A Survivorship Care Plan for Gynaecological Cancer Patients

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Brief Title

A Survivorship Care Plan for Gynaecological Cancer Patients

Official Title

Does a Post Treatment Survivorship Care Plan Improve Gynaecological Cancer Patient's Quality of Life and Self Efficacy? A Mixed Methods Pilot Study.

Brief 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.
    


Study Type

Observational


Primary Outcome

Change in EORTC

Secondary Outcome

 Improvement in Global QOL

Condition

Adenocarcinoma of the Gastroesophageal Junction


Study Arms / Comparison Groups

 Control Group
Description:  Participants randomised to the control group would receive usual rehabilitation care via the existing referral pathways.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

150

Start Date

August 2011

Completion Date

April 2015

Primary Completion Date

March 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Participants will: have a diagnosis of and have completed initial treatment for Stage
             I or II gynaecological cancer;

          -  will have recently completed a treatment pathway with radical intent;

          -  have received primary treatment at The Royal Marsden NHS Foundation Trust (RM);

          -  report that they have experienced a physical or psychosocial need resulting from the
             disease or it's treatment;

          -  be aged over 18 years;

          -  be willing and able to articulate their needs.

        Exclusion Criteria:

          -  Those eligible for end-of-life care,

          -  those with metastatic disease

          -  those that lack capacity to understand the purpose of the study and participate
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Clare Shaw, Phd, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT01582906

Organization ID

CCR 3664


Responsible Party

Sponsor

Study Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

 University of Surrey

Study Sponsor

Clare Shaw, Phd, Principal Investigator, Royal Marsden Hospital NHS Foundation Trust


Verification Date

November 2017