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

NCT07164365 | Active Not Recruiting DMC

• 1 other identifier: FM-CIE-0357-25
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Cancer, advanced disease, decisional conflict, shared decision making, interdisciplinary intervention, oncology, palliative care

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Score

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

  Immediately post-intervention

Secondary Outcomes (5)

• Patient satisfaction

  Immediately post-intervention and at 3 months follow-up

• Decision regret

  at 3 months after de intervention

• Perspective on shared decision-making

  Immediately post-intervention

• Symptom burden

  1 day after intervention and 3 months post intervention

• Neuroticism trait

  Immediately post-intervention

Study Arms (2)

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.

Behavioral: Interdisciplinary Shared Decision-Making Consultation

Control arm

NO INTERVENTION

Standard oncology consultation

Interventions

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.

Intervention Arm: Interdisciplinary shared decision-making consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, Bogota D.C., 111111, Colombia

Location

Related Publications (58)

• Ministerio de salud. Resolución 8430 de 1993. 1993. p. 1-19

  BACKGROUND

• 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

  BACKGROUND

• Jiménez OR. Interpretación clínica y psicodinámica del MMP1: inventario multifásico de la personalidad de Minnesota. Diana. 1987;

  BACKGROUND

• 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

  BACKGROUND

• Harkness AR, Mcnulty JL, Ben-Porath YS. The Personality Psychopathology Five (PSY-5) : Constructs and MMPI-2 Scales. Vol. 7, Psychological Assessment. 1995

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 21514818 BACKGROUND

• 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.

  PMID: 25894883 BACKGROUND

• 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.

  PMID: 18372376 BACKGROUND

• 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.

  PMID: 10813730 BACKGROUND

• Llanos Zavalaga F, Rosas Aguirre A, Mendoza Requena D, Contreras Ríos C. Universidad Peruana Cayetano Heredia. Rev Med Hered. 2001;12(2):52-7

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24593044 BACKGROUND

• 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.

  PMID: 10452420 BACKGROUND

• Urrutia M, Campos S, O'Connor A. [Validation of a Spanish version of the Decisional Conflict scale]. Rev Med Chil. 2008 Nov;136(11):1439-47. doi: 10.4067/s0034-98872008001100010. Spanish.

  PMID: 19301775 BACKGROUND

• Wang MM, Loh EW, Chou JF, Sung PM, Chou YY, Lin YK, Chen SF, Tam KW. Influence of Shared Decision Making on Decisional Conflict and Regret in Postpartum Mother-Infant Care: A Randomized Controlled Trial. Value Health. 2021 Sep;24(9):1335-1342. doi: 10.1016/j.jval.2021.03.011. Epub 2021 May 3.

  PMID: 34452714 BACKGROUND

• Niburski K, Guadagno E, Abbasgholizadeh-Rahimi S, Poenaru D. Shared Decision Making in Surgery: A Meta-Analysis of Existing Literature. Patient. 2020 Dec;13(6):667-681. doi: 10.1007/s40271-020-00443-6.

  PMID: 32880820 BACKGROUND

• Levy D, Dhillon HM, Lomax A, Marthick M, McNeil C, Kao S, Lacey J. Certainty within uncertainty: a qualitative study of the experience of metastatic melanoma patients undergoing pembrolizumab immunotherapy. Support Care Cancer. 2019 May;27(5):1845-1852. doi: 10.1007/s00520-018-4443-3. Epub 2018 Sep 4.

  PMID: 30178142 BACKGROUND

• Roccas S, Sagiv L, Schwartz SH, Knafo A. The Big Five personality factors and personal values. Pers Soc Psychol Bull. 2002;28(6):789-801

  BACKGROUND

• Komarraju M, Karau SJ, Schmeck RR, Avdic A. The Big Five personality traits, learning styles, and academic achievement. Pers Individ Dif. 2011 Sep;51(4):472-7

  BACKGROUND

• Di Fabio A, Saklofske DH, Gori A, Svicher A. Perfectionism: A network analysis of relationships between the Big Three Perfectionism dimensions and the Big Five Personality traits. Pers Individ Dif. 2022 Dec 1;199

  BACKGROUND

• Markon KE. Hierarchies in the Structure of Personality Traits. Soc Personal Psychol Compass. 2009 Sep;3(5):812-26

  BACKGROUND

• Zuckerman M, Kuhlman DM, Joireman J, Teta P, Kraft M. A Comparison of Three Structural Models for Personality: The Big Three, the Big Five, and the Alternative Five. Vol. 65, Journal of Personality and Social Psychology. 1993

  BACKGROUND

• Barlow DH, Ellard KK, Sauer-Zavala S, Bullis JR, Carl JR. The Origins of Neuroticism. Perspect Psychol Sci. 2014 Sep;9(5):481-96. doi: 10.1177/1745691614544528.

