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

Sexual Health Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771532
• Other study ID #: 105-2629-S-182-002
• Status: Completed
• Phase: N/A
• Start date: March 26, 2017
• Est. completion date: December 26, 2018

Study information

• Verified date: February 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sexual Health

Intervention

Behavioral:
• Received the GS-SHEP
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."

Locations

Country	Name	City	State
Taiwan	Cheng Gung Memorial Hospital	Taoyuan	Guishan Dist.

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (10)

Donovan KA, Taliaferro LA, Alvarez EM, Jacobsen PB, Roetzheim RG, Wenham RM. Sexual health in women treated for cervical cancer: characteristics and correlates. Gynecol Oncol. 2007 Feb;104(2):428-34. doi: 10.1016/j.ygyno.2006.08.009. Epub 2006 Sep 26. — View Citation

Guo C, Wang J, Wang Y, Qu X, Shi Z, Meng Y, Qiu J, Hua K. Novel artificial intelligence machine learning approaches to precisely predict survival and site-specific recurrence in cervical cancer: A multi-institutional study. Transl Oncol. 2021 May;14(5):101032. doi: 10.1016/j.tranon.2021.101032. Epub 2021 Feb 20. — View Citation

Hogan, R.M. Human sexuality : A nursing perspective. Norwork : Appleton- Century-Crofs.1985.

Hung H, You J, Chiang J, Hsieh P, Chiang S, Lai C, Tasi W, Yeh C, Chern Y, Hsu Y. Clinicopathological characteristics and outcomes of metachronous rectal cancer in patients with a history of cervical cancer with and without remote radiotherapy: Reports of 45 cases. Medicine (Baltimore). 2020 Jul 24;99(30):e21328. doi: 10.1097/MD.0000000000021328. — View Citation

Kau YC, Liu FC, Kuo CF, Huang HJ, Li AH, Hsieh MY, Yu HP. Trend and survival outcome in Taiwan cervical cancer patients: A population-based study. Medicine (Baltimore). 2019 Mar;98(11):e14848. doi: 10.1097/MD.0000000000014848. — View Citation

Lee J, Lin JB, Sun FJ, Chen YJ, Chang CL, Jan YT, Wu MH. Safety and efficacy of semiextended field intensity-modulated radiation therapy and concurrent cisplatin in locally advanced cervical cancer patients: An observational study of 10-year experience. Medicine (Baltimore). 2017 Mar;96(10):e6158. doi: 10.1097/MD.0000000000006158. — View Citation

Lee JT, Kuo HY, Huang KG, Lin JR, Chen ML. Diversity of sexual activity and correlates among women with gynecological cancer. Gynecol Oncol. 2020 Nov;159(2):503-508. doi: 10.1016/j.ygyno.2020.08.005. Epub 2020 Aug 27. — View Citation

Lee JT, Tsai JL. Transtheoretical model-based postpartum sexual health education program improves women's sexual behaviors and sexual health. J Sex Med. 2012 Apr;9(4):986-96. doi: 10.1111/j.1743-6109.2011.02419.x. Epub 2011 Aug 3. — View Citation

Lee JT, Yen HW. Randomized controlled evaluation of a theory-based postpartum sexual health education programme. J Adv Nurs. 2007 Nov;60(4):389-401. doi: 10.1111/j.1365-2648.2007.04395.x. — View Citation

Lee, J. T. Bringing Gender Sensitivity into Sexual Health Education Program for Women with Gynecologic Cancer in Taiwan. Ministry of Science and Technology Research Program Report, 2017.Program Number:103-2511-S-182-005-MY2.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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 a=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.
Primary	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 a=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.
Primary	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 a=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.
Primary	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 a=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.
Primary	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 a=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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.