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| ID | Type | Description | Link |
|---|---|---|---|
| FM-CIE-0357-25 | Other Identifier | Hospital Universitario San Ignacio |
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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.
Overall, the study is designed to inform best practices on supporting advanced cancer patients in complex treatment decisions, exploring the effects of an interdisciplinary, patient-centered intervention on decisional conflict and related outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm: Interdisciplinary shared decision-making consultation | Active Comparator | Interdisciplinary shared decision-making consultation (with oncologist, palliative care physician, psychologist) following a six-step shared decision-making process. |
|
| Control arm | No Intervention | Standard oncology consultation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interdisciplinary Shared Decision-Making Consultation | Behavioral | One additional face-to-face consultation with a team (oncologist, palliative care, psychologist), following a six-step shared decision-making process. |
| Measure | Description | Time Frame |
|---|---|---|
| Decisional Conflict Score | Measured using the Decisional Conflict Scale (16 items); score ≥25 defines clinically significant conflict | Immediately post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | 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. | Immediately post-intervention and at 3 months follow-up |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario San Ignacio | Bogotá | Bogota D.C. | 111111 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ministerio de salud. Resolución 8430 de 1993. 1993. p. 1-19 | ||
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| Background | Jiménez OR. Interpretación clínica y psicodinámica del MMP1: inventario multifásico de la personalidad de Minnesota. Diana. 1987; | ||
| Background | Trull TJ, David Useda J, Costa PT, Mccrae RR. Comparison of the MMPI-2 Personality Psychopathology Five (PSY-5), the NEO-PI, and the NEO-PI-R. Psychological Assessment. 1995 | ||
| Background | Harkness AR, Mcnulty JL, Ben-Porath YS. The Personality Psychopathology Five (PSY-5) : Constructs and MMPI-2 Scales. Vol. 7, Psychological Assessment. 1995 | ||
| Background | Gordon RM, Stoffey RW, Perkins BL. Comparing the Sensitivity of the MMPI-2 Clinical Scales and the MMPI-RC Scales to Clients Rated as Psychotic, Borderline or Neurotic on the Psychodiagnostic Chart. Psychology. 2013;04(09):12-6. | ||
| Background | Butcher JN, Graham JR, Ben-Porath YS, Tellegen A, Dahlstrom WG, Kaemmer B, et al. MMPI®-2 Inventario Multifásico de Personalidad de Minnesota®-2 Comité de tipificación del MMPI ®-2: Adaptación española: Manual. 2019 |
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We will share the demographic data of the participants in our database.
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Randomized clinical trial; parallel two-arm design (intervention and control)
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| Decision regret | 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. | at 3 months after de intervention |
| Perspective on shared decision-making | 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. | Immediately post-intervention |
| Symptom burden | 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. | 1 day after intervention and 3 months post intervention |
| Neuroticism trait | 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. | Immediately post-intervention |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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