study samples adolescent and young adult survivors of pediatric cancer, their parents, and one sibling; they are assessed using self-report questionnaires, so no intervention takes place

Questionnaires on identity formation and psychosocial functioning, assessed and reported at baseline, one year later, two years later, and five years later.

Questionnaire bundle

After obtaining informed consent, we will access the medical file of participants to obtain information on the diagnosis, time of diagnosis, treatment duration, type of treatment, and relapse (when applicable).

Obtaining information from survivors' medical file

Koen Luyckx, Dr.

The study investigators plan to conduct a longitudinal questionnaire study in adolescents and emerging adults (14-25 years of age at the start of the study) who survived childhood cancer to chart their identity development and broader social functioning. Additionally, the functioning of these survivors will be related to the functioning of their parents and siblings. The investigators shall focus especially on the current experience and impact of the earlier cancer experience. They will investigate to what extent the experience of a life-threatening disease has an effect on the daily life of survivors and over time and how the survivors develop through the course of adolescence and emerging adulthood on the psychosocial level. The formation of an adult identity is a very challenging task during adolescence and the way to adulthood and the fact that these youth had cancer during their childhood may especially complicate this process of identity formation. Furthermore, both parental and sibling functioning will be taken into account, which will allow us to examine inter-generational mechanisms (thus parental functioning that possibly impacts youth functioning and vice versa) and sibling functioning in these families. To investigate the latter, at each timepoint of the longitudinal study a sibling between 14 and 25 years of age at the start of the study will be included (if there is more than one sibling in a family, ideally the sibling who is closest in age will be the one who participates in the study). Moreover, a community sample that is matched on age and sex with the survivor of pediatric cancer will be assessed. This will allow the investigators to make well-founded comparisons regarding identity development and broader psychosocial functioning.

In the present longitudinal study, four main research questions will be investigated.

1. How does identity develop in cancer survivors? Based on previous findings from studies in identity development, it seems that young adults with a chronic disease like type 1 diabetes show less exploration or consider less identity possibilities from which they can choose, e.g. they dwell less upon the choice of education. Does this finding also apply to survivors of childhood cancer or are these youth more similar to a community sample? This research question may provide an answer to the question whether or not there is a continued (psychological) impact of childhood cancer on the later identity development of survivors. For this purpose the investigators shall make use of an identity model which was developed at their research department and which has gained much international research attention. In addition, the investigators want to look at illness-identity, which comprises the amount to which the earlier cancer experience is integrated into one's identity. Does the youngster feel still engulfed by the earlier cancer experience, or has he/she integrated this experience as part of his/her self-concept? Or does the youngster feel even enriched by the earlier cancer experience, thus did he/she end up even stronger through the experience?
2. How do survivors of pediatric cancer and/or their parents function on the psychological level, more specific on the level of life satisfaction and depressive symptoms, and what is the role of identity and personality variables herein? This question examines, among other factors, concepts like benefit-finding, post-traumatic growth, resilience,... Thereby it would be interesting to examine whether different subgroups can be identified, for example, which groups of persons display less adaptive functioning and why?
3. Are there certain parenting dimensions (e.g. overprotection, responsiveness, psychological control,...) which are more prevalent in families that were confronted with pediatric cancer and are these dimensions differently related to the psychosocial adaptation of survivors? Does this relate to certain aspects of survivor functioning, like depressive symptoms and quality of life? Thereby, transactional processes between survivor and parental functioning will be investigated, e.g. does identity development of survivors have an impact on parental well-being, and has parental well-being in turn an impact on survivor functioning? Taken together, the investigators want to investigate to what extent these contextual variables determine the functioning of adolescents and emerging adults.
4. What is the impact for siblings of cancer survivors? How do they go through their identity process? Do they experience the same parenting as the survivors experience themselves? E.g if survivors would experience more parental overprotection, would siblings experience overprotection to the same extent?