  PMID: 26186755 BACKGROUND

• Roemer L, Salters K, Raffa SD, Orsillo SM. Fear and avoidance of internal experiences in GAD: Preliminary tests of a conceptual model. Vol. 29, Cognitive Therapy and Research. 2005. p. 71-88

  BACKGROUND

• McLaughlin KA, Mennin DS, Farach FJ. The contributory role of worry in emotion generation and dysregulation in generalized anxiety disorder. Behav Res Ther. 2007 Aug;45(8):1735-52. doi: 10.1016/j.brat.2006.12.004. Epub 2006 Dec 28.

  PMID: 17270145 BACKGROUND

• Watson D, Clark LA, Harkness AR. Structures of personality and their relevance to psychopathology. J Abnorm Psychol. 1994 Feb;103(1):18-31.

  PMID: 8040477 BACKGROUND

• McCrae RR, Costa PT. Personality in adulthood: A five- factor theory perspective. . 2nd ed. New York: Guilford Press; 2003

  BACKGROUND

• Weiss A, Costa PT Jr. Domain and facet personality predictors of all-cause mortality among Medicare patients aged 65 to 100. Psychosom Med. 2005 Sep-Oct;67(5):724-33. doi: 10.1097/01.psy.0000181272.58103.18.

  PMID: 16204430 BACKGROUND

• Kates JM. Treatment-related Decisional Conflict, Quality of Life, and Comorbidity in Older Adults with Cancer. Asia Pac J Oncol Nurs. 2018 Oct-Dec;5(4):421-429. doi: 10.4103/apjon.apjon_32_18.

  PMID: 30271826 BACKGROUND

• Baek SK, Kim SY, Heo DS, Yun YH, Lee MK. Effect of advanced cancer patients' awareness of disease status on treatment decisional conflicts and satisfaction during palliative chemotherapy: a Korean prospective cohort study. Support Care Cancer. 2012 Jun;20(6):1309-16. doi: 10.1007/s00520-011-1218-5. Epub 2011 Jul 1.

  PMID: 21720748 BACKGROUND

• Baca-Dietz D, Wojnar DM, Espina CR. The shared decision-making model: Providers' and patients' knowledge and understanding in clinical practice. J Am Assoc Nurse Pract. 2020 Jun 30;33(7):529-536. doi: 10.1097/JXX.0000000000000401.

  PMID: 32618736 BACKGROUND

• Arch JJ, Bright EE, Finkelstein LB, Fink RM, Mitchell JL, Andorsky DJ, Kutner JS. Anxiety and Depression in Metastatic Cancer: A Critical Review of Negative Impacts on Advance Care Planning and End-of-Life Decision Making With Practical Recommendations. JCO Oncol Pract. 2023 Dec;19(12):1097-1108. doi: 10.1200/OP.23.00287. Epub 2023 Oct 13.

  PMID: 37831973 BACKGROUND

• Ter Stege JA, Oldenburg HSA, Woerdeman LAE, Witkamp AJ, Kieffer JM, van Huizum MA, van Duijnhoven FH, Hahn DEE, Gerritsma MA, Kuenen MA, Kimmings NAN, Ruhe QPQ, Krabbe-Timmerman IS, Riet MV, Corten EML, Sherman KA, Bleiker EMA. Decisional conflict in breast cancer patients considering immediate breast reconstruction. Breast. 2021 Feb;55:91-97. doi: 10.1016/j.breast.2020.12.001. Epub 2020 Dec 9.

  PMID: 33387811 BACKGROUND

• Calderon C, Ferrando PJ, Lorenzo-Seva U, Higuera O, Ramon Y Cajal T, Rogado J, Mut-Lloret M, Rodriguez-Capote A, Jara C, Jimenez-Fonseca P. Validity and Reliability of the Decision Regret Scale in Cancer Patients Receiving Adjuvant Chemotherapy. J Pain Symptom Manage. 2019 Apr;57(4):828-834. doi: 10.1016/j.jpainsymman.2018.11.017. Epub 2019 Jan 11.

