Sexual Dysfunctions, PsychologicalNCT01654458
A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
A study testing GyneGals Support Group in people with Sexual Dysfunctions, Psychological and Uterine Cervical Neoplasms, run by Women's College Hospital at 7 sites in 2 countries.
Trial summary
There is a high prevalence of sexual and body image problems among women treated for gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly personal nature of these problems, women are often reluctant to speak to their doctors about these concerns and have few resources for support… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Dysfunctions, Psychological, Uterine Cervical Neoplasms, Ovarian Neoplasms
- What is being tested?
- GyneGals Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jul 2012to Sep 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received surgical, radiation or chemotherapy treatments for any gynecologic cancer
- Not receiving active treatment
- Currently disease-free for a minimum of 3 months
- No more than 5 years post-diagnosis
- Distressed due to psychosexual concerns related to cancer
- Willing to discuss psychosexual concerns
Show all 10Show fewer
- 18 years or older
- Has access to a computer and the Internet
- Speaks, reads, and writes in English
- Provides informed consent
Who cannot join
- Acutely suicidal (i.e., actively suicidal within the previous 3 months)
- Has a major psychiatric illness
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada6 sites
Tom Baker Cancer Centre
Calgary, Alberta
Cross Cancer Institute
Edmonton, Alberta
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network (Princess Margaret Hospital)
Toronto, Ontario, M5G 2M9
Women's College Hospital
Toronto, Ontario, M5S 1B2
Vancouver Coastal Health Research Institute
Vancouver, British Columbia
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
There is a high prevalence of sexual and body image problems among women treated for gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly personal nature of these problems, women are often reluctant to speak to their doctors about these concerns and have few resources for support and information. The research team will conduct a prospective randomized controlled trail (RCT) to test the benefits of "GyneGals," a 12-week online (i.e. Internet-based) support group intervention for women who are sexually distressed due to gynecologic cancer and its treatment.
The primary aim of this study is to determine whether a professionally-facilitated, information-rich, online support group is beneficial for women who are sexually distressed due to gynecologic cancer and the side effects of treatment.
- Conditions
- Sexual Dysfunctions, Psychological, Uterine Cervical Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Genital Neoplasms, Female
- Being tested
- GyneGals Support Group
- Keywords
- Sexual Dysfunctions, Psychological, Psychotherapy, Group, Genital Neoplasms, Female, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Urogenital Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
- Medical subject headings
- Sexual Dysfunctions, Psychological, Uterine Cervical Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Genital Neoplasms, Female, Endometrial Neoplasms, Fallopian Tube Neoplasms, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GyneGals Support GroupBehavioural
12-week online (i.e. Internet-based), professionally-facilitated support group
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment Condition | Experimental | Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment. Receives: Behavioral: GyneGals Support Group |
| Waitlist Control Condition | No intervention | Waitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).
13-item self-report scale that measures sexually-related distress in women.
Measured: 9 months
Secondary outcomes (5)
Sexual function, as measured by the Sexual Function Questionnaire (SFQ).
25-item measure developed for cancer patients and can be completed by women regardless of sexual orientation or whether they have a partner.
Measured: 9 months (at months 1, 5, and 9)
Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G).
Consists of two independent scales designed to assess changes in sexuality and body image before and after diagnosis.
Measured: 9 months (at months 1, 5, and 9)
Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS).
14-item self-report questionnaire for detecting depression and anxiety in a hospital outpatient setting.
Measured: 9 months (at months 1, 5, and 9)
Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).
7-item measure assessing satisfaction with an individual's romantic relationship.
Measured: 9 months (at months 1, 5, and 9)
Perceived social support, as measured by MOS Social Support Survey (MOS-SS).
19 items and assesses emotional/informational support, tangible support, affectionate support, and positive social interaction, as well as providing an overall functional support index.
Measured: 9 months (at months 1, 5, and 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completion19 Jan 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexual Dysfunctions, PsychologicalStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, Sunnybrook Health Sciences Centre, Tom Baker Cancer Centre, Cross Cancer Institute, Vancouver Coastal Health Research Institute, Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Catherine C. Classen, PhD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654458
- Sponsor's protocol ID
- OVA-120243
- Other IDs
- 1009695, 12-0427-CE, 216-2012
- Status last verified
- Mar 2021
- First submitted
- 27 Jul 2012
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Classen CC, Chivers ML, Urowitz S, Barbera L, Wiljer D, O'Rinn S, Ferguson SE. Psychosexual distress in women with gynecologic cancer: a feasibility study of an online support group. Psychooncology. 2013 Apr;22(4):930-5. doi: 10.1002/pon.3058. Epub 2012 Feb 28.
