Ear, Nose, and Throat Diseases

Nervous System Diseases

Symptoms and General Pathology

All Conditions

Substance Related Disorders

Wounds and Injuries

Hearing Loss

Deafness

Ototoxicity

Hearing Disorders

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Neurologic Manifestations

Participants make an appointment at a hearing aid shop in Switzerland. They get the results right after the hearing test and may take it to their respective physician if wanted.

Participants visit a local hearing aid shop to assess their hearing function

Hearing test

Claudia Kuehni, MD

The HEAR-study pilots and evaluates a national, low-threshold screening program to detect hearing problems in Swiss adult childhood cancer survivors.

Participants will conduct a hearing test in a local hearing aid shop and report about their experiences at the shop in questionnaires and interviews. The screening program will be evaluated using the RE-AIM framework.

Hearing loss is an adverse event in childhood cancer survivors (CCS). It is caused by ototoxic cancer treatments, in particular platinum chemotherapy, cranial radiation with doses of ≥30 Gray, and surgery involving the auditory system.

Undetected hearing loss, even if mild, can have a strong impact on life. It affects language acquisition in infants, school performance and communication, thus interfering with survivors' professional life, social integration, and quality of life. Although hearing loss is irreversible in most CCS, it can be treated with speech therapy or hearing aids; therefore, early detection is important. Unfortunately, one third of CCS in Switzerland with ototoxic treatment did not get auditory follow-up screening after completion of acute cancer treatment.

CCS in follow-up care are often discharged to primary care, particularly for late effects that are not life threatening such as hearing loss. Multidisciplinary follow-up clinics for adult CCS were recently initiated in Switzerland. These provide risk-adapted individual examinations and counseling for CCS by organizing several medical examinations within one or two days, but capacity is limited. Additionally, extended visits in large hospitals are costly for the healthcare system and time-consuming for CCS. Low-threshold screening programs that are easily accessible and less time-consuming might therefore be a valuable addition to improve screening for hearing loss among CCS.

The main rationale for this study is to test a novel community-based, low-threshold screening approach for hearing loss in CCS in Switzerland. The screening program is tested and evaluated using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework for assessing health interventions including reach, effectiveness, adoption, implementation and maintenance (see outcome measures). The second aim is to use the data obtained to close knowledge gaps on risk factors of ototoxicity after childhood cancer. This will eventually lead to improved care and higher quality of life for affected CCS.

All participants undergo a hearing test (intervention).

Screening for Hearing Loss After Childhood Cancer

Improving Access to Screening for Hearing Loss After Childhood Cancer - a Novel Community-based Approach

Reach measures to which extent the target population participates in the program by assessing representativeness and participant population coverage.

Number of written informed consents is counted and divided by the number of people invited to get the response rate.

Number of participants that conducted hearing test is counted and divided by the number of people that consented to participate in the screening program.

Characteristics of responders (signed informed consent) are compared to those of non-responders. Data from the childhood cancer registry on age at study, age at diagnosis, diagnosis, treatment regimens and urbanicity are extracted and compared by using cross-field tabulations and chi-square tests for categorical variables and independent sample t-tests and analysis of variance for continuous variables.

This comparison gives information on the representativeness of the study population.

Motives for participation are assessed through interviews with study participants after the hearing test. They are asked why they participated.

Effectiveness focuses on evaluating immediate and long-term impacts (positive and negative) of the intervention. It examines whether the intervention achieves its objectives (i.e., detecting hearing loss) and what other impacts it might have (e.g. mental health).

Participants fill out two follow-up questionnaires 4 weeks after the hearing test and 6 months after the hearing test. In the first follow-up questionnaire, participants are asked what the result of the hearing test was. This data is compared to a baseline data that is collected through a questionnaire before the hearing test. Numbers of hearing impaired persons at baseline and at follow up are then compared.

In the second follow-up questionnaire, participants are asked, if they consulted a physician after receiving their hearing test result and if they have done something about their hearing impairment (if present). These numbers give information on the impact of the screening program on the population (e.g. new hearing aids).

In the interviews with study participants after the hearing test, they are asked how they felt before, during and after the hearing test and if something changed in their lifes since they got their hearing test results.

Emerging topics are collected, analysed and integrated in the second follow-up questionnaire to get more information from more participants.

Adoption assesses how the program is adopted by target settings (i.e., hearing aid shops, health care professionals), assessing stakeholder's willingness/readiness to adopt and implement the intervention.

In interviews with study participants, they are asked about their experiences with the screening program, how it compared to existing follow-up care programs, its advantages and disadvantages and their overall opinions on the program.

To get insight from all stakeholders involved, acousticians from the hearing aid shops and health care professionals from the fields of pediatric oncology, follow-up care and/or audiology are also interrogated.

Acousticians and health care professionals are asked for their opinions on the program and suggestions for improvement. Further, they are asked for challenges or difficulties they encountered or anticipated.

To get insight on how the program was used by the study population, observational data from the hearing aid provider are collected to see where the participants visited the hearing aid shops.

Implementation evaluates the feasibility of implementing the intervention within real-world contexts, assessing the extent to which the intervention is delivered consistently and as intended. It also includes required resources.

In the interviews with acousticians, they are asked about their experiences with study participants during the hearing test. They are asked if study participants differ from usual customers and in what way and if they treated them differently than usual customers (i.e. find out if they changed protocol in some way).

Further, they are asked if they reached capacity limits in their respective hearing aid shops and if they needed additional resources (than usual).

These interviews inform the design of a questionnaire to all acousticians that performed hearing tests on a study participant to get more information from more persons.

Costs for implementation are calculated based on empirical values and data from the hearing aid shops: Work time, infrastructure, skills, expertises.

Maintenance investigates the possibility of continuing the program beyond the research project, considering its long-term sustainability.

Assessed through interviews with and questionnaires to participants and stakeholders:

* Opinions of stakeholders and participants on the continuation of the screening program
* Identification of necessary requirements and resources for the program's future continuation
* Potential integration of the program into the existing follow-up care programs for childhood cancer survivors

Audiograms of adult CCS in Switzerland are collected from the hearing tests. The hearing function is then assessed using the International Society of Paediatric Oncology (SIOP) Boston Ototoxicity Scale for grading hearing loss.

Data from the childhood cancer registry on age at study, age at diagnosis, diagnosis, treatment regimens as well as from questionnaires (environmental risk factors) are extracted and used to identify risk factors associated with hearing loss.

Risk factors are identified by calculating Odds Ratios using univariable and multivariable logistic regression.

Krebsforschung Schweiz, Bern, Switzerland

University of Bern

Behaviors and Mental Disorders

Hearing Loss, Sensorineural

Tinnitus

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Quality of Life

People living with and beyond who experience ototoxicity as a result of chemotherapy

High frequency audiometry

Questionnaire on quality of life (Short Form 36 Item- SF-36)

Short-Form 36-Item Questionnaire (SF-36)

Questionnaire on Hearing loss (Hearing handicap inventory for adults/elderly- HHIA/HHIE)

Hearing handicap inventory for adults/elderly (HHIA/HHIE)

Questionnaire on Tinnitus (Tinnitus Handicap Inventory)

Tinnitus handicap inventory (THI)

David Baguley, PhD

This project aims to explore, in depth, the burden of hearing loss and tinnitus on cancer survivors. Using semi-structured interviews, audiograms and a variety of validated questionnaires, the specific impact ototoxicity has on quality of life will be investigated.

From this, we can identify the specific needs of patients experiencing hearing loss and tinnitus following chemotherapy and develop a tailored and personalised support system.

The medical and technological advances in cancer research have caused a decline in cancer deaths in recent decades. For example, the 5-year survival rate now is above 80% for many adult cancers, including breast and testicular cancers. In breast cancer alone, the mortality rate has reduced 39% since 1989 and currently has a 5 year survival rate over 90%. Due to this increase in survival rates and the intensity of treatment, many face long-term physical and psychological challenges in survivorship. Cancer survivors may experience altered body image and changes in sexual health and energy levels in addition to distress, anxiety, the fear of recurrence and the chronic side effects of their treatment. The need to research the long-term effects of chemotherapy and the impact they have on quality of life is crucial.