Longitudinal Identity Study of Childhood Cancer Survivors

The Long-term Impact of Pediatric Cancer on Adolescents, Emerging Adults, and Their Family: Identity, Psychosocial Functioning, and Development

Dimensions of Identity Development Scale (DIDS); dimensions: commitment making (range: 5 - 25), Identification with Commitment (range: 5 - 25), Exploration in Breadth (rang: 5 - 25), Exploration in Depth (range: 5 - 25), Ruminative Exploration (range: 5 - 25); for each dimension, a higher score indicates more identification with the dimension

Erikson Psychosocial Stage Inventory (EPSI); subscales: Synthesis (range: 5 - 30), Confusion (range: 5 - 30); for each scale, higher scores indicate more identification with the scale

Illness Centrality; total scale range: 0 - 4; A higher score indicates more identification with the scale

Self-Identity after Cancer; dimensions: victim of cancer (range: 1 - 5), cancer patient (range: 1 - 5), person who had cancer (range: 1 - 5), survivor (range: 1 - 5); for each dimension, a higher score indicates more identification with the dimension

Children's Revised Impact of Event Scale (CRIES-13); total scale range: 0 - 65; Higher scores indicate more sensitivity for PTSD; A score higher than 30 possibly indicates the presence of PTSD; subscales: Intrusion (range: 0 - 20), Avoidance (range: 0 - 20), Arousal (range: 0 - 25); Higher scores indicate more identification with the scale

Benefit scale from the Benefit and Burden Scale (BBSC); total scale range: 10 - 50; A higher score indicates more identification with the scale

Center for Epidemiologic Studies Depression (CES-D-12); total scale range: 0 - 36; a higher score indicates the presence of more depressive symptoms

Cancer Related Worries Scale; total scale range: 4 - 20; A higher score indicates the presence of more cancer-related worries

Satisfaction with Life Scale (SWLS); total scale range: 5 - 35; A higher score indicates more satisfaction with life

Short Form 36, physical subscale (SF-36); total scale range: 10 - 30: A higher score indicates worse bodily functioning

Rosenberg Self-Esteem Scale (RSES); total scale range: 10 - 40: A higher score indicates higher self-esteem

Brief Resilience Scale (BRS); total scale range: 6 - 30; A higher score corresponds to being more resilient

Big Five Inventory 10 (BFI-10); subscales: Extraversion (range: 2 - 10), Agreeableness (range: 2 - 10), Conscientiousness (range: 2 - 10), Neuroticism (range: 2 - 10), Openness (range: 2 - 10); for each scale, a higher score indicates more identification with the scale

Based on Goossens et al., 2013: Health risk behaviors in adolescents and emerging adults with congenital heart disease: psychometric properties of the Health Behavior Scale-Congenital Heart Disease

Multidimensional Health Locus of Control Scale (MHLCS): subscales: Internal Health Locus of Control (range 6 - 36), Powerful Others Health Locus of Control (range 6 - 36), Chance Health Locus of Control (range: 6 - 36); for each scale, a higher score indicates more identification with the scale

Multidimensional Scale of Perceived Social Support (MSPSS); subscales: support from special someone (range: 4 - 28), support from family (range: 4 - 28), support from friends (range: 4 - 28); for each subscale, a higher score indicates more support

Based on the 8-item Parental Expectations for Behavior Scale and the 8-item Parental Monitoring of Behavior Scale uit de 'Parental Regulation Scale - Youth Self-Report' (PRS -YSR; Barber, 2002); Behavioral Control; total scale range: 7 - 35; A higher score indicates more parental behavioral control

Child Report of Parent Behavior Inventory (CRPBI; Schaefer, 1965; Schludermann \& Schludermann, 1988); Responsiveness; total scale range: 7 - 35; A higher score indicates more parental responsiveness

based on Dutch Multidimensional Overprotective Parenting Scale, Kins \& Soenens, 2013; Overprotection / anxious parenting; Overprotection; total scale range: 8 - 40; A higher score indicates more parental overprotection

8-item Psychological Control Scale-Youth Self-Report ( Barber, 1996); Psychological Control; total scale range: 8 - 40; A higher score indicates more parental psychological control

