Know Cancer

forgot password

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

Phase 1
18 Years
Open (Enrolling by invite only)

Thank you

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

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.

Inclusion Criteria:

- Women finished treatment with a curative purpose independent of stage of cancer, type
of gynaecological cancer, or previous gynaecological cancer

- Meet a certain physical functioning criteria (Specified as; manage to walk 3.1 miles
per hour, lie down and rise up from the floor)

- To be willing to participate in the study for a period of 1- year and agrees to
participate as specified conditions according to the consent form

- Not having any significant amnesic symptoms

- Women with other diagnosis were included as far as criterion 3 was fulfilled

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Global- and health related quality of life

Outcome Time Frame:

Pre intervention, post intervention and at one year follow-up

Safety Issue:


Principal Investigator

Margrethe Vika, Associate Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Haukeland University Hospital


Norway: Regional Ethics Commitee

Study ID:




Start Date:

October 2009

Completion Date:

June 2014

Related Keywords:

  • Gynaecologicalcancer