Trial Information

Rehabilitation of Women Following Treatment for Gynaecological Cancer; a Randomized, Controlled Study

Previous studies have shown that gynaecological cancer patients may suffer from both
psychological and physiological long term side-effects. Cancer surgery, radiotherapy and
chemotherapy may result in physical symptoms like gastro-intestinal problems and related
pelvic pain (White, 2008).

The persons quality of life may also be influenced after finished cancer treatment and may
be manifested with both physical and psychological problems such as fatigue (subjective
experience of fatigue and lack of energy) (Vistad et al., 2007), anxiety and depression,
sleep problems and fear of relapse (Lagana et al., 2001, Wenzel et al., 2002, Hodginson,
2007). The concept of quality of life is something different operationalized and defined
across different studies. In the present study the quality of life will be defined from both
global- and health related quality of life. The physical and psychological after-effects of
the treatment also influences the social function, and hence the ability to get back to work
(Boer et al., 2009). It generally agreed that a high proportion of women of working age do
not come back to work after undergone cancer treatment. The women's experience of returning
to work, according to Kennedy et al. (2007), is a unknown area of cancer research.

Previous research have shown that participation in educational-, counselling- and physical
training groups may have positive effects on the quality of life for women treated for
gynaecological cancer. As far as we know, however, no randomized controlled studies have
measured and compared the effects of both educational and counselling intervention versus
physical training in groups on women's self-reported quality of life and coping. The purpose
of this study is therefore to evaluate and compare the effect of educational- and
counselling in groups and physical training in groups on women's self reported quality of
life and coping.

The present study is a collaboration between Haukeland University Hospital (HUH), Bergen
University College, University of Agder, University of Stavanger, Stavanger University
Hospital and Sørlandet Hospital. The study is carried out between 2009 and 2013. The
participants diagnosed and treated for gynaecological cancer between January 2007 - January
2012 received/will receive a information letter and informed consent per post or during the
regular follow-up appointments at the Hospitals. All women fulfilling the inclusion criteria
and finished treatment at HUH between January 2007 and to January 2012 are invited/will be
invited to participate in the present study. At Stavanger University Hospital and Sørlandet
Hospital patients finished treatment form 2008 is invited to participate in the present
study.

This intervention study has a randomized controlled design with: 1) Educational and
counselling groups, 2) Physical training in a group, 3) Control group, with three repeated
measures at pre- intervention, post-intervention and at 1-year follow-up. The educational
and counselling groups have one session a week over a period of seven weeks. The physical
training groups have two sessions a week for 16 weeks, focusing on strength and endurance
training. The control group follows only the standard post-treatment procedure at the
specific Hospitals.