Endometrial CancerSPARCNCT03611517
Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer
A study testing Sexual rehabilitation programme in people with Endometrial Cancer and Cervical Cancer, run by Leiden University Medical Center at 8 sites in Netherlands.
Trial summary
The aim of this randomized controlled trial is to demonstrate that a nurse-led sexual rehabilitation intervention significantly improves sexual recovery and functioning among gynaecological cancer (GC) patients treated with radiotherapy (RT), compared with usual care (i.e., oral information by a nurse or doctor and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Cervical Cancer, Vaginal Cancer
- What is being tested?
- Sexual rehabilitation programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 8 sitesNetherlands
- Study dates
- 7 Aug 2018to Jul 2022
- 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
- being diagnosed with on of the following gynaecological cancers: cervical cancer, endometrial cancer or vaginal cancer
- 18 years or older
- receiving radiotherapy for gynaecological cancer (RT/RTBT)
- wish to retain sexual activity in the short- or long-term.
Who cannot join
- being unavailable for follow-up
- having insufficient knowlegde of the Dutch language
- having a psychiatric disorder (e.g. major affective disorder, psychotic disorder, substance abuse disorder (i.e., alcohol, drugs), or posttraumatic stress disorder resulting from abuse in the pelvic floor and/or genitals (e.g., sexual abuse)).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites, 8 recruiting
- Recruiting
Academic Medical Center
Amsterdam
Henrike Westerveld, g.h.westerveld@amc.uva.nl
- Recruiting
Radiotherapiegroep
Arnhem
Dorien Haverkort, D.Haverkort@radiotherapiegroep.nl
- Recruiting
Catharina Hospital
Eindhoven
Hetty A van den Berg, hetty.vd.berg@catharinaziekenhuis.nl
- Recruiting
University Medical Center Groningen
Groningen
Jannet Beukema, j.c.beukema@umcg.nl
- Recruiting
MAASTRO clinic
Maastricht
Ludy Lutgens, ludy.lutgens@maastro.nl
- Recruiting
Radboudumc
Nijmegen
An Snyers, An.Snyers@radboudumc.nl
- Recruiting
Erasmus MC
Rotterdam
Jan Willem M Mens, MD, j.w.m.mens@erasmusmc.nl
- Not yet recruiting
University Medical Center Utrecht
Utrecht
Ina Jurgenliemk-Schulz, I.M.Schulz@umcutrecht.nl
About this study
Official title: SPARC Study: A Nurse-led Sexual Rehabilitation Programme for Women With Gynaecological Cancers Receiving Radiotherapy: a Randomized Multicentre Trial
The aim of this randomized controlled trial is to demonstrate that a nurse-led sexual rehabilitation intervention significantly improves sexual recovery and functioning among gynaecological cancer (GC) patients treated with radiotherapy (RT), compared with usual care (i.e., oral information by a nurse or doctor and written information).
Women with GC (n=220) who receive RT in one of the participating Dutch GC centres (n=9) will be randomized to either the sexual rehabilitation intervention (n= 110) or usual care (n= 110), stratified for combined RTBT vs. RT alone, and for having a partner (yes/no). Women are eligible for participation if they: have been diagnosed with either cervical, endometrial, or vaginal cancer; are treated with radiotherapy; are 18 years or older; and wish to retain their sexual activity on the short or long term.
Read more
The intervention consists of four one-hour sessions at 1 month, 3, 6, and 12 months after RT. Women who received RTBT will receive an additional appointment with the nurse (2 months after RTBT) to promote regular use of vaginal dilators in order to prevent stenosis. Participants are requested to complete questionnaires at baseline and at 1, 3, 6, and 12 months post-RT.
The primary endpoint is sexual functioning at 12 months. Secondary endpoints include vaginal symptoms and body concerns, fear of coital and non-coital sexual activity, sexual distress, treatment-related distress, generic health-related quality of life, psychological distress, and relationship dissatisfaction.
Hypothesis: The investigators expect women who receive the nurse-led sexual rehabilitation programme to report a greater improvement in sexual functioning from immediate post-radiotherapy to 1 year post-radiotherapy than women in the control group.
