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

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

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

Study Overview

• Status: Recruiting
• Conditions: Health-related Quality of Life
• Intervention / Treatment: Other: Questionnaires

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Diana de Jong-Bakker; Phone Number: +41616853604; Email: diana.bakkerdejong@claraspital.ch
• Study Contact Backup: Name: Arnoud Templeton, PD Dr med; Phone Number: +41616858330; Email: arnoud.templeton@claraspital.ch

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4058
      • Recruiting
      • St Clara Research Ltd
      • Contact: Diana de Jong-Bakker; Phone Number: +41616853604; Email: diana.bakkerdejong@claraspital.ch
      • Contact: Email: diana.bakkerdejong@claraspital.ch
      • Principal Investigator: Diana de Jong-Bakker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

It is planned to enroll at least 200 patients into this study. Patient recruitment will be conducted during 2 years (2024-2026)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A:paper vs digitally; 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.	Other: Questionnaires; EORTC QLQ-C30 (General Health), EORTC QLQ-SH22(sexual Health), Financial questionnaire as routinely used by the Social Department
B: digitally vs paper; 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.	Other: Questionnaires; EORTC QLQ-C30 (General Health), EORTC QLQ-SH22(sexual Health), Financial questionnaire as routinely used by the Social Department

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2024-2026
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.	2024-2026
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.	2024-2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of reported sexual problems		2024-2026
Patient preference	Reported patient preference of mode of reporting (electronically vs supervised)	2024-2026
Time	Time used by the Health care professional per completion mode	2024-2026

Collaborators and Investigators

• Sponsor: St. Claraspital AG
• Investigators: Principal Investigator: Diana de Jong-Bakker, St. Claraspital Klinische Forschung

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IMSUP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No