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

Predictive Cancer Model Clinical Trial

— VALUE_PERSARC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741944
• Other study ID #: NL76563.058.21
• Secondary ID: 12642NL9160
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: December 2023
• Source: Leiden University Medical Center
• Contact: Anouk A Kruiswijk, MSc
• Phone: +31715265137
• Email: a.a.kruiswijk[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Predictive Cancer Model
• Sarcoma
• Soft-tissue Sarcoma

Intervention

Other:
• Care with the use of PERSARC
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 care
All patients in control condition receive usual care.

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institue	Amsterdam	Noord-Holland
Netherlands	UMC Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden	Zuid-holland
Netherlands	Maastricht UMC	Maastricht	Limburg
Netherlands	Radboud UMC	Nijmegen	Gelderland
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	process evaluation - b) the extent and way PERSARC is used by patients and professionals	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
Other	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
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)