St Clara Research Ltd
Basel, Canton of Basel-City, 4058, Switzerland
Location status: Recruiting
Location contact
Diana de Jong-Bakker
CONTACT
Diana de Jong-Bakker
PRINCIPAL_INVESTIGATOR
CONTACT
Recruiting
NCT Number: NCT06490393
The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire
Effect of supervision on scoring and completion on Quality of Life Questionnaire
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
questionnaires
OtherEORTC QLQ-C30 (General Health), EORTC QLQ-SH22(sexual Health), Financial questionnaire as routinely used by the Social Department
Primary outcomes
-
EORTC QLQ-C30
Time frame: 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
Time frame: 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
Time frame: 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 outcomes
-
Incidence of reported sexual problems
Time frame: 2024-2026
-
Patient preference
Time frame: 2024-2026
Reported patient preference of mode of reporting (electronically vs supervised)
-
Time
Time frame: 2024-2026
Time used by the Health care professional per completion mode
Study contacts
Contact information is provided by the study sponsor or research team.
Arnoud Templeton, PD Dr med
CONTACT
Diana de Jong-Bakker
CONTACT
Sponsors and collaborators
Lead sponsor
St. Claraspital AG
Other
Registry information
Official study 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
Acronym: IMSUP
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Jul 8, 2024
- Registry last updated
- Jul 8, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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