Patient Journey in Advanced Gynecologic Cancers
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorTongji Hospital
About this trial
This is a mixed-methods survey study including a 2-phased sequential-explanatory design. This study is to understand the patient journey in conventional therapy for newly diagnosed stage III or IV CC or EC in China, including ①patients' treatment decision making factors and treatment experiences and ② patients' unmet needs during post-treatment surveillance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Newly diagnosed stage III or IV CC or EC
Completed their initial conventional therapies which must include at least chemotherapy, radiotherapy or a combination between Dec. 2022 to Dec. 2024 and the therapies were within 6 months after diagnosis.
Told by their physician that their disease is stable.
Disqualifiers
Previously treated with targeted biologic therapy anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
Previously participated in or participating in a clinical trial.
Patients who received another line of therapy after initial therapy.
Unable or unwilling to provide informed consent.
Trial population
It is estimated that \~780 patients will be included in this study. For qualitative insights, previous studies have shown that a minimum of 12 respondents (Guest et al. 2006) is required to reach data saturation. A sample size of \~30 will be sufficient to gather qualitative insights and attain saturation. For quantitative survey, considering most of the variables in quantitative survey are categorical variables, we tend to use 50% in the sample size formula since it will provide us with the maximum sample size required for any question, we calculated the sample size to be \~750 with a confidence interval of 95% and margin of error 5%. The number of specific experts interviewed may be fine-tuned depending on actual implementation.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
interview
Other intervention30 for Qualitative interview and 750 for quantitative survey
Treatment groups
780 Participants
are divided into 1 treatment groupGroup A: experimental group1 intervention
Trial outcomes
Primary outcomes
1
Treatment decision making
1. Information seeking in treatment decision 2. Treatment decision making factors 3. Clinical trial awareness
Time frame
1 day. At the time of the interview.2
Initial treatment experiences
1. Influence of treatment on daily life and work 2. Information and education during treatment 3. Coordination of care 4. Overall impression on care received and doctor/nurses' availability
Time frame
1 day. At the time of the interview.3
Unmet needs and gaps from diagnosis to post-treatment surveillance
1. Psychological and emotional needs 2. Social support needs 3. Healthcare needs 4. Gaps during follow-up care
Time frame
1 day. At the time of the interview.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: