Gynecologic CancerPhase 1NCT01304745
Rehabilitation of Women Following Treatment for Gynaecological Cancer; a Randomized, Controlled Study
A Phase 1 study testing Physical training in group and Educational and counseling in group in people with Gynecologic Cancer, run by Haukeland University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Physical training in group and Educational and counseling in group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2009to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
- Conditions
- Gynecologic Cancer
- Being tested
- Physical training in group, Educational and counseling in group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical training in groupBehavioural
Also called Physical exercise
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 groupBehavioural
Also called nurse-led patient education
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).
| Study group | Role | What they receive |
|---|---|---|
| Physical traning in group | Experimental | Not described Receives: Behavioral: Physical training in group |
| Educational and counselling group | Experimental | Not described Receives: Behavioral: Educational and counseling in group |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global- and health related quality of life
Measured: Pre intervention, post intervention and at one year follow-up
Secondary outcomes (1)
Coping strategies after gynaecological cancer
Measured: Pre intervention, post intervention and at one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startOct 2009
- Primary completionSep 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margrethe Vika, AP, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304745
- Sponsor's protocol ID
- 2009/896
- Status last verified
- Jul 2013
- First submitted
- 24 Feb 2011
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Women Following Treatment for Gynaecological Cancer; a Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT01304745
- Acronym / sponsor ID
- 2009/896
- Conditions
- Gynecologic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical traning in group | Experimental | Behavioral: Physical training in group |
| Educational and counselling group | Experimental | Behavioral: Educational and counseling in group |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical training in groupAlso: Physical exercisePhysical 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. | Behavioural | Physical traning in group |
| Educational and counseling in groupAlso: nurse-led patient educationEducational 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). | Behavioural | Educational and counselling group |
Primary outcome
Global- and health related quality of life
Time frame: Pre intervention, post intervention and at one year follow-up
1 secondary outcome
Coping strategies after gynaecological cancer
Time frame: Pre intervention, post intervention and at one year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margrethe Vika, AP principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Physical training in group and Educational and counseling in group in people with Gynecologic Cancer, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global- and health related quality of life (time frame: Pre intervention, post intervention and at one year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013.