Read the detailed description
The primary objective of this randomized controlled trial is to evaluate if the nurse-led sexual rehabilitation intervention improves sexual recovery and functioning in patients with gynaecological cancers (GC) who are treated with either external pelvic radiotherapy only (i.e., RT) or external pelvic radiotherapy combined with brachytherapy (i.e., RTBT) compared with usual care (Q1).
The secondary objective is to evaluate if the nurse-led sexual rehabilitation program decreases vaginal symptoms and body image concerns, fear of (non-)coital sexual activity, treatment-related distress, psychological and sexual distress, and vaginal physical symptoms (assessed during physical examination by the radiation oncologist), and improves/increases generic-related health related quality of life related to gynaecological cancer, relationship satisfaction, and frequency of dilator use, (Q2); to evaluate the cost-effectiveness of the intervention (Q3); and to evaluate whether an improvement in sexual functioning is moderated by treatment characteristics and pre-treatment patient characteristics, such as age or sexual functioning, and mediated by reduction of vaginal symptoms (and by regular use of dilators in women treated with RTBT) (Q4).
- Being tested
- Sexual rehabilitation programme
- Keywords
- Endometrial cancer, Cervical cancer, Vaginal cancer, sexuality, sexual problems, dilator, radiotherapy, gynaecological cancer, sexual rehabilitation programme
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms, Vaginal Neoplasms, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual rehabilitation programmeBehavioural
The intervention consists of 4 patient/couple sessions (each max. 60 minutes) scheduled at 1, 3, 6 and 12 months post-RT. Patients treated with RTBT have an additional session 2 months post RT. If preferred, one extra session of 30 minutes can be scheduled between 6 and 12 months after RT. The intervention includes (1) education on the specific cancer diagnosis and treatment, (2) education on the importance of regular dilation for prevention of vaginal stenosis (if indicated), (3) discussing and resolving potential fears and experienced barriers to performing vaginal dilation (if indicated) and sexual activity,(4) promoting couples' mutual coping and support processes and (5) specific sexual therapy techniques to address sexual and body image concerns.
| Study group | Role | What they receive |
|---|---|---|
| Sexual rehabilitation programme | Experimental | The intervention exists of a nurse-led sexual rehabilitation programme, which is provided in addition to the care as usual. The intervention consists of four one-hour sessions at 1 month, 3, 6, and 12 months after RT. Women treated with RTBT will receive an additional appointment with the nurse (2 months after RTBT). Furthermore, the latter group receives a vaginal dilator set. Receives: Behavioral: Sexual rehabilitation programme |
| Care as usual | No intervention | The control group receives the optimal care as usual, according to each participating hospital's guidelines. Additionally, all patients receive an information booklet including information concerning sexuality after RT for GC. Patients who underwent RTBT also receive a vaginal dilator set. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from 1 month in Sexual functioning at 12 months post RT/RTBT
The primary outcome measure is sexual functioning and will be assessed with the Dutch version of the 19-item Female Sexual Function Index (FSFI) questionnaire. The FSFI consists of 6 subscales measuring sexual desire (scoring range: 0.6 - 6.0), arousal (scoring range: 0 - 6.0), lubrication (scoring range: 0 - 6.0), orgasm (scoring range: 0 - 6.0), satisfaction (scoring range: 0.8 - 6.0), and pain (scoring range: 0 - 6.0). The scores of the questions are added per subscale, after which they are multiplied by a factor depending on the subscale ( sexual desire: 0.6; arousal: 0.3; lubrication: 0.3; orgasm: 0.4; satisfaction: 0.4; pain: 0.4) to give them a subscale score. By adding all 6 subscales together, the total score of the FSFI is obtained. The total score reflects overall sexual functioning (scoring range: 2.0 - 36.0). Higher scores indicate better sexual functioning. (measured at 1, 3, 6, 12 months post RT/RTBT and retrospectively (sexual functioning before diagnosis) at baseline
Measured: 12 months
Secondary outcomes (10)
Changes from 1 month in Vaginal symptoms and body image concerns at 12 months post RT/RTBT
Vaginal symptoms and body image concerns will be assessed with the Quality-of-Life Questionnaire (QLQ) Cervical Cancer Module (CX24) and Endometrial Cancer Module (EN24) of the Dutch version of the European Organization for Research and Treatment of Cancer (EORTC; EORTC-QLQ-CX24, EORTC-QLQ-EN24). The EORTC-QLQ-CX24 consists of 9 subscales: symptom experience (scoring range 11 - 44), lymphoedema (scoring range: 1-4), peripheral neuropathy (scoring range: 1-4), menopausal symptoms (scoring range: 1-4), sexual worry (scoring range: 1-4), body image (scoring range: 3-12), sexual activity (scoring range: 1-4), sexual enjoyment (scoring range: 1-4), sexual/vaginal functioning (scoring range: 4-16). Items 34, 38, 39, 40, 42, and 49 of the EORTC-QLQ-EN24 will be assessed (item range: 3). Lower scores indicate better sexual/vaginal functioning and lower body image concerns and relevant subscales. (measured at 1, 3, 6, 12 months post RT/RTBT).
Measured: 12 months
Change from 1 month in Fear of coital and non-coital sexual activity at 12 months post RT/RTBT
Fear of coital and non-coital sexual activity will be assessed with the 8-item Fear of Sexuality Questionnaire (FSQ). The FSQ consist of 2 subscales: fear of non-coital sexual activity (scoring range: 5-25), and fear of coitus (scoring range:3-15). A higher score indicates more fear. (measured at 1, 3, 6, 12 months post RT/RTBT).
Measured: 12 months
Change from 1 month in Level of sexual distress at 12 months post RT/RTBT
The level of sexual distress is assessed with the 12-item (scoring range: 0-48)Female Sexual Distress Scale (FSDS). Higher scores indicate more sexual dissatisfaction/distress. (measured at 1, 3, 6, 12 months post RT/RTBT and at baseline (retrospectively) concerning sexual functioning before diagnosis).
Measured: 12 months
Change from 1 month in Treatment related distress at 12 months post RT/RTBT
Treatment related distress is assessed with Dutch version of the 15-items Impact of Event Scale-revised (IES-R; in Dutch Schokverwerkingslijst (SVL)). The total scores on the IES-R have a possible range of 0-75, with higher scores indicating a greater frequency of intrusive thoughts and attempts at avoidance. Subscale scores can also be computed for the 7 intrusion items (scoring range: 0-35), and the 8 avoidance items (scoring range:0-40).
Measured: 12 months
Change from 1 month Generic health-related quality of life related to gynaecological cancer at 12 months post RT/RTBT
Generic health-related quality of life (QoL) related to gynaecological cancer is assessed with the Dutch version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). The QLQ-C30 is composed of 5 functional scales (resp. physical, role, cognitive, emotional, and social functioning) and 9 symptom scales and/or items (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), and a global health status/QoL scale. All scales/item measures have scoring ranges from 0-100. A high scale score for a functional scale represents a high/healthy level of functioning. A high scale score for a symptom scale/item scale represents a high level of symptomatology/problems. A high scale score for the global health status/QoL represents high QoL. For scoring principles, please see the EORTC QLQ-C30 Scoring Manual.
Measured: 12 months
change from 1 month in Psychological distress at 12 months post RT/RTBT
Psychological distress is assessed with the Dutch version of the 14-item Hospital Anxiety and Depression Scale (HADS). The HADS consists of two 7-item subscales, measuring anxiety (scoring range: 0-21) and depression (scoring range: 0-21). Higher scores on subscales indicate higher levels of anxiety and/or depression. (measured at 1, 3, 6, 12 months post RT/RTBT).
Measured: 12 months
Change from 1 month in Relationship dissatisfaction at 12 months post RT/RTBT
Relationship dissatisfaction is assessed with the 10-item relationship dissatisfaction subscale of the Maudsley Marital Questionnaire (MMQ; scoring range 0-80). Higher scores represent greater dissatisfaction. (measured at 1, 3, 6, 12 months post RT/RTBT).
Measured: 12 months
Change from 1 month in Frequency of dilator use at 12 months post RTBT
Patients treated with RTBT will in addition complete questions regarding the frequency of dilator use during the previous month. (measured at 1, 3, 6, 12 months post RTBT).
