Discussion
cancer, breast cancer
CANCER, BREAST CANCER
We found that the most common reasons to participate in the clinical trial were to support research and help others. Another frequent reason to participate were to receive the cooling treatment. A study by Sheridan et al. found that the potential for personal benefit from the study was the most commonly reported facilitator of research participation [Another major theme in the interviews focused on how taking part in a clinical trial demand personal resources. The participants mentioned factors that influence the decision to take part in the clinical trial, such as being informed, the comprehensiveness of the clinical trial, and the opportunity to back out of the trial. Barriers for taking part in clinical trials were personal and financial costs by participating and the large number of clinical trials introduced to patients. The latter meaning, the sheer number of trials they were presented to had a negative effect on the mental resources of the participants. An important finding, as these patients could be presented for several trials in the beginning of their breast cancer treatment.Many of the participants mentioned that the extra examination in the clinical trial induced a felling of safety. They felt their treatment was better when participating in the trial because of the additional follow-ups. However, one participant mentioned that some patients may not have energy to take part in extra examinations because of lack of energy that the cancer and the treatment induces. A study by Keruakous et al. found that frequent laboratory testing and office visits were a barrier to the patients’ willingness to participate in clinical trials [One of the participants mentioned that she experienced discomfort due to being in the control group and did not understand why everyone was not just given the cooling treatment. A study by Chatters et al. found that participants often had positive preconceptions regarding the effect of the intervention treatment. They also found that patients randomized for the control group felt disappointed and struggled to understand the need for a control arm in the study [Two of the participants from the intervention group had to stop receiving the intervention treatment because of side effects, emphasizing that receiving the intervention treatment can also create discomfort in a clinical trial.In the intervention group, the main reason to participate in the study was to help others, while in the control group, the main reason to participate was to receive the intervention treatment and further to support research. Although a slightly lower motivation for staying in the trial was observed in the control group compared to the intervention group, this did not transform into a higher dropout rate. Regarding the theme of personal resources, more participants from the control group mentioned that it demands a surplus of personal resources to take part in a clinical trial. This might be because the participants from the control group did not receive the intervention treatment as they wished for and therefore have thought more about the costs of participating in the trial. Regarding the theme of safety, there was no substantial difference between the two groups.Methodologically, a strength of this study was that all patients asked to participate in the study, agreed to participate. Another strength is that the study also contains interviews with participants that decided to drop out of the CryoPac study during the study period. Additionally, it is a strength that the participants agreed to be take part in two interviews, an interview before starting treatment and a more comprehensive interview after paclitaxel treatment, making it possible to follow up on the motivation to participate in the clinical trial and be informed about their experience with participating in the trial throughout the study period.A limitation in this study was that the participants were aware of which randomization group they belonged to when they answered the questions about their motivation to participate and the reason they decided to participate in the trial. This could have affected the participants’ answers. Additionally, a further limitation of the study is that only participants who decided to take part in the clinical trial were interviewed and consequently we do not have information from patients who declined to take part in the CryoPac study. To further understand the motivation to participate in randomized trials this study could have benefitted from having interviews with participants declined participating in the trial.The results from this qualitative study may be applicable when planning future clinical trial. Some practical implications are that it is important to plan the clinical trial such that it is easy to understand for the participants. The personal resources of the participants are also important to consider when informing patients about new clinical trials, so it does not become too overwhelming when they are asked to participate in different clinical trials and to engage in extra examinations due to the trial participation. Extra examinations in clinical trials can be experienced as an advantage by the patients, which can be used when informing new participants about a clinical trial. Finally, healthcare staff may be informed that initial disappointment of being allocated to the control group is reduced over time in most patients.