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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-10

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial; parallel two-arm design (intervention and control)
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Interdisciplinary Shared Decision-Making Consultation

Intervention Type BEHAVIORAL

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

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario San Ignacio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario San Ignacio

Bogotá, Bogota D.C., Colombia

Site Status

Countries

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Colombia

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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