Participation in a randomised controlled feasibility study of a complex intervention for the management of the Respiratory Symptom Distress Cluster in lung cancer: patient, carer and research staff views

Abstract

This paper reports finding from a nested qualitative study designed to elicit the views and perceptions of those who participated in a randomised controlled feasibility trial testing a non‐pharmacological intervention, Respiratory Distress Symptom Intervention (RDSI), for the management of the breathlessness–cough–fatigue symptom cluster in lung cancer. Semi‐structured interviews were conducted with 11 lung cancer patients, three caregivers and seven researchers involved in recruitment, consent, RDSI training and delivery and participant follow‐up. Thematic analysis identified key considerations including: the importance of informed consent emphasising commitment to completion of paperwork and raising awareness of potential sensitivities relating to content of questionnaires; ensuring screening for the presence of symptoms reflects the language used by patients; appreciation of the commitment required from participants to learn intervention techniques and embed them as part of everyday life; conduct of interviews with patients who decline to participate; and conduct of serial interviews with those receiving RDSI to further inform its routine implementation into clinical practice. This study will inform the development of a fully powered follow‐on trial testing the hypothesis that RDSI plus usual care is superior to usual care alone in the effective management of this symptom cluster in lung cancer.

Using qualitative methods in pilot and feasibility trials to inform recruitment and retention processes in full-scale randomised trials: a qualitative evidence synthesis

“…All the included studies were published in English19 28–61 and were conducted in three high-income countries: the UK (n=33), Canada (n=1) and Norway (n=1). The majority of included studies (n=33/94%) were funded by UK organisations with two non-UK funded studies.…”

“…Pre-existing beliefs and expectations among study participants hindered recruitment efforts in ten studies 19 30 33 36 39 42 45 52 59 60…”

“…Participants’ beliefs that undermined involvement in the trial process were: feelings of anxiety about a poor medical outcome and scepticism about being experimented on,36 60 negative image about the hospital ‘a place to die’,45 social desirability perception that the trial was designed to encourage people to stop smoking,19 60 feelings of isolation and powerlessness52 and a sense of denial (participants tended to deny their symptoms and therefore were ineligible) 59. In other cases, nurses believed they needed to protect patients from additional burden (which implicitly they believed the trial would cause) and this was cited as a main recruitment barrier 30…”

“…One study reported changes which were not explicitly linked to coded data 52. In three studies, no specific changes were planned to address these issues 30 45 59…”

“…Presentation of trial information was a major barrier to recruitment and this was evident in eight studies 32 34 50 52–55 59. In many cases, patients failed to understand the language of trial procedures or interpreted trial and clinical terminology quite differently than as intended by practitioners (eg, ‘trial’ was interpreted as ‘try and see’) 31 52 54.…”