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This trial will evaluate the SHARE-MC educational intervention designed to address sexual health needs and related adjustment in women with metastatic breast cancer.
This is a Phase II proof-of-concept investigational study evaluating the SHARE-MC educational intervention designed to address sexual health needs and related adjustment in women with metastatic breast cancer. Participants will be randomized 2:1 to receive either a group education session, or an individual self-management session. the SHARE MC intervention or enhanced usual care.
The research study procedures include: screening for eligibility, questionnaires, video conference, educational session, and coaching (as applicable).
It is expected that about 96 women will take part in this study. About 64 women will receive the group education session and about 32 will receive the individual self-management session.
Participation in this research study is expected to last about 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Education | Experimental | 64 participants will complete the following:
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| Enhanced Usual Care (Individual Self-Management) | Active Comparator | 32 participants will complete the following:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHARE-MC | Behavioral | SHARE-MC educational intervention sessions (plus questionnaires at multiple timepoints), delivered in a single synchronous videoconference via group session with ≤10 participants lasting approximately |
| Measure | Description | Time Frame |
|---|---|---|
| Female Sexual Function Index (FSFI) Full-scale Score Change from Baseline | The FSFI is a well-validated 19-item instrument assessing sexual function including lubrication, orgasm, pain and satisfaction. The total sexual function score is the sum of all domain scores, ranging from 2.0 (indicating not sexually active and no desire) to 36.0. A domain score of 0.0 means there was no sexual activity during the past month. Higher scores, both for individual domains and the total score, reflect better sexual functioning. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Symptom Inventory (BSI-18) Score Change from Baseline | The BSI-18 is a well-validated screen of psychological distress with subscales measuring anxiety, depression and somatization. BSI-18 items are rated on a 5-point, Likert scale: 0- not at all; 1- a little bit; 2- moderately; 3-quite a bit; 4-extremely. | Up to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon Bober | Contact | 6176326547 | sharon_bober@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sharon Bober | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Randomized assignment to intervention arm(s)
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| Informational Booklet | Other | Brief (<20 minutes) individual videoconference session in which participants receive a booklet. |
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| D017437 |
| Skin and Connective Tissue Diseases |