Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer (SPARC)
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|ClinicalTrials.gov Identifier: NCT03611517|
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : November 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Cervical Cancer Vaginal Cancer Gynecologic Cancer||Behavioral: Sexual rehabilitation programme||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||SPARC Study: A Nurse-led Sexual Rehabilitation Programme for Women With Gynaecological Cancers Receiving Radiotherapy: a Randomized Multicentre Trial|
|Actual Study Start Date :||August 7, 2018|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
Experimental: 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.
Behavioral: 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.
No Intervention: 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.
- 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
- Changes from 1 month in Vaginal symptoms and body image concerns at 12 months post RT/RTBT [ Time Frame: 12 months ]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).
- Change from 1 month in Fear of coital and non-coital sexual activity at 12 months post RT/RTBT [ Time Frame: 12 months ]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).
- Change from 1 month in Level of sexual distress at 12 months post RT/RTBT [ Time Frame: 12 months ]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).
- Change from 1 month in Treatment related distress at 12 months post RT/RTBT [ Time Frame: 12 months ]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).
- Change from 1 month Generic health-related quality of life related to gynaecological cancer at 12 months post RT/RTBT [ Time Frame: 12 months ]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.
- change from 1 month in Psychological distress at 12 months post RT/RTBT [ Time Frame: 12 months ]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).
- Change from 1 month in Relationship dissatisfaction at 12 months post RT/RTBT [ Time Frame: 12 months ]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).
- Change from 1 month in Frequency of dilator use at 12 months post RTBT [ Time Frame: 12 months ]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).
- Change from baseline in Vaginal symptoms at 12 months post RT/RTBT [ Time Frame: 12 months ]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).
- Cost-effectiveness [ Time Frame: 12 months ]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).
- Treatment credibility and expectancy for improvement [ Time Frame: at 1 month post RT/RTBT ]Treatment credibility and expectancy for improvement will be assessed using the 4-item Credibility and Expectancy Questionnaire (CEQ; scoring range: 4-36). Higher scores indicate higher expectations of the intervention (for intervention group) or care as usual (for control group).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611517
|Contact: Moniek M ter Kuile, PhDfirstname.lastname@example.org|
|Contact: SPARC onderzoeksteam||003175296863||SPARCstudie@lumc.nl|
|Academic Medical Center||Recruiting|
|Contact: Henrike Westerveld email@example.com|
|Contact: Dorien Haverkort D.Haverkort@radiotherapiegroep.nl|
|Contact: Hetty A van den Berg firstname.lastname@example.org|
|University Medical Center Groningen||Recruiting|
|Contact: Jannet Beukema email@example.com|
|Contact: Ludy Lutgens firstname.lastname@example.org|
|Contact: An Snyers An.Snyers@radboudumc.nl|
|Contact: Jan Willem M Mens, MD email@example.com|
|University Medical Center Utrecht||Not yet recruiting|
|Contact: Ina Jurgenliemk-Schulz I.M.Schulz@umcutrecht.nl|
|Study Chair:||Moniek M ter Kuile, PhD||Leiden University Medical Center|
|Principal Investigator:||Carien L Creutzberg, MD, PhD||Leiden University Medical Center|
|Principal Investigator:||Jan Willem M Mens, MD||Erasmus Medical Center|