Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation

Abstract

Study question Does the use of an online decision aid (DA) about fertility preservation (FP), in addition to standard counselling by a specialist in reproductive medicine, reduce decisional conflict compared to standard counselling alone? Summary answer Female cancer patients who could make use of the online DA had a significantly lower short-term decisional conflict score. What is known already Nowadays, female cancer patients have several options for preserving fertility, but having to decide whether to opt for FP within a short time frame after cancer diagnosis and before the start of treatment is challenging. According to previous studies focussing mainly on breast cancer patients, decisional conflict among these women is high, and they have expressed the need for additional support. Study design, size, duration The study was a randomized controlled trial including female cancer patients who were referred by their treating oncologist to a specialist in reproductive medicine for fertility counselling. Participants were randomly assigned to the control group (counselling only) or to the intervention group (counselling and additional use of the online DA immediately after counselling). Recruitment was ongoing from July 2016 to December 2017 at eight fertility centres in Switzerland and Germany. Participants/materials, setting, methods The online DA was developed by an interdisciplinary team of specialists in reproductive medicine, gynaecologists, oncologists and psychologists. Of 79 recruited participants, 59 completed the first assessment and could therefore be enrolled in the study. They were asked to complete an online questionnaire at three time points: at T1, after counselling (control group, n = 27) or after counselling and the additional use of the DA (intervention group, n = 24); at T2, 1 month later (N = 41: control group, n = 23; intervention group, n = 18); and at T3, 12 months later (N = 37: control group, n = 20; intervention group, n = 17). The survey comprised questions about fertility-related knowledge, attitude towards FP, willingness to undergo FP and socio-demographic data, as well as the decisional conflict and decisional regret scales. Main results and the role of chance All participants showed low decisional conflict scores. Women who used the online DA in addition to counselling (intervention group) showed a significantly lower total score on the Decisional Conflict Scale (DCS) compared to the control group at T1 (P = 0.008; M = 12.15, SD = 4.38; 95% CI, 3.35–20.95) and at T2 (P = 0.043; M = 9.35, SD = 4.48; 95% CI, 0.31–18.38). At T3, the mean total score of the DCS was still lower in the intervention group compared to the control group; however, this group difference was no longer significant (P = 0.199, M = 6.86, SD = 5.24; 95% CI, −3.78 to 17.51). The majority of participants had already made a decision regarding FP (yes or no) at T1 (72.5%): 91.7% in the intervention group compared to 55.6% in the control group (P = 0.014). Those who had decided already at T1 showed significantly lower decisional conflict (P = 0.007; M = 13.69, SD = 4.89; 95% CI, 3.86–23.52). The average number of DA sessions per user was 2.23, and 80.8% of the participants completed the DA’s value clarification exercises. Participants in the intervention group were satisfied with the DA and would recommend it to other patients. Limitations, reasons for caution The recruitment of participants was challenging because of the emotionally difficult situation patients were in. This led to the limited sample size for final analysis. Education levels were high in two-thirds of the participants. It is difficult to say whether the DA would be equally effective in women with a lower educational background. Wider implications of the findings There is evidence that the DA served as a helpful complement to the decision-making process for young female cancer patients qualifying for FP. This is, to our knowledge, the first randomized controlled trial evaluating a DA targeted at patients with several cancer types and in a language other than English (i.e. German). This study contributes to extending the range of the still limited number of DAs in the context of FP. Study funding/competing interest(s) The study was supported by a research grant of the Swiss Cancer Research. The authors declare that no competing interests exist. Trial registration number Clinicaltrials.gov, trial no. NCT02404883. Trial registration date 19 March 2015 Date of first patient’s enrolment 4 July 2016

Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study

“…Although it is well accepted that fertility-related distress after cancer is common, particularly among females,9 there is a lack of support resources for post-treatment survivors. Multiple cancer and fertility decision aids and support interventions exist for YA-Fs considering pretreatment fertility preservation 10–15. Consistent with the decision science literature,16 these studies demonstrate the benefit of decision aids for YA-Fs facing fertility decisions.…”

Integration of partners of young women with cancer in oncofertility evidence‐based informational resources

“…52,53 However, validated educational tools to support fertility decision making are still scarce, 54 and with respect to evaluated DA include one for young women with breast cancer in English 48 and another DA in Dutch 52 and one DA in German for young female cancer patients. 55 One of the first fertility-related DAs for young breast cancer patients was developed and validated by Peate in Australia. 48 This DA's evaluation took into consideration partner's input on the DA and collected information on their involvement during the evaluation process to assess DA's efficacy, such as whether the DA was shared with the partner, the extent to which partners had read the materials, whether the materials stimulated discussion between partners, how useful the partners considered the booklet (DA), and whether the partner contributed to the decision-making process about fertility-related issues.…”

“…The number of available written materials and online resources about fertility preservation for young cancer patients from different organizations are growing 52,53 . However, validated educational tools to support fertility decision making are still scarce, 54 and with respect to evaluated DA include one for young women with breast cancer in English 48 and another DA in Dutch 52 and one DA in German for young female cancer patients 55 …”

Does a web-based decision aid improve informed choice for fertility preservation in women with breast cancer (DECISIF)? Study protocol for a randomised controlled trial

“…Furthermore, they decrease decisional conflict 31. In the field of female FP, some interventions have been evaluated and led to similar results 30 32–38. Two PDAs are available for patients with breast cancer in English and Dutch, focusing on level of knowledge and on decisional conflict, respectively 35–37.…”