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

Recruiting

• Conditions: Health-related Quality of Life

• Registration Number: NCT06490393
• Lead Sponsor: St. Claraspital AG

Brief Summary

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

Study Timeline

• Study Start: 2024-04-17
• Study First Submitted: 2024-06-04
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-04
• Last Update Submitted: 2024-07-04
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2026-05-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EORTC QLQ-C30	2024-2026	To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers.
EORTC QLQ-SH22	2024-2026	To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers.
Questionnaire called "Financial consequences" routinely used by the Social department of St. ClaraSpital	2024-2026	To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers.

Secondary Outcome Measures

Name	Time	Method
Incidence of reported sexual problems	2024-2026
Patient preference	2024-2026	Reported patient preference of mode of reporting (electronically vs supervised)
Time	2024-2026	Time used by the Health care professional per completion mode

Trial Locations

Locations (1)

St Clara Research Ltd; 🇨🇭 Basel, Basel-Stadt, Switzerland