Feasibility and acceptability of psychosocial care for unsuccessful fertility treatment

Abstract Introduction Many people undergo fertility treatment to have biological children, but around four in ten patients complete all treatment cycles without having the children they desire. This triggers intense grief from which patients report taking on average 2 years to recover. Fertility guidelines and regulators stress the need to support patients through this process, but there is a scarcity of evaluated interventions to this end and evidence about when and how to offer care is lacking. This study explored patients' and healthcare professionals' (HCPs) experiences of and views about provision of psychosocial care (to patients facing unsuccessful fertility treatment, i.e., care provided by a mental health professional to address the emotional, cognitive, behavioural, relational and social needs that patients have at this stage of treatment). Methods Five qualitative online focus groups were conducted with Portuguese participants: three with patients waiting to initiate or undergoing their last cycle of in vitro fertilization/intracytoplasmic sperm injection or having completed it within the last 2 months without achieving a pregnancy and two with HCPs working at fertility clinics. Focus groups were recorded and transcribed verbatim, and data were analysed with Framework Analysis. Results Thirteen patients and nine HCPs participated. Analysis resulted in 1293 codes, systematically organized into 13 categories, 4 themes and 1 metatheme. The latter showed high consensus about the need for psychosocial care for unsuccessful treatment, but perceived challenges in its implementation. Themes reflected (1) consensual demand for psychosocial care at all stages of treatment but particularly at the end, (2) high perceived acceptability of integrating preventive care initiated during treatment with early psychosocial care only for those patients who experience unsuccessful treatment, (3) perceived challenges of implementing psychosocial care for unsuccessful treatment at clinics and (4) suggestions to promote its acceptability and feasibility. Conclusion Patients and HCPs perceive that clinics should improve care provision across the whole treatment pathway and in particular for unsuccessful fertility treatment. Suggestions were made to inform future research focusing on the development and evaluation of psychosocial interventions to this end. Patient or Public Contribution Patients and HCPs participated in the focus groups. Two HCPs also revised the manuscript.


