NCT07164365 — Effect of an Interdisciplinary Shared Decision-Making Intervention on Decisional Conflict in Advanced Cancer Patients Receiving Third-Line Therapy · CancerIndex
Clinical trial · Interventional
Effect of an Interdisciplinary Shared Decision-Making Intervention on Decisional Conflict in Advanced Cancer Patients Receiving Third-Line Therapy
Decisional Conflict in Patients With Advanced Cancer in a Shared Decision-Making Model: A Randomized Clinical Trial
The study aims to evaluate whether an interdisciplinary intervention based on a shared decision-making model can reduce decisional conflict in patients with metastatic solid tumors (lung, breast, colorectal, prostate, or ovarian cancer) who are indicated for third-line systemic treatment. Participants are randomized to receive either standard oncology consultation or an additional interdisciplinary consultation involving oncology, palliative care, and psychology. The intervention emphasizes providing information and support for treatment decisions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Measured using the Decisional Conflict Scale (16 items); score ≥25 defines clinically significant conflict
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
* Age ≥18 years
* Diagnosed with metastatic lung, breast, colon, ovary, or prostate cancer
* Have completed two prior lines of systemic therapy
* Indication for third-line systemic therapy (chemotherapy, immunotherapy, or hormone therapy)
* Under follow-up at Hospital San Ignacio
* Capacity to provide informed consent
* Exclusion Criteria:
References
Publications (58)
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Secondary outcomes (5)
measure
Patient satisfaction
timeFrame
Immediately post-intervention and at 3 months follow-up
description
Measure of the importance of patient satisfaction as a key quality indicator and highlights the use of the Likert scale as an effective tool for measuring perceptions of healthcare quality. The objective is to evaluate patient satisfaction by using the Likert scale, where scores of 7 denote satisfaction, and scores different from 7 indicate dissatisfaction.
measure
Decision regret
timeFrame
at 3 months after de intervention
description
Use of the Decision Regret Scale (EAD) to measure patients' regret after making healthcare decisions. The objective is to assess the level of decision regret, with higher scores indicating greater regret, to better understand patients' emotional responses and improve decision-making processes.
measure
Perspective on shared decision-making
timeFrame
Immediately post-intervention
description
This is a short, patient-centered questionnaire to assess the shared decision-making process in clinical settings. It is psychometrically robust, easy to use, and provides both an overall score and item-level insights, making it valuable for evaluating interventions and improving patient-physician collaboration in healthcare decisions.
measure
Symptom burden
timeFrame
1 day after intervention and 3 months post intervention
description
We are going to measure this using the Edmonton Symptom Assessment Scale (ESAS) is a brief, patient-completed tool designed to assess the severity of common symptoms in palliative care, especially among cancer patients. It uses 10 visual numeric scales to evaluate both physical and psychological symptoms, is validated in multiple languages, and is widely used in clinical and research settings for ongoing symptom monitoring.
measure
Neuroticism trait
timeFrame
Immediately post-intervention
description
We are going to measure this using the MMPI-2, which is a comprehensive psychological assessment tool designed to evaluate a wide range of personality traits and psychopathological conditions. It is widely used in clinical and research settings, and for this study, only the neuroticism dimension will be assessed using a subset of 33 items. The results are interpreted using standardized T scores, with higher scores indicating greater psychological distress or maladaptive traits.
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