Ignite Creation Date:
2024-05-05 @ 11:20 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01304745
Status:
UNKNOWN
Last Update Posted:
2013-07-09
First Post:
2011-02-24
Brief Title:
Rehabilitation of Women Following Treatment for Gynaecological Cancer a Randomized Controlled Study
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Rehabilitation of Women Following Treatment for Gynaecological Cancer a Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2013-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 womens 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 womens 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 womens 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 receivedwill 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 invitedwill 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
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 womens 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 womens 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 womens 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 receivedwill 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 invitedwill 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None