Health-related Quality of LifeIMSUPNCT06490393
The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire
An observational study of Health-related Quality of Life, run by St. Claraspital AG at 1 site in Switzerland.
Trial summary
Effect of supervision on scoring and completion on Quality of Life Questionnaire Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health-related Quality of Life
- What is being tested?
- Questionnaires
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Apr 2024to 1 Jul 2027
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is planned to enroll at least 200 patients into this study. Patient recruitment will be conducted during 2 years (2024-2026)
Who may be able to join
- 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
Who cannot join
- One or more of the inclusion criteria not met.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
St Clara Research Ltd
Basel, Canton of Basel-City, 4058
Diana de Jong-Bakker, +41616853604, diana.bakkerdejong@claraspital.ch
diana.bakkerdejong@claraspital.ch
About this study
Official 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
Effect of supervision on scoring and completion on Quality of Life Questionnaire
Read the 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
- Conditions
- Health-related Quality of Life
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
EORTC QLQ-C30 (General Health), EORTC QLQ-SH22(sexual Health), Financial questionnaire as routinely used by the Social Department
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2024-2026
Secondary outcomes (3)
Incidence of reported sexual problems
Measured: 2024-2026
Patient preference
Reported patient preference of mode of reporting (electronically vs supervised)
Measured: 2024-2026
Time
Time used by the Health care professional per completion mode
Measured: 2024-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start17 Apr 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-related Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- St. Claraspital AG
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana de Jong, St. Claraspital AG
- Investigators
- Diana de Jong-Bakker, Principal investigator, St. Claraspital Klinische Forschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490393
- Sponsor's protocol ID
- IMSUP
- Acronym
- IMSUP
- Status last verified
- Jul 2024
- First submitted
- 4 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06490393
- Acronym / sponsor ID
- IMSUP / IMSUP
- Conditions
- Health-related Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Claraspital AGUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A:paper vs digitally | – | Other: QuestionnairesArm 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. |
| B: digitally vs paper | – | Other: QuestionnairesArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to enroll at least 200 patients into this study. Patient recruitment will be conducted during 2 years (2024-2026)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- One or more of the inclusion criteria not met.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesEORTC QLQ-C30 (General Health), EORTC QLQ-SH22(sexual Health), Financial questionnaire as routinely used by the Social Department | Other | A:paper vs digitally, B: digitally vs paper |
Primary outcome
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.
3 secondary outcomes
Incidence of reported sexual problems
Time frame: 2024-2026
Patient preference
Time frame: 2024-2026
Time
Time frame: 2024-2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana de Jong-Bakker principal investigator
St. Claraspital Klinische Forschung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health-related Quality of Life, run by St. Claraspital AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana de Jong-Bakker (+41616853604, diana.bakkerdejong@claraspital.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ-C30 (time frame: 2024-2026). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.