Possibia

5294289

Last Update Posted: 2024-08-09

Recruiting has ended

All Genders

accepted

5 Years-99 Years

60 Estimated Participants

No Expanded Access

Observational Study

Does not accept healthy volunteers

Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study

This is a mixed-methods observational study that incorporates both qualitative interviews and quantitative data collection through a web-based longitudinal survey (day 1, months 2 and 4).

This study will collect qualitative data through interviews with patients and caregivers and qualitative data through a web-based longitudinal survey.

Both parts of the study are designed to collect information on HRQoL, symptom severity, and pain among patients with PROS who are receiving treatment with alpelisib in the US. In addition, patients who have not been treated with alpelisib will also participate in the quantitative part of the study by providing data on HRQoL, symptom severity, and pain, collected from a single administration of the web-based survey.

Fifteen participants treated with alpelisib will be recruited to take part in an hour-long, one-on-one qualitative interview scheduled by GP and conducted by a trained QM qualitative researcher. This subset of 15 participants will complete the first online assessment 1 week after the interview to prevent biasing of their survey responses due to the interview experience. Those that do not take part in the qualitative interview will be directed to complete the online survey upon enrollment (i.e., Day 1, Month 2, Month 4 in reference to time since enrollment in quantitative portion, which is independent of time since the start of treatment). All participants will be directed to complete the online survey which will be accessed through a web link.

Eligibility

Relevant conditions:

PIK3CA-related Overgrowth Spectrum

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

locations

Data sourced from ClinicalTrials.gov