A Survivorship Care Plan for Gynaecological Cancer Patients
Condition: Adenocarcinoma of the Gastroesophageal Junction; Cervical Cancer; Endometrial Cancer; Esophageal Cancer; Fallopian Tube Cancer; Gastric Cancer; Ovarian Cancer; Sarcoma; Vaginal Cancer; Vulvar Cancer
MeSH terms: Endometrial Neoplasms; Fallopian Tube Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Observational

Summary: 
      After treatment women surviving gynaecological cancer may experience lateeffects and longterm
      challenges specific to their disease and treatment resulting in functional deficits and a
      reduction in societal integration (Yabroff et al., 2004, Yadav, 2007). The available research
      on best models of posttreatment rehabilitation support for women posttreatment for
      gynaecological cancer is limited. The primary objective of this study is to determine if
      there is any additional benefit, over usual rehabilitation care, of additional rehabilitation
      appointments to develop a survivorship care plan on cancer specific health related quality of
      life.

      Secondary objectives are to determine any additional benefit to general selfefficacy, generic
      health related quality of life or social and health economics for patients who have completed
      treatment for stage I or II gynaecological cancer. Also to explore the patient's perspectives
      of the intervention. The study will be open to patients attending the outpatient
      gynaecological clinics of the Royal Marsden NHS Foundation Trust having recently completed
      treatment for Stage I or II gynaecological cancer. They will report that they have
      experienced a physical or psychosocial need resulting from the disease or its treatment; be
      aged over 18 years and be willing and able to articulate their needs. The study will last for
      six months for each participant. It will involve completing questionnaires and attending two
      extra rehabilitation appointments to develop a survivorship care plan at the hospital may
      also include attending for an interview about being involved in the study for those
      randomised to the intervention group
    

Detailed description: 
      Purpose and design We conducted a preliminary qualitative study last year (Rec Ref
      10/H0608/56) where gynaecological patients reported unmet rehabilitation care needs, both
      physical and psychosocial. At the end of treatment patients said that they were unaware of
      how to resolve these needs. They also reported that they wanted support and information to
      manage consequences of cancer and treatment themselves rather than become 'overmedicalised'
      and require treatment from a professional, if that were possible (Sandsund et al., 2011).
      Since there is as yet no body of evidence to prove a best model of delivery we have developed
      this study to reflect the intervention participants in the study suggested would best support
      them.

      During the preliminary study participants made suggestions that may improve their journey
      through treatment. Of the five focus groups all suggested a meeting in clinic with a
      rehabilitation professional at the end of their treatment to explore their rehabilitation
      needs. The intervention was as such described and defined by the patients in the preliminary
      study.

      After the study was analysed and presented to the Rehabilitation Research Group discussions
      started regarding research questions and a design for this interventional study. The Head of
      Therapies, a representative from the Psychological Care/ Psychological Support Service and a
      Nurse Consultant in Living with and Beyond Cancer have been involved in the development of
      the protocol from the preliminary study in order to ensure its' conduct will be feasible
      within The Royal Marsden NHS Foundation Trust (RM).

      There have been discussions amongst the research group and the authors as to the best way to
      clinically screen for physical and psychosocial problems. The FACTG, the EORTC and the
      Distress Thermometer were most thoroughly considered. The Distress Thermometer was chosen as
      the questions were felt to best cover issues we felt the participant group may have. It has
      been used in a National Cancer Survivorship Initiative/ Department of Health project for
      which RM was one of the sites. on evaluation of the project it was found to be clinically
      useful as a screening tool and was acceptable to our patients.

      The European Organisation for Research and Treatment of Cancer Quality of life Questionnaire
      - C30 (EORTC QLQC30),General Self Efficacy Scale (GSES), Short Form 36 (SF36) were chosen for
      their wide use in rehabilitation intervention studies because of their ability to detect
      change over time reliably in cancer populations. We believe that the primary outcome measure
      the EORTC will be sensitive enough to detect changes due to the intervention. The
      statistician has given advice to this regard and provided the statistical support for the
      study to date.

      A Health Economist who is involved with other studies at RM has developed the study specific
      forms to measure the economic evaluation of impact on health and social care provision. She
      will perform the cost analysis of this information to see if the intervention has had any
      health or social economic impact. The patient's perspectives of the intervention will be
      sought using qualitative interviews for a randomised sample of those completing the study.
      This will be used to assess the acceptability of the intervention to patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We aim to capture patients with gynaecological cancers at Stage I or II. Overall there were
        approximately 500 referrals of patients with Stage I or II gynaecological cancer to the
        Royal Marsden NHS Foundation Trust (RM) in the year April 2009 to April 2010. There were
        729 gynaecological referrals of all stages of cancer. Of these, 333 were referred to the
        surgical team and 396 to the medical teams. Of those 729 patients, 378 were referred to the
        Rehabilitation Department, the majority of whom were referred post-surgery and seen as
        inpatients, leaving 48% of patients with gynaecological cancer never seen by a
        rehabilitation professional at RM.