NCT06490393 - The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire | Crick

Overview

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

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Health-related Quality of Life

Interventions

QuestionnairesOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

St Clara Research Ltd

Basel, Canton of Basel-City, Switzerland

RECRUITING

Outcomes

Primary Outcomes

EORTC QLQ-C30

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.

Time frame: 2024-2026

EORTC QLQ-SH22

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.

Time frame: 2024-2026

Questionnaire called "Financial consequences" routinely used by the Social department of St. ClaraSpital

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.

Time frame: 2024-2026

Secondary Outcomes

Incidence of reported sexual problems

Time frame: 2024-2026

Patient preference

Reported patient preference of mode of reporting (electronically vs supervised)

Time frame: 2024-2026

Time

Time used by the Health care professional per completion mode

Time frame: 2024-2026

Central Contacts

Diana de Jong-Bakker

CONTACT

+41616853604 diana.bakkerdejong@claraspital.ch

Arnoud Templeton, PD Dr med

CONTACT

+41616858330 arnoud.templeton@claraspital.ch