Trial Title:
The Value of a Risk Prediction Tool (PERSARC) for Effective Treatment Decisions of Soft-tissue Sarcomas Patients
NCT ID:
NCT05741944
Condition:
Soft-tissue Sarcoma
Predictive Cancer Model
Conditions: Official terms:
Sarcoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
Care with the use of PERSARC
Description:
PERSARC is a personalized risk assessment tool which provides patients and STS
professionals insight into the personalized risks and benefits of each treatment option
based on patient's age, tumor size, tumor depth and histology. PERSARC will be used in
multidisciplinary tumour boards to guide treatment advice and in consultation in which
the oncological/orthopaedic surgeon informs the patient about his/her diagnoses and
discusses the benefits and harms of all relevant treatment options
Arm group label:
Care with the use of PERSARC (intervention)
Intervention type:
Other
Intervention name:
standard care
Description:
All patients in control condition receive usual care.
Arm group label:
standard care (control)
Summary:
The goal of this clinical trial is to assess the (cost-)effectiveness of a personalised
risk assessment tool (PERSARC) to increase patients' knowledge about risks and benefits
of treatment options and to reduce decisional conflict in comparison with usual care in
high-grade extremity Soft-Tissue Sarcoma-patients.
High-grade (2-3) extremity Soft-Tissue Sarcoma patients (>= 18 years) will either receive
standard care (control group) or care with the use of PERSARC; i.e. PERSARC will be used
in multidisciplinary tumour boards to guide treatment advice and in consultation in which
the oncological/orthopaedic surgeon informs the patient about his/her diagnoses and
discusses the benefits and harms of all relevant treatment options (intervention group)
Detailed description:
To assess whether the use of the personalized risk assessment tool (PERSARC) is
(cost)effective in reducing decisional conflict and increasing informed choices in
high-grade extremity Soft-Tissue Sarcoma patients compared to usual care (co-primary
outcomes). In addition, we aim to assess in a process evaluation (a) the involvement of
patients in decision-making (b) the extent and way PERSARC is used by patients and
professionals, and (c) how satisfied patients and professionals were with the use of
PERSARC.
Study design: To assess the (cost)effectiveness of PERSARC in treatment decisions of
high-grade extremity Soft-Tissue Sarcoma-patients, a parallel cluster randomized trial
will be conducted in the 6 Dutch hospitals that are Soft-tissue sarcoma expertise
centers. Hospitals will be randomized between standard care (control condition) or care
with the use of PERSARC (intervention). Outcomes will be assessed within one week after
treatment decision has been made (T1), and after 3, 6 and 12 months after the treatment
decision has been made (T2, T3, T4) in at least 120 patients. See main study
parameters/endpoints for a description of the outcomes that will be measured at these
time points. Actual use of PERSARC, satisfaction with/added value of PERSARC and barriers
and facilitators for the integration of PERSARC in treatment decision-making processes
during patient-clinician encounters will be measured in a process evaluation using
questionnaires, interviews, and audio-recording/observation of consultations.
Study population: Patients (>= 18 years) with primarily diagnosed (histologically
confirmed) grade 2-3 extremity Soft-Tissue Sarcoma, who do not have a treatment plan yet
and will be treated with curative intent. Patients with sarcoma subtypes or treatment
options other than those mentioned in PERSARC are unable to participate. Furthermore,
patients need to be Dutch fluency and literacy and mentally competent.
Intervention (if applicable): High-grade extremity Soft-Tissue Sarcoma patients will
either receive standard care (control group) or care with the use of PERSARC; i.e.
PERSARC will be used in multidisciplinary tumour boards to guide treatment advice and in
consultation in which the oncological/orthopaedic surgeon informs the patient about
his/her diagnoses and discusses the benefits and harms of all relevant treatment options
(intervention group).
Main study parameters/endpoints: The co-primary outcomes are decisional conflict
(Decisional Conflict Scale(DCS) (T1) and informed choice (T1). Informed choice is a
combined outcome incorporating knowledge, attitudes concerning trade-offs between quality
and length of life (QQ_Questionnaire) (T1), and treatment decision (T1). Secondary
outcomes, include regret (Decision_Regret_Scale) (T3, T4), worry (Cancer_Worry_scale)
(T1, T2, T3, T4), involvement in decision-making according to patients (SDM-Q-9) (T1),
patient reported outcome using the Patient Reported Outcome Measures (PROMIS Global
health) (T1, 2, 3, 4), and (PROMIS physical function) (T1, 2, 3, 4), utilities for the
cost-effectiveness analysis (EQ-5D-5L) (T1, T2, T3, T4), health care cost (iMCQ) (T2, T3,
T4) and absenteeism/presenteeism from paid work (T2, T3, T4).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients >= 18 years
- Histologically diagnosed with grade 2-3 STS in their extremities.
- Who do not have a treatment plan yet
- Dutch fluency and literacy
- Mentally competent
- Signed informed consent
- Patient owns a phone with internet access (WiFi)
Exclusion Criteria:
- Patient that are treated without curative intent
- Patient that needs to be treated with chemotherapy or isolated limb perfusion
- Patients were surgery is not indicated
- Sarcoma subtypes not included in the PERSARC risk assessment tool
In summary: patients with sarcoma subtypes and/or patients that need to be treated with
other treatment modalities than those included in the PERSARC risk assessment tool are
excluded.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Radboud UMC
Address:
City:
Nijmegen
Zip:
6525GA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Han Bonenkamp, MD-PhD
Phone:
+31243617365
Email:
han.bonenkamp@radboudumc.nl
Facility:
Name:
Maastricht UMC
Address:
City:
Maastricht
Zip:
6229HX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marc Bemelmans, MD-PhD
Phone:
+31433875492
Email:
m.bemelmans@mumc.nl
Facility:
Name:
Netherlands Cancer Institue
Address:
City:
Amsterdam
Zip:
1066CX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Yvonne Schrage, MD-PhD
Email:
y.schrage@nki.nl
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2333ZA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Anouk A Kruiswijk, MSc
Phone:
+31715265137
Email:
a.a.kruiswijk@lumc.nl
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Zip:
3015GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Cees Verhoef, MD-PhD
Phone:
+3110 704 0704
Email:
c.verhoef@erasmucmc.nl
Facility:
Name:
UMC Groningen
Address:
City:
Groningen
Zip:
9713GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Robert-Jan van Ginkel, MD-PhD
Phone:
+3150-3612317
Email:
r.j.van.ginkel@umcg.nl
Facility:
Name:
UMC Utrecht
Address:
City:
Utrecht
Zip:
3584CX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Arjen Witkamp, MD
Phone:
+31887556968
Email:
a.j.witkamp@umcutrecht.nl
Start date:
August 24, 2021
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Leiden University Medical Center
Agency class:
Other
Source:
Leiden University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05741944
