Communicating trial results to participants Not Applicable
Conditions
Interventions
In Show RESPECT, ICON8 sites will be randomised using 2 by 2 by 2 factorial cluster randomisation. Therefore there will be 8 possible intervention combinations. The interventions within the study are:
Sponsors
University College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Participant in the ICON8 trial 2. Currently being followed up at an ICON8 trial site in England, Scotland, Wales and Northern Ireland 2.1. Including those with reduced follow-up arrangements 3. Aged 18 years or older
Exclusion criteria
Exclusion criteria: 1. Participant has previously informed their site that they do not wish to attend any further visits in relation to the ICON8 trial 2. Lost to follow-up from the ICON8 trial 3. Site staff consider the patient to be too unwell to be contacted about this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is participant’s satisfaction with the way they found out the results of ICON8, measured using a 5-point Likert scale one month after receiving the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The extent of participant’s agreement with the statement ‘the information about the trial results told me everything I wanted to know’, measured using a 5-point Likert scale one month after receiving the intervention. 2. Participants’ Ease of understanding of the results, measured using a 5-point Likert scale one month after receiving the intervention. 3. How upsetting participants found the results, measured using a 5-point Likert scale one month after receiving the intervention. 4. Participants’ willingness to take part in another trial in the future, measured using a 5-point Likert scale one month after receiving the intervention. 5. Participants’ likelihood of recommending taking part in a clinical trial to friends and family, measured using a 5-point Likert scale one month after receiving the intervention. 6. How glad participants are to have found out the results, measured using a 5-point Likert scale one month after receiving the intervention. 7. Participants’ regret at finding out the results, measured using a 5-point Likert scale one month after receiving the intervention. 8. Reported uptake of the interventions offered, measured using self-report via a questionnaire one month after receiving the intervention. 9. Proportion of participants who reported wanting to find out the results but not having done so, measured using a questionnaire one month after receiving the intervention. 10. Proportion of participants who reported not wanting to find out the results who did find out the results, measured using a questionnaire one month after receiving the intervention. 11. Participants’ reported ease of finding out the results, measured using a 5-point Likert scale one month after receiving the intervention. 12. Other ways participants would have liked to receive the result, measured using free-text question in a questionnaire one month after receiving the intervention. 13. Participants preferred way to receive the results, measured using a multiple choice ques | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactAnnabelle South
Outcome results
None listed