Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer

NCT03611517 | Unknown

• 3 other identifiers: P17.31710674NL62767.058.17
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 8

Brief 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 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.

Conditions

Endometrial Cancer; Cervical Cancer; Vaginal Cancer; Gynecologic Cancer

Keywords

Endometrial cancer; Cervical cancer; Vaginal cancer; sexuality; sexual problems; dilator; radiotherapy; gynaecological cancer; sexual rehabilitation programme

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (10)

• Changes from 1 month in Vaginal symptoms and body image concerns at 12 months post RT/RTBT

  12 months

• Change from 1 month in Fear of coital and non-coital sexual activity at 12 months post RT/RTBT

  12 months

• Change from 1 month in Level of sexual distress at 12 months post RT/RTBT

  12 months

• Change from 1 month in Treatment related distress at 12 months post RT/RTBT

  12 months

• Change from 1 month Generic health-related quality of life related to gynaecological cancer at 12 months post RT/RTBT

  12 months

Other Outcomes (1)

• Treatment credibility and expectancy for improvement

  at 1 month post RT/RTBT

Study Arms (2)

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.

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.

Interventions

Sexual rehabilitation programme BEHAVIORAL

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.

Sexual rehabilitation programme

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being diagnosed with on of the following gynaecological cancers: cervical cancer, endometrial cancer or vaginal cancer
• years or older
• receiving radiotherapy for gynaecological cancer (RT/RTBT)
• wish to retain sexual activity in the short- or long-term.

You may not qualify if:

• 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)).

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (8)

Academic Medical Center

Amsterdam, Netherlands

RECRUITING

Radiotherapiegroep

Arnhem, Netherlands

RECRUITING

Catharina Hospital

Eindhoven, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

MAASTRO clinic

Maastricht, Netherlands

RECRUITING

Radboudumc

Nijmegen, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Netherlands

NOT YET RECRUITING

Related Publications (6)

• 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.

  PMID: 25248115 BACKGROUND

• 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.

  PMID: 27787681 BACKGROUND

• 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.

  PMID: 25424559 BACKGROUND

• 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.

  PMID: 25218609 BACKGROUND

• 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.

  PMID: 38961193 DERIVED

• 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.

  PMID: 34863145 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms; Vaginal Neoplasms; Sexuality

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases; Vaginal Diseases; Sexual Behavior; Behavior

Study Officials

• Moniek M ter Kuile, PhD

  Leiden University Medical Center

  STUDY CHAIR

• Carien L Creutzberg, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• Jan Willem M Mens, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moniek M ter Kuile, PhD

CONTACT

0031715263121; m.m.ter_kuile@lumc.nl

SPARC onderzoeksteam

CONTACT

003175296863; SPARCstudie@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, clinical psychologist, associate professor

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: August 2, 2018
• Study Start: August 7, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (8)