To determine the emotional impact of Molar Pregnancy on women

  • Research type

    Research Study

  • Full title

    To determine the emotional impact of Molar Pregnancy and chemotherapy treatment upon women and their partners ( Other title on Patient and Participant consent forms : To investigate the emotional impact of a complete molar pregnancy diagnosis and the impact of chemotherapy treatment on women and their partners.)

  • IRAS ID

    127437

  • Contact name

    Janette de Aristizabal

  • Contact email

    janette.dearistizabal@imperial.nhs.uk

  • Sponsor organisation

    Charing Cross Hospital

  • Duration of Study in the UK

    2 years, 0 months, 0 days

  • Research summary

    Gestational trophoblastic disease is an umbrella term covering a group of related conditions which includes complete molar pregnancy, partial molar pregnancy choriocarcinoma,placental site tumour and epithelial site tumour.All of which are characterised by abnormal growth and at times spread of placental tissue.

    As stated my aim in this study is to focus upon the emotional impact of women who need chemotherapy treatment for a diagnosis of a partial mole and complete mole. In this study I also aim to assess the emotional significance of chemotherpay treatment for molar pregnancy diagnosis on the woman's partner.

    Suggested methodology

    To select

    A sample of women with a diagnosis of complete molar or partial molar pregnancy their patners.

    A 'Control group of Women' and their patners dervied from a convience sample of visitors to the hospital.

    A sample of women undergoing methotrexate treatment for molar pregnancy and their partners

    A sample of women requiring Actinomycin treatment and their partners

    A sample of women requiring EMA-CO treatment and their partners.

    As part of the study I aim to gain consent from the participants to complete three questionnaires anonomously within 1 Week of registration with the molar pregancy follow up service, then as appropriate 24-48 hours following the start or change of a chemotherapy regime.The control group will return their questionnaires by envelope

    Those women (and their partners)registered for follow up with the molar pregnancy service will be sent questionaires and requested to return them to the molar pregnancy unit via stamped addressed envelope.Those participants who are inpatients will be provided with envelopes and a ward based collection box to maintain confidentiality

    The suggested psychological scales to be used are the following

    1) HADS (Hospital Anxiety and Depression Scale)

    2) FACT-G (Psychological assessment of emotional and physical wellbeing in cancer patients.

    3)Impact of Events Scale ( A psychological scale to assess the distress posed by a traumatic life event.)

  • REC name

    London - Bloomsbury Research Ethics Committee

  • REC reference

    15/LO/0505

  • Date of REC Opinion

    16 Apr 2015

  • REC opinion

    Unfavourable Opinion