  PMID: 30639730 BACKGROUND

• Gilovich T, Medvec VH. The experience of regret: what, when, and why. Psychol Rev. 1995 Apr;102(2):379-95. doi: 10.1037/0033-295x.102.2.379.

  PMID: 7740094 BACKGROUND

• Hotta K, Kiura K, Takigawa N, Yoshioka H, Hayashi H, Fukuyama H, Nishiyama A, Yokoyama T, Kuyama S, Umemura S, Kato Y, Nogami N, Segawa Y, Yasugi M, Tabata M, Tanimoto M. Desire for information and involvement in treatment decisions: lung cancer patients' preferences and their physicians' perceptions: results from Okayama Lung Cancer Study Group Trial 0705. J Thorac Oncol. 2010 Oct;5(10):1668-72. doi: 10.1097/JTO.0b013e3181f1c8cb.

  PMID: 20871267 BACKGROUND

• Mallinger JB, Shields CG, Griggs JJ, Roscoe JA, Morrow GR, Rosenbluth RJ, Lord RS, Gross H. Stability of decisional role preference over the course of cancer therapy. Psychooncology. 2006 Apr;15(4):297-305. doi: 10.1002/pon.954.

  PMID: 16041829 BACKGROUND

• Ankolekar A, De Ruysscher D, Reymen B, Houben R, Dekker A, Roumen C, Fijten R. Shared decision-making for prophylactic cranial irradiation in extensive-stage small-cell lung cancer: an exploratory study. Transl Lung Cancer Res. 2021 Jul;10(7):3120-3131. doi: 10.21037/tlcr-21-175.

  PMID: 34430352 BACKGROUND

• Pecanac KE, Brown RL, Steingrub J, Anderson W, Matthay MA, White DB. A psychometric study of the decisional conflict scale in surrogate decision makers. Patient Educ Couns. 2018 Nov;101(11):1957-1965. doi: 10.1016/j.pec.2018.07.006. Epub 2018 Jul 7.

  PMID: 30054105 BACKGROUND

• Coronado-Vazquez V, Canet-Fajas C, Delgado-Marroquin MT, Magallon-Botaya R, Romero-Martin M, Gomez-Salgado J. Interventions to facilitate shared decision-making using decision aids with patients in Primary Health Care: A systematic review. Medicine (Baltimore). 2020 Aug 7;99(32):e21389. doi: 10.1097/MD.0000000000021389.

  PMID: 32769870 BACKGROUND

• Jeon BM, Kim SH, Lee SJ. Decisional conflict in end-of-life cancer treatment among family surrogates: A cross-sectional survey. Nurs Health Sci. 2018 Dec;20(4):472-478. doi: 10.1111/nhs.12537. Epub 2018 Jun 19.

  PMID: 29920890 BACKGROUND

• Lenz ER, Pugh LC. Middle range theory for nursing. 3rd ed. Smith Mary Jane, Liehr Patricia R., editors. NewYork: Springer; 2014. 95-165 p

  BACKGROUND

• Emanuel EJ, Emanuel LL. Four models of the physician-patient relationship. JAMA. 1992 Apr 22-29;267(16):2221-6. No abstract available.

  PMID: 1556799 BACKGROUND

• Kane HL, Halpern MT, Squiers LB, Treiman KA, McCormack LA. Implementing and evaluating shared decision making in oncology practice. CA Cancer J Clin. 2014 Nov-Dec;64(6):377-88. doi: 10.3322/caac.21245. Epub 2014 Sep 8.

  PMID: 25200391 BACKGROUND

• Laidsaar-Powell R, Butow P, Bu S, Charles C, Gafni A, Fisher A, Juraskova I. Family involvement in cancer treatment decision-making: A qualitative study of patient, family, and clinician attitudes and experiences. Patient Educ Couns. 2016 Jul;99(7):1146-1155. doi: 10.1016/j.pec.2016.01.014. Epub 2016 Jan 28.

