Effect of an Interdisciplinary Shared Decision-Making Intervention on Decisional Conflict in Advanced Cancer Patients Receiving Third-Line Therapy (SharedDecision)

Hospital Universitario San Ignacio

Status: Active, not recruiting

Conditions: Decisional Conflict, Advanced/Metastatic Solid Tumors, Shared Decision-making

Treatments: Behavioral: Interdisciplinary Shared Decision-Making Consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT07164365

FM-CIE-0357-25 (Other Identifier)

Details and patient eligibility

About

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.

Full description

• Problem Statement: In Colombia, advanced cancer is common and treatment options become increasingly complex by the third line of therapy, often lacking standardized guidelines. This complexity, along with uncertainty about prognosis and treatment benefits, can lead to significant decisional conflict for patients.
• 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Intervention Arm: Interdisciplinary shared decision-making consultation

Active Comparator group

Description:

Interdisciplinary shared decision-making consultation (with oncologist, palliative care physician, psychologist) following a six-step shared decision-making process.

Treatment:

Behavioral: Interdisciplinary Shared Decision-Making Consultation

Control arm

No Intervention group

Description:

Standard oncology consultation