Measured: 12 months
Change from baseline in Vaginal symptoms at 12 months post RT/RTBT
Vaginal symptoms will be assessed during physical examination. Vaginal symptoms include grade of mucosal atrophy, dryness, fibrosis, and signs of vaginal shortening and/or stenosis. Vaginal symptoms will be recorded using the Common Terminology Criteria for Adverse Events (CTCAE) v.4.037. (measured at 1, 3, 6, 12 months post RT/RTBT).
Measured: 12 months
Cost-effectiveness
A cost-effectiveness analysis will be conducted in which the costs of the intervention will be related to shifts in other health care costs and the impact on patient outcome. A cost-price analysis will be performed for the nurse-led intervention (including training, counselling hours and materials). Other health care use will be limited to sexuality-related health care utilization (including gynaecologist, radiation oncologist, general practitioner, psychologist, and sexologist), estimated from patient reports and valued using standard prices. the Dutch tariff for the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) will be used (measured at 1, 3, 6, 12 months post RT/RTBT).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start7 Aug 2018
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After signed informed consent, women complete the baseline questionnaire. After completion of the baseline questionnaire and before the end of RT, patients will be randomized to either the intervention group or the control group. The control group receives care as usual. The intervention group receives the nurse-led sexual rehabilitation intervention. All patients have follow-up appointments with their radiation-oncologist (or gynecologic oncologist) at 1, 3, 6 and 12 months post RT. For the intervention group, the sexual rehabilitation intervention sessions with the nurse will be planned immediately following the appointment with the radiation-oncologist. Women in the intervention group who are treated with RTBT receive an extra session 2 months after the end of radiotherapy. All patients are asked to complete questionnaires at baseline, and 1, 3, 6, and 12 months after completion of RT.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, MMterKuile, Leiden University Medical Center
- Investigators
- Moniek M ter Kuile, PhD, Study chair, Leiden University Medical CenterCarien L Creutzberg, MD, PhD, Principal investigator, Leiden University Medical CenterJan Willem M Mens, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611517
- Sponsor's protocol ID
- P17.317
- Other IDs
- 10674, NL62767.058.17
- Acronym
- SPARC
- Status last verified
- Feb 2020
- First submitted
- 29 May 2018
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bakker RM, ter Kuile MM, Vermeer WM, Nout RA, Mens JW, van Doorn LC, de Kroon CD, Hompus WC, Braat C, Creutzberg CL. Sexual rehabilitation after pelvic radiotherapy and vaginal dilator use: consensus using the Delphi method. Int J Gynecol Cancer. 2014 Oct;24(8):1499-506. doi: 10.1097/IGC.0000000000000253.
PubMed 25248115Bakker RM, Mens JW, de Groot HE, Tuijnman-Raasveld CC, Braat C, Hompus WC, Poelman JG, Laman MS, Velema LA, de Kroon CD, van Doorn HC, Creutzberg CL, Ter Kuile MM. A nurse-led sexual rehabilitation intervention after radiotherapy for gynecological cancer. Support Care Cancer. 2017 Mar;25(3):729-737. doi: 10.1007/s00520-016-3453-2. Epub 2016 Oct 27.
PubMed 27787681Bakker RM, Vermeer WM, Creutzberg CL, Mens JW, Nout RA, Ter Kuile MM. Qualitative accounts of patients' determinants of vaginal dilator use after pelvic radiotherapy. J Sex Med. 2015 Mar;12(3):764-73. doi: 10.1111/jsm.12776. Epub 2014 Nov 25.
PubMed 25424559Vermeer WM, Bakker RM, Stiggelbout AM, Creutzberg CL, Kenter GG, ter Kuile MM. Psychosexual support for gynecological cancer survivors: professionals' current practices and need for assistance. Support Care Cancer. 2015 Mar;23(3):831-9. doi: 10.1007/s00520-014-2433-7. Epub 2014 Sep 14.
