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A nurse-led sexual rehabilitation programme for women with gynaecological cancers receiving radiotherapy: a randomized multicentre trial.

A nurse-led sexual rehabilitation programme for women with gynaecological cancers receiving radiotherapy: a randomized multicentre trial. - Sexual rehabilitation Program After Radiotherapy for gynaecological Cancers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55440
Enrollment
220
Registered
2018-03-05
Start date
2018-08-07
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sexual complaints sexual problems

Interventions

Women in the intervention group receive information about sexual rehabilitation after gynaecological cancer (a brochure and website) and guidance in sexual rehabilitation from an oncology-nurse by m

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The study population will be composed of 220 women, who 1) are 18 years or older, 2) will be treated with radiotherapy for gynaecological cancer and who 3) wish to retain sexual activity on the short- or long-term. The study sample will consist of women who will be treated with RT or RT+BT for gynaecological cancer: • RT: Postoperative pelvic external beam radiotherapy for cancer of the cervix, vagina or endometrium. • RT+BT: either primary or postoperative pelvic external beam radiotherapy for cancer of the cervix, vagina or endometrium with a brachytherapy boost by intra-uterine and/or vaginal brachytherapy; this includes treatment with RT+BT for local relapse after previous surgery for cervix, vaginal or endometrial cancer.

Exclusion criteria

Exclusion criteria: Women will be excluded from the study if they: 1) are living abroad during follow-up; 2) have insufficient knowledge of the Dutch language; 3) have major psychiatric disorders (i.e., major affective disorder, psychotic disorder, substance abuse related disorder, or posttraumatic stress disorder resulting from abuse in the area of the pelvic floor and genitals (e.g. sexual abuse)).

Design outcomes

Primary

MeasureTime frame
The primary outcome is sexual functioning 12 months after radiotherapy.

Secondary

MeasureTime frame
The secondary outcomes include: sexual functioning 24 months after radiotherapy, vaginal symptoms and body image concerns, fear of coital and non-coital sexual activity, sexual distress, treatment-related distress, generic health-related quality of life related to gynaecological cancer, psychological distress, relationship dissatisfaction, frequency of dilator use, and vaginal physical symptoms.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)