Assessing the health impacts of parenthood on people with cystic fibrosis: the HOPeCF prospective cohort protocol.

People with cystic fibrosis (CF) are living longer and healthier lives with a growing number considering and pursuing parenthood. The decision of whether to become a parent is complex for people with CF, and CF is a major factor in reproductive decision-making. Unfortunately, in people with CF who become parents, there are no prospective studies of disease trajectory, no data on the impact of parenthood on mental health, disease self-management, or quality of life, and no research regarding non-genetic parenthood. Health Outcomes of Parents with CF (HOPeCF) is a prospective, multicentre observational cohort study which will enrol 146 new parents with CF of children less than 5 years of age. The primary aim of this 60-month study is to assess the rate of lung function decline as impacted by mental health, parental stress and responsibility, and the use of CF transmembrane conductance regulator modulators. In addition, we will conduct dyadic interviews with a subset of study participants and their key supports (partner/family/friend) to inform future interventions. This longitudinal, observational multicentre study is a necessary and timely step in understanding parental health outcomes in CF and will provide data essential for care guidance to people with CF, their partners, and healthcare providers. The University of Pittsburgh Institutional Review Board approved this study (STUDY23080161). As people with a variety of paediatric-onset chronic diseases are living longer and considering parenthood, these results may have widespread applicability and will be distributed at international meetings and submitted to peer-reviewed journals.

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Competing interests: TK receives grant support from the Cystic Fibrosis Foundation (CFF) and the National Institutes of Health (NIH). She receives consulting fees from the CFF as a facilitator in the Partnership Enhancement Program. She is the Vice Chair of the CFF Sexual Health, Reproduction and Gender Research Working Group. She has received honoraria from the CFF, Johns Hopkins University and Spark Healthcare. ML receives grant support from the CFF and the NIH. RJ receives grant support from the CFF and the NIH. She also receives grant funding to her institution from Vertex, Sound Pharma, 4D molecular therapeutics and Armata. She receives consulting fees from Vertex, Boehringer Ingelheim, Recode and Insmed. She receives travel support from the CFF. She is the Chair of the CFF Sexual Health, Reproduction and Gender Research Working Group and serves on the CFF’s Clinical Research Executive Committee. AMG reports personal fees from the Belgian Cystic Fibrosis Foundation/King Baudouin Foundation; grants, personal fees and travel reimbursement from the Cystic Fibrosis Foundation, grants from the Dutch Cystic Fibrosis Foundation; travel reimbursement from the European Cystic Fibrosis Society; travel reimbursement from the French Cystic Fibrosis Society; personal fees from the Italian Cystic Fibrosis Research Foundation; grant funding from the NIH, personal fees from Saudi Pediatric Pulmonology Association; grants and personal fees from Vertex Pharmaceuticals and personal fees from Virginia Commonwealth University. DSS receives grant funding from the NIH. JT-C receives grant support from the CFF and the NIH. She also receives grant funding to her institution from Vertex, Eloxx and 4D: molecular therapeutics. She has received consulting fees from Vertex, Insmed and 4D: molecular therapeutics. She has received speaking fees from Vertex for non-branded speaking engagements. She has received funding from Abbvie for her role as Data Monitoring Committee Chair. She serves as the adult patient care representative to the CFF Board of Trustees, and on the CF Foundation’s Clinical Research Executive Committee, Clinical Research Advisory Board, as immediate past chair of the CF TDN’s Sexual Health, Reproduction and Gender Research Working Group, and as Co-Chair of the Heath Equity Team Science Awards study section and on the Racial Justice Working Group. She also serves on the scientific advisory board for Emily’s Entourage, and on the ATS Respiratory Health Awards Committee and as Chair-Elect of the International Conference Committee (with previous service on the Scientific Grant Review and Clinical Problems Programming Committee). She is an Associate Editor for the Journal of Cystic Fibrosis and a member of the International Advisory Board for the Lancet Respiratory Medicine Journal. She serves on the Clinical Trials Review (CTLR) Study section for the NIH/National Heart. Blood, Lung Institute.