| INTRODUCTION
Parenthood is a universal goal shared by many people (77%-97%). 1,2 Over 9% of people worldwide face challenges to become parents (e.g., fertility problems or some life circumstances, such as being in a same-sex relationship or being single). 3,4 In vitro fertilization/ intracytoplasmic sperm injection (IVF/ICSI) are the recommended treatments used by many to achieve their parenthood goals. 5 However, around 4 in every 10 people undergoing IVF/ICSI end all treatment cycles without achieving a live birth and need to adjust to a life without the children they desired. 6 This study explored patients' and healthcare professionals' (HCPs') experiences of and views about provision of psychosocial care (to patients facing unsuccessful fertility treatment, i.e., care provided by a mental health professional to address the emotional, cognitive, behavioural, relational and social needs that patients have at this stage of treatment). 7,8 Unsuccessful fertility treatment, defined in this study as the last IVF/ICSI cycle reimbursed by the NHS being unsuccessful and no new cycles being attempted, triggers intense and prolonged grief. 9,10 National and international guidelines and regulators stress that it is the responsibility of fertility clinics to care for patients adjusting to this experience. 5,7,11 However, there is a scarcity of evaluated psychosocial interventions to this end and a lack of evidence about when and how such interventions should be offered to patients.
Patients report dissatisfaction with care at this stage of treatment, in particular, about being offered no closure from the clinic, no support resources and left to their own to face what they perceive as a catastrophic life event. 9,10 Preventive psychosocial care, delivered before unsuccessful treatment is experienced, can be helpful to provide information about common emotional reactions to validate and normalize experiences and minimize the impact of expected negative effects, 12,13 to foster hope by promoting self-efficacy and agency in adversity 14,15 and to foster the therapeutic relationship, empowering patients to engage with timely support from their clinics after treatment ends. 16 It can also promote patients' insight about the need for support, as many are overwhelmed by their grief reactions, or paradoxically, do not realize that they are grieving. 16,17 Offering this type of care is a recommended practice across several life-threatening health contexts, when the futility of treatment is acknowledged and a shift towards discussion of the implications of this happens (e.g., end-of-life discussions). 18 Such care was proved to be feasible, valued by patients and effective in sustaining their hope and quality of life during follow-up periods. 19,20 However, evidence suggests that this is still not a common practice in fertility care. 21,22 One barrier may be that discussing possible adverse fertility outcomes is challenging for patients and HCPs alike because this triggers anxiety 23,24 and can reduce motivation for treatment. 24,25 However, the reality is that little is known about what are patients' and HCPs' views and preferences about preventive psychosocial care.
After unsuccessful treatment, early psychosocial care should target therapeutic goals known to promote psychosocial healthy adjustment in this context. The Three Tasks Model of Adjustment to Unmet Parenthood Goals (3TM) identified three therapeutic goals to be targeted: promoting acceptance of one's unmet parenthood goals (UPGs), that is, willingness to experience the loss and the emotions and thoughts that it triggers without struggle; facilitating meaningmaking, that is, construction of positive meanings related to one's UPGs and re-evaluation of life values and priorities; and promoting the pursuit of meaningful alternative life goals. 17  (one individual/couple therapeutic session while patients prepare to initiate their last IVF/ICSI treatment cycle) and early (one individual/ couple and five weekly group sessions starting 1-2 weeks after unsuccessful treatment) psychosocial care. Figure 1 shows the Beyond Fertility logic model, which is a visual representation of how this complex intervention works. 31,32 In sum, there is scarce evidence on how patients and HCPs experience provision of psychosocial care for unsuccessful treatment.
Although offering preventive and early psychosocial care seems supported by research, it is unclear whether patients and HCPs perceive it as helpful and appropriate (i.e., acceptable) and possible to be implemented at fertility clinics (i.e., feasible). Research suggests that patients are willing to discuss the possibility of treatment cycles being unsuccessful if it helps them prepare for this eventuality, 24 but discussing definite unsuccessful treatment may be far more challenging. Nonetheless, research also shows that patients lower their expectations when they progress through unsuccessful cycles 23 and revise down their parenthood goals (and desire) as these become less achievable. 33,34 Therefore, it would be expected that patients become more willing to prepare for unsuccessful treatment as they perceive that they are more susceptible to it. In turn, HCPs report that discussing negative outcomes and managing patients' emotions in this context are major challenges in their clinical practice. 35  HCPs were also asked to state their occupation, workplace and years of experience in fertility care.

| Focus group scripts
One semi-structured script was developed following existing guidelines, 37,38 available in Supporting Information: Appendix S1. yes, totally) and the extent to which patients would engage/HCPs believed patients would engage with it over the seven sessions (from 1: not at all to 7: will totally engage).

| Procedure
Consecutive female patients were contacted by phone, informed about the study and invited to participate with their partner.
A convenience sample of HCPs was also invited via email.
An information sheet and consent form, and the invitation link for the focus group session were sent to those willing to participate.
Five focus groups were carried out, separately with patients (September 2020 and January 2021) and HCPs (September 2020), to promote a safe and comfortable environment for participants to share their views. 37 The focus groups were carried out via the zoom platform, 39

| Data analysis
Descriptive statistics were used to characterize participants' background. Framework Analysis was used on the qualitative data to   and four (two of them with the partners) did not show up (due to unforeseen events, technological issues, unknown reasons). Of the twenty-one HCPs invited, seven did not reply, one refused due to lack of interest, three withdrew from the study due to lack of time and unforeseen events and one did not show up due to unknown reasons.

| Ethical approval
Focus group composition and the characteristics of each participant's code (Pa, Psy, Fs) are presented in Table 1.

| Data generation
Framework Analysis yielded 1293 different codes, which were systematically organized into 13 categories, grouped into 4 themes and 1 metatheme. Figure 2 shows the framework thematic map.

| Challenges in implementation at fertility clinics
HCPs considered that it can be challenging to identify patients starting their last cycle, as many may undergo additional cycles in the private sector or with gametes/embryos donation. In addition, long waiting lists make it difficult to anticipate when patients will start the cycle and schedule the first session.   48 and evaluative studies on its acceptability and effectiveness report promising results. [49][50][51] However, results suggest that for a minority of patients, in-person individual or group-based formats may not be adequate. For these patients, online individual or self-help interventions, for instance, www.myjourney.pt 52 may be preferable, as they ensure privacy, bypass possible stigma and offer more flexibility in access.