Illness Intrusiveness Questionnaire Parent Report (IIQ-Parent Report); total scale range: 13 - 91; A higher score indicates more illness intrusiveness

Parenting Stress Index - Sense of Competence Scale; total scale range: 13 - 78; A higher score indicates a lower sense of parental competence

Parental Burden Questionnaire, subscale role restriction; total scale range: 6 - 24; A higher score indicates a greater sense of role restriction

Family Functioning Questionnaire, subscale parental relationship quality; total scale range: 5 - 20; A higher score indicates a greater sense of partner relationship quality

Benefit Finding Scale; total scale range: 15 - 105; A higher score indicates more benefit finding

Research Foundation Flanders

Universitaire Ziekenhuizen KU Leuven

KU Leuven

Associate professor at the Faculty of Psychology and Educational Sciences

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Death

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

Patients will be monitored allowing the delivery of timely and personalized care via a 4-level program:

1. Screening and psychosocial monitoring through a mobile application where patients have a messaging system to contact their psychologist and reference nurse.
2. Psychoeducation and health education campus, where patients can consult videos and online resources developed by health professionals, containing scientifically validated information.
3. Psychosocial support community where patients can share doubts, fears, and experiences with other patients with advanced lung cancer. This private social network is monitored by team specialists when necessary.
4. Online group psychotherapy of 8 weekly sessions of 90 minutes based on Meaning-Centered Group Psychotherapy (MCGP; Breitbart et al., 2010). Patients at this level will be on a waiting list, so the pool starts when there are 4-8 users available.

This group will receive standard psychosocial care for cancer survivors at ICO Hospitalet center led by a clinical psychologist. It consists of 7 individual sessions of 45-60 minutes, scheduled every 2-3 weeks during 9 months and focused on emotional support and psychoeducation. Moreover, they will be offered the education materials from the 2nd step of the platform, as they are compiled in a website open to all patients and relatives.

1. Screening and monitoring: weekly administration of an emotional state thermometer. If the score is \>5, participants are asked to complete the HADS. If HADS' score \>10, step 2 is assigned. The same procedure is followed for steps 3 \& 4. Participants remain in each step for 2 weeks, and all level changes are preceded by a videoconference with a health professional
2. Online psychoeducation campus: displays co-constructed videos and posts developed by health professionals and patients about LC diagnosis and treatment aspects.
3. Online support community: anonymous survivors with LC diagnoses are included. Professionals and patient mentors supervise and foster debate, peer support, and resolve health Q\&As.
4. Weekly online group psychotherapy led by a clinical psychologist and composed of eight 90-minute sessions. Eligible users are placed on a waiting list, starting when 5-6 users are available.

E-health ecosystem of stepped psychosocial care

Usual psychosocial care for cancer survivors at ICOHospitalet centre led by a clinical psychologist. Usual psychosocial care consists of 7 individual sessions of 45-60 minutes, with 2-3 weeks of space between sessions, based on Individual Meaning-Centered Psychotherapy (IMCP) for Patients With Advanced Cancer (Breitbart et al., 2012). Moreover, they will be offered the education materials from the 2nd step of the platform, as they are compiled on a website open to all patients and relatives.

Usual psychosocial care

Maria Serra Blasco, PhD

Cristian Ochoa, PhD

Being diagnosed with cancer impairs many areas of a person's life. Although efficacious educational, emotional and social interventions exist in this regard, they often reach few survivors and late. This project, carried out by a specialized centre in cancer care and health research, will study the effectiveness, costs, and utility associated with a digital ecosystem tailored to meet the needs of patients with advanced lung cancer. This solution bridges the gap between patients and professionals to offer health services precisely when they are needed. The project is developed in the first year of an advanced lung cancer diagnosis, comparing the effects of the digital ecosystem with usual care in terms of their capacity to improve various psychosocial indicators. A comparative economic analysis will be carried out as well, to prove the cost-utility of the digital ecosystem presented.

