Clinical trial NCT03611517: Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer
Official title: SPARC Study: A Nurse-led Sexual Rehabilitation Programme for Women With Gynaecological Cancers Receiving Radiotherapy: a Randomized Multicentre Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2018-08-02
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)).

Primary outcomes:
measure: Change from 1 month in Sexual functioning at 12 months post RT/RTBT
timeFrame: 12 months
Secondary outcomes:
measure: Changes from 1 month in Vaginal symptoms and body image concerns at 12 months post RT/RTBT
timeFrame: 12 months
measure: Change from 1 month in Fear of coital and non-coital sexual activity at 12 months post RT/RTBT
timeFrame: 12 months
measure: Change from 1 month in Level of sexual distress at 12 months post RT/RTBT
timeFrame: 12 months
measure: Change from 1 month in Treatment related distress at 12 months post RT/RTBT
timeFrame: 12 months
measure: Change from 1 month Generic health-related quality of life related to gynaecological cancer at 12 months post RT/RTBT
timeFrame: 12 months
measure: change from 1 month in Psychological distress at 12 months post RT/RTBT
timeFrame: 12 months
measure: Change from 1 month in Relationship dissatisfaction at 12 months post RT/RTBT
timeFrame: 12 months
measure: Change from 1 month in Frequency of dilator use at 12 months post RTBT
timeFrame: 12 months
measure: Change from baseline in Vaginal symptoms at 12 months post RT/RTBT
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
measure: Treatment credibility and expectancy for improvement
timeFrame: at 1 month post RT/RTBT
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Arnhem
country: Netherlands
facility: Radiotherapiegroep
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Leiden University Medical Center
name: Moniek M ter Kuile, PhD
role: STUDY_CHAIR
affiliation: Leiden University Medical Center
name: Carien L Creutzberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Jan Willem M Mens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.