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临床试验/NCT07671937
NCT07671937尚未招募不适用

INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study

University of Alabama at Birmingham3 个研究点 分布在 1 个国家目标入组 2,748 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,748
试验地点
3
主要终点
Treatment modifications

研究概览

简要总结

The purpose of the study is to characterize baseline multidisciplinary tumor board (MDTB) context and variability, evaluate the relationship between baseline fitness of patients with cancer and initial treatment recommendations, and assess the impact of the INSPIRE intervention, which involves including electronic patient reported outcomes (ePROs) within MDTB on MDTB discussion content, provider burden, treatment recommended and received, healthcare utilization, and patient-reported outcomes.

详细描述

Study Type/Design This multi-methods study will include two participant groups: patient participants and clinician/provider participants. The patient portion includes an initial prospective observational cohort followed by a randomized controlled trial of the INSPIRE intervention, which involves inclusion of electronic patient-reported outcomes in tumor board discussions. The clinician/provider portion includes audio recording of multidisciplinary tumor board discussions and an optional post-study semi-structured interview with clinicians/providers to understand experiences with the INSPIRE intervention, including feasibility, usefulness, workflow considerations, and implementation challenges.

Patient Participants Patients who agree to participate will complete patient-reported questionnaires at baseline, 3 months, and 6 months. Questionnaires may be completed online by text or email, by phone with responses entered by a research assistant, in person on a tablet, or on paper, based on patient preference. The baseline questionnaire will include questions about health, daily function, quality of life, nutrition, cognition, social support, caregiver support, treatment preferences, and decision-making preferences. At UAB, some of these electronic patient-reported outcomes may already be collected as part of standard clinical care. If a patient has already completed overlapping questionnaires as part of standard care, the patient will not be asked to repeat those questions. Instead, the study team will abstract the relevant information from the electronic medical record or electronic patient-reported outcomes system for research purposes. If the patient has not completed the standard-of-care questionnaires, the patient will complete the study-specific REDCap questionnaire in English or Spanish.

For patients in the initial observational cohort, baseline questionnaire completion may occur within 2 weeks of enrollment. If patients do not complete more than 50% of the questionnaires within 2 weeks, they will be excluded from the study. For patients in the randomized intervention component, completion of the baseline questionnaire will be required before tumor board presentation. The study team will document patients who are unable to complete the questionnaire and the reason. Participants will also complete follow-up questionnaires at approximately 3 months and 6 months after enrollment. These follow-up questionnaires may be completed electronically, by phone, or on paper and will be entered into REDCap. If a patient does not complete a follow-up questionnaire, the research coordinator will make up to three attempts to contact the patient to encourage completion. These contacts may occur by phone, patient portal, or in person during clinic.

The baseline questionnaire is expected to take approximately 40 minutes if the full study questionnaire is completed. If the patient has already completed some electronic patient-reported outcomes as part of standard care, the abbreviated questionnaire is expected to take approximately 20 minutes. The 3-month and 6-month questionnaires are expected to take approximately 10 minutes each. Patients will not be asked to complete any additional clinic visits or study-specific medical procedures.

Use of Patient Questionnaire Information in Tumor Board

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • We will include two populations: (1) patients and (2) clinical team members involved in the MDTB.
  • Inclusion Criteria:
  • Inclusions Criteria- Patients:
  • aged 18 years or older;
  • with suspected or confirmed diagnosis of pancreatic, breast, and gynecologic cancer (all stages) within 8 weeks of diagnosis;
  • intention to be treated at a participating institution;
  • with verbal fluency in English or Spanish; and
  • scheduled to be discussed at MDTB.
  • Inclusion criteria - Clinicians:
  • All clinical team members participating in the pancreatic, breast, or gynecologic MDTB at a participating site will be included and have pre-emptively agreed to participation.
  • Exclusion Criteria:
  • Exclusion criteria - Patients:
  • Individuals with plans to receive cancer treatment outside the participating institution and inability to speak English or Spanish.
  • Exclusion criteria - Clinician:
  • Clinicians will retain the opportunity to opt-out of participation, in which case their portions of the discussion will not be included in the analysis; however, this is not anticipated based on pilot data.

研究组 & 干预措施

Group B- Enhanced Clinician Awareness

Active Comparator

Patient-reported outcomes (PROs) captured with no personal data presented to multidisciplinary tumor board; other patient's PROs may be presented. This groups is a contemporary control.

干预措施: Capture of patient-reported outcomes (Behavioral)

Group B- Enhanced Clinician Awareness

Active Comparator

Patient-reported outcomes (PROs) captured with no personal data presented to multidisciplinary tumor board; other patient's PROs may be presented. This groups is a contemporary control.

干预措施: Enhanced Clinician Awareness (Behavioral)

Group C- INSPIRE intervention

Experimental

Patient-reported outcomes presented to multidisciplinary tumor board

干预措施: INSPIRE (INtegrating Systematic PatIent-Reported Evaluations) (Behavioral)

Group C- INSPIRE intervention

Experimental

Patient-reported outcomes presented to multidisciplinary tumor board

干预措施: Capture of patient-reported outcomes (Behavioral)

Group C- INSPIRE intervention

Experimental

Patient-reported outcomes presented to multidisciplinary tumor board

干预措施: Enhanced Clinician Awareness (Behavioral)

Group A- Enhanced Usual Care

Active Comparator

Patient-reported outcomes captured; no data presented in any multidisciplinary tumor board. This group is a historical control.

干预措施: Capture of patient-reported outcomes (Behavioral)

结局指标

主要结局

Treatment modifications

时间窗: Tumor board presentation to 3 months

Any dose reduction or delay during treatment.

次要结局

  • Treatment Modifications (2)(Tumor board presentation to 6 months)
  • Symptom Experience(Tumor board to 6 months)
  • Symptom Experience (1)(Tumor board to 3 months)
  • Treatment alignment(Tumor board presentation to 3 months)
  • Treatment Intensity(Tumor board presentation to 3 months)
  • Surgical Complications(Tumor board presentation to 3 months)
  • Surgical Complications(Tumor board presentation to 6 months)
  • ER visits - Any (1)(Tumor board presentation to 3 months)
  • ER visits - Any (2)(Tumor board presentation to 6 months)
  • ER visits - Count (1)(Tumor board presentation to 3 months)
  • ER visits - Count (2)(Tumor board presentation to 6 months)
  • Hospitalization - Any (1)(Tumor board presentation to 3 months)
  • Hospitalization - Any (2)(Tumor board presentation to 6 months)
  • Hospitalization - Count (1)(Tumor board presentation to 3 months)
  • Hospitalizations - Count (2)(Tumor board presentation to 6 months)
  • ICU - Any (1)(Tumor board presentation to 3 months)
  • ICU - Any (2)(Tumor board presentation to 6 months)
  • ICU - Count (1)(Tumor board presentation to 3 months)
  • ICU - Count (2)(Tumor board presentation to 6 months)
  • Perception of Decision-Making Style(3 months from tumor board)
  • Patient Activation (1)(3 months from tumor board)
  • Patient Activation (2)(6 months from tumor board)
  • Treatment Satisfaction (1)(3 months from tumor board)
  • Treatment Satisfaction (2)(6 months from tumor board)
  • Decision Regret (1)(3 months from tumor board)
  • Decision Regret (2)(6 months from tumor board)
  • Quality of Life (1)(3 months from tumor board)
  • Quality of Life (2)(6 months from tumor board)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabrielle Rocque

Associate Professor

University of Alabama at Birmingham

研究点 (3)

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