Palliative Care (PC) for patients with advanced life-limiting diseases and the management of their symptoms during the trajectory of illness has evolved considerably (Clark, 2007). PC is conceptualized as an approach to improve the quality of life of patients and their relatives "through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other physical, psychosocial and spiritual problems". In recent years, survival rates have increased for most cancer diagnoses, in both early and advanced stages. Therefore, patients suffering a disease considered incurable are living longer with cumulative psychosocial comorbidity derived from both the illness itself and its associated treatments. The American and European societies for medical oncology have recently recommended integrating early psychosocial PC into standard oncological practice for patients with metastatic or advanced stage diseases like lung cancer (LC) in their professional guidelines. This decision has been recently supported by meta-analytic results as well. Those studies show that palliative interventions including physical and psychological aspects have beneficial effects on patients, both on short-term quality of life and in general symptom burden.

Despite the advantages of such integrated PC interventions, healthcare systems usually encounter several barriers to implementing psychosocial care in palliative settings, like in advanced LC. The most typical include poor early detection of such needs; long waiting lists; and mobility restrictions, with many patients unable to attend visits in person. The literature strongly suggests that emotional distress is associated with worse quality of life, lower adherence to oncological treatments and adoption of unhealthy lifestyles. Actually, it is also demonstrated that stress reduction may even extend survival years. Since LC patients show great symptom variability, erratic evolution and high emotional impact along with a limited prognosis, it is urgent to increase the currently small proportion of patients with early screening, close and intensive monitoring and prompt referral to PC teams. To this aim, new approaches in psychosocial PC are needed to overcome the barriers experienced today.

In the last years, two main actions have been proposed to improve the implementation of psychosocial care in PC, placing a focus on its accessibility and efficiency. For example, recent studies have introduced earlier stepped (low to high intensity) and adaptive treatments as an ingenious and sensible response to the challenge of offering proper psychosocial interventions, with high cost-effectiveness in cancer. Another comprehensive action is to make use of Information and Communication Technologies (ICT). ICT has emerged in the last few years as an innovative resource to set this new wave of health practices in motion, with an exponential increase in its use and implementation during the COVID pandemic, to guarantee continuity of care in vulnerable advanced cancer patients. ICT have also shown their capability to overcome most of the limitations expressed in conventional care settings. These tools have provided faster and more intense follow-up options to monitor patients' warning signs, facilitating better communication between patients and professionals, and also leveraging cheaper and more accessible clinical treatments compared to traditional alternatives, even at the end of life. Nevertheless, the few studies comparing ICT and usual psychosocial interventions have found mixed effectiveness results so far.

Recently, ONCOMMUN, a European proposal for creating an e-health ecosystem (https://oncommun.eu/), has combined these two promising actions to facilitate early psychosocial care in an online and stepped psychosocial program. ONCOMMUN has shown promising preliminary results on breast cancer (BC) and a high potential for therapeutic application in advanced and palliative settings, like LC. The first level of care in this program is an online screening and monitoring tool, followed by a patient's campus comprising educational interventions (second level), a psychosocial support community (third level), and psychotherapeutic treatment groups through videoconference (fourth level).

The current project has been designed as a randomized non-inferiority controlled trial to compare an e-health ecosystem of psychosocial care, based on the ONCOMMUN proposal, against traditional in-person psychosocial treatment in PC during advanced LC. Our group proposes the development and adaptation of this digital ecosystem by integrating screening and monitoring tools with educational and psychological interventions, building upon the results of its recent implementation in BC. This innovative e-health ecosystem intends to foster healthy experiences, integrating a four-stepped psychosocial program of early PC focused on patients with a diagnosis of non-small cell lung carcinoma (NSCLC) at advanced stages (III and IV).

OBJECTIVES (3 years)

General

1. To offer early detection and tailored treatment of psychosocial and physical needs of advanced LC survivors.
2. To implement and assess an online stepped ecosystem for psychosocial and educational screening, monitoring and care, through the use of an e-health platform specifically developed for advanced LC patients.

