Neoplasms

All Conditions

Behaviors and Mental Disorders

Head and Neck Neoplasms

Quality of Life

A cross-sectional study on late effects after modern treatment in long-term survivors of head and neck cancer (HNC). Participants fill in questionnaires and participate at a one day visit at the hospital including blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. Data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans.This will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients.

The purpose of this study is to provide knowledge on late effects and mortality risk after modern treatment in long-term survivors of head and neck cancer (HNC). This will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients. For head and neck cancer (HNC) survivors of today, with the rising proportion of HPV induced cancer and with improved modern treatment, the late effects and mortality risk has changed compared to survivors previous decades.

The investigators will assess the prevalence and severity of a broad range of late effects and identify associated risk factors for the following late effects;

* Chronic fatigue
* Hearing loss and tinnitus
* Oral late effects, including taste and smell disturbances and osteoradionecrosis
* Dysphagia and malnutrition
* Body image, intimacy and endocrine dysfunction

In addition,possible biological explanatory mechanisms for fatigue and possibly other selected late effects will be explored. Data will be compared to age and gender matched reference data for those where this is available.

Design: a cross-sectional study

Assessments: Patient-reported questionnaires, blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. Data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans.

H&N Cancer; Survivorship and Late Effects

Survivorship and Late Effects in Head and Neck Cancer Survivors

Data from 50-100 of the participants will be included in the EORTC 1629 - Late toxicity and long-term quality of life in head and neck cancer survivors

Assess prevalence of fatigue, dysphagia, xerostomia, hearing problems, oral health, body image and intimacy in surivors of head and neck cancer more than 5 years after treatment. Patients filled in a set of patient-reported questionnaires: 1) EORTC core quality of life questionnaire, the EORTC QLQ-C30 version 3, 2) EORTC disease specific module, the EORTC QLQ-H\&N35 3) The Fatigue Questionnaire, 4) The scale for chemotherapy induced neurotoxicity (SCIN), 5) EORTC-QLQ-OH15, 6) Body image scale.

to explore associated risk factors for fatigue, dysphagia, xerostomia, hearing problems, oral health in surivors of head and neck cancer more than 5 years after treatment

University of Oslo

Oslo University Hospital

Senior Oncologist, PhD, Researchgroupleader skin and head and neck cancer, Department of Oncology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Sally Taylor, PhD

Grant Punnett

Development of a patient reported outcome measure (PROM) for ovarian cancer patients receiving combined surgery and radiotherapy

The study will be conducted in four stages:

Stage I - Item generation Approximately 20 interviews will be conducted with ovarian patients receiving combined surgery and chemotherapy to capture their experiences including quality of life, symptom experience, and other relevant themes that may emerge. The interviews will be audio recorded and transcribed verbatim. The qualitative data will be analysed thematically and key quotes extracted which will be used to create a draft item list. Interviews will be conducted either in person or virtually depending on national social distancing guidance at the time. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.

Stage II - Cognitive interviewing Following the initial interviews, approximately 7 participants will undergo cognitive interviews to ensure that all items are clear and easily understood. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.

Stage III - Item reduction and refinement of the draft PROM A draft PROM and the EORTC QLQ-C30 (a validated measure of health related quality of life for cancer patients in clinical trials) will be administered to approximately 100 ovarian cancer participants receiving combined surgery and chemotherapy. Approximately 50 patients will be asked to repeat the draft PROM approximately one week later to assess test-retest reliability. Hierarchical item reduction and Rasch analysis will be used to determine which items should be included in the final PROM.

Stage IV- Pilot testing The final PROM will be pilot tested with approximately 10 patients at The Christie site to assess its acceptability

Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment

Generic cancer quality of life questionnaire

The Christie NHS Foundation Trust

Financial Stress

Initial examination of the developed questionnaire in the first 100 participants to identify problematic questions and to optimise the instrument.

To evaluate test-retest reliability, collected data of the first 100 patients will be used as baseline value and re-assessed in Study 2.

Second examination in 300 additional participants and re-assessment in participants from Study 1 (n=400) to validate modified questionnaire in its final form.

To evaluate test-retest reliability, data of Study 1 is compared against Study 2 of the same participant sample (n=100).

Newly developed patient-reported instrument to measure financial effects of a cancer diagnosis and therapy of cancer patients in Germany

Patient reported outcome measure

Eva C Winkler, Prof. Dr. Dr.

This study aims to develop and to validate a standardised German-language instrument for measuring experienced financial effects of a cancer diagnosis and therapy in a cross-sectional bi-centre study. Obtained data will make the patient-related description of financial difficulties more comprehensible, communicable and addressable in the future, e.g. by offering targeted advisory aids or considering financial effects in health technology assessments.

Methods and analysis:

Phase 1: Construct definition and item generation

Preliminary study:

The preliminary study aims to identify dimensions, topics and risk factors that are relevant for the assessment of financial effects through qualitative interviews with patients, focus group discussions with potential users of a new instrument (social services, HTA-institutions, payers) and a systematic literature review.

Preliminary questionnaire:

In order to derive a pre-final questionnaire, the aim of this part of the study is to define the construct of financial effects and to generate a list of appropriate indicators for measuring financial effects based on the results available from the literature. The pre-final questionnaire will be peer-reviewed by the interdisciplinary project team (oncology/medical ethics, health economics, methods of empirical social research).

