The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire
- Conditions
- Health-related Quality of Life
- Interventions
- Other: Questionnaires
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- One or more of the inclusion criteria not met.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A:paper vs digitally Questionnaires 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. B: digitally vs paper Questionnaires 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.
- 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