Specific objectives

1. To compare the capacity of the digital ecosystem to detect and deliver early psychosocial care compared to treatment as usual.
2. To improve or cushion the consequences of the advanced lung cancer course and treatment in terms of emotional distress, demoralization and quality of life.
3. To explore the potential mediating and facilitating role of spirituality in an optimal psychosocial adaptation.
4. To study the cost-utility associated with both interventions in terms of Quality-Adjusted Life Years (QALY), through the estimation of patients' use of additional health services, their degree of pharmacological adherence, intake of psychotropic medication, and time spent in disability leaves.
5. To disseminate to cancer patients, professionals and the general public the results of the study.

Procedure and data acquisition

1. Development of an LC platform: LC platform will be adapted from the BC platform and fed by the results of the pilot LC system and focus groups with professionals and patients. The LC solution will share a set of structural items (e.g., measurement instruments, instant symptom management), to which specific resources for LC will be added. Patients' experience will be at the centre of this development stage to maximize usability and understanding of all resources.
2. Validation with users: Patients with advanced LC diagnosis will be invited to participate by their medical team. If interested, they will be contacted by our group and a face-to-face meeting will be scheduled, where the study will be described and informed consent signed in case of acceptance. Participants will be then randomized to 1) e-health ecosystem or 2) usual psychosocial care by an external researcher blind to the research questions and treatment conditions, using a random sequence of numbers generated by REDCap software. In the eHealth ecosystem group, participants lacking equipment will be offered webcams and tablets as needed. There are specific processes of the system that will only apply to ICOnnecta't branch as they will measure the platform usability and their associate emotional state during the study (see Interventions section below). All other measures will be administered from T0 to T3 through a professional online survey platform compliant with the latest European General Data Protection Regulation (GDPR; EC/2016/679).

Data collection and analysis

Two databases will be created: The first one will associate participants' identifiable personal data (e.g., names, patient ID) with an alphanumeric code, and will be saved in an encrypted external hard drive stored in a key-protected closet within the office of the PI. The second database, created via REDCap system, will record all data to be analyzed making use of alphanumeric codes and will be stored in a secure collaborative cloud also GDPR-compliant. This procedure will allow us to conduct the analyses anonymously. Data will be monthly downloaded from REDCap and backed up in a second encrypted external hard drive. Every 3 months one researcher will conduct a data integrity check. While online systems automatically keep a registry of users' access, a notebook will remain next to the hard drives for researchers authorized by PIs to record their name, date and time when drives are retrieved and returned. Finally, the information collected through the eHealth ecosystem will also be stored in a GDPR-compliant server.

Descriptive results will be provided for sociodemographic and clinical variables, as well as for education, usability and satisfaction indicators, while between-group differences will be assessed with Student's t-test and chi-square tests as appropriate. Multilevel linear models (MLM) will be used to compare both groups in outcome variables, while effect sizes (Hedges' g) will be reported and non-inferiority tested. For QALY analyses, results from the EQ-5D-3L will be used together with costs associated with professional salaries, adherence, infrastructure, psychotropic medication and sick leaves. The effect of any potential confounding variable will be analyzed. Analyses will be conducted using SPSS v24.021 (IBM SPSS Statistics 21, 2017) by the IDIBELL biostatistics department.

Non-inferiority randomized trial testing two experimental conditions: 1) ehealth ecosystem, 2) usual psychosocial care. Assessment of main outcomes are conducted at recruitment (T0), 3 months from T0 (T1), 6 months from T0 (T2), and 9 months from T0 (T3). Hence, the design is 2 (treatment conditions) X 4 (assessments). The whole project's methodology adheres to the principles of Responsible Research and Innovation (RRI).

The sample size has been estimated with the support of the R software (R Core Team, 2020), setting a non-inferiority margin of 5 points in the Hospital Anxiety and Depression Scale (Vaganian et al., 2020), with power at 80% and one-tailed α of 2.5%. A dropout rate of 25% was assumed. It was anticipated that 152 participants were necessary (n = 76 per arm) to ensure that a two-sided 95% confidence interval would exclude the non-inferiority threshold.