Phase 2: Questionnaire Piloting and Validation

Cognitive pre-test:

A cognitive pre-test of the pre-final questionnaire is conducted to examine comprehension of questions and response option and identify any potential problems respondents would have to understand the questions and to respond to them. The results are used in order to further optimize the first draft of the questionnaire.

Quantitative evaluation and validation:

Quantitative evaluation and validation of the developed questionnaire will be performed based on two studies on the target population by determining the distribution parameters of the indicators and their measurement characteristics. In the first study, the pre-final questionnaire will be tested and after adjustment, the final version will be applied in study 2. Participants of the first study (n=100) will be surveyed again within the second study (n=400 participants), while data of the additional participants (n=300) in study 2 will be measured at a single time point.

For validation purposes, additional scales measuring similar and unrelated constructs, as well as criteria (external concepts affected by financial effects) will be included in the questionnaire. Validity will be assessed by subsequent examining of different relationships between the developed instrument and predefined third variables and criteria. Factorial validity will be examined by factor analyses. Furthermore reliability and test-fairness of the instrument will be assessed through further psychometric testing.

Phase 3: Further applicability of the questionnaire To formulate well-founded recommendations for the use of the instrument, a pilot screening program for social services is evaluated through qualitative interviews with representatives of social services and patients regarding practicability of the instrument. A synthesis of all project results will translate into overall recommendations within the clinical and regulatory context.

Financial Effects of a Tumor Disease - Development and Validation of a Patient Reported Outcome Measure in Germany

Financial Effects of a Tumor Disease

Distribution analyses (correspondence to the normal distribution; skew and excess with evidence for possible ceiling and floor effects)

Exploratory Factor Analysis (EFA) will be used to analyse the factorial structure of the instrument to investigate which theoretically defined properties of the construct can adequately covered and differentiated with help of single indicators (items and questions).

Preliminary assessment of reliability with Guttmans-Lambda

Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) will be used.

Correlations between the measurements between the first and second survey will be obtained to evaluate test-retest-reliability.

Test fairness will be evaluated by means of Multi-Group Confirmatory Factor Analysis (MG-CFA).

Chair of Methods in Empirical Social Research, Institute of Sociology, Technische Universität Dresden

Health Economics and Health Care Management, Bielefeld University

Haematology and Oncology, University of Jena

University Hospital Heidelberg

Prof. Dr. Dr.

All Drugs and Chemicals

Immunomodulating Agents

This is an observational study using the Consilium CareTM smartphone ePRO application.

Consilium CareTM

Andreas Trojan, Prof.Dr.med

Panogiotis Samaras, PD. Dr.med.

Panagiotis Samaras, PD.Dr.med

This study is designed as a feasibility study implementing electronic Patient Reported Outcomes (ePRO) in CAR T treatment for hematological malignancies, in order to describe AE reporting. ePRO assessments will be explored for their feasibility to engage in monitoring and management of CAR T-related toxicities as well as using these digital ePRO tools may improve both, its safety and accessibility.

ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy

ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy: Feasibility Study (CARTePRO)

Response time in seconds obtained during trail-making test (ePRO) according to daily administration via consilium careTM app, as a potential indicator for ICANS and other CAR T cell therapy-related adverse events.

Occurrence of CRS-related adverse events (ePRO): fever, myalgia, rigors, fatigue, and loss of appetite

Number and severity of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE) after 12 weeks (ePRO).

CTCAE on a 5 point scale: Grade 1 is mild, grade 2 moderate, grade 3 severe, grade 4 life-threatening, and grade 5 corresponds to death. Grade 3 and higher correspond to the WHO definition of serious adverse drug reaction ("serious ADR").

Occurrence and type of therapy-associated unplanned consultations. Unplanned consultations are defined as additional consultations outside of planned therapy or control visits at the treatment center or with the investigator, as well as unplanned visits to other physicians or emergency services.

Adherence, measured as percentage of days during intervention with electronically captured consilium careTM app usage

Well-being according to the ECOG Performance Status as daily ePRO before and after CAR T cell reinfusion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
H&N Cancer; Survivorship and Late Effects	NCT04758026	Head and Neck N... Survivorship		18 Years -	Oslo University Hospital
Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment	NCT05274867	Ovarian Cancer Surgery Chemotherapy Patient Reporte...		18 Years -	The Christie NHS Foundation Trust
Financial Effects of a Tumor Disease - Development and Validation of a Patient Reported Outcome Measure in Germany	NCT05319925	Cancer	Patient reporte...	18 Years -	University Hospital Heidelberg
Development of a Patient Reported Outcome Measure for Advanced Ovarian Cancer Patients Receiving Surgical and Chemotherapy Treatment	NCT05274867	Ovarian Cancer Surgery Chemotherapy Patient Reporte...		18 Years -	The Christie NHS Foundation Trust
ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy	NCT05354973	Patient Reporte... CAR T-Cell Ther...	Consilium CareT...	18 Years -	Stiftung Swiss Tumor Institute
ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy	NCT05354973	Patient Reporte... CAR T-Cell Ther...	Consilium CareT...	18 Years -	Stiftung Swiss Tumor Institute

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