Long-term effectiveness of an online decision aid for female cancer patients regarding fertility preservation: Knowledge, attitude, and decisional regret.

INTRODUCTION: The decision, whether to undergo fertility preservation or not is highly demanding for cancer patients. Decision aids may act as an additional source of support. So far, only a limited number of decision aids regarding fertility preservation for female cancer patients exist and have been evaluated systematically. This paper presents the results of secondary analyses of the first randomized controlled trial evaluating an online decision aid for female cancer patients affected by different types of cancer. It focuses on fertility-related knowledge, attitude toward fertility preservation, and long-term effectiveness regarding decisional regret. MATERIAL AND METHODS: Young female cancer patients between 18 and 40 years of age were recruited after fertility counseling with a reproductive specialist. They were assigned to either the control group (counseling only) or the intervention group (counseling followed by the additional use of the decision aid). Both groups had to complete a questionnaire after counseling as well as 1 and 12 months later, covering topics such as fertility-related knowledge, attitude towards fertility preservation, decisional conflict and regret. Recruitment was ongoing during 18 months in eight fertility centers located in Switzerland and Germany. RESULTS: Mean age of participating women was 29.31 years (SD 4.57). Of the entire sample (n = 51) 53% were affected with breast cancer, 27.4% with lymphoma, and 19.6% with various other types of cancer. Knowledge regarding the most common fertility preservation methods was high and comparable in both groups. Positive attitude significantly exceeded negative attitude among all participants (p = 0.001). Although the altogether low scores for decisional regret were on a higher level in the control group (T2: mean = 19.00, SD = 13.24; T3: mean = 22.0, SD = 20.67) than in the intervention group (T2: mean = 14.12, SD = 11.07; T3: mean = 12.94, SD = 13.24), there were no statistically significant differences between and within both groups. There was a positive association between decisional conflict and decisional regret at T3 (p = 0.001, r = 0.510). CONCLUSIONS: This decision aid was suitable as an additional source of knowledge and may positively impact decisional regret in the long term. Results suggest that the provision of an online decision aid as a complement to fertility counseling may facilitate decision-making.

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

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.

Fertility Preservation in Young Female Cancer Patients: Development and Pilot Testing of an Online Decision Aid.

PURPOSE: Impairment of fertility is a common sequela of successful cancer treatment. Therefore, fertility preservation (FP) should be discussed with all young cancer patients. Decisions about FP are challenging. Patients wish more specific support and the first results concerning the helpfulness of decision aids (DA) were promising. Aside from describing the process of development and the content of an online DA in German, the objective of this study was to pilot test users' satisfaction with the DA and its effect on knowledge about FP and decisional conflict (DC). METHODS: In this prospective consecutive study, a control group (n = 20, fertility counseling) was followed by and compared with an intervention group (n = 20, counseling and additional use of the DA, developed by an interdisciplinary team) of recently diagnosed female cancer patients between 18 and 40 years. RESULTS: Nearly all participants who applied the DA considered it helpful for decision-making and recommendable. Knowledge about FP was high with regard to FP techniques women went for. DC was moderate according to the mean score (M = 27.92, standard deviation = 13.27) and only in 20%, the score was above the threshold for high DC. There was no difference between the control and intervention group for knowledge and DC. CONCLUSION: The DA seems to serve as additional and well-accepted support tool in decision-making for patients and professionals. Referral to a reproductive specialist is crucial to warrant comprehensive information. These results need to be confirmed with the current ongoing randomized controlled study.