PubMed 25218609Suvaal I, Hummel SB, Mens JM, Tuijnman-Raasveld CC, Tsonaka R, Velema LA, Westerveld H, Cnossen JS, Snyers A, Jurgenliemk-Schulz IM, Lutgens LCHW, Beukema JC, Haverkort MAD, Nowee ME, Nout RA, de Kroon CD, van den Hout WB, Creutzberg CL, van Doorn HC, Ter Kuile MM. Efficacy of a nurse-led sexual rehabilitation intervention for women with gynaecological cancers receiving radiotherapy: results of a randomised trial. Br J Cancer. 2024 Sep;131(5):808-819. doi: 10.1038/s41416-024-02775-8. Epub 2024 Jul 3.
PubMed 38961193Suvaal I, Hummel SB, Mens JM, van Doorn HC, van den Hout WB, Creutzberg CL, Ter Kuile MM. A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial. BMC Cancer. 2021 Dec 4;21(1):1295. doi: 10.1186/s12885-021-08991-2.
PubMed 34863145
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARC Study: A Nurse-led Sexual Rehabilitation Programme for Women With Gynaecological Cancers Receiving Radiotherapy: a Randomized Multicentre Trial
- ClinicalTrials.gov ID
- NCT03611517
- Acronym / sponsor ID
- SPARC / P17.317
- Keywords
- Endometrial cancer, Cervical cancer, Vaginal cancer, sexuality, sexual problems, dilator, radiotherapy, gynaecological cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 2 Aug 2018 (actual)
- 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 aim of this randomized controlled trial is to demonstrate that a nurse-led sexual rehabilitation intervention significantly improves sexual recovery and functioning among gynaecological cancer (GC) patients treated with radiotherapy (RT), compared with usual care (i.e., oral information by a nurse or doctor and written information).
Women with GC (n=220) who receive RT in one of the participating Dutch GC centres (n=9) will be randomized to either the sexual rehabilitation intervention (n= 110) or usual care (n= 110), stratified for combined RTBT vs. RT alone, and for having a partner (yes/no). Women are eligible for participation if they: have been diagnosed with either cervical, endometrial, or vaginal cancer; are treated with radiotherapy; are 18 years or older; and wish to retain their sexual activity on the short or long term.
The intervention consists of four one-hour sessions at 1 month, 3, 6, and 12 months after RT. Women who received RTBT will receive an additional appointment with the nurse (2 months after RTBT) to promote regular use of vaginal dilators in order to prevent stenosis. Participants are requested to complete questionnaires at baseline and at 1, 3, 6, and 12 months post-RT.
The primary endpoint is sexual functioning at 12 months. Secondary endpoints include vaginal symptoms and body concerns, fear of coital and non-coital sexual activity, sexual distress, treatment-related distress, generic health-related quality of life, psychological distress, and relationship dissatisfaction.
Hypothesis: The investigators expect women who receive the nurse-led sexual rehabilitation programme to report a greater improvement in sexual functioning from immediate post-radiotherapy to 1 year post-radiotherapy than women in the control group.
Detailed description
The primary objective of this randomized controlled trial is to evaluate if the nurse-led sexual rehabilitation intervention improves sexual recovery and functioning in patients with gynaecological cancers (GC) who are treated with either external pelvic radiotherapy only (i.e., RT) or external pelvic radiotherapy combined with brachytherapy (i.e., RTBT) compared with usual care (Q1).
The secondary objective is to evaluate if the nurse-led sexual rehabilitation program decreases vaginal symptoms and body image concerns, fear of (non-)coital sexual activity, treatment-related distress, psychological and sexual distress, and vaginal physical symptoms (assessed during physical examination by the radiation oncologist), and improves/increases generic-related health related quality of life related to gynaecological cancer, relationship satisfaction, and frequency of dilator use, (Q2); to evaluate the cost-effectiveness of the intervention (Q3); and to evaluate whether an improvement in sexual functioning is moderated by treatment characteristics and pre-treatment patient characteristics, such as age or sexual functioning, and mediated by reduction of vaginal symptoms (and by regular use of dilators in women treated with RTBT) (Q4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After signed informed consent, women complete the baseline questionnaire. After completion of the baseline questionnaire and before the end of RT, patients will be randomized to either the intervention group or the control group. The control group receives care as usual. The intervention group receives the nurse-led sexual rehabilitation intervention. All patients have follow-up appointments with their radiation-oncologist (or gynecologic oncologist) at 1, 3, 6 and 12 months post RT. For the intervention group, the sexual rehabilitation intervention sessions with the nurse will be planned immediately following the appointment with the radiation-oncologist. Women in the intervention group who are treated with RTBT receive an extra session 2 months after the end of radiotherapy. All patients are asked to complete questionnaires at baseline, and 1, 3, 6, and 12 months after completion of RT.
