Effect of an Interdisciplinary Shared Decision-Making Intervention on Decisional Conflict in Advanced Cancer Patients Receiving Third-Line Therapy
NCT ID: NCT07164365
Last Updated: 2025-09-10
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
62 participants
INTERVENTIONAL
2025-08-10
2026-04-30
Brief Summary
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Detailed Description
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* Objective: To determine whether a structured interdisciplinary intervention using shared decision-making reduces decisional conflict compared to standard care.
* Population: Adults (≥18 years) with metastatic lung, breast, colon, ovary, or prostate cancer at Hospital San Ignacio, eligible for third-line systemic therapy.
* Intervention: The intervention group receives an additional consultation involving a medical oncologist, palliative care physician, and psychologist. The session follows six steps: inviting the patient to participate, describing options, detailing benefits and risks, clarifying patient goals, facilitating decision deliberation, and outlining next steps-all based on the shared decision-making model.
* Control Group: Receives standard oncology consultation only.
* Randomization: Assignment is done randomly and independently.
* Outcomes:
* Primary: Decisional conflict measured by the Decisional Conflict Scale.
* Secondary: Patient satisfaction, decision regret, perceptions of shared decision-making, symptom burden, and levels of neuroticism, all assessed with validated instruments.
* Sample Size: 62 participants (31 per group) are planned, allowing for potential losses.
* Follow-up: Patients are assessed immediately after intervention/consultation and again at three months.
* Analysis: Data will be analyzed by intention-to-treat, using quantitative scales, and adjusting for confounding factors. Subgroup analyses by demographic and clinical characteristics are planned.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Arm: Interdisciplinary shared decision-making consultation
Interdisciplinary shared decision-making consultation (with oncologist, palliative care physician, psychologist) following a six-step shared decision-making process.
Interdisciplinary Shared Decision-Making Consultation
One additional face-to-face consultation with a team (oncologist, palliative care, psychologist), following a six-step shared decision-making process.
Control arm
Standard oncology consultation
No interventions assigned to this group
Interventions
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Interdisciplinary Shared Decision-Making Consultation
One additional face-to-face consultation with a team (oncologist, palliative care, psychologist), following a six-step shared decision-making process.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hospital Universitario San Ignacio
OTHER
Responsible Party
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Locations
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Hospital Universitario San Ignacio
Bogotá, Bogota D.C., Colombia
Countries
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References
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Other Identifiers
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FM-CIE-0357-25
Identifier Type: OTHER
Identifier Source: secondary_id
FM-CIE-0357-25
Identifier Type: -
Identifier Source: org_study_id
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