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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06490393
Acronym
IMSUP
Enrollment
200
Registered
2024-07-08
Start date
2024-04-17
Completion date
2027-07-01
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health-related Quality of Life

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

Interventions

OTHERQuestionnaires

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

Sponsors

St. Claraspital AG
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
EORTC QLQ-C302024-2026To 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-SH222024-2026To 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. ClaraSpital2024-2026To 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

MeasureTime frameDescription
Incidence of reported sexual problems2024-2026
Patient preference2024-2026Reported patient preference of mode of reporting (electronically vs supervised)
Time2024-2026Time used by the Health care professional per completion mode

Countries

Switzerland

Contacts

Primary ContactDiana de Jong-Bakker
diana.bakkerdejong@claraspital.ch+41616853604
Backup ContactArnoud Templeton, PD Dr med
arnoud.templeton@claraspital.ch+41616858330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026