Trial Information

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

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.