Needs for RehabilitationNCT01638741
The Need for Rehabilitation and the Connection With Attachment Styles Among Patients With Gynaecological Cancer
An observational study of Needs for Rehabilitation and Adult Attachment Style, run by Kamila Adellund Holt at 1 site in Denmark.
Trial summary
The purpose of this study is to provide new knowledge about: Integration of rehabilitation in a highly specialized gynaecological department. Development and testing of an individually adapted rehabilitation process. Needs for rehabilitation among women with gynaecological cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Needs for Rehabilitation, Adult Attachment Style, Quality of Life.
- What is being tested?
- Rehabilitation goals of patients with gynaecological cancer.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Oct 2014
- Phase
- Observational
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study Population Description * Patients referred to Odense University Hospital outpatient clinic with suspition for gynaecological cancer. The patients are from to Regions in Danmark, Region Zealand and Region South Denmark.
Who may be able to join
- suspicion of gynaecological cancer
- surgery for gynaecological cancer
Who cannot join
- do not speak Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, Fyn, 5000
Kamila A. Holt, Ph.D. student, 0045 26822657, kamila.holt@rsyd.dk
About this study
Official title: Rehabilitation and the Association With Attachment Styles Among Patients With Gynaecological Cancer
The purpose of this study is to provide new knowledge about:
- Integration of rehabilitation in a highly specialized gynaecological department.
- Development and testing of an individually adapted rehabilitation process.
- Needs for rehabilitation among women with gynaecological cancer.
- Connection between adult attachment style for women with gynaecological cancer and their quality of life, rehabilitation needs and symptoms of depression /PTSD.
- Being tested
- Rehabilitation goals of patients with gynaecological cancer.
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation goals of patients with gynaecological cancer.Behavioural
Conversations with the nurse and supportive phone calls. Conversation are structured and placed 1 and 3 months after surgery. Phone calls are carried out at two and three months after surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Quality of life at 5 months after surgery.
EORCT QLQ-C 30 (QLQ is quality of life questionnaire) and EORCT QLQ-OV28 (OV - Ovarian) and EORCT QLQ-EN ( EN - endometrial) 24 and EORCT QLQ- CX 24 ( CX - cervix.
Measured: at baseline and 5 months after surgery
Secondary outcomes (3)
Change from baseline in Revised Adult Attachment at 5 months after surgery.
Revised Adult Attachment Scale (RAAS- 18) is used to measure attachment style among women with gynaecological cancer.
Measured: At baseline and 5 months after sugery
Change from baseline in Depression at 5 months after surgery.
MDI-12 (Major Depression Inventory), ICD-10 (International Classification of Diseases), measure the depression level in the period from baseline and 5 months after surgery.
Measured: At baseline and 5 months after surgery.
Change from baseline in Posttraumatic stress disorder at 5 months after surgery
To measure the Posttraumatic stress disorder we uge HTQ-17 (Harvard Trauma Questionnaire) for PTSD (Post Traumatic Stress Disorder).
Measured: At baseline and 5 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2013 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needs for RehabilitationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kamila Adellund Holt
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital
- Responsible party
- Sponsor-investigator, Kamila Adellund Holt, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638741
- Sponsor's protocol ID
- Rehabilitation
- Status last verified
- Apr 2013
- First submitted
- 17 May 2012
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation and the Association With Attachment Styles Among Patients With Gynaecological Cancer
- ClinicalTrials.gov ID
- NCT01638741
- Acronym / sponsor ID
- Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kamila Adellund HoltUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 12 Jul 2012 (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 this study is to provide new knowledge about:
- Integration of rehabilitation in a highly specialized gynaecological department.
- Development and testing of an individually adapted rehabilitation process.
- Needs for rehabilitation among women with gynaecological cancer.
- Connection between adult attachment style for women with gynaecological cancer and their quality of life, rehabilitation needs and symptoms of depression /PTSD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population Description * Patients referred to Odense University Hospital outpatient clinic with suspition for gynaecological cancer. The patients are from to Regions in Danmark, Region Zealand and Region South Denmark.
Key inclusion criteria (2 listed)
- suspicion of gynaecological cancer
- surgery for gynaecological cancer
Key exclusion criteria (1 listed)
- do not speak Danish
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 |
|---|---|---|
| Rehabilitation goals of patients with gynaecological cancer.Conversations with the nurse and supportive phone calls. Conversation are structured and placed 1 and 3 months after surgery. Phone calls are carried out at two and three months after surgery. | Behavioural | – |
Primary outcome
Change from baseline in Quality of life at 5 months after surgery.
Time frame: at baseline and 5 months after surgery
EORCT QLQ-C 30 (QLQ is quality of life questionnaire) and EORCT QLQ-OV28 (OV - Ovarian) and EORCT QLQ-EN ( EN - endometrial) 24 and EORCT QLQ- CX 24 ( CX - cervix.
3 secondary outcomes
Change from baseline in Revised Adult Attachment at 5 months after surgery.
Time frame: At baseline and 5 months after sugery
Change from baseline in Depression at 5 months after surgery.
Time frame: At baseline and 5 months after surgery.
Change from baseline in Posttraumatic stress disorder at 5 months after surgery
Time frame: At baseline and 5 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Needs for Rehabilitation and Adult Attachment Style, run by Kamila Adellund Holt at 1 site in Denmark.
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 2 inclusion and 1 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 24 Apr 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 Denmark. 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.
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?
Contact Kamila A. Holt, Ph.D. student (0045 26 82 26 57, kamila.holt@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Quality of life at 5 months after surgery. (time frame: at baseline and 5 months after surgery). 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 24 Apr 2013.