Observational study of the development and evaluation of a fertility preservation patient decision aid for teenage and adult women diagnosed with cancer: the Cancer, Fertility and Me research protocol
نویسندگان
چکیده
INTRODUCTION Women diagnosed with cancer and facing potentially sterilising cancer treatment have to make time-pressured decisions regarding fertility preservation with specialist fertility services while undergoing treatment of their cancer with oncology services. Oncologists identify a need for resources enabling them to support women's fertility preservation decisions more effectively; women report wanting more specialist information to make these decisions. The overall aim of the 'Cancer, Fertility and Me' study is to develop and evaluate a new evidence-based patient decision aid (PtDA) for women with any cancer considering fertility preservation to address this unmet need. METHODS AND ANALYSIS This is a prospective mixed-method observational study including women of reproductive age (16 years +) with a new diagnosis of any cancer across two regional cancer and fertility centres in Yorkshire, UK. The research involves three stages. In stage 1, the aim is to develop the PtDA using a systematic method of evidence synthesis and multidisciplinary expert review of current clinical practice and patient information. In stage 2, the aim is to assess the face validity of the PtDA. Feedback on its content and format will be ascertained using questionnaires and interviews with patients, user groups and key stakeholders. Finally, in stage 3 the acceptability of using this resource when integrated into usual cancer care pathways at the point of cancer diagnosis and treatment planning will be evaluated. This will involve a quantitative and qualitative evaluation of the PtDA in clinical practice. Measures chosen include using count data of the PtDAs administered in clinics and accessed online, decisional and patient-reported outcome measures and qualitative feedback. Quantitative data will be analysed using descriptive statistics, paired sample t-tests and CIs; interviews will be analysed using thematic analysis. ETHICS AND DISSEMINATION Research Ethics Committee approval (Ref: 16/EM/0122) and Health Research Authority approval (Ref: 194751) has been granted. Findings will be published in open access peer-reviewed journals, presented at conferences for academic and health professional audiences, with feedback to health professionals and program managers. The Cancer, Fertility and Me patient decision aid (PtDA) will be disseminated via a diverse range of open-access media, study and charity websites, professional organisations and academic sources. External endorsement will be sought from the International Patient Decision Aid Standards (IPDAS) Collaboration inventory of PtDAs and other relevant professional organisations, for example, the British Fertility Society. TRIAL REGISTRATION NUMBER NCT02753296; pre-results.
منابع مشابه
I-6: Fertility Preservation in Male Patient with Cancer
Studies suggest that the ability to have biological children is of great importance to many people. The cancer and its treatment often pose a threat to fertility. Rates of permanent infertility and compromised fertility after cancer treatment vary and depend on many factors. Male infertility can result from the disease itself (best documented in patients with testicular cancer and Hodgkin’s lym...
متن کاملI-35: Emergency Stimulation for Onco -Fertility Patients
Background Fertility preservation for female cancer patients prior to cancer therapy has emerged as an essential component of comprehensive patient care. In the US, approximately 6% of women diagnosed with invasive cancer between 2007 and 2011 that were under 45 years old. The incidence of cancers in reproductive age women signifies a need for fertility preservation options and this need is inc...
متن کاملI-29: Fertility Preservation in Early, Low Grade Endometrial Cancer
Background Endometrial cancer is the most common gynecologic malignancy in the United States, with over 40,000 cases diagnosed each year, typically in the postmenopausal women. 25% of cases affect premenopausal women. 14% of endometrial cancers are diagnosed in women younger than 45 years old. 5% of these tumors are diagnosed in women younger than 40 years old. In this talk the learning objecti...
متن کاملP-222: Ovarian Stimulation for Fertility Preservation in Cancer Patients: A Prospective Study
Background: To determine whether random-start controlled ovarian stimulation (COS), in which a stimulation is performed regardless to day of patient’s menstrual cycle, has similar outcomes in comparison to conventional early follicular phase-start COS for cryopreservation of fertilized oocytes in cancer patients. Materials and Methods: This prospective study was performed at two infertility cen...
متن کاملI-37: Controlled Ovarian Stimulation in Cancer Patients
Recent advances in the technology of vitrification of human oocytes and embryos have increased the opportunities for fertility preservation in cancer patients. Ovarian stimulation in this group of patients is associated with some unique challenges. A controversy in this field rotated around the hypothesis that the transient elevations of estrogen during an IVF cycle may stimulate tumor growth; ...
متن کامل