The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire

NCT ID: NCT06490393

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-17

Study Completion Date

2027-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Effect of supervision on scoring and completion on Quality of Life Questionnaire

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This protocol will study the impact of supervision on completion and scoring of sensitives domains of QoL Questionnaires and QoL Questionnaires in general in a multi-center, randomized, cross-over design in cancer patients receiving systemic antineoplastic therapy

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health-related Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A:paper vs digitally

Arm A: patients in Arm A will receive first an invitation to complete the QoL questionnaires on paper under supervision of an HCP in the hospital before their cycle of systemic antineoplastic therapy starts. Prior to their subsequent cycle of systemic antineoplastic therapy (regardless of duration of cycle), patients in Arm A will be asked to complete the same QoL questionnaires digitally at home.

Questionnaires

Intervention Type OTHER

EORTC QLQ-C30 (General Health), EORTC QLQ-SH22(sexual Health), Financial questionnaire as routinely used by the Social Department

B: digitally vs paper

Arm B: patients in Arm B will receive first an invitation to complete the QoL questionnaires digitally at home before their cycle of systemic antineoplastic therapy starts. Prior to their subsequent cycle of systemic antineoplastic therapy (regardless of duration of cycle), patients in Arm B will be asked to complete the same QoL questionnaires on paper under supervision in the hospital.

Questionnaires

Intervention Type OTHER

EORTC QLQ-C30 (General Health), EORTC QLQ-SH22(sexual Health), Financial questionnaire as routinely used by the Social Department

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaires

EORTC QLQ-C30 (General Health), EORTC QLQ-SH22(sexual Health), Financial questionnaire as routinely used by the Social Department

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient is ≥18 years of age and legally competent
* Signed informed consent available
* Systemic oncologic treatment (e.g. chemotherapy, immunotherapy, endocrine therapy)
* Current systemic therapy started at least 4 weeks before randomization and is scheduled to continue for at least another 4 weeks after randomization in the same dose and interval
* Patient is ready and able to complete quality of life questionnaires in German (on paper
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Claraspital AG

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Diana de Jong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diana de Jong-Bakker

Role: PRINCIPAL_INVESTIGATOR

St. Claraspital Klinische Forschung

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St Clara Research Ltd

Basel, Canton of Basel-City, Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Diana de Jong-Bakker

Role: CONTACT

+41616853604

Arnoud Templeton, PD Dr med

Role: CONTACT

+41616858330

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Diana de Jong-Bakker

Role: primary

+41616853604

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IMSUP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.