Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

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

The study is designed as an observational cohort study, aiming to evaluate, whether a structured recording of symptoms by a mobile app contributes insight in the follow-up modalities of ovarian cancer patients.

Mobile app ovarian cancer followup (ePRO)

Pius Wyss, Prof.Dr.med

The observational study will examine different follow-up modalities for ovarian cancer patients with the ultimate goal of improving follow-up strategies for an improved well-being and better clinical outcomes. The primary objective is to quantify the effects of conservative clinical diagnostics by collecting symptoms via ePRO in addition to intensive diagnostics (CA-125 testing, imaging diagnostics) during follow-up, on survival, time to clinical recurrence and well-being.

The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer

The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer: A Multicenter Observational Cohort Study

Overall survival three years after the end of primary therapy / start of follow-up

Total number of tumor relapses occurring in the follow-up period

Well-being according to the ECOG Performance Status

GRADE ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
5. Dead

Amount and frequency of patient data entries

Platinum-sensitivity and the patients' platinum free interval (PFI)

Unplanned hospitalizations and emergencies 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 (e.g., GP) or emergency services.

Symptoms that led to further diagnostic measures (imaging diagnostics and CA-125 testing) and possibly the detection of tumor relapse

Klinik Hirslanden, Zurich

Manja Gideon Foundation

Stiftung Swiss Tumor Institute

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients with oncological, medical treatment for breast cancer, colon cancer, prostate cancer, lung cancer or hematological malignancies.

The app is used to record the study parameters for a period of 90 days.

The following measures are used for data collection:

* Interview during regular consultation with doctor
* Web-App for gathering doctors data
* "Consilium" Smartphone App for gathering patient data During the course of care, the patient enters in a regular manner symptoms and treatment side effects in the Smartphone app. A continuous capture of the symptoms and treatment side effect is provided. If no entry is made within 3 days the patient is prompted to enter the data via a push message.
* Well-being through a patient rating on a visual analog scale
* Registration of symptoms and treatment side effects is done through the app

After completion of the study patients will be questioned according to:

• Usability and usefulness of the Smartphone app

Andreas Trojan, Prof. Dr. med.

The study investigates the influence of the use of a Smartphone App, on changes in general well-being and the occurrence of symptoms during a tumor therapy. With this documentation, medical professionals should be enabled to judge the influence of symptoms on quality of life during different time periods, between planed visits on site.

The study will examine the number, characteristics and intensity of electronically reported symptoms and therapy side effects depending on treatment and characteristics of patients with cancer of breast, colon, prostate, lung and hematological malignancies during a three-month period from the initiation of therapy. This period frequently represents the duration of a therapeutic regimen.

The level of agreement κ between the ECOG/CTCAE ratings by physicians at the time of the regular consultation, and the ratings derived from the daily PROs between consultations, will be analyzed in order to determine the reliability and utility of self-reported electronic symptom monitoring.

The purpose is to evaluate different qualities of symptoms self-reported electronically between consultations with respect to the course of treatment application, out-patient settings, gender and age. In particular, outpatients with frequent (weekly) consultations will be compared to patients with infrequent consultations (3-weekly or less frequent).

The study will also aim to identify the conditions and factors that might increase the likelihood of an unplanned consultation or emergency hospitalization.

In particular, the proposed study design and associated primary and secondary endpoints will enable us to test the following hypotheses:

1. In patient groups with infrequent outpatient visits (3-weekly or less) as is determined by the treatment schedule, the level of agreement κ between ePRO-derived ECOG/CTCAE ratings and physician-derived ECOG/CTCAE ratings (at time of consultation) is at least as high as in patient groups with weekly visits for symptoms having occurred within the week before the visit. However, κ is expected lower in the group with infrequent visits for symptoms having occurred more than 2 weeks prior to consultation, due to higher fidelity of ePRO-derived ratings for long-ago symptoms.
2. Regular visits of outpatients undergoing infusion therapy (as determined by the treatment schedule) do not significantly decrease the number of unplanned and emergency consultations necessary.
3. Young female and older male patient groups report significantly more severe and worsening symptoms and side effects.

Patients with the most common types of cancer in the treatment center will be included:

Breast, Colon, Prostate, Lung, Hematological malignancies

Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients

Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients Depending on Form of Medication Application, Age and Outpatient Characteristics: Observational Study

Level of agreement κ with respect to categories of common toxicity criteria (ECOG/CTCAE) categories between ePRO recording and the treating physician at time of consultation

Assessment of the number, characteristics and intensity of electronically reported symptoms and therapy side effects during the first three months of therapy

Rating of different qualities of electronically reported symptoms in out-patient settings with respect to: course of treatment application (oral vs. infusion vs. radiation), treatment (systemic vs. local), gender and age

Number and nature of unplanned consultations, (consultation vs. emergency hospitalizations)

Number of days in the hospital during for each event (≤2 days or \> 2 days)

Assessment of patients' characteristics for a discontinuation of the use of the mobile monitoring

Evaluation of the usability and usefulness of the smartphone app in the course of the treatment as rated by physician and patient after completion of the study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer	NCT05352217	Patient Reporte... Ovarian Neoplas...	Mobile app ovar...	18 Years -	Stiftung Swiss Tumor Institute
Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients	NCT03578731	Telemedicine eHealth	app	18 Years -	OnkoZentrum Zürich AG

Spots Global Cancer Trial Database for electronic patient reported outcome