  PMID: 26873544 BACKGROUND

• Gennari A, Andre F, Barrios CH, Cortes J, de Azambuja E, DeMichele A, Dent R, Fenlon D, Gligorov J, Hurvitz SA, Im SA, Krug D, Kunz WG, Loi S, Penault-Llorca F, Ricke J, Robson M, Rugo HS, Saura C, Schmid P, Singer CF, Spanic T, Tolaney SM, Turner NC, Curigliano G, Loibl S, Paluch-Shimon S, Harbeck N; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021 Dec;32(12):1475-1495. doi: 10.1016/j.annonc.2021.09.019. Epub 2021 Oct 19. No abstract available.

  PMID: 34678411 BACKGROUND

• Lowrance WT, Breau RH, Chou R, Chapin BF, Crispino T, Dreicer R, Jarrard DF, Kibel AS, Morgan TM, Morgans AK, Oh WK, Resnick MJ, Zietman AL, Cookson MS. Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART II. J Urol. 2021 Jan;205(1):22-29. doi: 10.1097/JU.0000000000001376. Epub 2020 Sep 22.

  PMID: 32960678 BACKGROUND

• Gonzalez Del Alba A, Mendez-Vidal MJ, Vazquez S, Castro E, Climent MA, Gallardo E, Gonzalez-Billalabeitia E, Lorente D, Maroto JP, Arranz JA. SEOM clinical guidelines for the treatment of advanced prostate cancer (2020). Clin Transl Oncol. 2021 May;23(5):969-979. doi: 10.1007/s12094-021-02561-5. Epub 2021 Feb 24.

  PMID: 33625671 BACKGROUND

• Garvelink MM, Boland L, Klein K, Nguyen DV, Menear M, Bekker HL, Eden KB, LeBlanc A, O'Connor AM, Stacey D, Legare F. Decisional Conflict Scale Use over 20 Years: The Anniversary Review. Med Decis Making. 2019 May;39(4):301-314. doi: 10.1177/0272989X19851345. Epub 2019 May 29.

  PMID: 31142194 BACKGROUND

• Lee YH, Chou XY, Lai YH, Liang YH, Hung CT, Hsaio CC, Gao ZX. Decisional conflict and its determinants among patients with cancer undergoing immunotherapy combined with chemotherapy or targeted therapy: a cross-sectional study. Sci Rep. 2023 Aug 5;13(1):12715. doi: 10.1038/s41598-023-39280-6.

  PMID: 37543690 BACKGROUND

• van Steenhoven JEC, den Dekker BM, Kuijer A, van Diest PJ, Nieboer P, Zuetenhorst JM, Imholz ALT, Siesling S, van Dalen T. Patients' perceptions of 70-gene signature testing: commonly changing the initial inclination to undergo or forego chemotherapy and reducing decisional conflict. Breast Cancer Res Treat. 2020 Jul;182(1):107-115. doi: 10.1007/s10549-020-05683-6. Epub 2020 May 19.

  PMID: 32430679 BACKGROUND

• Hoesseini A, Dorr MC, Dronkers EAC, de Jong RJB, Sewnaik A, Offerman MPJ. Decisional Conflict in Patients With Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2023 Feb 1;149(2):160-167. doi: 10.1001/jamaoto.2022.4269.

  PMID: 36547952 BACKGROUND

• Ribi K, Kalbermatten N, Eicher M, Strasser F. Towards a novel approach guiding the decision-making process for anticancer treatment in patients with advanced cancer: framework for systemic anticancer treatment with palliative intent. ESMO Open. 2022 Jun;7(3):100496. doi: 10.1016/j.esmoop.2022.100496. Epub 2022 May 18.

  PMID: 35597176 BACKGROUND

• Fondo Colombiano de Enfermedades de Alto Costo. Situación del cáncer en la población adulta atendida en el SGSSS de Colombia 2022. Bogotá: Cuenta de Alto Costo (CAC); 2023. 58 p.

  BACKGROUND

• Ferlay J, Bray F, Soerjomataram I, Znaor A, Ervik M, Lam F, et al. International Agency for Research on Cancer. 2024 (cited 2024 Sep 7). Global Cancer Observatory: Cancer Today.

  BACKGROUND

• Saini KS, Twelves C. Determining lines of therapy in patients with solid cancers: a proposed new systematic and comprehensive framework. Br J Cancer. 2021 Jul;125(2):155-163. doi: 10.1038/s41416-021-01319-8. Epub 2021 Apr 13.

  PMID: 33850304 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial; parallel two-arm design (intervention and control)

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: September 10, 2025
• Study Start: August 10, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CO (1)