Trial Information

TENDRILS: A Multimedia Intervention for Women's Sexual Dysfunction After Cancer

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.

The homework may involve writing or dictating comments in a section called "My Journey"
about how cancer affected your sex life or fertility. This is just for your own private
use, unless you choose to share your writing with your counselor. Writing the comments may
take about 15-20 minutes each time. The homework may also involve trying what is called
"relaxing touch" with your partner, learning to tense and relax muscles around your vaginal
entrance, or trying to change negative thoughts about sex. You will be able to use the
website on your own schedule, but it is estimated that you may spend 30-60 minutes per week
on the website, plus another 30 minutes per week of homework time. The homework may be
practiced alone or with your sexual partner. Your partner will be given a separate user name
and password to view Tendrils during the 12 weeks. Your partner will not be able to view
your comments in "My Journey," or your questionnaires, however.

When you use the Tendrils website, the system will record how many times you visit the
website, how much time you spend on each visit, and which web pages you view. Any time you
leave the Tendrils website, the recording stops. The recording only happens on the Tendrils
website.

Participants assigned to Group 2 will attend 3 sexual counseling sessions at M. D. Anderson
during the 12-week study. Each counseling session will last about an hour. The counselor
will be a trained health care professional who will try to help you get the most out of the
Tendrils program.

Once a week during the 12 weeks, participants in both Group 1 and Group 2 will be asked to
log onto the Tendrils website and answer 3 questions about the website. This is called a
diary entry. The questions ask how much time you spent reading printouts from the website,
listening to audio or viewing video portions of the website on a portable media player, or
doing homework recommended on the website.

You will be able to access the website after the 12 weeks, as long as the research study is
in progress. However, your password will become inactive if you do not complete
questionnaires at the end of 12 weeks.

At the end of the 12 weeks, and then 3 months and 6 months later, you will be asked to
complete the same questionnaires that you completed at the beginning of the study. You will
not need to answer the medical questions or questions about your background. If the sexual
relationship ends during the course of the study, you will still be asked to complete these
follow-up questionnaires. You will be able to access the website during the 6-month
follow-up period.

If you receive a loaner laptop, you will be asked to return it at the end of the 12 weeks.
However, you will still be able to access the website using any computer that has an
internet connection, for example at the home of a friend or at a public library. You will
also have the option of coming to M. D. Anderson to complete follow-up questionnaires online
and we will compensate you for parking.

The Tendrils website is hosted on a secure server, which means that the information you give
online is protected by a special firewall. Your user name and password will be different
than your real name. No identifying information, such as your real name or address, will be
entered in the Tendrils website. Only the study chair and 1 or 2 members of the research
team will be able to see the list that links your user name and password to your real name.
The list of passwords and names will be destroyed at the end of the project.

After returning the last questionnaire at the 6-month follow-up time, your participation in
the research study will be finished.

This is an investigational study. If you do not have a computer, researchers will try to
loan you a laptop during the study. (If a loaner laptop is not available, it is possible
that you may have to be on a waiting list to start the study until someone else finishes
using the laptop.) Postage-paid return envelopes for the questionnaires will be provided, if
needed. Loaner printers are available.

Up to 240 women will take part in this study. All will be enrolled at M. D. Anderson.