Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer

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Brief Title

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

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).
    


Study Type

Interventional


Primary Outcome

Change from 1 month in Sexual functioning at 12 months post RT/RTBT

Secondary Outcome

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

Condition

Endometrial Cancer

Intervention

Sexual rehabilitation programme

Study Arms / Comparison Groups

 Sexual rehabilitation programme
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

220

Start Date

August 7, 2018

Completion Date

July 2022

Primary Completion Date

July 2022

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)).
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Moniek M ter Kuile, PhD, 0031715263121, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT03611517

Organization ID

P17.317

Secondary IDs

10674

Responsible Party

Principal Investigator

Study Sponsor

Leiden University Medical Center

Collaborators

 Dutch Cancer Society

Study Sponsor

Moniek M ter Kuile, PhD, Study Chair, Leiden University Medical Center


Verification Date

February 2020