Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer
NCT ID: NCT03611517
Last Updated: 2020-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2018-08-07
2022-07-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sexual rehabilitation programme
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.
Sexual rehabilitation programme
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.
Care as usual
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.
No interventions assigned to this group
Interventions
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Sexual rehabilitation programme
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.
Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* receiving radiotherapy for gynaecological cancer (RT/RTBT)
* wish to retain sexual activity in the short- or long-term.
Exclusion Criteria
* 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)).
18 Years
FEMALE
No
Sponsors
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Dutch Cancer Society
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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MMterKuile
PhD, clinical psychologist, associate professor
Principal Investigators
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Moniek M ter Kuile, PhD
Role: STUDY_CHAIR
Leiden University Medical Center
Carien L Creutzberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Jan Willem M Mens, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Academic Medical Center
Amsterdam, , Netherlands
Radiotherapiegroep
Arnhem, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
MAASTRO clinic
Maastricht, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Bakker 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.
Bakker 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.
Vermeer 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.
Suvaal 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.
Suvaal 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.
Other Identifiers
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10674
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NL62767.058.17
Identifier Type: OTHER
Identifier Source: secondary_id
P17.317
Identifier Type: -
Identifier Source: org_study_id
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