There is a need to broaden research beyond the survival rates and address the need for support for those who are adapting to a life after cancer. Survivors are left with often permanent and possible life-debilitating effects from treatment. To date, there has been little research on the specific late effects of chemotherapy and the associated impact on quality of life.

Platinum-based chemotherapy, although highly effective, is known to cause ototoxicity, presenting often as permanent high frequency hearing loss and tinnitus. Hearing loss and tinnitus are associated with a higher risk of depression, social isolation and anxiety. The quality of social interactions for a person with hearing loss and tinnitus is diminished as taking part in conversations becomes challenging. This is particularly problematic as it means that the quality of life of these cancer survivors is reduced.

The impact hearing loss and tinnitus has on quality of life in cancer survivors remains unclear and under-studied. Because cancer therapies can potentially cause life-threatening side effects such as cardiotoxicity and nephrotoxicity, these become the priority. However, once these side acute effects subside, other long-term side effects remain and can permanently reduce quality of life. Cancer survivors may have already experienced a difficult journey from the diagnosis itself, the physical challenges of treatment and finally, remission. Re-adapting back to their previous life whilst in remission, but with added permanent side effects, both physically and psychologically, can be extremely difficult for some survivors.

Currently, there is little information and support offered to these patients who suffer from ototoxicity, potentially leading to many being undiagnosed and untreated. These patients can be affected by this toxicity for the rest of their lives, which can have a detrimental impact on their quality of life. It is essential that a deeper understanding and increased awareness of how hearing loss and tinnitus affects the quality of life of cancer survivors is sought to improve long-term symptoms management and support offered. This study aims to develop this and improve the support given to cancer survivors.

Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors

Long-term Ototoxicity in Cancer Survivors Treated With Chemotherapy and the Impact on Quality of Life

Data will be anonymised and made confidential, statistical analysis will be performed before data is shared.

Questionnaire on quality of life, scale between 0-100 with 0 being bad quality of life and 100 being good

Questionnaire on hearing loss scale from 0-100, 0 being no handicap and 100 being a big handicap

Questionnaire on Tinnitus from 0-100, 0 being no handicap and 100 being a bit handicap

National Institute for Health Research, United Kingdom

International Stem Cell Forum

University of Nottingham

Neoplasms

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Breast Neoplasms

Pain

Shoulder Pain

Breast Diseases

Skin Diseases

Arthralgia

Joint Diseases

Participants randomised to the Intervention group will be referred to an expert assessment of their shoulder impairments at the Shoulder Sector, Vejle Hospital - Orthopaedic Department. The expert assessment will be performed by experienced specialists (e.g. physician and physiotherapist) who are specialised in shoulder diagnostics using x-ray, ultrasound, anamnesis/history and standard clinical tests such as Neers, Hawkins, Jobe´s Empty Can, Painful Arc and Resisted External Rotation. The participant's diagnosis based on the history, symptoms and clinical findings will be used to guide the individualised treatment plan. The individualised treatment plan will typically contain a referral to physiotherapeutic treatment at the municipality or private practice, receive specialised physiotherapeutic rehabilitation at Vejle Hospital, get an ultrasound guided corticosteroid injection in the shoulder or offer surgery.

Participants randomised to the Control comparator group will receive a pamphlet from the secretary and perform the exercises at home. This pamphlet contains a program with minimal exercise recommendations for the shoulder consisting of mobility, stretching, strength exercises and tissue treatment. The purpose is to stimulate circulation, improve shoulder function (mobility), increase muscle strength and reduce shoulder pain. The program consists of three warm-up exercises (arm swing, shoulder rolling and scapula-back pocket exercise) followed by three stretching exercises for the breast and shoulder area. Furthermore the pamphlet includes a tissue treatment and four strength exercises for the shoulder (external rotation, extension and flexion of the shoulder and diagonal pull apart). Mobility (with 5-10 repetitions), stretching exercises (in 30 seconds) and tissue treatments will be performed twice a day, while the strength exercises will be performed once a day with 3x12 repetitions.

The participant's diagnosis based on the history, symptoms and clinical findings will be used to guide the individualised treatment plan.

The expert assessment of shoulder impairments and individualised treatment plan

This pamphlet contains a program with minimal exercise recommendations for the shoulder consisting of mobility, stretching, strength exercises and tissue treatment.