| Arm | Type | Receives |
|---|---|---|
| Sexual rehabilitation programme | Experimental | Behavioral: Sexual rehabilitation programmeThe intervention exists of a nurse-led sexual rehabilitation programme, which is provided in addition to the care as usual. The intervention consists of four one-hour sessions at 1 month, 3, 6, and 12 months after RT. Women treated with RTBT will receive an additional appointment with the nurse (2 months after RTBT). Furthermore, the latter group receives a vaginal dilator set. |
| Care as usual | No intervention | –The control group receives the optimal care as usual, according to each participating hospital's guidelines. Additionally, all patients receive an information booklet including information concerning sexuality after RT for GC. Patients who underwent RTBT also receive a vaginal dilator set. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being diagnosed with on of the following gynaecological cancers: cervical cancer, endometrial cancer or vaginal cancer
- 18 years or older
- receiving radiotherapy for gynaecological cancer (RT/RTBT)
- wish to retain sexual activity in the short- or long-term.
Key exclusion criteria (3 listed)
- being unavailable for follow-up
- having insufficient knowlegde of the Dutch language
- having a psychiatric disorder (e.g. major affective disorder, psychotic disorder, substance abuse disorder (i.e., alcohol, drugs), or posttraumatic stress disorder resulting from abuse in the pelvic floor and/or genitals (e.g., sexual abuse)).
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 |
|---|---|---|
| Sexual rehabilitation programmeThe intervention consists of 4 patient/couple sessions (each max. 60 minutes) scheduled at 1, 3, 6 and 12 months post-RT. Patients treated with RTBT have an additional session 2 months post RT. If preferred, one extra session of 30 minutes can be scheduled between 6 and 12 months after RT. The intervention includes (1) education on the specific cancer diagnosis and treatment, (2) education on the importance of regular dilation for prevention of vaginal stenosis (if indicated), (3) discussing and resolving potential fears and experienced barriers to performing vaginal dilation (if indicated) and sexual activity,(4) promoting couples' mutual coping and support processes and (5) specific sexual therapy techniques to address sexual and body image concerns. | Behavioural | Sexual rehabilitation programme |
Primary outcome
Change from 1 month in Sexual functioning at 12 months post RT/RTBT
Time frame: 12 months
The primary outcome measure is sexual functioning and will be assessed with the Dutch version of the 19-item Female Sexual Function Index (FSFI) questionnaire. The FSFI consists of 6 subscales measuring sexual desire (scoring range: 0.6 - 6.0), arousal (scoring range: 0 - 6.0), lubrication (scoring range: 0 - 6.0), orgasm (scoring range: 0 - 6.0), satisfaction (scoring range: 0.8 - 6.0), and pain (scoring range: 0 - 6.0). The scores of the questions are added per subscale, after which they are multiplied by a factor depending on the subscale ( sexual desire: 0.6; arousal: 0.3; lubrication: 0.3; orgasm: 0.4; satisfaction: 0.4; pain: 0.4) to give them a subscale score. By adding all 6 subscales together, the total score of the FSFI is obtained. The total score reflects overall sexual functioning (scoring range: 2.0 - 36.0). Higher scores indicate better sexual functioning. (measured at 1, 3, 6, 12 months post RT/RTBT and retrospectively (sexual functioning before diagnosis) at baseline
10 secondary outcomes
Changes from 1 month in Vaginal symptoms and body image concerns at 12 months post RT/RTBT
Time frame: 12 months
Change from 1 month in Fear of coital and non-coital sexual activity at 12 months post RT/RTBT
Time frame: 12 months
Change from 1 month in Level of sexual distress at 12 months post RT/RTBT
Time frame: 12 months
Change from 1 month in Treatment related distress at 12 months post RT/RTBT
Time frame: 12 months
Change from 1 month Generic health-related quality of life related to gynaecological cancer at 12 months post RT/RTBT
Time frame: 12 months
change from 1 month in Psychological distress at 12 months post RT/RTBT
Time frame: 12 months
Change from 1 month in Relationship dissatisfaction at 12 months post RT/RTBT
Time frame: 12 months
Change from 1 month in Frequency of dilator use at 12 months post RTBT
Time frame: 12 months
Change from baseline in Vaginal symptoms at 12 months post RT/RTBT
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Background: PubMed 25248115Bakker RM, ter Kuile MM, Vermeer WM, Nout RA, Mens JW, van Doorn LC, de Kroon CD, Hompus WC, Braat C, Creutzberg CL. Sexual rehabilitation after pelvic radiotherapy and vaginal dilator use: consensus using the Delphi method. Int J Gynecol Cancer. 2014 Oct;24(8):1499-506. doi: 10.1097/IGC.0000000000000253.