PubMed 22374732Wiljer D, Urowitz S, Barbera L, Chivers ML, Quartey NK, Ferguson SE, To M, Classen CC. A qualitative study of an internet-based support group for women with sexual distress due to gynecologic cancer. J Cancer Educ. 2011 Sep;26(3):451-8. doi: 10.1007/s13187-011-0215-1.
PubMed 21594587Classen CC, Drozd A, Brotto LA, Barbera L, Carter J, Chivers ML, Koval J, Robinson JW, Urowtiz S, Wiljer D, & Ferguson SE. Protocol of a randomized controlled trial of an online support group for sexual distress due to gynecologic caner. Journal of Clinical Trials 5(4), 2015. DOI: 10.4172/2167-0870.1000234
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT01654458
- Acronym / sponsor ID
- OVA-120243
- Conditions
- Sexual Dysfunctions, Psychological, Uterine Cervical Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Genital Neoplasms, Female
- Keywords
- Sexual Dysfunctions, Psychological, Psychotherapy, Group, Genital Neoplasms, Female, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Urogenital Neoplasms, Uterine Cervical Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Sunnybrook Health Sciences Centre, Tom Baker Cancer Centre, Cross Cancer Institute, Vancouver Coastal Health Research Institute, Memorial Sloan Kettering Cancer Center
- Study start
- Jul 2012
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 31 Jul 2012 (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.
There is a high prevalence of sexual and body image problems among women treated for gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly personal nature of these problems, women are often reluctant to speak to their doctors about these concerns and have few resources for support and information. The research team will conduct a prospective randomized controlled trail (RCT) to test the benefits of "GyneGals," a 12-week online (i.e. Internet-based) support group intervention for women who are sexually distressed due to gynecologic cancer and its treatment.
The primary aim of this study is to determine whether a professionally-facilitated, information-rich, online support group is beneficial for women who are sexually distressed due to gynecologic cancer and the side effects of treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment Condition | Experimental | Behavioral: GyneGals Support GroupReceives the 12-week GyneGals Support Group within a month of completing the baseline assessment. |
| Waitlist Control Condition | No intervention | –Waitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Received surgical, radiation or chemotherapy treatments for any gynecologic cancer
- Not receiving active treatment
- Currently disease-free for a minimum of 3 months
- No more than 5 years post-diagnosis
- Distressed due to psychosexual concerns related to cancer
Key exclusion criteria (2 listed)
- Acutely suicidal (i.e., actively suicidal within the previous 3 months)
- Has a major psychiatric illness
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 |
|---|---|---|
| GyneGals Support Group12-week online (i.e. Internet-based), professionally-facilitated support group | Behavioural | Immediate Treatment Condition |
Primary outcome
Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).
Time frame: 9 months
13-item self-report scale that measures sexually-related distress in women.
5 secondary outcomes
Sexual function, as measured by the Sexual Function Questionnaire (SFQ).
Time frame: 9 months (at months 1, 5, and 9)
Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G).
Time frame: 9 months (at months 1, 5, and 9)
Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS).
Time frame: 9 months (at months 1, 5, and 9)
Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).
Time frame: 9 months (at months 1, 5, and 9)
Perceived social support, as measured by MOS Social Support Survey (MOS-SS).
Time frame: 9 months (at months 1, 5, and 9)
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 18 Mar 2021.
- Background: PubMed 22374732Classen CC, Chivers ML, Urowitz S, Barbera L, Wiljer D, O'Rinn S, Ferguson SE. Psychosexual distress in women with gynecologic cancer: a feasibility study of an online support group. Psychooncology. 2013 Apr;22(4):930-5. doi: 10.1002/pon.3058. Epub 2012 Feb 28.
- Background: PubMed 21594587Wiljer D, Urowitz S, Barbera L, Chivers ML, Quartey NK, Ferguson SE, To M, Classen CC. A qualitative study of an internet-based support group for women with sexual distress due to gynecologic cancer. J Cancer Educ. 2011 Sep;26(3):451-8. doi: 10.1007/s13187-011-0215-1.
- BackgroundClassen CC, Drozd A, Brotto LA, Barbera L, Carter J, Chivers ML, Koval J, Robinson JW, Urowtiz S, Wiljer D, & Ferguson SE. Protocol of a randomized controlled trial of an online support group for sexual distress due to gynecologic caner. Journal of Clinical Trials 5(4), 2015. DOI: 10.4172/2167-0870.1000234
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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.
Catherine C. Classen, PhD principal investigator
Women's College Hospital
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GyneGals Support Group in people with Sexual Dysfunctions, Psychological and Uterine Cervical Neoplasms, run by Women's College Hospital at 7 sites in 2 countries.
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 10 inclusion and 2 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 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, 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?
Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R). (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01654458, which also lists 3 linked publications.
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 18 Mar 2021.