Locally Advanced Cervical CarcinomaCECILNCT05701735
Decision Aid for Chemotherapy in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer
A study testing CECIL Patient Decision Aid in people with Locally Advanced Cervical Carcinoma, run by University of Santo Tomas Hospital, Philippines at 3 sites in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Carcinoma
- What is being tested?
- CECIL Patient Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesPhilippines
- Study dates
- 20 Feb 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Philippines3 sites, 3 recruiting
- Recruiting
Our Lady of Lourdes Hospital
Manila, National Capital Region, 1016
Warren Bacorro, MD, 09171665927, warren.bacorro.gs@ust.edu.ph
Genalin Amparo, MD, gingfabul@yahoo.com
- Recruiting
Manila Doctors Hospital
Manila, NCR, 1000
Warren Bacorro, MD, warren.bacorro.gs@ust.edu.ph
Aida Bautista, MD, aidabautista85@yahoo.com
- Recruiting
University of Santo Tomas Hospital
Manila, NCR, 1008
Warren Bacorro, MD, warren.bacorro.gs@ust.edu.ph
Teresa Sy Ortin, MD, ttsy-ortin@ust.edu.ph
About this study
Official title: Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer (CECIL): Development, Validation and Clinical Testing
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.
Read the 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.
- Conditions
- Locally Advanced Cervical Carcinoma
- Being tested
- CECIL Patient Decision Aid
- Keywords
- Patient decision aid, Cervical cancer, Chemotherapy, Radiotherapy, Elderly, Renal failure, Decisional conflict
- Medical subject headings
- Uterine Cervical Neoplasms, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CECIL Patient Decision AidBehavioural
Also called Decision Support Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: CECIL Patient Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: After use of the patient decision aid and prior to the second consultation visit (for treatment decision and implementation planning), usually within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start20 Feb 2023
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase 1: Embedded mixed-methods design Phase 2: Experimental, block-randomized two-arm trial design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santo Tomas Hospital, Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- University of Santo Tomas - Graduate School, University of Santo Tomas - Faculty of Medicine and Surgery, Philippine Council for Health Research & Development, Manila Doctors Hospital, Our Lady of Lourdes Hospital
- Responsible party
- Principal investigator, Warren Bacorro, University of Santo Tomas Hospital, Philippines
- Investigators
- Warren Bacorro, MD, Study chair, University of Santo Tomas Hospital, Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701735
- Sponsor's protocol ID
- USTH-BCI-RO-2022-02
- Acronym
- CECIL
- Status last verified
- Feb 2024
- First submitted
- 27 Dec 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data generated in this study will remain confidential and will be stored securely at the University of Santo Tomas Hospital - Benavides Cancer Institute and will be made available upon request and upon approval of the study team.
Publications
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.
PubMed 37677124
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer (CECIL): Development, Validation and Clinical Testing
- ClinicalTrials.gov ID
- NCT05701735
- Acronym / sponsor ID
- CECIL / USTH-BCI-RO-2022-02
- Conditions
- Locally Advanced Cervical Carcinoma
- Keywords
- Patient decision aid, Cervical cancer, Chemotherapy, Radiotherapy, Elderly, Renal failure, Decisional conflict
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Santo Tomas Hospital, PhilippinesUniversity, hospital or other
- Collaborators
- University of Santo Tomas - Graduate School, University of Santo Tomas - Faculty of Medicine and Surgery, Philippine Council for Health Research & Development, Manila Doctors Hospital, Our Lady of Lourdes Hospital
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1: Embedded mixed-methods design Phase 2: Experimental, block-randomized two-arm trial design
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: CECIL Patient Decision AidRoutine 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CECIL Patient Decision AidAlso: Decision Support InterventionThe 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. | Behavioural | Patient decision aid |
Primary outcome
Decisional conflict
Time frame: 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.
1 secondary outcome
Utility in preparation for decision-making
Time frame: After use of the patient decision aid and prior to the second consultation visit (for treatment decision and implementation planning), usually within one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Results publication: PubMed 37677124Bacorro 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.
- Individual participant dataSharing planned: Yes. All data generated in this study will remain confidential and will be stored securely at the University of Santo Tomas Hospital - Benavides Cancer Institute and will be made available upon request and upon approval of the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Bacorro, MD study chair
University of Santo Tomas Hospital, Philippines
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CECIL Patient Decision Aid in people with Locally Advanced Cervical Carcinoma, run by University of Santo Tomas Hospital, Philippines at 3 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Warren Bacorro, MD (+639171665927, warren.bacorro.gs@ust.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict (time frame: Prior to the second consultation visit (for treatment decision and implementation planning), usually within one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.