Cancer SurvivorshipNCT06458049
Sexual Health and Rehabilitation Online (SHAREonline)
A study testing Group Session, Coaching Call and Educational Materials in people with Cancer Survivorship and Sexual Function Disturbances, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
SHAREonline is a study for young female cancer survivors that are experiencing changes in sexual health and function. The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women only
- Conditions the study is for
- Cancer Survivorship, Sexual Function Disturbances
- What is being tested?
- Group Session, Coaching Call and Educational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Has never been sexually active
- Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently
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 Online (SHAREonline): An Educational Intervention for Young Adult Women After Cancer
SHAREonline is a study for young female cancer survivors that are experiencing changes in sexual health and function.
The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.
Read the detailed description
The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.
Participants in this study would first complete health questionnaires and then be randomized to take part in one of two types of education sessions delivered by an instructor over videoconference: 1) Group education session or 2) Individual self-management session.
About 56 women will receive the group education session and about 28 will receive the individual self-management session.
It is expected that about 84 women will take part in this study.
- Conditions
- Cancer Survivorship, Sexual Function Disturbances
- Being tested
- Group Session, Coaching Call, Educational Materials
- Keywords
- Cancer Survivorship, Sexual Function Disturbances
- 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
On-line educational session-3 modules-1 hour each for a total of 3 hours
Coaching CallBehavioural
Single Coaching phone call at one month
Educational MaterialsBehavioural
Individual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer
| Study group | Role | What they receive |
|---|---|---|
| SHAREonline | Experimental | Participants will receive:
* One online group session structured around three 60-minute modules and creation of a personal action plan
* Single Coaching phone call at one month
* Questionnaires to complete at baseline, 2 and 4 Months Receives: Behavioral: Group Session; Behavioral: Coaching Call |
| Individual Self Management | Active comparator | Brief individualized session with online and written materials and guidance.
All Participants will complete study questionnaires at baseline, 2 months and 4 months post intervention Receives: Behavioral: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sexual Function
The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction.
Measured: Baseline to 2 months
Secondary outcomes (10)
Change in Emotional Distress
BSI-18 (Brief Symptom Inventory) The BSI-18 is a well-validated screening measure of psychological distress with subscales measuring anxiety, depression and somatization that is frequently used with oncology populations.
Measured: Baseline to 2 month
Change in Sexual Function
The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction.
Measured: Baseline to 4 months
Change in Emotional Distress
BSI-18 (Brief Symptom Inventory) The BSI-18 is a well-validated screening measure of psychological distress with subscales measuring anxiety, depression and somatization that is frequently used with oncology populations.
Measured: Baseline to 4 months
Enrollment Rate
Measured through study accrual with a benchmark of enrollment greater than or equal to 40% of eligible candidates
Measured: Baseline to 1 month
Intervention Acceptability Rate
Intervention Satisfaction Questionnaire will be assessed using a benchmark mean score of 4
Measured: Up to 1 month-post intervention
Study Engagement Rate
Measured through study engagement with a benchmark of study engagement greater than or equal to 70% of eligible candidates
Measured: Baseline to 1 month
Intervention Completion Rate
Measured through intervention completion with a benchmark of intervention completion greater than or equal to 60% of eligible candidates
Measured: Baseline to 4 months
Distress about Sexual Function
Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function.
Measured: Baseline to 2 months
Distress about Sexual Function
Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function.
Measured: Baseline to 4 months
Sexual Function, Satisfaction and Sexual Inactivity
PROMIS Sexual Function and Satisfaction (PROMIS SexFS) is a short screening
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 posted13 Jun 2024
- Study start19 Feb 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorshipStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sharon Bober, Ph.D, Dana-Farber Cancer Institute
- Investigators
- Sharon Bober, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458049
- Sponsor's protocol ID
- 21-697
- Other IDs
- R21CA279278
- Status last verified
- Feb 2026
- First submitted
- 10 Jun 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Miklos EM, Recklitis CJ, Reese JB, Medeiros-Nancarrow C, Bober SL. Sexual health and REhabilitation online (SHAREonline): study protocol of an optimisation trial. BMJ Open. 2026 Sep 2;16(9):e111471. doi: 10.1136/bmjopen-2025-111471.
PubMed 42692509
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Health and Rehabilitation Online (SHAREonline): An Educational Intervention for Young Adult Women After Cancer
- ClinicalTrials.gov ID
- NCT06458049
- Acronym / sponsor ID
- 21-697
- Conditions
- Cancer Survivorship, Sexual Function Disturbances
- Keywords
- Cancer Survivorship, Sexual Function Disturbances
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Jun 2024 (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.
SHAREonline is a study for young female cancer survivors that are experiencing changes in sexual health and function.
The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.
Detailed description
The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.
Participants in this study would first complete health questionnaires and then be randomized to take part in one of two types of education sessions delivered by an instructor over videoconference: 1) Group education session or 2) Individual self-management session.
About 56 women will receive the group education session and about 28 will receive the individual self-management session.
It is expected that about 84 women will take part in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHAREonline | Experimental | Behavioral: Group Session, Behavioral: Coaching CallParticipants will receive: * One online group session structured around three 60-minute modules and creation of a personal action plan * Single Coaching phone call at one month * Questionnaires to complete at baseline, 2 and 4 Months |
| Individual Self Management | Active comparator | Behavioral: Educational MaterialsBrief individualized session with online and written materials and guidance. All Participants will complete study questionnaires at baseline, 2 months and 4 months post intervention |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Has never been sexually active
- Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently
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 SessionOn-line educational session-3 modules-1 hour each for a total of 3 hours | Behavioural | SHAREonline |
| Coaching CallSingle Coaching phone call at one month | Behavioural | SHAREonline |
| Educational MaterialsIndividual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer | Behavioural | Individual Self Management |
Primary outcome
Change in Sexual Function
Time frame: Baseline to 2 months
The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction.
10 secondary outcomes
Change in Emotional Distress
Time frame: Baseline to 2 month
Change in Sexual Function
Time frame: Baseline to 4 months
Change in Emotional Distress
Time frame: Baseline to 4 months
Enrollment Rate
Time frame: Baseline to 1 month
Intervention Acceptability Rate
Time frame: Up to 1 month-post intervention
Study Engagement Rate
Time frame: Baseline to 1 month
Intervention Completion Rate
Time frame: Baseline to 4 months
Distress about Sexual Function
Time frame: Baseline to 2 months
Distress about Sexual Function
Time frame: Baseline to 4 months
Sexual Function, Satisfaction and Sexual Inactivity
Time frame: Baseline to 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 42692509Miklos EM, Recklitis CJ, Reese JB, Medeiros-Nancarrow C, Bober SL. Sexual health and REhabilitation online (SHAREonline): study protocol of an optimisation trial. BMJ Open. 2026 Sep 2;16(9):e111471. doi: 10.1136/bmjopen-2025-111471.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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, PhD 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, Coaching Call and Educational Materials in people with Cancer Survivorship 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 0 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: Baseline to 2 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 NCT06458049, which also lists 1 linked publication.
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 24 Feb 2026.