Clinical trial NCT05771532: A Prospective and Randomized Controlled Evaluation of Sexual Health Education Program of Gynecological Cancer Women
Official title: Evaluation of a Gender-sensitive Sexual Health Education Program for Women With Gynecologic Cancer: A Prospective and Randomized Controlled Evaluation of Sexual Health Education Program of Cervical Cancer Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Health
Keywords: Sexual Self-efficacy
Sexuality
Health Education
Gender sensitivity
Transtheoretical Model
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 63
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For this two-group, controlled trial, 63 participants with cervical cancer were recruited from the gynecological wards of a large-scale medical center in northern Taiwan. The control group (n=30) received routine sexual health teaching (a 10-15-minute routine individual sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. The experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet).
Primary purpose: OTHER

Brief summary: The purpose of this study was to evaluate the effectiveness of the Gender-Sensitive -Sexual Health Education Program (GS-SHEP) in enhancing the sexual health of patients with gynecologic cancer.

Detailed description: This study recruited patients with cervical cancer from the gynecological wards of a large-scale medical center in northern Taiwan. A total of 63 participants were divided into two groups. The control group (n=30) received routine sexual health teaching (a 10-15-minute routine individual sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. The experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet). GS-SHEP effectiveness was examined using a self-report instrument to measure background information and three dependent variables: "sexual knowledge," "sexual attitudes," "sexual self-efficacy", and "sexual activity". Data were collected at baseline, one week, six weeks, four months, and seven months after intervention and analyzed using the statistical software SPSS 20.0.

Eligibility criteria: Inclusion Criteria:

1. Women were recruited to participant if they were just been diagnosis with cervical cancertment within the previous 1 weeks.
2. 20 to 80 years old.
3. Able to read, write, and speak Chinese.
4. In order to comply with the spirit of gender sensitivity in this study, participants do not exclude whether they have a partner or different sexual orientation.

Exclusion Criteria:

1. Presence of other malignant disease.
2. Impaired mental function.
3. sexual dysfunction (pre-existing sexual dysfunction may confound the impact of cancer treatment on sexual activity).
4. History of female genital organ surgery before diagnosis of gynecological cancer, or a dependent functional status.

Primary outcomes:
measure: Gynecological Cancer Sexual Knowledge
timeFrame: Data were collected at baseline.
measure: Gynecological Cancer Sexual Knowledge
timeFrame: Data were collected at 1 week after intervention.
measure: Gynecological Cancer Sexual Knowledge
timeFrame: Data were collected at 6 weeks after intervention.
measure: Gynecological Cancer Sexual Knowledge
timeFrame: Data were collected at 4 months after intervention.
measure: Gynecological Cancer Sexual Knowledge
timeFrame: Data were collected at 6 months after intervention.
measure: Gynecological Cancer Sexual Attitudes
timeFrame: Data were collected at baseline.
measure: Gynecological Cancer Sexual Attitudes
timeFrame: Data were collected at 1 week after intervention.
measure: Gynecological Cancer Sexual Attitudes
timeFrame: Data were collected at 6 weeks after intervention.
measure: Gynecological Cancer Sexual Attitudes
timeFrame: Data were collected at 4 months after intervention.
measure: Gynecological Cancer Sexual Attitudes
timeFrame: Data were collected at 6 months after intervention.
measure: Gynecological Cancer Sexual self-efficacy
timeFrame: Data were collected at baseline.
measure: Gynecological Cancer Sexual self-efficacy
timeFrame: Data were collected at 1 week after intervention.
measure: Gynecological Cancer Sexual self-efficacy
timeFrame: Data were collected at 6 weeks after intervention.
measure: Gynecological Cancer Sexual self-efficacy
timeFrame: Data were collected at 4 months after intervention.
measure: Gynecological Cancer Sexual self-efficacy
timeFrame: Data were collected at 6 months after intervention.
measure: Diversity of Sexual Activity
timeFrame: Data were collected at baseline.
measure: Diversity of Sexual Activity
timeFrame: Data were collected at 1 week after intervention.
measure: Diversity of Sexual Activity
timeFrame: Data were collected at 6 weeks after intervention.
measure: Diversity of Sexual Activity
timeFrame: Data were collected at 4 months after intervention.
measure: Diversity of Sexual Activity
timeFrame: Data were collected at 6 months after intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Cheng Gung Memorial Hospital
state: Guishan Dist.
Study officials:
affiliation: Chang Gung University
name: Jian Tao LEE, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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