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Recruiting NCT06490393

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

Observational Health-related Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: Health-related Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Impact of Supervision by a Health Care Professional on Quality of Life (QoL) Questionnaire Scoring and Completion:, Randomized, Cross-over Study in Cancer Patients Receiving Systemic Antineoplastic Therapy

Overview

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

Detailed description

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

Interventions

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

Primary outcome measures

  • EORTC QLQ-C30 [Time frame: 2024-2026]
  • EORTC QLQ-SH22 [Time frame: 2024-2026]
  • Questionnaire called "Financial consequences" routinely used by the Social department of St. ClaraSpital [Time frame: 2024-2026]
Secondary outcome measures (3)
  • Incidence of reported sexual problems [Time frame: 2024-2026]
  • Patient preference [Time frame: 2024-2026]
  • Time [Time frame: 2024-2026]

Eligibility criteria

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

Exclusion criteria

  • One or more of the inclusion criteria not met.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Switzerland · 1 center
  • St Clara Research Ltd — Basel

Identifiers

NCT: NCT06490393 · IMSUP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