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NCT Number: NCT06458049

Sexual Health and Rehabilitation Online (SHAREonline)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Survivorship Mental Disorders Sexual Dysfunctions, Psychological Sexual Function Disturbances

Age range

19 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Group Session

Behavioral

On-line educational session-3 modules-1 hour each for a total of 3 hours

Coaching Call

Behavioral

Single Coaching phone call at one month

Educational materials

Behavioral

Individual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer

Primary outcomes

  1. Change in Sexual Function

    Time frame: 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 outcomes

  1. Change in Emotional Distress

    Time frame: 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.

  2. Change in Sexual Function

    Time frame: 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.

  3. Change in Emotional Distress

    Time frame: Baseline to 4 months

    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.

  4. Enrollment Rate

    Time frame: Baseline to 1 month

    Measured through study accrual with a benchmark of enrollment greater than or equal to 40% of eligible candidates

  5. Intervention Acceptability Rate

    Time frame: Up to 1 month-post intervention

    Intervention Satisfaction Questionnaire will be assessed using a benchmark mean score of 4

  6. Study Engagement Rate

    Time frame: Baseline to 1 month

    Measured through study engagement with a benchmark of study engagement greater than or equal to 70% of eligible candidates

  7. Intervention Completion Rate

    Time frame: Baseline to 4 months

    Measured through intervention completion with a benchmark of intervention completion greater than or equal to 60% of eligible candidates

  8. Distress about Sexual Function

    Time frame: Baseline to 2 months

    Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function.

  9. Distress about Sexual Function

    Time frame: Baseline to 4 months

    Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function.

  10. Sexual Function, Satisfaction and Sexual Inactivity

    Time frame: Baseline to 2 months

    PROMIS Sexual Function and Satisfaction (PROMIS SexFS) is a short screening

Other outcomes

  1. Sexual Self-efficacy

    Time frame: Baseline to 2 months

    Sexual Self-Efficacy Scale is a 5-item scale developed to measure perceived sexual self-efficacy to address sexual health after cancer.

  2. Sexual Self-efficacy

    Time frame: Baseline to 4 months

    Sexual Self-Efficacy Scale is a 5-item scale developed to measure perceived sexual self-efficacy to address sexual health after cancer.

  3. Coaching Satisfaction Summary

    Time frame: Up to 1 month post-coaching session

    Brief participant questionnaire to provide feedback about coaching session.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 13, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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