Psychosocial eHealth in Advanced Lung Cancer

Stepped and Early Psychosocial Care in Advanced Lung Cancer Through E-health

Emotional distress will be assessed through the Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983). The HADS measures symptoms of anxiety and depression and consists of 14 items: seven items for the anxiety subscale (HADS Anxiety) and seven for the depression subscale (HADS Depression). HADS Anxiety focuses mainly on symptoms of generalized anxiety disorder and HADS Depression is focused on anhedonia, the main symptom of depression. Each item is scored on a response scale with four alternatives ranging between 0 and 3. Higher scores means higher levels of depression and anxiety.

Spirituality will be assessed through the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp; Peterman et al., 2002). This scale includes factors of meaning, peace and faith, assessed through 12 items rated on a 0-4 Likert scale. The overall score ranges between 0 and 48, and between 0 and 16 for each subscale, where higher scores are indicative of greater spiritual well-being.

Demoralization will be measured through the Demoralization Scale (DS-II; Kissane et al., 2004). The DS-II is a 3-point response, self-report scale comprising 16 items and 2 subscales: distress and coping ability, and meaning and purpose. Scores \<10 indicate no demoralization, between 10-19 moderate demoralization, and \>20 severe demoralization.

Health-Related Quality Of Life (HRQOL) will be assessed through the Functional Assessment of Cancer Therapy-Lung (FACT-L; Cella et al., 1995). The FACT-L is a 36-item, lung cancer-specific instrument that also includes the symptom-based Lung Cancer Sub-scale (LCS). It has 36 items organized into 5 subscales: 1) physical well-being, 2) functional well-being, 3) social/family well-being, 4) emotional well-being and 5) lung cancer. Responses are scored on a Likert-type scale ranging from 0 (not at all) to 4 (very much). Higher scores correspond to a better quality of life.

QoL will be measured through the European Quality of Life Scale (EQ-5D-3L; EQ-5D User Guides, 2021). The EQ-5D-3L consists of 2 pages: the EQ5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale of 100 points where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

Symptom management will be measured through the Edmonton Symptom Assessment System (ESAS-r; Carvajal et al., 2012). ESAS-r is an instrument that is commonly used both in PC and in advanced cancer situations. It has 10 visual numerical scales that assess physical and psychological symptoms. Patients choose the number that best represents the intensity of each symptom on a scale of 0 to 10.

Medication adherence will be measured through the Simplified Medication Adherence Questionnaire (ARMS-e; Kripalani et al., 2009). The ARMS-e assesses medication adherence in patients with chronic conditions in 12 self-reported items with 4 response possibilities: never, sometimes, most of the time and always. Lower overall scores correspond to better adherence.

Users' satisfaction with the platform will be measured through a 0-10 Visual Analogic Scale (VAS). Higher scores correspond to higher satisfaction.

Platform's usability will be asked to users through a 0-10 Visual Analogic Scale (VAS). Higher scores correspond to higher usability.

Emotional wellbeing will be measured through an emotional thermometer (ET; Harju et al., 2019) using a Visual Analogue Scale (VAS) (0-10). Higher scores correspond to higher well-being.

Asociación Española contra el Cáncer

Institut d'Investigació Biomèdica de Bellvitge

Institut Català d'Oncologia

Anxiety Disorders

Mental Disorders

Psychotic Disorders

Patients randomized to the music intervention arm will select a preferred genre of music from an internet based resource.

These patient's will have no music playing during the first radiotherapy session.

The patient's preferred music will be played during the first radiotherapy treatment session from speakers located inside the treatment room. The duration of the music will be 10 to 20 minutes. The music will be turned off at the patient's request if it bothers them. Length of music playing and if the patient requested that it be turned off, will be recorded.

Music

Natalie A. Lockney, M.D.

The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.

Receiving radiotherapy induces anxiety in at least 1/3 of patients who did not have a previously existing anxiety condition1. Female gender is a positive predictive factor for psychosocial decline during radiotherapy. One-fourth of patients disrupt their planned radiotherapy treatment course due to anxiety. Music therapy has demonstrated effectiveness in reducing anxiety when implemented in other medical settings including mechanical ventilation, burn debridement and venipuncture in pediatric patients. There have been some trials which have found a reduction in anxiety when pre-recorded music along with other relaxation techniques have been implemented during radiotherapy. This trial seeks to investigate the benefit of pre-recorded music alone in reducing anxiety experienced during the first radiotherapy treatment session in female cancer patients.