A minimal physiotherapeutic rehabilitation program delivered in a pamphlet

Kim Gordon Ingwersen, PT, PhD

In breast cancer patients late-term upper limb sequelae, such as shoulder pain and impaired shoulder function remain common after primary breast cancer surgery. The aim of this trial is to evaluate whether an expert assessment of shoulder impairments, followed by an individualised treatment plan, is superior to a minimal physiotherapeutic rehabilitation program in reducing shoulder symptoms, assessed 12 weeks after initiation of treatment, among women with late-term shoulder impairments after primary breast cancer surgery.

Worldwide, breast cancer is the second most common cancer. Internationally, an age-standardised incidence rate between 83.1 and 111.9 per 100.000 women is seen, with Denmark taking an unfortunate second place. Standard surgical treatment in Denmark is breast-conserving surgery (BCS) or mastectomy in combination with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND). In part due to early diagnosis and optimised treatment methods, 5-year survival has improved to a current 87%. Despite fewer mastectomies and more BCS, less invasive surgical procedures of the axilla (e.g. fewer ALND vs. SLND), and more refined radiotherapy procedures, late-term upper limb impairment still remains common. The most frequent are lymphoedema, sensory disturbances, pain and impaired shoulder function, with up to 70% of patients reporting at least one of these symptoms three years after surgery. These impairments lead to difficulties in activities of daily living, increased risk of depression and anxiety and decreased quality of life (QoL).

Previous research has primarily focused on prevention and treatment of lymphedema, and less on other upper limb impairments. Pre- and early postoperative physiotherapeutic interventions are known to be effective in reducing shoulder pain and improving shoulder function after breast cancer treatment. Nonetheless, late-term upper limb impairments need further focus with prevalence´s of up to 50% is reported for impaired shoulder function and pain up to 6 years after surgery, and a substantial knowledge gap exists as to how to help these women. Currently, no standardised evaluation of their impairments or treatment is offered, and it is therefore up to the individual woman to seek care, resulting in large variations in rehabilitation. Thus a substantial knowledge gap exists in how to meet the rehabilitation needs of these women and evaluation of the actual burden of late-term shoulder impairments after primary treatment for breast cancer and the effect of different treatment strategies is warranted.

The primary aim of this study is to investigate whether the effect of a patient-centred specialised intervention, consisting of an expert assessment followed by an individualised treatment plan (i.e. Intervention group), is superior to a minimal physiotherapeutic rehabilitation program delivered in a pamphlet (i.e. Control comparator group) among women with late-term shoulder impairments 3-7 years after their primary breast cancer surgery. The hypothesis is that women randomised to the Intervention Group will improve significantly more in shoulder function and pain 12 weeks after initiating the treatment than those randomised to the Control comparator group.

This trial is a stratified (by type of surgery and radiotherapy), block randomised (1:1 allocation), controlled, parallel group and assessor blinded superiority trial conducted in Denmark. 130 participants with late-term shoulder impairments 3-7 years after primary surgery for breast cancer will be recruited.

An Individualised Treatment vs. a Minimal Program in Women With Late-term Shoulder Impairments After Breast Cancer.

Effectiveness of an Expert Assessment and Individualised Treatment in Comparison to a Minimal Home-based Exercise Program in Women With Late-term Shoulder Impairments After Primary Breast Cancer Surgery.

Personal data for the primary and all secondary outcome measures will only be made available if required by the scientific journal, in which the result of the trial are published.

Pain medication consumption in the past week due to shoulder related pain including questions about yes/no, type (prescription or nonprescription medicine) and frequency will be collected by using a patient-reported questionnaire.

PHQ-9 is a 9-item patient-reported outcome measure to assess depression within the last 2 weeks. The total score ranges from 0 to 27; 5-9 = minimal symptoms, 10-14 = minor/mild depression, 15-19 = major depression, moderately severe, \>20 = major depression, severe. The higher the score, patients report severe depression and reduction in the PHQ-9 score will suggest improvement. PHQ-9 is a reliable and valid measure of depression in cancer patients and the general population and can measure changes over time.

