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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
84
On-line educational session-3 modules-1 hour each for a total of 3 hours
Single Coaching phone call at one month
Individual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer
Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGChange 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.
Time frame: Baseline to 2 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 4 months
Enrollment Rate
Measured through study accrual with a benchmark of enrollment greater than or equal to 40% of eligible candidates
Time frame: Baseline to 1 month
Intervention Acceptability Rate
Intervention Satisfaction Questionnaire will be assessed using a benchmark mean score of 4
Time frame: Up to 1 month-post intervention
Study Engagement Rate
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Measured through study engagement with a benchmark of study engagement greater than or equal to 70% of eligible candidates
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 4 months
Sexual Function, Satisfaction and Sexual Inactivity
PROMIS Sexual Function and Satisfaction (PROMIS SexFS) is a short screening
Time frame: Baseline to 2 months