The Value of a Risk Prediction Tool (PERSARC) for Effective Treatment Decisions of Soft-tissue Sarcomas Patients

NCT05741944 | Active Not Recruiting DMC

• 3 other identifiers: NL76563.058.2112642NL9160
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief 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)

Conditions

Soft-tissue Sarcoma; Predictive Cancer Model

Outcome Measures

Primary Outcomes (2)

• Decisional Conflict Scale

  Decisional conflict scale Items are given a score value of: strongly agree (0) - strongly disagree (4) Total score: 16 items are a) summed, b) divided by 16, and c) multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)

  T1 (one week after treatment decision)

• Informed choice

  combined outcome incorporating knowledge (self-developed questionnaire), attitudes concerning trade-offs between quality and length of life (QQ\_Questionnaire, see below) and treatment decision self-developed knowledge questionnaire: a knowledge score was considered to reflect adequate decision-relevant knowledge if at least 50% of knowledge statements were correctly answered, which means a knowledge score ≥3 for the present study; no knowledge (0) - high knowledge (6)

  T1 (one week after treatment decision)

Secondary Outcomes (8)

• Decision Regret Scale

  T3 (6m), T4 (12months)

• Cancer Worry Scale

  T1 (one week after treatment decision), T2 (3months), T3 (6months), T4 (12months)

• SDM-Q-9

  T1 (one week after treatment decision), T2 (3months), T3 (6months), T4 (12months)

• PROMIS Global health

  T1 (one week after treatment decision), T2 (3months), T3 (6months), T4 (12months)

• PROMIS Physical function

  T1 (one week after treatment decision), T2 (3months), T3 (6months), T4 (12months)

Other Outcomes (3)

• process evaluation - a) the involvement of patients in decision-making

  T1

• process evaluation - b) the extent and way PERSARC is used by patients and professionals

  end of study

• process evaluation - c) how satisfied patients and professionals were with the use of PERSARC

  T1

Study Arms (2)

Care with the use of PERSARC (intervention)

EXPERIMENTAL

Patients in the intervention condition receive usual care with PERSARC added at two points in the decision making process. First, PERSARC will be used in multidisciplinary tumour boards (MTB) by STS professionals to guide treatment advice. Second, PERSARC will be used in patient consultations where the oncological/orthopaedic surgeon informs the patient about his/her diagnosis and discusses the benefits and harms of all relevant treatment options.

Other: Care with the use of PERSARC

standard care (control)

SHAM COMPARATOR

All patients in the control condition receive standard care

Other: standard care

Interventions

Care with the use of PERSARC OTHER

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

Care with the use of PERSARC (intervention)

standard care OTHER

All patients in control condition receive usual care.

standard care (control)

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (7)

Radboud UMC

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Maastricht UMC

Maastricht, Limburg, 6229HX, Netherlands

Location

Netherlands Cancer Institue

Amsterdam, North Holland, 1066CX, Netherlands

Location

UMC Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

Location

UMC Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

Location

Related Publications (1)

• Kruiswijk AA, van de Sande MAJ, Haas RL, van den Akker-van Marle EM, Engelhardt EG, Marang-van de Mheen P, van Bodegom-Vos L; VALUE-PERSARC research group. (Cost-)effectiveness of an individualised risk prediction tool (PERSARC) on patient's knowledge and decisional conflict among soft-tissue sarcomas patients: protocol for a parallel cluster randomised trial (the VALUE-PERSARC study). BMJ Open. 2023 Nov 2;13(11):e074853. doi: 10.1136/bmjopen-2023-074853.

  PMID: 37918933 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Leti van Bodegom-Vos, PhD

  LUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 23, 2023
• Study Start: August 24, 2021
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provided a methodological sound proposal. Access needs to be requested at the Principal Investigator.

Locations

NL (7)