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Soft-tissue SarcomaVALUE_PERSARCNCT05741944

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

A study testing Care with the use of PERSARC in people with Soft-tissue Sarcoma and Predictive Cancer Model, run by Leiden University Medical Center at 7 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft-tissue Sarcoma, Predictive Cancer Model
What is being tested?
Care with the use of PERSARC
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
7 sitesNetherlands
Study dates
24 Aug 2021to 29 Aug 2025
Phase
Interventional
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

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Netherlands7 sites

  • Netherlands Cancer Institue

    Amsterdam, North Holland, 1066CX

  • UMC Groningen

    Groningen, Provincie Groningen, 9713GZ

  • Leiden University Medical Center

    Leiden, South Holland, 2333ZA

  • Maastricht UMC

    Maastricht, Limburg, 6229HX

  • Radboud UMC

    Nijmegen, Gelderland, 6525GA

  • Erasmus MC

    Rotterdam, South Holland, 3015GD

  • UMC Utrecht

    Utrecht, Utrecht, 3584CX

Other trials in Netherlands

About this study

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)

Read the 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).

Being tested
Care with the use of PERSARC, standard care
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Care with the use of PERSARCOther

    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

  • standard careOther

    All patients in control condition receive usual care.

Study groups in NCT05741944
Study groupRoleWhat they receive
Care with the use of PERSARC (intervention)ExperimentalPatients 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.
Receives: Other: Care with the use of PERSARC
standard care (control)Sham comparatorAll patients in the control condition receive standard care
Receives: Other: standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: T1 (one week after treatment decision)

  2. 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)

    Measured: T1 (one week after treatment decision)

Secondary outcomes (8)

  1. Decision Regret Scale

    Decision Regret Scale

    Items are given a score value of:

    strongly disagree (1) - strongly agree(5)

    Total score:

    Scoring consist of reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items. These means were converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25.

    Measured: T3 (6m), T4 (12months)

  2. Cancer Worry Scale

    Cancer Worry Scale

    Level of cancer worry was measured by the Dutch version of the Cancer Worry Scale, consisting of 6 questions with 4 response options (1 = not at all or rarely; 2 = sometimes; 3 = often; 4 = almost all the time), such that each individual attains a score ranging from 6 (minimum worry) to 24 (maximum worry).

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

  3. SDM-Q-9

    Involvement in decision-making according to patients.

    Items are scored from completely disagree (0) to completely agree (5)

    Summing up all items leads to a raw total score between 0-45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM.

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

  4. PROMIS Global health

    Patient reported outcome measure

    10 item questionnaire lowest score (0) to highest (20). 0 Points represents the patient's most severe physical and/or mental impairment, while 20 represents the best possible state of health.

    The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores are indicative of a healthier patient.

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

  5. PROMIS Physical function

    Patient reported outcome measure

    10 item questionnaire lowest score (0) to highest (20).

    Scores are standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores are indicative of a healthier patient.

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

  6. EQ-5D-5L

    The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain and anxiety). Lowest score (1) - highest (5)

    Higher scores indicate unable to/ extreme problems

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

  7. Medical consumption questionnaire (iMCQ)

    Medical consumption questionnaire (health care cost) focusing on healthcare use inside and outside the hospital. For the evaluation of cost, standard prices published in the Dutch costing guidelines will be used.

    Measured: T2 (3months), T3 (6months), T4 (12months)

  8. Productivity cost questionnaire (iPCQ) Cost of absenteeism from paid work will be calculated using the friction cost method.

    absenteeism/presenteeism from paid work

    Measured: T2 (3months), T3 (6months), T4 (12months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2023
  2. Study start24 Aug 2021
  3. Primary completion29 Aug 2024
  4. Study completion29 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05741944
Sponsor's protocol ID
NL76563.058.21
Other IDs
12642, NL9160
Acronym
VALUE_PERSARC
Status last verified
Sep 2025
First submitted
31 Jan 2023
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results of this trial, after deidentification (text, tables, figures, and appendices).

Publications

  • Kruiswijk AA, de Mheen PJM, Vlug LAE, Engelhardt EG, Fiocco M, Haas RL, Schrage YM, Verhoef C, Bemelmans MHA, van Ginkel RJ, Bonenkamp JJ, Witkamp AJ, van de Sande MAJ, van Bodegom-Vos L; VALUE-PERSARC research group. Evaluating the effectiveness of a risk prediction model (PERSARC) on improving treatment decisions quality for patients with soft-tissue sarcomas: the VALUE-PERSARC study. BMC Med Inform Decis Mak. 2025 Sep 29;25(1):345. doi: 10.1186/s12911-025-03166-6.

    PubMed 41023919

  • 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.

    PubMed 37918933

Questions about this trial

What is this clinical trial studying?

A study testing Care with the use of PERSARC in people with Soft-tissue Sarcoma and Predictive Cancer Model, run by Leiden University Medical Center at 7 sites in Netherlands.

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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Netherlands. 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decisional Conflict Scale (time frame: T1 (one week after treatment decision)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05741944, which also lists 2 linked publications.

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 9 Sep 2025.

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