The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire
ConditionHealth-related Quality of Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSt. Claraspital AG
About this trial
Effect of supervision on scoring and completion on Quality of Life Questionnaire
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
One or more of the inclusion criteria not met.
Trial population
It is planned to enroll at least 200 patients into this study. Patient recruitment will be conducted during 2 years (2024-2026)
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Questionnaires
Other interventionEORTC QLQ-C30 (General Health), EORTC QLQ-SH22(sexual Health), Financial questionnaire as routinely used by the Social Department
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: A:paper vs digitally1 intervention
Group B: B: digitally vs paper1 intervention
Trial outcomes
Primary outcomes
1
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
2024-20262
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
2024-20263
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
2024-2026Secondary outcomes
1
Incidence of reported sexual problems
Time frame
2024-20262
Patient preference
Reported patient preference of mode of reporting (electronically vs supervised)
Time frame
2024-20263
Time
Time used by the Health care professional per completion mode
Time frame
2024-2026Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov