Decisional Conflict, Advanced/Metastatic Solid Tumors, Shared Decision-makingSharedDecisionNCT07164365

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

A study testing Interdisciplinary Shared Decision-Making Consultation in people with Decisional Conflict, Advanced/Metastatic Solid Tumors, Shared Decision-making, run by Hospital Universitario San Ignacio at 1 site in Colombia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Decisional Conflict, Advanced/Metastatic Solid Tumors, Shared Decision-making
What is being tested?: Interdisciplinary Shared Decision-Making Consultation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteColombia
Study dates: 10 Aug 2025to Apr 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Hospital Universitario San Ignacio
Bogotá, Bogota D.C., 111111

Other trials in Colombia

About this study

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

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.

Read the detailed 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.

Conditions: Decisional Conflict, Advanced/Metastatic Solid Tumors, Shared Decision-making
Being tested: Interdisciplinary Shared Decision-Making Consultation
Keywords: Cancer, advanced disease, decisional conflict, shared decision making, interdisciplinary intervention, oncology, palliative care
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interdisciplinary Shared Decision-Making ConsultationBehavioural
One additional face-to-face consultation with a team (oncologist, palliative care, psychologist), following a six-step shared decision-making process.

Study groups in NCT07164365
Study group	Role	What they receive
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. Receives: Behavioral: Interdisciplinary Shared Decision-Making Consultation
Control arm	No intervention	Standard oncology consultation

What is being measured

The primary outcome is the main question the study is designed to answer.

Decisional Conflict Score
Measured using the Decisional Conflict Scale (16 items); score ≥25 defines clinically significant conflict
Measured: Immediately post-intervention

Secondary outcomes (5)

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.
Measured: Immediately post-intervention and at 3 months follow-up
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 2025Apr 2026

First posted10 Sep 2025
Study start10 Aug 2025
Primary completionJan 2026 (estimated)
Study completionApr 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (58)Papers the sponsor has linked to this study.
Other trials for Decisional Conflict, Advanced/Metastatic Solid Tumors, Shared Decision-makingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized clinical trial; parallel two-arm design (intervention and control)
Masking: None (open label)
Enrolment: 62 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07164365
Sponsor's protocol ID: FM-CIE-0357-25
Other IDs: FM-CIE-0357-25
Acronym: SharedDecision
Status last verified: Sep 2025
First submitted: 28 Jul 2025
Last updated: 10 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will share the demographic data of the participants in our database.

Publications

Ministerio de salud. Resolución 8430 de 1993. 1993. p. 1-19
Ben-Porath YS, Hosteller K, Butcher JN, Graham JR, Ben-Porath S. New Subscales for the MMPI-2 Social Introversion (Si) Scale. Vol. l, Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989
Jiménez OR. Interpretación clínica y psicodinámica del MMP1: inventario multifásico de la personalidad de Minnesota. Diana. 1987;
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
Harkness AR, Mcnulty JL, Ben-Porath YS. The Personality Psychopathology Five (PSY-5) : Constructs and MMPI-2 Scales. Vol. 7, Psychological Assessment. 1995
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.
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
Carvajal A, Centeno C, Watson R, Bruera E. A comprehensive study of psychometric properties of the Edmonton Symptom Assessment System (ESAS) in Spanish advanced cancer patients. Eur J Cancer. 2011 Aug;47(12):1863-72. doi: 10.1016/j.ejca.2011.03.027. Epub 2011 Apr 22.
PubMed 21514818
Aktas A, Walsh D, Kirkova J. The psychometric properties of cancer multisymptom assessment instruments: a clinical review. Support Care Cancer. 2015 Jul;23(7):2189-202. doi: 10.1007/s00520-015-2732-7. Epub 2015 Apr 19.
PubMed 25894883
Nekolaichuk C, Watanabe S, Beaumont C. The Edmonton Symptom Assessment System: a 15-year retrospective review of validation studies (1991--2006). Palliat Med. 2008 Mar;22(2):111-22. doi: 10.1177/0269216307087659.
PubMed 18372376
Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71. doi: 10.1002/(sici)1097-0142(20000501)88:93.0.co;2-5.
PubMed 10813730
Llanos Zavalaga F, Rosas Aguirre A, Mendoza Requena D, Contreras Ríos C. Universidad Peruana Cayetano Heredia. Rev Med Hered. 2001;12(2):52-7
Floriano N, Aranda R, Manuel J, González R, Maribel A, Rodríguez A, et al. Validación de Shared Decision Making Questionnaire-physician version (SDM-Q-Doc) en español Revista Clínica de. Medicina de Familia (Internet). 2020;13(3):190-7. Available from: http://www.redalyc.org/articulo.oa?id=169664978003
De las Cuevas C, Perestelo-Perez L, Rivero-Santana A, Cebolla-Marti A, Scholl I, Harter M. Validation of the Spanish version of the 9-item Shared Decision-Making Questionnaire. Health Expect. 2015 Dec;18(6):2143-53. doi: 10.1111/hex.12183. Epub 2014 Mar 5.
PubMed 24593044
Charles C, Gafni A, Whelan T. Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med. 1999 Sep;49(5):651-61. doi: 10.1016/s0277-9536(99)00145-8.
PubMed 10452420

