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

Not Applicable

Recruiting

• Conditions: Locally Advanced Cervical Carcinoma
• Interventions: Behavioral: CECIL Patient Decision Aid

• Registration Number: NCT05701735
• Lead Sponsor: University of Santo Tomas Hospital, Philippines

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. What is the effectiveness of the decision aid in reducing decisional conflict?

2. What is the utility of the decision aid in preparing for decision-making?

Participants will be asked to accomplish the Decisional Conflict Scale before and after using the decision aid.

Researchers will compare patients given routine care and the decision aid with patients given routine care to see if the decision aid reduces decisional conflict.

Detailed Description

In locally advanced cervical cancer (LACC), adding chemotherapy (ChT) to radiotherapy (RT) improves survival at the cost of increased toxicity. Among patients with cisplatin contraindications, compliance to RT may be compromised. Shared decision-making (SDM) allows for more patient engagement in the decision-making process and decision implementation planning. In cancer-related decision-making, patient decision aids (PtDA) facilitate the SDM process and have increased patient knowledge and satisfaction and decreased decisional conflict and attitudinal barriers improved patient satisfaction and treatment compliance.

The CECIL study is a two-phase study to develop, validate and test the effectiveness of a PtDA for cisplatin-intolerant LACC patients faced with the decision of adding ChT to RT. Phase 1 is a mixed-methods study to develop a PtDA prototype and determine its content validity and user acceptability. Phase 2 is a block-randomized clinical trial to determine its effectiveness in reducing decisional conflict and its utility in preparing for decision-making. Adult women with biopsy-proven untreated LACC with cisplatin contraindications will be included in this trial.

Study Timeline

• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-27
• Study Start: 2023-02-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Patient decision aid	CECIL Patient Decision Aid	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

Primary Outcome Measures

Name	Time	Method
Decisional conflict	Prior to the second consultation visit (for treatment decision and implementation planning), usually within one week	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.

Secondary Outcome Measures

Name	Time	Method
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	For the experimental group, the overall utility of the decision will be measured using the Preparation for Decision-Making Scale (PDMS). This will be reported as the averaged individual user mean scores using the PDMS and the confidence interval.

Trial Locations

Locations (3)

University of Santo Tomas Hospital; 🇵🇭 Manila, NCR, Philippines

Our Lady of Lourdes Hospital; 🇵🇭 Manila, Metro Manila, Philippines

Manila Doctors Hospital; 🇵🇭 Manila, NCR, Philippines