Sexual DysfunctionNCT00614276
Female Sexual Dysfunction Intervention
An observational study of Sexual Dysfunction, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- Focus Group, TENDRILS and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women, over 18 years old, with cancer-related sexual dysfunction.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TENDRILS: A Multimedia Intervention for Women's Sexual Dysfunction After Cancer
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.
Read the detailed description
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.
- Conditions
- Sexual Dysfunction
- Being tested
- Focus Group, TENDRILS, Questionnaires, Sexual Counseling Sessions
- Keywords
- Sexual Dysfunction, Cancer-related Sexual Dysfunction, Female Cancer Survivors, Tendrils, Website program, Self-help tool, Sexual counseling, Questionnaires
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
To evaluate a multimedia intervention program for women with cancer-related sexual dysfunction.
TENDRILSBehavioural
Tendrils: A Sexual Renewal Program for Women Surviving Cancer - a website designed to give women information about sexual problems related to cancer and its treatment, and the website suggests ways to overcome those problems.
QuestionnairesBehavioural
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. The questionnaires take about 30-45 minutes to complete.
Sexual Counseling SessionsBehavioural
Attend 3 sexual counseling sessions at M. D. Anderson.
| Study group | Role | What they receive |
|---|---|---|
| Phase I - Focus Groups | Not described Receives: Behavioral: Focus Group; Behavioral: TENDRILS; Behavioral: Questionnaires | |
| Phase II TENDRILS | Phase II - TENDRILS Program only. Receives: Behavioral: TENDRILS; Behavioral: Questionnaires | |
| Phase II TENDRILS + Counseling | Phase II - TENDRILS + Sexual Counseling Sessions. Receives: Behavioral: TENDRILS; Behavioral: Questionnaires; Behavioral: Sexual Counseling Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score on Female Sexual Function Index (FSFI)
Measured: Baseline, after the 12-week treatment period, and at 3- and 6-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Leslie R Schover, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614276
- Sponsor's protocol ID
- 2006-0340
- Status last verified
- Oct 2013
- First submitted
- 30 Jan 2008
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TENDRILS: A Multimedia Intervention for Women's Sexual Dysfunction After Cancer
- ClinicalTrials.gov ID
- NCT00614276
- Acronym / sponsor ID
- 2006-0340
- Conditions
- Sexual Dysfunction
- Keywords
- Sexual Dysfunction, Cancer-related Sexual Dysfunction, Female Cancer Survivors, Tendrils, Website program, Self-help tool, Sexual counseling, Questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2007
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I - Focus Groups | – | Behavioral: Focus Group, Behavioral: TENDRILS, Behavioral: Questionnaires |
| Phase II TENDRILS | – | Behavioral: TENDRILS, Behavioral: QuestionnairesPhase II - TENDRILS Program only. |
| Phase II TENDRILS + Counseling | – | Behavioral: TENDRILS, Behavioral: Questionnaires, Behavioral: Sexual Counseling SessionsPhase II - TENDRILS + Sexual Counseling Sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women, over 18 years old, with cancer-related sexual dysfunction.
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus GroupTo evaluate a multimedia intervention program for women with cancer-related sexual dysfunction. | Behavioural | Phase I - Focus Groups |
| TENDRILSTendrils: A Sexual Renewal Program for Women Surviving Cancer - a website designed to give women information about sexual problems related to cancer and its treatment, and the website suggests ways to overcome those problems. | Behavioural | Phase I - Focus Groups, Phase II TENDRILS, Phase II TENDRILS + Counseling |
| QuestionnairesThe 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. The questionnaires take about 30-45 minutes to complete. | Behavioural | Phase I - Focus Groups, Phase II TENDRILS, Phase II TENDRILS + Counseling |
| Sexual Counseling SessionsAttend 3 sexual counseling sessions at M. D. Anderson. | Behavioural | Phase II TENDRILS + Counseling |
Primary outcome
Total score on Female Sexual Function Index (FSFI)
Time frame: Baseline, after the 12-week treatment period, and at 3- and 6-month follow-ups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie R Schover, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score on Female Sexual Function Index (FSFI) (time frame: Baseline, after the 12-week treatment period, and at 3- and 6-month follow-ups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.