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

St. Claraspital AG

Status: Enrolling

Conditions: Health-related Quality of Life

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT06490393

IMSUP

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

A:paper vs digitally

Description:

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.

Treatment:

Other: Questionnaires

B: digitally vs paper

Description:

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.

Treatment:

Other: Questionnaires