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

18 Years
60 Years
Open (Enrolling)
Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Fallopian Tube Cancer, Gastric Cancer, Ovarian Cancer, Sarcoma, Vaginal Cancer, Vulvar Cancer

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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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change in EORTC

Outcome Description:

The primary endpoint will be the change from baseline to six months in EORTC global quality of life score. The mean change with 95% confidence interval will be evaluated for each arm. All patients will be included in an ITT analysis: patients with missing data at six months will be assumed to have a change of 0 points from baseline.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Clare Shaw, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden Hospital NHS Foundation Trust


United Kingdom: Research Ethics Committee

Study ID:

CCR 3664



Start Date:

August 2011

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Gastroesophageal Junction
  • Cervical Cancer
  • Endometrial Cancer
  • Esophageal Cancer
  • Fallopian Tube Cancer
  • Gastric Cancer
  • Ovarian Cancer
  • Sarcoma
  • Vaginal Cancer
  • Vulvar Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma
  • Sarcoma