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Decisional Conflict in Patients With Advanced Cancer in a Shared Decision-Making Model: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT07164365
Acronym / sponsor ID: SharedDecision / FM-CIE-0357-25
Conditions: Decisional Conflict, Advanced/Metastatic Solid Tumors, Shared Decision-making
Keywords: Cancer, advanced disease, decisional conflict, shared decision making, interdisciplinary intervention, oncology, palliative care
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 62 participants (estimated)
Lead sponsor: Hospital Universitario San IgnacioUniversity, hospital or other
Study start: 10 Aug 2025 (actual)
Primary completion: Jan 2026 (estimated)
Study completion: Apr 2026 (estimated)
First posted: 10 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized clinical trial; parallel two-arm design (intervention and control)

Arm	Type	Receives
Intervention Arm: Interdisciplinary shared decision-making consultation	Active comparator	Behavioral: Interdisciplinary Shared Decision-Making ConsultationInterdisciplinary 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interdisciplinary Shared Decision-Making ConsultationOne additional face-to-face consultation with a team (oncologist, palliative care, psychologist), following a six-step shared decision-making process.	Behavioural	Intervention Arm: Interdisciplinary shared decision-making consultation

Primary outcome

Decisional Conflict Score
Time frame: Immediately post-intervention
Measured using the Decisional Conflict Scale (16 items); score ≥25 defines clinically significant conflict

5 secondary outcomes

Patient satisfaction
Time frame: Immediately post-intervention and at 3 months follow-up
Decision regret
Time frame: at 3 months after de intervention
Perspective on shared decision-making
Time frame: Immediately post-intervention
Symptom burden
Time frame: 1 day after intervention and 3 months post intervention
Neuroticism trait
Time frame: Immediately post-intervention

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
BackgroundMinisterio de salud. Resolución 8430 de 1993. 1993. p. 1-19
BackgroundBen-Porath YS, Hosteller K, Butcher JN, Graham JR, Ben-Porath S. New Subscales for the MMPI-2 Social Introversion (Si) Scale. Vol. l, Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989
BackgroundJiménez OR. Interpretación clínica y psicodinámica del MMP1: inventario multifásico de la personalidad de Minnesota. Diana. 1987;
BackgroundTrull 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
BackgroundHarkness AR, Mcnulty JL, Ben-Porath YS. The Personality Psychopathology Five (PSY-5) : Constructs and MMPI-2 Scales. Vol. 7, Psychological Assessment. 1995
BackgroundGordon 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.
BackgroundButcher 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
Background: PubMed 21514818Carvajal A, Centeno C, Watson R, Bruera E. A comprehensive study of psychometric properties of the Edmonton Symptom Assessment System (ESAS) in Spanish advanced cancer patients. Eur J Cancer. 2011 Aug;47(12):1863-72. doi: 10.1016/j.ejca.2011.03.027. Epub 2011 Apr 22.
Background: PubMed 25894883Aktas A, Walsh D, Kirkova J. The psychometric properties of cancer multisymptom assessment instruments: a clinical review. Support Care Cancer. 2015 Jul;23(7):2189-202. doi: 10.1007/s00520-015-2732-7. Epub 2015 Apr 19.
Background: PubMed 18372376Nekolaichuk C, Watanabe S, Beaumont C. The Edmonton Symptom Assessment System: a 15-year retrospective review of validation studies (1991--2006). Palliat Med. 2008 Mar;22(2):111-22. doi: 10.1177/0269216307087659.
Background: PubMed 10813730Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71. doi: 10.1002/(sici)1097-0142(20000501)88:93.0.co;2-5.
BackgroundLlanos Zavalaga F, Rosas Aguirre A, Mendoza Requena D, Contreras Ríos C. Universidad Peruana Cayetano Heredia. Rev Med Hered. 2001;12(2):52-7
Individual participant dataSharing planned: Yes. We will share the demographic data of the participants in our database.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decisional Conflict Score (time frame: Immediately post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07164365, which also lists 58 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.