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

Study Overview
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Brief Summary
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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)

Detailed Description
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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).

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

Conditions
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Soft-tissue Sarcoma, Predictive Cancer Model

Intervention / Treatment
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* Other: Care with the use of PERSARC
* Other: standard care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Care with the use of PERSARC (intervention)<br>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<br>* 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<br>|
| Sham Comparator: standard care (control)<br>All patients in the control condition receive standard care | Other: standard care<br>* All patients in control condition receive usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |