TENDRILS: A Multimedia Intervention for Women's Sexual Dysfunction After Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Total score on Female Sexual Function Index (FSFI)
研究概览
简要总结
The goal of this psychosocial research study is to learn whether a website program called "Tendrils: Sexual Renewal for Women after Cancer " may help female cancer survivors improve their sex lives when used either as a self-help tool or in combination with brief sexual counseling by a health care professional.
Objectives:
Sexual dysfunction is the most common long-term consequence of cancer treatment, affecting half of survivors of breast and gynecological cancer and many women treated for other cancers. Yet, few women get the help they need for sexual problems. Our primary objective is to develop and evaluate a multimedia intervention program for women with cancer-related sexual dysfunction. Tendrils: A Sexual Renewal Program for Women Surviving Cancer will: 1) explain the causes of cancer-related sexual dysfunction; 2) offer self-help strategies to prevent or overcome problems; 3) advise women on seeking appropriate medical help; and 4) possibly serve as the core of a counseling program, along with a therapist manual. Tendrils is aimed at a wide audience, from newly diagnosed to long-term survivors, across cancer sites. Material will be presented with sensitivity to religious and cultural attitudes about sexuality. Animations will illustrate anatomy and physiology. The software will let women use Tendrils in a variety of formats: over the internet, on a CD-Rom, printed out, or as downloaded digital video or audio on a handheld computer or media player. Video vignettes will illustrate problems and strategies. Five female cancer survivors will host the program, sharing their experiences.
详细描述
The Tendrils website is designed to give women information about sexual problems related to cancer and its treatment, and the website suggests ways to overcome those problems. The website can be viewed on a computer, or parts of it may be printed out or downloaded to portable media players (such as mp3 players). The program includes videos describing women's personal experiences with sexual problems after cancer.
If you appear to be eligible to take part in this study, you will be mailed an informed consent form to review and sign and a 19-item questionnaire about your sexual function that may take 5 to 10 minutes to complete. If the questionnaire results also show you are eligible for the study, and you have completed the informed consent form, you will be given a user name and password to view the Tendrils web site. On the web site you will fill out a set of questionnaires. The questionnaires ask about your background (such as age, education, relationships), your cancer diagnosis and treatment, and the quality of your life in terms of your health, your general emotions, and your sexual function (such as your desire for sex, ability to enjoy sex, and/or any problems with painful sex). In total, the questionnaires will take about 30-35 minutes to complete. If your questionnaires suggest that you are very depressed or upset, a psychologist on the research team will request an in-person interview with you to discuss your feelings. The psychologist will decide whether taking part in the study would be too stressful for you. If this is the case, you will be taken off study. You will also be given a list of referrals for mental health care in the community.
You will be randomly assigned (as in the toss of a coin) to one of 2 groups. There will be an equal chance of being assigned to either group. If you are assigned to Group 1, you will work with the Tendrils program for 12 weeks on your own. If you are assigned to Group 2, in addition to working with the Tendrils program on your own, you will attend 3 sexual counseling sessions at M. D. Anderson.
Once you have submitted your questionnaires, you will view the Tendrils website over the internet at home over the course of 12 weeks. If you do not log onto the Tendrils website within 2 weeks after receiving your user name and password, you will be called on the telephone as a reminder. If you do not log on within 4 weeks, you will be taken off study and your password will expire.
To use the Tendrils website, you will read the information, listen to audio interviews of women discussing their sexual problems after cancer (or view videotaped interviews), and practice "homework" that is designed to help to improve your sexual life. The women in the videos discuss, for example, the types of sexual problems they had (such as losing the desire for sex or experiencing pain during sex), how their sexual problems affected their self-esteem or relationships, and what the women did to solve the sexual problems. The videos do not show real people having sexual activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Phase I: Woman cancer survivor
- •Phase I: Speaks and reads English well enough to evaluate the website and participate in a focus group
- •Phase II: Had breast cancer or a gynecological cancer diagnosed 1 to 5 years previously
- •Phase II: Has a sexual partner in relationship of at least 6 months' duration.
- •Phase II: Has a score on the Female Sexual Function Inventory below the cut-off criterion indicating sexual dysfunction (i.e. less than 26.55 total score).
- •Phase II: Lives in commuting distance of MDACC so that can attend 3 counseling sessions if randomized to professional treatment group.
- •Phase II: Currently no evidence of active cancer.
- •Phase II: Not receiving any cancer treatment other than hormonal therapy.
排除标准
- •Phase I: Under age 18
- •Phase II: Under age 18
- •Phase II: Currently in mental health care for a sexual problem.
- •Phase II: BSI-18 at study entry indicates high distress and a visit with project staff confirms that the participant is too distressed to benefit safely from the intervention.
- •Phase II: Cannot arrange for participant to have privacy when accessing internet at home, even if we offer loaner laptop and subsidized internet service.
结局指标
主要结局
Total score on Female Sexual Function Index (FSFI)
时间窗: Baseline, after the 12-week treatment period, and at 3- and 6-month follow-ups.
次要结局
未报告次要终点