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NCT Number: NCT07164365

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario San Ignacio

Bogotá, Bogota D.C., 111111, Colombia

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

Treatment and study plan

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.

Primary outcomes

  1. Decisional Conflict Score

    Time frame: Immediately post-intervention

    Measured using the Decisional Conflict Scale (16 items); score ≥25 defines clinically significant conflict

Secondary outcomes

  1. Patient satisfaction

    Time frame: Immediately post-intervention and at 3 months follow-up

    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.

  2. Decision regret

    Time frame: at 3 months after de intervention

    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.

  3. Perspective on shared decision-making

    Time frame: Immediately post-intervention

    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.

  4. Symptom burden

    Time frame: 1 day after intervention and 3 months post intervention

    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.

  5. Neuroticism trait

    Time frame: Immediately post-intervention

    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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario San Ignacio

Other

Registry information

Official study title

Decisional Conflict in Patients With Advanced Cancer in a Shared Decision-Making Model: A Randomized Clinical Trial

Acronym: SharedDecision

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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