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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01304745
• Other study ID #: 2009/896
• Status: Not yet recruiting
• Phase: Phase 1
• First received: February 24, 2011
• Last updated: July 7, 2013
• Start date: October 2009
• Est. completion date: June 2014

Study information

• Verified date: July 2013
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate and compare the effect of: 1 Educational and counselling in groups, 2) Physical training in group with 3) Control group, on global- and health related quality of life and coping in patients finished treatment for gynaecological cancer.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: June 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Behavioral:
• Physical training in group
Physical training in group, 6-9 participants, two times av week (1.5 hours) over a period of 16 weeks, focusing on strength and endurance training including body awareness and relaxation.
• Educational and counseling in group
Educational and counseling groups with 6-9 participants, with seven group meetings 2.5 hours over a period of seven weeks. Each session starts with a (20 minutes) lecture were one out of seven different topics are presented (Fatigue, sexuality, coping and coping strategies, etc).

Locations

Country	Name	City	State
Norway	Margrethe Vika	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global- and health related quality of life		Pre intervention, post intervention and at one year follow-up	No
Secondary	Coping strategies after gynaecological cancer		Pre intervention, post intervention and at one year follow-up	No