reported measure to assess patient function and distress after prostate cancer treatment. It covers multiple health-related quality of life (HRQOL) domains, namely urinary (incontinence and irritative/obstructive), bowel, sexual, and hormonal functionality. Each of these domains are assessed in terms of their function and bother and summarized into domain summary scores. The higher the EPIC-26 score (maximum 100 points), the better the patient's assessment of functionality in the dimension covered. This scale will only be completed by prostate cancer patients.

In order to assess prostate cancer patients' expectancy and the perceived credibility of the WINGS-IP1 Smartphone Application the investigators will use the 'Credibility Expectancy Questionnaire' (CEQ, \[Devilly \& Borkovec, 2000\]). A total of six items are rated on a 1-9 or a 0%-100% scale, depending upon the item. Higher scores refer to higher expectancy and higher credibility. This scale will only be completed by prostate cancer patients.

In addition, the 'Expanded Prostate Cancer Index Composite' (EPIC-26, \[Wei et al., 2000\]) will be assessed in prostate cancer patients six months post-prostatectomy as part of the clinical standard procedures at the University Hospital Basel. Hence, instead of a follow-up assessment 12 weeks after T1, the investigators will retrieve prostate cancer patients' EPIC-26 data from hospital records entered during the standard six months post-prostatectomy follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm	NCT04638699	Psycho-Oncology Visceral Cancer Screening Psychosocial St...	OptiScreen trai...	18 Years -	Hannover Medical School
Breaking Potentially Bad News in Lung Cancer Workup: Telephone Versus In-person Breaking of Final Diagnosis	NCT04315207	Lung Cancer Diagnoses Disea... Psychosocial St...	Telephone call In-person meeti...	18 Years -	Naestved Hospital
Feasibility of Technology-Based SSIP in Prostate Cancer Patients	NCT05720832	Prostate Cancer Psychosocial St...	WINGS-IP1 Smart...	18 Years -	Wings Health AG

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