Implementation of the Study Participant Feedback Questionnaire to understand participant experience in a phase 3 oncology clinical trial.

ABSTRACT:

Objectives

To understand participant experience in the INTERLINK-1 clinical trial using the Study Participant Feedback Questionnaire (SPFQ), explore factors associated with participant experience and evaluate the implementation of the SPFQ.

Design

Phase 3, randomised, double-blind, placebo-controlled, multicentre trial.

Setting

79 sites in 21 countries from October 2020 to October 2022.

Participants

371 adults with recurrent/metastatic head and neck squamous cell carcinoma (39% aged >66 years, 69% White and 81% male).

Primary outcome measures

SPFQ administered at enrolment (SPFQ-A), during the trial (SPFQ-B) and at trial completion (SPFQ-C).

Results

A total of 223, 64 and 93 participants completed the SPFQ-A, SPFQ-B and SPFQ-C, respectively. Early

SUBMITTER: Nowojewski A 

PROVIDER: S-EPMC12570934 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature