Malignant Female Reproductive System NeoplasmPESUNCT01784406
Person-centred Support for Women After Treatment for Gynaecological Cancer
A study testing Autonomy supportive counselling in people with Malignant Female Reproductive System Neoplasm and Follow-up, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Women treated for gynaecological cancer perceive many difficulties in life on the personal, social, and physical levels. Today they are offered a 3 to 5 year follow-up programme at the hospital where the main purpose is to improve survival. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm, Follow-up, Supportive Care
- What is being tested?
- Autonomy supportive counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jun 2015
- Phase
- Interventional
- 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 only surgically treated for cervix, ovarian (including borderline tumors), endometrial or vulva cancer, who attend follow up at the Gynaecological Department at The University Hospital Rigshospitalet in Copenhagen.
- The women should read, write and understand the danish language.
Who cannot join
- Known recurrence.
- Participation in the preliminary pilotstudy.
- Health related problems both physical or psychological, that prevent participation. For example cognitive impairment, or patients with psychiatric diseases that is estimated to require nurses with competences within the psychiatric speciality.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Gynaecological Department, Juliane Marie Centret,Copenhagen University Hospital Rigshospitalet
Copenhagen, Copenhagen Ø, 2100
About this study
Official title: Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial
Women treated for gynaecological cancer perceive many difficulties in life on the personal, social, and physical levels. Today they are offered a 3 to 5 year follow-up programme at the hospital where the main purpose is to improve survival. However, the women are very nervous before follow-up visits and although they feel safe about them, they express that their needs of psychosocial care and self-management support are not fulfilled.
The proposed study will test a person-centred intervention tailored the women's needs in a randomised controlled trial. The intervention will be based on the method Guided Self Determination (GSD), which has proved able to realize empowerment in practice in relationships between patients and healthcare professionals. GSD involves systematic use of condition-adjusted worksheets ('reflection sheets'), and advanced professional communication. Using reflection sheets filled out by each woman as the starting point for communication, problem solving will be tailored her personal needs. We expect that the intervention has the potential to support the women in better managing specific complications and difficulties related to concerns about recovery, body perception, fertility and establishment of intimate relations with their partner, all aspects important for the women's quality of life in the follow-up period after cancer diagnosis and treatment. The study will be the first to test GSD in cancer patients.
- Conditions
- Malignant Female Reproductive System Neoplasm, Follow-up, Supportive Care, Psychosocial Circumstances, Survivorship
- Being tested
- Autonomy supportive counselling
- Keywords
- Self-management intervention, Psychosocial care, Autonomy-supportive, Gynaecological cancer survivors, Guided self-Determination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomy supportive counsellingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Autonomy-supportive counselling | Experimental | 2-4 autonomy-supportive conversations with an experienced nurse, educated both theoretically and practically in the method Guided Self-Determination that includes specific "reflection sheets" and use of advanced communication; in addition to standard care. Receives: Behavioral: Autonomy supportive counselling |
| Control | No intervention | Standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)
+/- one week for practical reasons
Measured: 9 months after randomisation
Secondary outcomes (8)
Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS)
+/- one week for practical reasons
Measured: 3 months after randomisation
Changes in Quality of life in the two groups
Quality of life at 9 months minus the quality of life at the time of randomisation.
Measured: 9 months
Positive and negative impact of cancer measured by Impact of Cancer version 2 (IOCv2)
+/- one week for practical reasons
Measured: 3 and 9 months after randomisation
Self-esteem measured by Rosenbergs Self Esteem Scale
+/- one week for practical reasons
Measured: 3 and 9 months after randomisation
Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)
Also used as screening instrument baseline.
+/- one week for practical reasons
Measured: 3 and 9 months from randomisation
Autonomy-supportive relationship between patient and health care professionals measured by Health Care Climate Questionnaire (HCCQ)
+/- one week for practical reasons
Measured: 3 and 9 months from randomisation
Distress measured by Distress Thermometer(DT).
Also used as screening instrument baseline.
+/- one week for practical reasons.
Measured: 3 and 9 months from randomisation
Symptom monitoring and recognition
Womens ability to know what symptoms to monitor and react to in case of recurrence
Measured: 3 and 9 months after randomisation (+/- one week for practical reasons)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Linnet Olesen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784406
- Sponsor's protocol ID
- H-4-2012-FSP(94)
- Acronym
- PESU
- Status last verified
- Jan 2016
- First submitted
- 3 Feb 2013
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01784406
- Acronym / sponsor ID
- PESU / H-4-2012-FSP(94)
- Conditions
- Malignant Female Reproductive System Neoplasm, Follow-up, Supportive Care, Psychosocial Circumstances, Survivorship
- Keywords
- Self-management intervention, Psychosocial care, Autonomy-supportive, Gynaecological cancer survivors, Guided self-Determination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Feb 2013 (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.
Women treated for gynaecological cancer perceive many difficulties in life on the personal, social, and physical levels. Today they are offered a 3 to 5 year follow-up programme at the hospital where the main purpose is to improve survival. However, the women are very nervous before follow-up visits and although they feel safe about them, they express that their needs of psychosocial care and self-management support are not fulfilled.
The proposed study will test a person-centred intervention tailored the women's needs in a randomised controlled trial. The intervention will be based on the method Guided Self Determination (GSD), which has proved able to realize empowerment in practice in relationships between patients and healthcare professionals. GSD involves systematic use of condition-adjusted worksheets ('reflection sheets'), and advanced professional communication. Using reflection sheets filled out by each woman as the starting point for communication, problem solving will be tailored her personal needs. We expect that the intervention has the potential to support the women in better managing specific complications and difficulties related to concerns about recovery, body perception, fertility and establishment of intimate relations with their partner, all aspects important for the women's quality of life in the follow-up period after cancer diagnosis and treatment. The study will be the first to test GSD in cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autonomy-supportive counselling | Experimental | Behavioral: Autonomy supportive counselling2-4 autonomy-supportive conversations with an experienced nurse, educated both theoretically and practically in the method Guided Self-Determination that includes specific "reflection sheets" and use of advanced communication; in addition to standard care. |
| Control | No intervention | –Standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women only surgically treated for cervix, ovarian (including borderline tumors), endometrial or vulva cancer, who attend follow up at the Gynaecological Department at The University Hospital Rigshospitalet in Copenhagen.
- The women should read, write and understand the danish language.
Key exclusion criteria (3 listed)
- Known recurrence.
- Participation in the preliminary pilotstudy.
- Health related problems both physical or psychological, that prevent participation. For example cognitive impairment, or patients with psychiatric diseases that is estimated to require nurses with competences within the psychiatric speciality.
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 |
|---|---|---|
| Autonomy supportive counselling | Behavioural | Autonomy-supportive counselling |
Primary outcome
Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)
Time frame: 9 months after randomisation
+/- one week for practical reasons
8 secondary outcomes
Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS)
Time frame: 3 months after randomisation
Changes in Quality of life in the two groups
Time frame: 9 months
Positive and negative impact of cancer measured by Impact of Cancer version 2 (IOCv2)
Time frame: 3 and 9 months after randomisation
Self-esteem measured by Rosenbergs Self Esteem Scale
Time frame: 3 and 9 months after randomisation
Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 and 9 months from randomisation
Autonomy-supportive relationship between patient and health care professionals measured by Health Care Climate Questionnaire (HCCQ)
Time frame: 3 and 9 months from randomisation
Distress measured by Distress Thermometer(DT).
Time frame: 3 and 9 months from randomisation
Symptom monitoring and recognition
Time frame: 3 and 9 months after randomisation (+/- one week for practical reasons)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Statistical analysis planLink provided by the sponsor.
- Copenhagen University Hospital, Rigshospitalet has changed to a new web system therefore a new url adress/Statistical analysis planLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autonomy supportive counselling in people with Malignant Female Reproductive System Neoplasm and Follow-up, run by Copenhagen University Hospital, Rigshospitalet 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 3 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: finished, as of the sponsor's last update on 15 Jan 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS) (time frame: 9 months after randomisation). 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 15 Jan 2016.