Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

All Drugs and Chemicals

Immunomodulating Agents

This arm will continue standard procedure regarding side effect registration and handling

This arm will be assigned to intervention by weekly electronic reporting of side effects and quality of life. A specifically developed alert-algorithm will in real-time guide both patient and alert clinical staff if symptoms are increasing or quality of life is deteriorating.

Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.

Electronic patient-reported outcomes

Gry Assam Taarnhøj, MD

Electronic reporting of patient-reported outcomes with alert algorithm will be tested in a randomized trial in bladder cancer patients undergoing chemo- or immunotherapy. The clinical endpoints will be:

* Quality of life
* Completion of treatment
* Hospital admission
* Dose reductions
* Survival

Bladder cancer is in Europe the 4th most incident cancer among men and the 7th most frequent cause of cancer death. Many patients will receive chemo- or immunotherapy in either the neoadjuvant setting or for recurrent or metastatic disease. The registration and handling of side effect is crucial in bladder cancer treatment, since the missing identification and insufficient treatment of such can lead to incomplete treatment and thereby decreased effect. It is therefore of utmost importance to develop new tools which can increase identification of the side effects and improve treatment to secure the best life expectancies for these patients.

This study will in a randomized trial using PRO-CTCAE™ questions, EORTC QLQ-C30 + QLQ-BLM30 in one arm versus standard procedure regarding side effect registration and handling in the other arm, test the effect of electronic reporting of side-effects and quality of life with a specifically developed alert-algorithm. Both study arms will include chemotherapy and immunotherapy patients as standard therapy.

Patient-reported Outcomes in Bladder Cancer

Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study

Registration of whether patients complete the planned treatment and if not if the cessation was preventable.

Registration of whether patients by closer contact to clinic between visits can decrease the rate of hospital admissions for preventable causes during treatment.

Registration of differences in quality of life between the two arms in the study. EORTC QLQ-C30(scale range 0-100, a higher score indicating better quality of life) and QLQ-BLM30(scale range 0-100, a higher score indicating increase in symptom burden) will be used for as quality of life measurement. The scores will be presented graphically in separate figures. The EORTC QLQ-BLM30 cannot be applied without the QLQ-C30, hence the aggregation of measures in the present outcome measure category.

Differences between the two arms will be tested using t-test and analysis of covariance (ANCOVA).

Differences in median overall survival and analysis of survival differences between the intervention-arm and the standard of care arm. The analysis will be carried out with log-rank analysis and Kaplan-Meier curves. The analysis will be carried out separately for chemotherapy and immunotherapy recipients.

Registration of differences in number of dose reductions of chemotherapy between the two arm in the study.

Herlev Hospital

Danish Cancer Society

Aalborg University Hospital

Odense University Hospital

Rigshospitalet, Denmark

Clinical Oncologist, Consultant, DMSc

Behaviors and Mental Disorders

Head and Neck Neoplasms

Quality of Life

First phase. 97 participants. This group will continue standard procedure regarding side effect registration and handling. When the 97 patients have been included and have finished their radiotherapy the second phase will be initiated.

Second phase. 194 participants. This group will be assigned to the intervention which is weekly electronic Patient-Reported Outcomes. Patients report the symptoms (PRO) on a tablet before each weekly control visit. The clinician will use the patients PRO answers as part of the consultation. The PRO symptoms consist of head and neck relevant items fra PRO-CTCAE™ (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) and EORTC (European Organisation for Research and Treatment of Cancer) item library.

Weekly reporting of patient-reported outcomes on a tablet for closer contact between patient and clinic during radiotherapy.

Electronic Patient-Reported Outcome

Cecilie Holländer-Mieritz, MD

Helle Pappot, MD, DMSc

Maria Andersen, MD

Elo Andersen, MD

Claus A. Kristensen, MD, PhD

Jørgen Johansen, MD, PhD

Hanne Primdahl

Cecilie Holländer-Mieirtz, MD

Weekly electronic reporting of patient-reported outcomes will be tested in a national trial in participants undergoing radiotherapy for head and neck cancer.

The study is a national study under the Danish Head and Neck Cancer Group (DAHANCA) and all 6 centers in Denmark will participate.

The clinical endpoints will be:

* Quality of life
* Objective toxicity score (DAHANCA)
* Opioid treatment
* Tube feeding
* Weight loss
* Hospitalization
* Compliance to treatment

There is a high level of evidence for improved disease control in head and neck cancer (HNC) using regimens with accelerated radiotherapy and concomitant chemotherapy. These intense regimens can result in severe acute and late side effect. The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). In Denmark, the Danish Head and Neck Cancer Group (DAHANCA) toxicity score has been used as an instrument in assessing objective treatment induced toxicity. New research in other cancer treatments indicate, that systematic patient assessment of side effects may improve treatment outcome. Patient Reported Outcomes (PROs) can be used for symptom monitoring. Interactive use of PRO may secure early recognition of specific symptoms in the individual patient and timely management of side effects.

This trial it is a prospective nationwide, single armed sequential cohort study will investigate the effects of active use of PROs in clinical counselling and decision making during primary or post-operative curative radiotherapy for squamous-cell carcinoma of the head and neck (HNSCC). It will investigate quality of life and the management of side effects in standard clinical counselling (control group) versus standard clinical counselling plus the PRO (PRO group). The EORTC QLQ-C30 (quality of life questionnaire) and EQ-D5-L5 will be answered in both groups. In the PRO group the participants will be asked to complete the electronic PRO (PRO CTCAE™ HNC relevant items supplemented by HNC specific items fra the EORTC library) weekly. The electronic PRO questionnaire is designed to give feedback to treating physician and nurses at visits during and shortly after radiotherapy.

A prospective nation-wide, sequential cohort study.

* First phase control group. 97 participants. No Intervention: Standard of care.This arm will continue standard procedure regarding side effect registration and handling.
* Second phase. PRO group. 194 participants. Intervention: Active use of electronic patient-reported outcomes.This arm will be assigned to intervention by weekly electronic reporting of side effects and quality of life.

Patient-Reported Outcomes in Head and Neck Cancer

Management of Side Effects in Head and Neck Cancer by Systematic Use of PRO During Radiotherapy- The National DAHANCA PRO Study

Registration of differences in quality of life between the two groups in the study. EORTC QLQ-C30(scale range 0-100, a higher score indicating better quality of life) will be used for as quality of life measurement. The scores will be presented graphically in separate figures. Differences between the groups will be tested using t-test and analysis of covariance.

EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention. The scores will be presented graphically in separate figures. Differences between the groups will be tested using t-test and analysis of covariance.

DAHANCA toxicity score is an objective grading of the patients symptoms by the clinician. Scale 0-4, where 0 is no/nothing and 4 is severe. Registration of differences in DAHANCA toxicity score and electronic PRO

Registration of differences in weight loss in the two groups.

Number of hospitalizations reported in the medical record at the control visit 2 months after end af radiotherapy

Number of participants completing planned Cisplatinum

Registration of differences in time to opioid treatment in the two groups

Registration of differences in time to Time to tube-feeding/other feeding in the two groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Patient-reported Outcomes in Bladder Cancer	NCT03584659	Bladder Cancer Urothelial Carc...	Electronic pati...	18 Years -	Rigshospitalet, Denmark
Patient-Reported Outcomes in Head and Neck Cancer	NCT03918382	Head and Neck C... Radiotherapy Si...	Electronic Pati...	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for electronic reporting of symptoms