Decision Aid for Chemotherapy in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer

NCT05701735 | Recruiting

• 1 other identifier: USTH-BCI-RO-2022-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to investigate the utility and effectiveness of a decision aid in cisplatin-intolerant patients with locally advanced cervical cancer. The main questions it aims to answer are:

1. 1.What is the effectiveness of the decision aid in reducing decisional conflict?
2. 2.What is the utility of the decision aid in preparing for decision-making?

Conditions

Locally Advanced Cervical Carcinoma

Keywords

Patient decision aid; Cervical cancer; Chemotherapy; Radiotherapy; Elderly; Renal failure; Decisional conflict

Outcome Measures

Primary Outcomes (1)

• Decisional conflict

  Decisional Conflict Scale (DCS) scores of ≥25 will indicate significant decisional conflict. The proportion of participants having pretest (baseline) and posttest decisional conflict scores of ≥25 for each group will be reported.

  Prior to the second consultation visit (for treatment decision and implementation planning), usually within one week

Secondary Outcomes (1)

• Utility in preparation for decision-making

  After use of the patient decision aid and prior to the second consultation visit (for treatment decision and implementation planning), usually within one week

Study Arms (2)

Routine care

NO INTERVENTION

Routine in-house workflow for initial and follow-up consultation, disclosure of diagnosis, and apprisal and counseling regarding treatment options

Patient decision aid

EXPERIMENTAL

Routine in-house workflow for initial and follow-up consultation, disclosure of diagnosis, and apprisal and counseling regarding treatment options plus provision of a decision aid after the initial consultation

Behavioral: CECIL Patient Decision Aid

Interventions

CECIL Patient Decision Aid BEHAVIORAL

The CECIL patient decision aid explicitly identifies the disease, the index decision, and the treatment options, describes the positive and negative features and consequences of each option, and guides the patient in examining personal values and preferences, to arrive at a quality and realistic decision. The decision aid will be developed and validated according to the guidelines and standards published by the International Patient Decision Aids Standards (IPDAS) Collaboration.

Also known as: Decision Support Intervention

Patient decision aid

Eligibility Criteria

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

You may qualify if:

• Squamous, adeno- or adenosquamous histology
• International Federation of Gynaecology and Obstetrics (FIGO) Stage I-B3, II-A2, II-B to IV-A
• Contraindication to ChT, including but not limited to hydronephrosis, renal or cardiac dysfunction, frailty, or refusal
• Grade 6 level English literacy
• Informed consent

You may not qualify if:

• Other histologies
• Metastatic disease
• Other active cancers
• Prior cancer EXCEPT for a cancer treated curatively, in remission for ≥5 years, with low recurrence risk; adequately treated lentigo maligna or non-melanoma skin cancer without evidence of disease; or adequately treated carcinoma-in-situ without evidence of disease
• Prior pelvic radiotherapy, brachytherapy, or chemotherapy
• Pregnancy
• Cognitive impairment or psychological disturbance limiting study compliance

Sponsors & Collaborators

• University of Santo Tomas Hospital, Philippines: lead
• University of Santo Tomas - Graduate School: collaborator
• University of Santo Tomas - Faculty of Medicine and Surgery: collaborator
• University of Santo Tomas Hospital - Benavides Cancer Institute: collaborator
• Philippine Council for Health Research & Development: collaborator
• Manila Doctors Hospital: collaborator
• Our Lady of Lourdes Hospital: collaborator

Study Sites (3)

Our Lady of Lourdes Hospital

Manila, National Capital Region, 1016, Philippines

RECRUITING

Manila Doctors Hospital

Manila, NCR, 1000, Philippines

RECRUITING

University of Santo Tomas Hospital

Manila, NCR, 1008, Philippines

RECRUITING

Related Publications (1)

• Bacorro W, Baldivia K, Mariano J, Dancel E, Antonio L, Gonzalez G, Ortin TS, Canlas R. Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer: Development, Alpha Testing, and Peer Validation. JCO Glob Oncol. 2023 Sep;9:e2300096. doi: 10.1200/GO.23.00096.

  PMID: 37677124 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Renal Insufficiency

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Warren Bacorro, MD

  University of Santo Tomas Hospital - Benavides Cancer Institute

  STUDY CHAIR

Central Study Contacts

Warren Bacorro, MD

CONTACT

+639171665927; warren.bacorro.gs@ust.edu.ph

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Given the nature of the intervention, true blinding could not be done on the participant, who is also the assessor. Blinding is necessary to control for participant expectation bias and participant performance bias. The provider (gynecologic oncologist) of the standard of care (standard consultation) is blinded to the subsequent assignment to either arm.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase 1: Embedded mixed-methods design Phase 2: Experimental, block-randomized two-arm trial design

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 27, 2023
• Study Start: February 20, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Five years after study completion
• Access Criteria: Data will only be made available to people directly involved with the study or requesting and approved parties who have signed a Confidentiality Agreement.

Locations

PH (3)