Trial reportBMJ open2025
Implementation of the Study Participant Feedback Questionnaire to understand participant experience in a phase 3 oncology clinical trial.
Trial report in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04590963 (A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
Who cites it
1 citing paper in PubMed.
- Participant Experience, Acceptability and Feasibility of Virtual and Digitally Supported Visits in a Phase IIa COPD Trial.Journal of patient experience · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
objectivesTo 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.
designPhase 3, randomised, double-blind, placebo-controlled, multicentre trial.
setting79 sites in 21 countries from October 2020 to October 2022.
participants371 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).
resultsA total of 223, 64 and 93 participants completed the SPFQ-A, SPFQ-B and SPFQ-C, respectively. Early termination of the INTERLINK-1 study limited the number of SPFQ-B and SPFQ-C responses. For all but one question, over 80% of participants selected positive responses, indicating positive experience with regards to enrolment (SPFQ-A), site (SPFQ-B) and overall trial (SPFQ-C). Individually, quality of life, continent and race were significantly associated with participant experience. Small numbers of negative and neutral responses enabled the construction of multiple ordinal regression models and were used to identify unbiased coefficients associated with patient experience. The models showed that males and participants in Asia reported worse experiences in questions regarding trial enrolment (p<0.05). Recent adverse events and higher Eastern Cooperative Oncology Group (ECOG) performance status were significantly negatively associated with trial site satisfaction (B1; OR 0.24, 95% CI 0.06 to 0.96, p<0.05) and site staff-related questions (B5; OR 0.18, 95% CI 0.04 to 0.93, p<0.05), respectively. Indications of acquiescence bias were found, possibly due to SPFQ question design.
conclusionsOverall, participants reported positive experiences in the INTERLINK-1 study as evaluated by the SPFQ. Specific aspects of participant experience varied by sex, continent, recent adverse events and ECOG status. Further investigation is required to understand the causes of these findings to develop strategies for improved participant experience. Observations from this study will be used to inform future SPFQ implementation and develop strategies for better, more equitable trial experiences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT04590963.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.