GAD-7 is a 7-item patient-reported outcome measure to assess anxiety within the last 2 weeks. The total score ranges from 0 to 21; 0-4 = minimal anxiety symptoms, 5-9 = mild anxiety symptoms, 10-14 = moderate anxiety symptoms, \>15 severe levels of anxiety symptoms. The higher the score, patients report severe anxiety and reduction in the GAD-7 score will suggest improvement. GAD-7 is a reliable and valid measure of anxiety in cancer patients and the general population.

SPADI is a 13-item patient-reported outcome measure to assess shoulder pain (5 items) and shoulder function (8 items) within the last week. The items are scored on a numeric rating scale that ranges from 0 (no pain/no difficulty) to 10 (worst pain/so difficult that required help). Each domain score is equally weighted and added to a total percentage score that ranges from 0 (best) to 100 (worst). The higher the score, patients reported shoulder impairments. The region specific questionnaire can be used in patients with different or unspecified shoulder diagnoses. SPADI is valid, reliable and responsible measure among patients with shoulder impairments.

Change in SPADI pain will be reported as a separate subscale. The 5-item pain subscale are scored on a numeric rating scale that ranges from 0 (no pain) to 10 (worst pain). The higher the score, patients report greater shoulder pain and reduction in the SPADI pain score will suggest improvement.

Change in SPADI function will be reported as a separate subscale. A 6-item version (exclusion of question three and seven) of the disability subscale exhibited adequate fit in the Danish version. The 6-item disability subscale are scored on a numeric rating scale that ranges from 0 (no difficulty) to 10 (so difficult that required help). The higher the score, patients report greater shoulder disabilities and reduction in the SPADI function score will suggest improvement.

Response to treatment will be computed for the SPADI change score for each woman in both treatment groups and presented dichotomised (i.e. responder and non-responder) as number (and percentages) responders. Women will be classified as an responder if the SPADI change score improves by 8 points or more (≥), corresponding to the minimal clinically important difference on SPADI from baseline to 12 weeks follow-up.

The GPE will evaluate the impression of the treatment's success including overall shoulder problems on a 7-point Likert scale ranging from "markedly worse" to "markedly improved".

A smartphone inclinometer (GetMyROM) will be used to assess A-ROM in flexion, internal rotation, external rotation and abduction respectively the operated side. After one test trial, the mean value of three measurements will be taken for both flexion, rotation and abduction respectively the operated side.

A smartphone inclinometer (GetMyROM) will be used to assess P-ROM in flexion, internal rotation, external rotation and abduction respectively the operated side. After one test trial, the mean value of three measurements will be taken for both flexion, rotation and abduction respectively the operated side.

Number of visits to a healthcare professional (e.g. physician, chiropractor or physiotherapist) at hospital, municipality rehabilitation or private practice due to the shoulder symptoms during the intervention period, will be collected by using a patient-reported questionnaire.

The NRS pain scale is a single 11-item patient reported outcome measure used to assess the maximum shoulder pain intensity. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain intensity and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.

The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain during general activities. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.

The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain at rest. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.

The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain during sleep. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.

The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain during flexion/rotation/abduction. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.

Open Patient data Explorative Network

Vejle Hospital

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Participants will receive a direct link to access the SHUTi program (per randomization) from the study team.

Participants will receive a direct link to access online patient education (per randomization) from the study team.

SHUTi is a fully automated, interactive and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is presented in six "Cores," metered out over time.

Sleep Healthy Using the Internet (SHUTi) Intervention Group

The online PE program provides static information about: insomnia symptoms; the impact, prevalence, and causes of insomnia; when to see a doctor; and basic lifestyle, environmental, and behavioral strategies to improve sleep.

Online Patient Education (PE) Control Group

Tara Brinkman, PhD

There is evidence that survivors of childhood cancer have a high prevalence of poor sleep, including symptoms of insomnia. Insomnia is highly comorbid and has been associated with impaired cognitive performance, a range of psychiatric disorders, cardiovascular disease, and reduced quality of life. However, we still lack knowledge about the direct impact of available internet-based insomnia treatment programs for survivors of childhood cancer experiencing insomnia, in addition to how improving insomnia symptoms impacts neurocognitive function and late health morbidities in this population. Therefore, in this study, we will utilize the resources available in the Childhood Cancer Survivor Study (CCSS) to use an accepted, established, efficacious internet-delivered CBTi insomnia treatment program and evaluate the efficacy of this program in adult survivors of childhood cancer. Positive results from this study and our use of an internet-based intervention are likely generalizable and be scalable to the large and geographically diverse population of childhood cancer survivors with chronic health conditions.

Primary Objective

To examine the efficacy of an eHealth intervention for improving symptoms of insomnia among adult survivors of childhood cancer.

Secondary Objectives

To examine the impact of an eHealth intervention for insomnia on the clinical severity of insomnia symptoms in adult survivors of childhood cancer.

To determine whether treatment of insomnia symptoms will improve neurocognitive function in adult survivors of childhood cancer with both insomnia and neurocognitive impairment.

To explore the mediating effects of improved neurocognitive function, emotional distress, and cardiovascular health on the association between insomnia symptoms and quality of life.

Participants with clinically significant insomnia and neurocognitive impairment are eligible for the current study. Participants will complete a 9-week internet-based insomnia treatment program (SHUTi) or receive sleep education, depending on randomized group assignment. Participants will complete home-based assessments at 3 time points (baseline, post-intervention, 6 months). These assessments will include online questionnaires measuring insomnia symptoms, neurocognitive problems, fatigue, daytime sleepiness, and health related quality of life. In addition, at each time point participants will be asked to wear an activity monitor for one week to measure physical activity and sleep patterns. Each assessment time point will also include a home visit from Examination Management Services Inc (EMSI) to measure blood pressure, heart rate, cardiovascular biomarkers, and neurocognitive function.

eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer

eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer: A Randomized Clinical Trial

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request

This is a 7-item, Likert scale, self-report questionnaire assessing perception of sleep and consequences of insomnia. The scores range from 0 to 28 with higher values indicating increasing symptom burden.

The CCSS-NCQ was developed specifically to address neurocognitive concerns of adult survivors of childhood cancer and includes assessment of problems with memory, task efficiency, organization, and emotional regulation. T-scores are calculated using sibling normative data (Mean= 50, SD=10) with higher scores indicating worse problems.

This is a computerized assessment that measures 3 domains of cognitive function; Executive Function, Processing Speed and Working Memory. Age, sex, and race specific T-Scores (M=50, SD=10) are calculated. Higher scores indicate better functioning.

An online diary and will be included in the SHUTi program (including the patient education arm). The sleep dairy will assess daily sleep behaviors (e.g. time in bed, sleep onset latency, nighttime awakenings, sleep quality).

This questionnaire measures symptoms of depression. Scores range from 0 to 27 with higher scores indicating more severe symptoms.

This questionnaire measures symptoms of anxiety with scores ranging from 0 to 21. Higher scores indicate greater symptoms of anxiety.

This questionnaire measures general health-related quality of life. T-scores are calculated (M=50, SD=10) with higher scores indicated better quality of life.

National Cancer Institute (NCI)

St. Jude Children's Research Hospital

Physical examination, diagnostic tests depending on examined organ system (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels).

Physical examination, diagnostic tests, laboratory tests

Personal history and focused questionnaires per organ system including symptoms, medication use, physical activity, and general wellbeing.

Personal history, questionnaire

Claudia E Kuehni, MD

Maria Otth, MD

Nicolas X von der Weid, MD

Jochen Rössler, MD

Marc Ansari, MD

The SCCSS-FollowUp is a national, multicenter cohort study designed to investigate late effects in childhood cancer survivors in a prospective and longitudinal way. The study is embedded in regular follow-up care and inclusion in the study takes place in a step-wise approach. The investigators collect data from clinical examinations, laboratory and functional tests, and questionnaires to learn more about late effects of childhood cancer treatments.

Background: Survival after childhood cancer has increased substantially over the last decades. In Switzerland, 10-year survival now exceeds 85%. This results in increasing numbers of childhood cancer survivors - estimated 6,600 survivors currently in Switzerland. Due to the cancer treatment or the cancer itself, a large part of the childhood cancer survivors suffer from late effects. As survivors of childhood cancer have decades of life ahead, it is of special interest to minimize potentially avoidable chronic diseases, impaired quality of life, deaths, and health care costs. There is a need to assess clinical data prospectively in a standardized way across clinics to study late effects on a national level. Such data are currently not available in Switzerland and the SCCSS-FollowUp aims to fill this gap.

Objectives: The SCCSS-FollowUp assesses the prevalence of late effects through risk-adapted medical examinations (in accordance with international guidelines and evidence), identifies CCS with asymptomatic late effects through functional testing, e.g. echocardiography or lung function testing, standardizes clinical follow-up examinations in CCS in Switzerland, and collects follow-up data in a longitudinal way. The SCCSS-FollowUp also investigates sociodemographic, treatment, lifestyle, and clinical risk factors for late effect development.

Methods: The SCCSS-FollowUp recruits eligible childhood cancer survivors in a stepwise approach by identifying CCS at risk because of specific treatment modalities (e.g. exposure to anthracyclines or thoracic irradiation). The investigators ask eligible survivors for participation. Those who consent receive before or during the next follow-up visits focused questionnaires. The questionnaires are short and focus on one organ system, but participants can receive different questionnaires at subsequent visits. The data generated during the follow-up visits, such as clinical examination, functional and laboratory test results, and the completed questionnaires are entered in the SCCSS-FollowUp database. The examinations and tests are performed in a standardized way in all participating clinics and according to follow-up guidelines or other evidence-based literature.

Rationale and significance:

The data collected within the SCCSS-FollowUp allow research on late effects on a national level and based on objective clinical data obtained during routine care. The SCCSS-FollowUp helps to learn more about late effects, especially subclinical damage, which are not detectable by questionnaire only. Early detection of these late effects and timely treatment can prevent and mitigate further deterioration. Furthermore, the SCCSS-FollowUp helps to assess risk factors for late effects development which can be used to amend cancer treatment in future patients. The SCCSS-FollowUp thus helps to improve the health of current and future childhood cancer survivors.

The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)

Number of people with cough or shortness of breath when at risk for pulmonary late effects

Number of people with signs of disturbed breathing or abnormal breathing sounds when at risk for pulmonary late effects

Number of people with abnormal pulmonary function testing (e.g. spirometry, body plethysmography) when at risk for pulmonary late effects

Cumulative dose of chemotherapeutic agents or radiotherapy, exposure to surgery and hematopoietic stem cell transplantation for each participant (not exhaustive)

Collection of information on age at diagnosis, time since diagnosis, and gender for each participant (not exhaustive)

Collection of information on smoking status, physical activity, and body mass index for each participant (not exhaustive)

Collection of information on arterial hypertension or obesity for each participant (not exhaustive)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Screening for Hearing Loss After Childhood Cancer	NCT06036407	Childhood Cance... Hearing Loss	Hearing test	18 Years -	University of Bern
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors	NCT04281953	Quality of Life Cancer Hearing Loss, S... Tinnitus, Subje... Late Effect	High frequency ... Short-Form 36-I... Hearing handica... Tinnitus handic...	18 Years -	University of Nottingham
An Individualised Treatment vs. a Minimal Program in Women With Late-term Shoulder Impairments After Breast Cancer.	NCT05277909	Shoulder Pain Late Effect Breast Cancer Rehabilitation	The expert asse... A minimal physi...	18 Years - 78 Years	Vejle Hospital
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer	NCT04317742	Childhood Cance... Insomnia Neurocognitive ... Survivorship Late Effect Sleep	Sleep Healthy U... Online Patient ...	18 Years - 65 Years	St. Jude Children's Research Hospital
The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)	NCT04732273	Late Effect Childhood Cance...	Physical examin... Personal histor...	-	University of Bern
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer	NCT04317742	Childhood Cance... Insomnia Neurocognitive ... Survivorship Late Effect Sleep	Sleep Healthy U... Online Patient ...	18 Years - 65 Years	St. Jude Children's Research Hospital
The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)	NCT04732273	Late Effect Childhood Cance...	Physical examin... Personal histor...	-	University of Bern

Spots Global Cancer Trial Database for late effect

Every month we try and update this database with for late effect cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for late effect

Every month we try and update this database with for late effect cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for late effect cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.