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

NCT ID: NCT05771532

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-26

Study Completion Date

2018-12-26

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.

Conditions

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Sexual Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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The experimental group

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."

Group Type EXPERIMENTAL

Received the GS-SHEP

Intervention Type BEHAVIORAL

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."

The control group

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."

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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."

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Tao LEE, Professor

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

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Cheng Gung Memorial Hospital

Taoyuan District, Guishan Dist., Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 30882680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32791729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17005248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28272204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33618238 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 32861538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17919161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21812937 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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105-2629-S-182-002

Identifier Type: -

Identifier Source: org_study_id

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