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

NCT05701735UNKNOWNNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

University of Santo Tomas Hospital, Philippines

Enrollment

Start Date

2023-02-20

Completion Date

2024-09-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

CECIL Patient Decision Aid

Conditions

Locally Advanced Cervical Carcinoma

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Locations

Our Lady of Lourdes Hospital, Manila, Philippines

Manila Doctors Hospital, Manila, Philippines

University of Santo Tomas Hospital, Manila, Philippines

Linked Papers

Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer: Development, Alpha Testing, and Peer Validation

PURPOSEIn locally advanced cervical cancer (LACC), adding cisplatin to radiotherapy (RT) improves survival but increases toxicity. Among patients with cisplatin contraindications, RT compliance may be compromised by toxicity because of cisplatin or a substitute. In shared decision making, a patient decision aid (PtDA) may decrease decisional conflict and attitudinal barriers, thereby improving treatment compliance.METHODSFollowing International Patient Decision Aid Standards (IPDAS) guidelines, a steering committee of two radiation oncologists, a gynecologic oncologist, an oncology nurse, a clinical psychologist, a cancer survivor, and a caregiver developed the chemotherapy or exclusion in cisplatin-intolerant patients with LACC (CECIL) prototype, a PtDA for cisplatin-intolerant patients with LACC deciding about adding chemotherapy to RT. The prototype was alpha-tested using the e-Delphi method. The patient decision aid research group Ottawa Acceptability Questionnaire was used to evaluate comprehensibility, length, amount of information, neutrality, and overall suitability for decision making. The prototype was then independently evaluated by local internal, local external, and international reviewers using the IPDAS checklist version 4, which encompasses information, probabilities, values, guidance, development, evidence, disclosure, plain language, and evaluation.RESULTSAlpha testing showed high practitioner acceptability (all items with mean and median scores ≥4; overall mean score 4.70 of 5.00) and good patient acceptability (all items rated good to excellent). Content validation showed that the PtDA satisfied all IPDAS six qualifying and six certification criteria, with high overall mean score (3.63 of 4.00) for all 17 applicable quality criteria.CONCLUSIONThe CECIL prototype shows good practitioner and patient acceptability, and content validity on peer review. Clinical testing to determine its effectiveness in reducing decisional conflict is ongoing.

Linked Investigators

Kathleen Baldivia

Rodel Canlas

Teresa Sy Ortin

Warren Bacorro