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Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation.
Hum Reprod. 2019 Sep 29; 34(9):1726-1734.HR

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.

Authors+Show Affiliations

Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.Medical Oncology, University Hospital Basel, Basel, Switzerland.Gynecology and Gynaecologic Oncology, St. Claraspital Basel, Basel, Switzerland.Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.Department of Gynaecology and Obstetrics, University Hospital Zurich, Zurich, Switzerland.Division of Gynaecological Endocrinology and Reproductive Medicine, University Women's Hospital, University Hospital of Heidelberg, Heidelberg, Germany.Centre for Infertility, Prenatal Medicine, Endocrinology and Osteology, Amedes Experts, Hamburg, Germany.Centre for Infertility, Prenatal Medicine, Endocrinology and Osteology, Amedes Experts, Hamburg, Germany.Obstetrics and Reproductive Medicine, University Women's Hospital Saarland, Homburg, Germany.Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31398258

Citation

Ehrbar, Verena, et al. "Randomized Controlled Trial On the Effect of an Online Decision Aid for Young Female Cancer Patients Regarding Fertility Preservation." Human Reproduction (Oxford, England), vol. 34, no. 9, 2019, pp. 1726-1734.
Ehrbar V, Urech C, Rochlitz C, et al. Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation. Hum Reprod. 2019;34(9):1726-1734.
Ehrbar, V., Urech, C., Rochlitz, C., Zanetti Dällenbach, R., Moffat, R., Stiller, R., Germeyer, A., Nawroth, F., Dangel, A., Findeklee, S., & Tschudin, S. (2019). Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation. Human Reproduction (Oxford, England), 34(9), 1726-1734. https://doi.org/10.1093/humrep/dez136
Ehrbar V, et al. Randomized Controlled Trial On the Effect of an Online Decision Aid for Young Female Cancer Patients Regarding Fertility Preservation. Hum Reprod. 2019 Sep 29;34(9):1726-1734. PubMed PMID: 31398258.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation. AU - Ehrbar,Verena, AU - Urech,Corinne, AU - Rochlitz,Christoph, AU - Zanetti Dällenbach,Rosanna, AU - Moffat,Rebecca, AU - Stiller,Ruth, AU - Germeyer,Ariane, AU - Nawroth,Frank, AU - Dangel,Astrid, AU - Findeklee,Sebastian, AU - Tschudin,Sibil, PY - 2019/02/12/received PY - 2019/06/17/revised PY - 2019/8/10/pubmed PY - 2019/8/10/medline PY - 2019/8/10/entrez KW - cancer KW - decision aid KW - decision making KW - decisional conflict KW - female cancer patients KW - fertility preservation KW - oncofertility KW - randomized SP - 1726 EP - 1734 JF - Human reproduction (Oxford, England) JO - Hum. Reprod. VL - 34 IS - 9 N2 - 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. SN - 1460-2350 UR - https://www.unboundmedicine.com/medline/citation/31398258/Randomized_controlled_trial_on_the_effect_of_an_online_decision_aid_for_young_female_cancer_patients_regarding_fertility_preservation_ L2 - https://academic.oup.com/humrep/article-lookup/doi/10.1093/humrep/dez136 DB - PRIME DP - Unbound Medicine ER -