Consented, eligible female subjects to be randomized to "Music" or "No Music" to evaluate pre and post treatment anxiety level via STAI and SDT anxiety questionnaire at their first radiotherapy treatment for cancer.

Multiple studies document a higher rate of psychological distress in female cancer patients.The study is limited to females to decrease confounding prognostic factors related to anxiety during cancer therapy. By restricting enrollment to women in this study, is to gain proof of concept that the intervention is effective and can be determined with a smaller sample size.

Music of Choice to Decrease Anxiety During Radiation Treatment

A Randomized Trial of Music to Decrease Anxiety in Women Starting Radiation Therapy for Cancer

Percent change in mean anxiety score as measured with the State-Trait Anxiety Inventory (STAI) questionnaire. Assessed by the mean value (pre minus post radiotherapy STAI score) divided by mean pre-treatment score multiplied by 100. A score of 39-40 on each subset suggests clinically significant anxiety.

Percentage change in mean anxiety score as measured with the Symptom Distress Thermometer (SDT). Scale of 0 - 10; with 10 being clinically significant distress.

The magnitude of change in anxiety score of STAI in "high anxiety" patients (pre-treatment STAI ≥ 40) as a result of listening to music during the first radiotherapy session.

The magnitude of change in anxiety score of SDT in "high anxiety" patients (pre-treatment SDT ≥ 4) as a result of listening to music during the first radiotherapy session. Scale of 0 - 10; with 10 being clinically significant distress.

The number and percentage of patients who drop from a "high" to "low" anxiety level in both intervention groups using STAI scores. A score of 39-40 on each subset suggests clinically significant anxiety.

The number and percentage of patients who drop from a "high" to "low" anxiety level in both intervention groups using SDT scores. Scale of 0 - 10; with 10 being clinically significant distress.

University of Florida

Eye Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Cognitive Dysfunction

Retinoblastoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Cognition Disorders

Neurocognitive Disorders

Neuroepithelioma

Central Nervous System Depressants

All Drugs and Chemicals

Herbal and Botanical

Anesthetics

Children and adults who survived retinoblastoma (8-35 years of age)

Children and adults who (might) carry a genetic risk to develop retinoblastoma (8-35 years of age)

Parents of Rb patients, Rb survivors, or Rb risk carriers (6 months-12 years of age)

Estimated intelligence (subtasks of Wechsler Intelligence Scale for Children - Fifth edition -Dutch version \[WISC-V-NL\] or Wechsler Adult Intelligence Scale - Forth edition - Dutch version \[WAIS-IV-NL\]); Vienna reaction time; Rey auditory verbal learning test; Word fluency; Beery-Buktenica Developmental Test of Visual-Motor Integration, 6th Edition; Test of Everyday Attention for Children (TEA-Ch), subtask Score!/ or Test of Everyday Attention (TEA), subtask Elevator task; Trail making test; Word-color interference test

Neuropsychological assesment

Anxiety (PROMIS); Depression (PROMIS); Peer-interaction (PROMIS); Perceived neurocognitive functioning (PROMIS); Participation and activity (PAY-CY); Trauma (KJTS/PCL-5); Health related quality of life (PEDSQL)

Psychosocial functioning and quality of life (questionnaires)

Anxiety (PROMIS); Depression (PROMIS); Distress Thermometer-Parents (DT-P); Trauma (PCL-5)

Parental psychosocial functioning (questionnaires)

Annette C. Moll, MD PhD

A retrospective crosssectional observational study of the effects of oncological treatment and frequent general anesthesia on neuropsychological development, psychosocial functioning (in terms of anxiety, depression, peer relations, perceived cognitive functioning and potential trauma) and health related quality of life in children and young adults who were treated or screened for retinoblastoma.

