Document text
Principal Investigator: Sharon L. Bober
Organization: DANA-FARBER CANCER INST
Fiscal Year: 2024
Award: $255,280
Funding agency: National Cancer Institute
Project Summary
Sexual dysfunction is one of the most common and distressing consequences of cancer therapy for young
female (YF) cancer survivors, with more than 50% of YF survivors reporting chronic sexual problems,2,3,4
including pain with sexual activity, vulvo-vaginal atrophy, and low desire. Severe sexual dysfunction sharply
diminishes psychological well-being and quality-of-life7,8 for YF survivors. For young women who are
developing or trying to maintain intimate relationships, the consequences can be devastating5. However,
sexual health rehabilitation is not available for most young women suffering from treatment-related sexual
dysfunction.36,37 To address this gap in survivorship care, the PI previously developed and piloted a brief (3-
hour), group-delivered, skills-based intervention called SHARE (Sexual Health And Rehabilitation). SHARE is
a self-management intervention that integrates state-of-the-art sexual rehabilitation with body awareness
training, elements of mindfulness-based cognitive therapy and individual action planning. In two previous
single-arm, pilot trials, SHARE significantly reduced cancer-related female sexual dysfunction15 as well as
psychological distress. However, in its existing form, SHARE requires in-person attendance, which limits
access only to those with the time, means and ability to attend. To overcome this barrier, while building on our
previous success, we adapted the intervention for online delivery via videoconference format (SHAREonline)
and subsequently conducted informal pretesting of materials and format. Synchronous videoconferencing is a
format that has been shown to be as effective as in-person group61 but never before used to deliver sexual
rehabilitation to young cancer survivors. We now propose a Phase II “proof-of-concept” RCT to examine
preliminary effects of SHAREonline to reduce sexual dysfunction and psychological distress in a sample of 84
YF survivors. We will randomize 84 young female cancer survivors with sexual health concerns to either the
SHAREonline intervention or to an Enhanced Usual Care attention control condition (2:1) consisting of
education only. Sexual function will be assessed at baseline and at 8- and 16-weeks post-intervention.
Feasibility, acceptability, and credibility, including credibility of the control condition, will be examined to
prepare for a definitive efficacy trial. Women also receive take-home educational materials and a single
booster telephone call 4 weeks post-group session. SHAREonline was developed to meet the needs for
accessible and efficient intervention for young survivors. Whereas most YF survivors currently have no access
to evidence-based sexual health rehabilitation, SHAREonline has the potential to help close a major gap in
survivorship care. Evaluating preliminary effects of SHAREonline is a critical next step for planning a future
efficacy trial, and ultimately ensuring SHAREonline is an effective and widely available intervention to improve
the health and quality-of-life of young female cancer suffering from pronounced sexual dysfunction.
Terms: <Active Follow-up><Address><Adherence><Adult females><Adult women><Age><Anxiety><Arousal><Atrophic><Atrophy><Awareness><Behavioral><Body Image><Breast Cancer survivor><Cancer Burden><Cancer Intervention><Cancer Patient><Cancer Survivor><Cancer Survivorship><Cancer Treatment><Cancers><Caring><Chronic><Clinical><Collaborations><Competence><Control Groups><Data><Development><Distress><Dropout><E-learning><Education><Education for Intervention><Educational Intervention><Educational Materials><Educational aspects><Elements><Emotional well being><Ensure><Ethnic Origin><Ethnicity><Evaluation><Feels well><Female><Females in adulthood><Future><Goals><Health><Home><Hour><Impairment><Individual><Instruction Intervention><Intervention><Intervention Strategies><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Malignant Neoplasms><Malignant Tumor><Materials Testing><Medical Rehabilitation><Mental Depression><Modeling><National Cancer Burden><Normal mental condition><Normal mental state><Normal psyche><Oophorectomy><Ovariectomy><Pain><Painful><Participant><Patients><Persons><Phase><Phone><Preparation><Provider><Psychological Well Being><QOL><Quality of life><Race><Races><Randomized><Randomized, Controlled Trials><Recovery><Regimen><Rehabilitation><Rehabilitation therapy><Reporting><Research><Risk Reduction><Sampling><Self Determination><Self Efficacy><Self Management><Sense of well-being><Sex Behavior><Sex Disorders><Sex Functioning><Sexual Activity><Sexual Behavior><Sexual Dysfunction><Sexual Health><Survivors><Telephone><Testing><Time><Training><Training Intervention><Travel><Treatment Side Effects><Treatment-related side effects><Videoconferencing><Well in self><Woman><Women in adulthood><Work><active followup><adult youth><advocacy organizations><ages><anti-cancer therapy><arm><attentional control><behavior change><behavior test><behavioral health intervention><behavioral test><biopsychosocial><body perception><cancer diagnosis><cancer risk><cancer therapy><cancer-directed therapy><care as usual><clinical significance><clinically significant><computer-assisted instruction><computer-based education><computer-based instruction><computer-based learning><computer-based training><cost><delivered on-line><delivered online><depression><developmental><digital education><digital learning><eLearning><efficacy trial><electronic learning><emotional wellbeing><emotional wellness><evidence base><female gonadectomy><follow up><follow-up><followed up><followup><homes><improved><instructional intervention><internet-assisted education><internet-based training><interventional strategy><malignancy><mental well-being><mental wellbeing><mental wellness><mindfulness based cognitive therapy><multimedia learning><neoplasm/cancer><novel><on-line delivery><on-line education><on-line learning><online delivery><online education><online intervention><online learning><pilot trial><post intervention><preference><preparations><primary outcome><psychologic><psychological><psychological distress><psychological wellbeing><psychological wellness><racial><racial background><racial origin><randomisation><randomization><randomized control trial><randomly assigned><reduce risk><reduce risks><reduce that risk><reduce the risk><reduce these risks><reduces risk><reduces the risk><reducing risk><reducing the risk><rehab therapy><rehabilitative><rehabilitative therapy><response><risk-reducing><satisfaction><secondary outcome><self esteem><self wellness><sense of wellbeing><sex activity><sex identity><sexual activities><sexual functioning><sexual identity><side effect><skills><socio-demographics><sociodemographics><success><survivorship><technology-enhanced learning><theories><treatment as usual><uptake><usual care><video conferencing><videoconference><videoconferences><virtual learning><web based delivery><web-based instruction><web-based training><young adult><young adulthood><young cancer survivor><young woman>