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| ID | Type | Description | Link |
|---|---|---|---|
| 12642 | Other Grant/Funding Number | KWF Dutch Cancer Society | |
| NL9160 | Registry Identifier | The Netherlands National Trial Register (NTR) |
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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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| standard care (control) | Sham Comparator | All patients in the control condition receive standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | T3 (6m), T4 (12months) |
| Measure | Description | Time Frame |
|---|---|---|
| process evaluation - a) the involvement of patients in decision-making | audio recordings of the patient-clinician consultation The audio-recordings of the patient consultations will be transcribed verbatim and assessed by two independent reviewers using the OPTION-5 | T1 |
| process evaluation - b) the extent and way PERSARC is used by patients and professionals |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Leti van Bodegom-Vos, PhD | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud UMC | Nijmegen | Gelderland | 6525GA | Netherlands | ||
| Maastricht UMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41023919 | Derived | 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. | |
| 37918933 |
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Individual participant data that underlie the results of this trial, after deidentification (text, tables, figures, and appendices).
Immediately following publication. No end date.
Researchers who provided a methodological sound proposal. Access needs to be requested at the Principal Investigator.
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|
| standard care | Other | All patients in control condition receive usual care. |
|
| 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). | T1 (one week after treatment decision), T2 (3months), T3 (6months), T4 (12months) |
| 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. | T1 (one week after treatment decision), T2 (3months), T3 (6months), T4 (12months) |
| 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. | T1 (one week after treatment decision), T2 (3months), T3 (6months), T4 (12months) |
| 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. | T1 (one week after treatment decision), T2 (3months), T3 (6months), T4 (12months) |
| 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 | T1 (one week after treatment decision), T2 (3months), T3 (6months), T4 (12months) |
| 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. | T2 (3months), T3 (6months), T4 (12months) |
| Productivity cost questionnaire (iPCQ) Cost of absenteeism from paid work will be calculated using the friction cost method. | absenteeism/presenteeism from paid work | T2 (3months), T3 (6months), T4 (12months) |
To gain insight into (b) the extent and way in which PERSARC is used by patients, user data from the VALUE-PERSARC app will be evaluated at group level (control vs intervention) (Google analytics within the app). Use of PERSARC by professionals will be examined through a checklist regarding the use of PERSARC in patient consultations and MTB Additionally, to gain further understanding of the integration of PERSARC in treatment decision making processes, 5-15 randomly selected patients and 3-4 STS professionals (one per intervention hospital) will be interviewed using a semi-structured interview scheme. |
| end of study |
| process evaluation - c) how satisfied patients and professionals were with the use of PERSARC | Satisfaction with the use of PERSARC (c) for patients and professionals who participated in the intervention arm and all professionals will be evaluated with a self-developed satisfaction questionnaire send to all eligible patients and professionals. Patients in the intervention arm will fill in the questionnaire within the VALUE-PERSARC app. Professionals are asked to fill in the questionnaire online, with reminders send after one week. | T1 |
| Maastricht |
| Limburg |
| 6229HX |
| Netherlands |
| Netherlands Cancer Institue | Amsterdam | North Holland | 1066CX | Netherlands |
| UMC Groningen | Groningen | Provincie Groningen | 9713GZ | Netherlands |
| Leiden University Medical Center | Leiden | South Holland | 2333ZA | Netherlands |
| Erasmus MC | Rotterdam | South Holland | 3015GD | Netherlands |
| UMC Utrecht | Utrecht | Utrecht | 3584CX | Netherlands |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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