Retinoblastoma (Rb) is the most common form of ocular cancer in children, with high survival rates in developed countries (\>90%). Rb can develop unilateral (one eye affected, sometimes hereditary), or bilateral (both eyes, always hereditary). Children are usually diagnosed at a young age (\<5 years) and are subjected to an intensive treatment and follow-up protocol immediately after. If Rb is diagnosed in early disease stages, eye-saving treatment could be provided, such as laser, cryo-, chemotherapy and/or radiotherapy -or a combination of these. When discovered in a later disease stage, enucleation (removing the eye) is often inevitable. Brothers and sisters or offspring of heredity Rb survivors that are at risk to develop Rb themselves (so called 'Rb risk carriers') will be screened according to the Dutch Rb Screening Protocol. The medical treatment and follow-up of Rb patients and screening of Rb risk carriers takes place under general anesthesia (GA) up to four or five years of age. At this age the brain is still developing and therefore extra vulnerable to iatrogenic damage, including neuropsychological complications. Immediate effects of the oncological treatment, as well as secondary effects due to multiple GA on cognitive development in Rb survivors is still understudied. Rb survivors report disease-related limitations in daily life and lower health related quality of life (HRQoL), which might be related to impaired cognitive functioning. Apart from possible immediate or secondary treatment effects, children with Rb are known to be experiencing psychosocial struggles, including anxiety and depression, declined participation and/or pediatric trauma, which may negatively affect HRQoL as well. Despite the impact on general wellbeing and HRQoL, the cognitive and emotional aspects of Rb are largely under addressed in pediatric care. It is important to gain insight in the cognitive development and psychosocial functioning from childhood into young adulthood of Rb survivors, as well psychosocial functioning of the parents in order to provide timely interventions, minimizing possible long-term consequences. It is hypothesized that extensive treatment and multiple GA is negatively associated with cognitive functioning, psychosocial functioning and HRQoL in Rb survivors and Rb risk carriers. Moreover, that psychological struggles and/or trauma strengthen these associations.

Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors

Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors (8-35 Years): The Role of Cancer Treatment and Repeated Anesthesia

Datasets and statistical codes of the study will be made available upon request to the international science and rehabilitation community

General cognitive functioning, psychosocial functioning and health related Quality of life in Rb survivors and Rb risk carriers

Effects of biological and physiological factors on cognitive functioning, psychosocial functioning and health related quality of life in Rb survivors and Rb risk carriers

To assess psychosocial functioning and HRQoL in parents of Rb patients, Rb survivors and Rb risk carriers (0-12 years old).

Mapping neuropsychological profiles in Rb survivors and Rb risk carriers (8-35 years)

Mapping overall psychosocial functioning in Rb survivors, Rb risk carriers (8-35 years and parents)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Longitudinal Identity Study of Childhood Cancer Survivors	NCT03424343	Pediatric Cance...	Questionnaire b... Obtaining infor...	14 Years - 25 Years	KU Leuven
Psychosocial eHealth in Advanced Lung Cancer	NCT05497973	Lung Cancer, No... Lung Cancer Non... Lung Cancer Non... Lung Cancer Sta... Lung Cancer	E-health ecosys... Usual psychosoc...	18 Years - 80 Years	Institut Català d'Oncologia
Music of Choice to Decrease Anxiety During Radiation Treatment	NCT03527225	Anxiety Cancer	Music	18 Years -	University of Florida
Longitudinal Identity Study of Childhood Cancer Survivors	NCT03424343	Pediatric Cance...	Questionnaire b... Obtaining infor...	14 Years - 25 Years	KU Leuven
Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors	NCT06227962	Retinoblastoma Neurocognitive ... Health-Related ...	Neuropsychologi... Psychosocial fu... Parental psycho...	6 Months - 35 Years	Amsterdam UMC, location VUmc
Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors	NCT06227962	Retinoblastoma Neurocognitive ... Health-Related ...	Neuropsychologi... Psychosocial fu... Parental psycho...	6 Months - 35 Years	Amsterdam UMC, location VUmc

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