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

NCT06490393 | Recruiting

• 1 other identifier: IMSUP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Health-related Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Incidence of reported sexual problems

  2024-2026

• Patient preference

  2024-2026

• Time

  2024-2026

Study Arms (2)

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

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

Interventions

Questionnaires OTHER

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

A:paper vs digitally; B: digitally vs paper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

Sponsors & Collaborators

• St. Claraspital AG: lead

Study Sites (1)

St Clara Research Ltd

Basel, Canton of Basel-City, 4058, Switzerland

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Diana de Jong-Bakker

  St. Claraspital Klinische Forschung

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana de Jong-Bakker

CONTACT

+41616853604; diana.bakkerdejong@claraspital.ch

Arnoud Templeton, PD Dr med

CONTACT

+41616858330; arnoud.templeton@claraspital.ch

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: July 8, 2024
• Study Start: April 17, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)