Breast Cancer SurvivorsNCT03571841
Sexual Health and Rehabilitation After Ovarian Suppression Treatment
A study testing Group Session and Telephone Booster in people with Breast Cancer Survivors and Sexual Function Disturbances, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of breast cancer recurrence. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer Survivors, Sexual Function Disturbances, Ovarian Suppression Treatment
- What is being tested?
- Group Session and Telephone Booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 1 Dec 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with a history of breast cancer who are currently on chemical ovarian suppression
- Current age ≤ 50
- No active cancer therapy in the past 6 months and no future therapy planned
- Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
- English-speaking
Who cannot join
- History of pelvic radiation
- Prior participation in one of Dr. Bober's sexual health workshops
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Sexual Health and Rehabilitation After Ovarian Suppression Treatment (SHARE-OS): An Educational Intervention for Young Breast Cancer Survivors
This research study is evaluating an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of breast cancer recurrence.
Read the detailed description
The purpose of this research is to study the effectiveness of an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of cancer recurrence. The aim is to develop an effective intervention to help women manage these changes and restore sexual health and functioning.
- This study consists of attending a group educational session followed by a one-on-one telephone coaching session.
- The group educational session will last about 4 hours, and will include information on resources, self-help strategies, and relaxation techniques.
- The telephone coaching session will take place four weeks after the group session, and will last about 15 minutes
- Being tested
- Group Session, Telephone Booster
- Keywords
- Breast Cancer Survivors, Sexual Function Disturbances, Ovarian Suppression Treatment
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group SessionBehavioural
The 4-hour group session will be structured around three 60-minute modules and creation of a personal action plan
Telephone BoosterBehavioural
One month following the group session, women will receive a telephone booster session (<15 minutes). This brief telephone check-in is intended to help women review progress with their individualized action-plan, problem-solve around continuing problems, and plan for maintenance moving forward.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Experimental | For breast cancer survivors currently on chemical ovarian suppression who are experiencing sexual dysfunction.
* Group Session
* Telephone Booster Session Receives: Behavioral: Group Session; Behavioral: Telephone Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sexual Function (FSFI)
Baseline to 2 Month Follow-up Paired t-test (Wilcoxon signed-rank test)
Measured: Paired t-test (Wilcoxon signed-rank test) Baseline to 2 Month Follow-up
Secondary outcomes (1)
Change in participants psychological distress on Brief Symptom Inventory
Paired t-test (Wilcoxon signed-rank test)
Measured: Baseline to 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start1 Dec 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Howard Cox Fund for Women Assistant Professors
- Responsible party
- Principal investigator, Sharon Bober, Ph.D, Dana-Farber Cancer Institute
- Investigators
- Sharon Bober, Ph.D, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571841
- Sponsor's protocol ID
- 18-140
- Status last verified
- Nov 2021
- First submitted
- 18 Jun 2018
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Health and Rehabilitation After Ovarian Suppression Treatment (SHARE-OS): An Educational Intervention for Young Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03571841
- Acronym / sponsor ID
- 18-140
- Keywords
- Breast Cancer Survivors, Sexual Function Disturbances, Ovarian Suppression Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Howard Cox Fund for Women Assistant Professors
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 28 Jun 2018 (actual)
- 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.
This research study is evaluating an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of breast cancer recurrence.
Detailed description
The purpose of this research is to study the effectiveness of an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of cancer recurrence. The aim is to develop an effective intervention to help women manage these changes and restore sexual health and functioning.
- This study consists of attending a group educational session followed by a one-on-one telephone coaching session.
- The group educational session will last about 4 hours, and will include information on resources, self-help strategies, and relaxation techniques.
- The telephone coaching session will take place four weeks after the group session, and will last about 15 minutes
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Experimental | Behavioral: Group Session, Behavioral: Telephone BoosterFor breast cancer survivors currently on chemical ovarian suppression who are experiencing sexual dysfunction. * Group Session * Telephone Booster Session |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with a history of breast cancer who are currently on chemical ovarian suppression
- Current age ≤ 50
- No active cancer therapy in the past 6 months and no future therapy planned
- Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
- English-speaking
Key exclusion criteria (2 listed)
- History of pelvic radiation
- Prior participation in one of Dr. Bober's sexual health workshops
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 |
|---|---|---|
| Group SessionThe 4-hour group session will be structured around three 60-minute modules and creation of a personal action plan | Behavioural | Educational Intervention |
| Telephone BoosterOne month following the group session, women will receive a telephone booster session (<15 minutes). This brief telephone check-in is intended to help women review progress with their individualized action-plan, problem-solve around continuing problems, and plan for maintenance moving forward. | Behavioural | Educational Intervention |
Primary outcome
Change in Sexual Function (FSFI)
Time frame: Paired t-test (Wilcoxon signed-rank test) Baseline to 2 Month Follow-up
Baseline to 2 Month Follow-up Paired t-test (Wilcoxon signed-rank test)
1 secondary outcome
Change in participants psychological distress on Brief Symptom Inventory
Time frame: Baseline to 2 Months
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 12 Nov 2021.
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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.
Sharon Bober, Ph.D principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Session and Telephone Booster in people with Breast Cancer Survivors and Sexual Function Disturbances, run by Dana-Farber Cancer Institute 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 5 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 12 Nov 2021. 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?
Change in Sexual Function (FSFI) (time frame: Paired t-test (Wilcoxon signed-rank test) Baseline to 2 Month Follow-up). 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 12 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.