Clinical trial NCT05701735: Decision Aid for Chemotherapy in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer
Official title: Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer (CECIL): Development, Validation and Clinical Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Locally Advanced Cervical Carcinoma
Keywords: Patient decision aid
Cervical cancer
Chemotherapy
Radiotherapy
Elderly
Renal failure
Decisional conflict
Lead sponsor: University of Santo Tomas Hospital, Philippines
Sponsor class: OTHER
Collaborators: name: University of Santo Tomas - Graduate School
name: University of Santo Tomas - Faculty of Medicine and Surgery
name: University of Santo Tomas Hospital - Benavides Cancer Institute
name: Philippine Council for Health Research & Development
name: Manila Doctors Hospital
name: Our Lady of Lourdes Hospital
First posted: 2023-01-27
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase 1: Embedded mixed-methods design Phase 2: Experimental, block-randomized two-arm trial design
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decisional conflict
timeFrame: Prior to the second consultation visit (for treatment decision and implementation planning), usually within one week
Secondary outcomes:
measure: Utility in preparation for decision-making
timeFrame: After use of the patient decision aid and prior to the second consultation visit (for treatment decision and implementation planning), usually within one week
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Our Lady of Lourdes Hospital
state: Metro Manila
city: Manila
country: Philippines
facility: Manila Doctors Hospital
state: NCR
city: Manila
country: Philippines
facility: University of Santo Tomas Hospital
state: NCR
Study officials:
affiliation: University of Santo Tomas Hospital - Benavides Cancer Institute
name: Warren Bacorro, MD
role: STUDY_CHAIR
References:
citation: 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.