Sexual Health and Rehabilitation Online (SHAREonline)

Sexual Function Disturbances Clinical Trial

Official title:

Sexual Health and Rehabilitation Online (SHAREonline): An Educational Intervention for Young Adult Women After Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458049
• Other study ID #: 21-697
• Secondary ID: R21CA279278
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: June 2024
• Source: Dana-Farber Cancer Institute
• Contact: Sharon Bober, PhD
• Phone: 617-632-6547
• Email: sharon_bober[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 49 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Cancer Survivorship
• Sexual Dysfunctions, Psychological
• Sexual Function Disturbances

Intervention

Behavioral:
• Group Session
On-line educational session-3 modules-1 hour each for a total of 3 hours
• Coaching Call
Single Coaching phone call at one month
• Educational Materials
Individual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sexual Self-efficacy	Sexual Self-Efficacy Scale is a 5-item scale developed to measure perceived sexual self-efficacy to address sexual health after cancer.	Baseline to 2 months
Other	Sexual Self-efficacy	Sexual Self-Efficacy Scale is a 5-item scale developed to measure perceived sexual self-efficacy to address sexual health after cancer.	Baseline to 4 months
Other	Coaching Satisfaction Summary	Brief participant questionnaire to provide feedback about coaching session.	Up to 1 month post-coaching session
Primary	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.	Baseline to 2 months
Secondary	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.	Baseline to 2 month
Secondary	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.	Baseline to 4 months
Secondary	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.	Baseline to 4 months
Secondary	Enrollment Rate	Measured through study accrual with a benchmark of enrollment greater than or equal to 40% of eligible candidates	Baseline to 1 month
Secondary	Intervention Acceptability Rate	Intervention Satisfaction Questionnaire will be assessed using a benchmark mean score of 4	Up to 1 month-post intervention
Secondary	Study Engagement Rate	Measured through study engagement with a benchmark of study engagement greater than or equal to 70% of eligible candidates	Baseline to 1 month
Secondary	Intervention Completion Rate	Measured through intervention completion with a benchmark of intervention completion greater than or equal to 60% of eligible candidates	Baseline to 4 months
Secondary	Distress about Sexual Function	Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function.	Baseline to 2 months
Secondary	Distress about Sexual Function	Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function.	Baseline to 4 months
Secondary	Sexual Function, Satisfaction and Sexual Inactivity	PROMIS Sexual Function and Satisfaction (PROMIS SexFS) is a short screening	Baseline to 2 months