A Prospective and Randomized Controlled Evaluation of Sexual Health Education Program of Gynecological Cancer Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sexual Health

Intervention / Treatment
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* Behavioral: Received the GS-SHEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women were recruited to participant if they were just been diagnosis with cervical cancertment within the previous 1 weeks. 20 to 80 years old. Able to read, write, and speak Chinese. 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: Presence of other malignant disease. Impaired mental function. sexual dysfunction (pre-existing sexual dysfunction may confound the impact of cancer treatment on sexual activity). History of female genital organ surgery before diagnosis of gynecological cancer, or a dependent functional status.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The experimental group<br>The experimental group (n=33) received a gender-sensitive and transtheoretical model (TTM)-based sexual health education program, which includes a 10-15-minute individual sexual health education and a sexual health pamphlet. The TTM-based sexual health education program was performed by a nurse educator with more than one year of clinical experience in gynecological nursing, who received formal training through enrollment in a course entitled  a gender-sensitive and transtheoretical model (TTM)-based sexual health education training program. | Behavioral: Received the GS-SHEP<br>* 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, and sexual self-efficacy.<br>|
| No Intervention: The control group<br>The control group (n=30) received a 10-15-minute routine sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. Both were provided by nursing staff with no formal training in  a gender-sensitive and transtheoretical model (TTM)-based sexual health education training program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gynecological Cancer Sexual Knowledge | The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention. Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge. | Data were collected at baseline. | 
| Gynecological Cancer Sexual Knowledge | The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention. Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge. | Data were collected at 1 week after intervention. | 
| Gynecological Cancer Sexual Knowledge | The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention. Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge. | Data were collected at 6 weeks after intervention. | 
| Gynecological Cancer Sexual Knowledge | The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention. Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge. | Data were collected at 4 months after intervention. | 
| Gynecological Cancer Sexual Knowledge | The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention. Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge. | Data were collected at 6 months after intervention. | 
| Gynecological Cancer Sexual Attitudes | The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention. Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of do not agree at all (1) to totally agree (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment. | Data were collected at baseline. | 
| Gynecological Cancer Sexual Attitudes | The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention. Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of do not agree at all (1) to totally agree (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment. | Data were collected at 1 week after intervention. | 
| Gynecological Cancer Sexual Attitudes | The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention. Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of do not agree at all (1) to totally agree (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment. | Data were collected at 6 weeks after intervention. | 
| Gynecological Cancer Sexual Attitudes | The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention. Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of do not agree at all (1) to totally agree (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment. | Data were collected at 4 months after intervention. | 
| Gynecological Cancer Sexual Attitudes | The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention. Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of do not agree at all (1) to totally agree (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment. | Data were collected at 6 months after intervention. | 
| Gynecological Cancer Sexual self-efficacy | The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention. Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee & Yen, 2007)。 | Data were collected at baseline. | 
| Gynecological Cancer Sexual self-efficacy | The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention. Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee & Yen, 2007)。 | Data were collected at 1 week after intervention. | 
| Gynecological Cancer Sexual self-efficacy | The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention. Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee & Yen, 2007)。 | Data were collected at 6 weeks after intervention. | 
| Gynecological Cancer Sexual self-efficacy | The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention. Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee & Yen, 2007)。 | Data were collected at 4 months after intervention. | 
| Gynecological Cancer Sexual self-efficacy | The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention. Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee & Yen, 2007)。 | Data were collected at 6 months after intervention. | 
| Diversity of Sexual Activity | Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied). | Data were collected at baseline. | 
| Diversity of Sexual Activity | Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied). | Data were collected at 1 week after intervention. | 
| Diversity of Sexual Activity | Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied). | Data were collected at 6 weeks after intervention. | 
| Diversity of Sexual Activity | Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied). | Data were collected at 4 months after intervention. | 
| Diversity of Sexual Activity | Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied). | Data were collected at 6 months after intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Self-efficacy, Sexuality, Health Education, Gender sensitivity, Transtheoretical Model