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

Sponsor

University of Santo Tomas Hospital, Philippines (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05701735

Collaborator

University of Santo Tomas - Graduate School (Other), University of Santo Tomas - Faculty of Medicine and Surgery (Other), University of Santo Tomas Hospital - Benavides Cancer Institute (Other), Philippine Council for Health Research & Development (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Cervical Carcinoma	Behavioral: CECIL Patient Decision Aid	N/A

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 nonrandomized sequential comparison group pretest-post-test 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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Phase 1: Embedded mixed-methods design Phase 2: Quasi-experimental, non-randomized, sequential comparison-group pretest-posttest designPhase 1: Embedded mixed-methods design Phase 2: Quasi-experimental, non-randomized, sequential comparison-group pretest-posttest design

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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. Therefore, the control group will not be made aware of a subsequent experimental group, and the experimental group will not be made aware of a prior control group.

Primary Purpose:

Other

Official Title:

Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer (CECIL): Development, Validation and Clinical Testing

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Routine care Routine in-house workflow for initial and follow-up consultation, disclosure of diagnosis, and apprisal and counseling regarding treatment options
Experimental: 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	Behavioral: CECIL Patient Decision Aid 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. Other Names: Decision Support Intervention

Arm

Intervention/Treatment

No Intervention: Routine care

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

Experimental: 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

Behavioral: CECIL Patient Decision Aid

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.

Other Names:

Decision Support Intervention

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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