Cancer Survivorship, Sexual Function Disturbances
Conditions
Keywords
Cancer Survivorship, Sexual Function Disturbances
Brief 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.
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.
Interventions
BEHAVIORALGroup Session
On-line educational session-3 modules-1 hour each for a total of 3 hours
BEHAVIORALCoaching Call
Single Coaching phone call at one month
BEHAVIORALEducational Materials
Individual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Female cancer survivors age 19-49 * Cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior * Diagnosed with first cancer ≥ age 18 * No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned * Ability to read and write in English * Bothered by significant sexual dysfunction as evidenced by a Female Sexual Functioning Index (FSFI) score of ≤26. * Regular access to the internet
Exclusion criteria
* Has never been sexually active * 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 |
|---|---|---|
| Change in Sexual Function | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | Baseline to 1 month | Measured through study accrual with a benchmark of enrollment greater than or equal to 40% of eligible candidates |
| Intervention Acceptability Rate | Up to 1 month-post intervention | Intervention Satisfaction Questionnaire will be assessed using a benchmark mean score of 4 |
| Change in Emotional Distress | Baseline to 2 month | 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. |
| Change in Sexual Function | Baseline to 4 months | The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction. |
| Intervention Completion Rate | Baseline to 4 months | Measured through intervention completion with a benchmark of intervention completion greater than or equal to 60% of eligible candidates |
| Distress about Sexual Function | Baseline to 2 months | Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function. |
| Study Engagement Rate | Baseline to 1 month | Measured through study engagement with a benchmark of study engagement greater than or equal to 70% of eligible candidates |
| Sexual Function, Satisfaction and Sexual Inactivity | Baseline to 2 months | PROMIS Sexual Function and Satisfaction (PROMIS SexFS) is a short screening |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSharon Bober, PhD
Dana-Farber Cancer Institute
Outcome results
None listed