- Background: PubMed 27787681Bakker RM, Mens JW, de Groot HE, Tuijnman-Raasveld CC, Braat C, Hompus WC, Poelman JG, Laman MS, Velema LA, de Kroon CD, van Doorn HC, Creutzberg CL, Ter Kuile MM. A nurse-led sexual rehabilitation intervention after radiotherapy for gynecological cancer. Support Care Cancer. 2017 Mar;25(3):729-737. doi: 10.1007/s00520-016-3453-2. Epub 2016 Oct 27.
- Background: PubMed 25424559Bakker RM, Vermeer WM, Creutzberg CL, Mens JW, Nout RA, Ter Kuile MM. Qualitative accounts of patients' determinants of vaginal dilator use after pelvic radiotherapy. J Sex Med. 2015 Mar;12(3):764-73. doi: 10.1111/jsm.12776. Epub 2014 Nov 25.
- Background: PubMed 25218609Vermeer WM, Bakker RM, Stiggelbout AM, Creutzberg CL, Kenter GG, ter Kuile MM. Psychosexual support for gynecological cancer survivors: professionals' current practices and need for assistance. Support Care Cancer. 2015 Mar;23(3):831-9. doi: 10.1007/s00520-014-2433-7. Epub 2014 Sep 14.
- Derived from this study: PubMed 38961193Suvaal I, Hummel SB, Mens JM, Tuijnman-Raasveld CC, Tsonaka R, Velema LA, Westerveld H, Cnossen JS, Snyers A, Jurgenliemk-Schulz IM, Lutgens LCHW, Beukema JC, Haverkort MAD, Nowee ME, Nout RA, de Kroon CD, van den Hout WB, Creutzberg CL, van Doorn HC, Ter Kuile MM. Efficacy of a nurse-led sexual rehabilitation intervention for women with gynaecological cancers receiving radiotherapy: results of a randomised trial. Br J Cancer. 2024 Sep;131(5):808-819. doi: 10.1038/s41416-024-02775-8. Epub 2024 Jul 3.
- Derived from this study: PubMed 34863145Suvaal I, Hummel SB, Mens JM, van Doorn HC, van den Hout WB, Creutzberg CL, Ter Kuile MM. A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial. BMC Cancer. 2021 Dec 4;21(1):1295. doi: 10.1186/s12885-021-08991-2.
- Individual participant dataSharing planned: No
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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.
Moniek M ter Kuile, PhD study chair
Leiden University Medical Center
Carien L Creutzberg, MD, PhD principal investigator
Leiden University Medical Center
Jan Willem M Mens, MD principal investigator
Erasmus Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual rehabilitation programme in people with Endometrial Cancer and Cervical Cancer, run by Leiden University Medical Center at 8 sites in Netherlands.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. 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 Moniek M ter Kuile, PhD (0031715263121, m.m.ter_kuile@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from 1 month in Sexual functioning at 12 months post RT/RTBT (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03611517, which also lists 6 linked publications.
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 Feb 2020.