Metastatic Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer
Brief summary
This trial will evaluate the SHARE-MC educational intervention designed to address sexual health needs and related adjustment in women with metastatic breast cancer.
Detailed description
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.
Interventions
BEHAVIORALSHARE-MC
SHARE-MC educational intervention sessions (plus questionnaires at multiple timepoints), delivered in a single synchronous videoconference via group session with ≤10 participants lasting approximately
Brief (\<20 minutes) individual videoconference session in which participants receive a booklet.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized assignment to intervention arm(s)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women diagnosed with metastatic breast cancer * Age ≥ 18 * Functionally appropriate to participate in the intervention, as assessed by 3 functional assessment items from the EQ-5D (see Eligibility Screening, Appendix A) * Bothered by significant sexual dysfunction as evidenced by a Female Sexual Functioning Index (FSFI) score of ≤26. (See Eligibility Screening, Appendix A) * Ability to read and write in English * Regular access to the internet
Exclusion criteria
* Diagnosis of any cancer prior to age 18 * Has never been sexually active * Prior participation in Dr. Bober's sexual health research studies or workshops; or previous appointments with Dr. Bober through the DFCI Sexual Health Program. * Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index (FSFI) Full-scale Score Change from Baseline | Up to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Symptom Inventory (BSI-18) Score Change from Baseline | Up to 8 weeks | 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. |
Countries
United States
Contacts
CONTACTSharon Bober
PRINCIPAL_INVESTIGATORSharon Bober
Dana-Farber Cancer Institute
Outcome results
None listed