Online Support for Sexual Dysfunction in Cancer Survivors

Overseen By Sharon Bober, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Never sexually active, Impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two online programs designed to assist young female cancer survivors experiencing changes in sexual health and function. The goal is to determine if these interventions can manage and improve sexual well-being. One group will receive a personalized session and materials, while the other will participate in a group session, create an action plan, and receive a follow-up call. Women who had cancer (excluding non-melanoma skin cancer) more than a year ago, are not in active treatment, and are experiencing significant sexual dysfunction may find this trial beneficial. Participants need internet access and the ability to communicate in English.

As an unphased trial, this study provides a unique opportunity to explore innovative interventions that could enhance quality of life.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these interventions are safe for young female cancer survivors?

Research has shown that the SHAREonline program is generally safe. Studies have not identified any specific safety issues with the online sessions or materials, indicating that most people handle the program well. As the study involves online support and guidance, it is unlikely to cause physical side effects. Participants can expect a safe experience while learning to manage changes in sexual health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SHAREonline intervention because it offers a unique, holistic approach to addressing sexual dysfunction in cancer survivors. Unlike traditional treatments that often focus solely on medication or in-person therapy, SHAREonline combines the convenience of online group sessions with personalized action plans and follow-up coaching calls. This method not only provides practical strategies but also fosters a supportive community, making it more accessible and personalized compared to standard care options. By integrating digital tools with personal guidance, SHAREonline has the potential to enhance both the effectiveness and accessibility of treatment for survivors.

What evidence suggests that this trial's interventions could be effective for managing sexual dysfunction in cancer survivors?

Research has shown that online self-help programs can improve sexual health in cancer survivors. In one study, most participants experienced clear improvements in sexual function (65.2%) and a decrease in sexual distress (66.7%). Another study found that internet-based support significantly increased sexual satisfaction in women. This trial will compare two approaches: the SHAREonline intervention, which includes an online group session and coaching, and an Individual Self Management approach with personalized materials. These early findings suggest that SHAREonline could help young female cancer survivors manage changes in their sexual health. ^{1 2 3 6 7}

Who Is on the Research Team?

Sharon Bober, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for young female cancer survivors who are dealing with changes in their sexual health and functioning. Details about specific inclusion or exclusion criteria have not been provided, but typically participants must meet certain health conditions to join.

Inclusion Criteria

I am a female cancer survivor aged 19-49.

Ability to read and write in English

I was diagnosed with my first cancer at 18 or older.

Exclusion Criteria

I have never been sexually active.

I do not have any impairments that would prevent me from completing study tasks on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete health questionnaires and are randomized to either a group education session or an individual self-management session delivered by videoconference

1 month

1 group session (online) or 1 individual session (online)

Follow-up

Participants are monitored for changes in sexual function and emotional distress, with questionnaires completed at baseline, 2 months, and 4 months post-intervention

4 months

Questionnaires at baseline, 2 months, and 4 months

What Are the Treatments Tested in This Trial?

Interventions

• SHAREonline Intervention

Trial Overview SHAREonline compares two brief interventions delivered via videoconference aimed at helping these women manage changes in sexual health. The study evaluates the effectiveness of group sessions, coaching calls, and educational materials.

How Is the Trial Designed?

Group I: SHAREonline Experimental Treatment 2 Interventions

Participants will receive: * One online group session structured around three 60-minute modules and creation of a personal action plan * Single Coaching phone call at one month * Questionnaires to complete at baseline, 2 and 4 Months

Group II: Individual Self Management Active Control 1 Intervention

Brief individualized session with online and written materials and guidance. All Participants will complete study questionnaires at baseline, 2 months and 4 months post intervention

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A survey of 220 female cancer survivors revealed that common sexual health issues included pain during intercourse (87.2%), vaginal dryness (85.3%), and low libido (82.6%), with menopausal women experiencing these issues more frequently.

The majority of participants adhered to recommended therapies, such as vaginal moisturizers and lubricants (96.9-100%), and reported significant improvements in their sexual health, with 92% feeling more informed and 91% willing to recommend the program to others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. Rash, JK., Seaborne, LA., Peterson, M., et al.[2023]

A systematic review of 171 studies on self-reported sexual function in women with a history of cancer revealed that nearly all studies indicated a decline in sexual function after cancer treatment compared to healthy controls.

The review identified 37 different measures of sexual function, with dedicated questionnaires providing more detailed assessments, suggesting that integrating these measures into patient care can enhance the understanding of quality of life in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Reported Sexual Function Measures Administered to Female Cancer Patients: A Systematic Review, 2008-2014. Jeffery, DD., Barbera, L., Andersen, BL., et al.[2018]

Internet-based technologies have been explored in ten studies to provide psychosexual interventions and support for cancer survivors, aiming to improve sexual functioning and quality of life after treatment.

While initial evidence suggests that online interventions can enhance sexual outcomes for cancer patients, more extensive and controlled research is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can sexual outcomes be enhanced after cancer using online technology? Wootten, AC., Pillay, B., Abbott, JA.[2016]

A web-based intervention designed for prostate cancer survivors and their partners aims to improve sexual intimacy and satisfaction, consisting of 10 tailored modules addressing various aspects of sexual health and recovery.

The study will involve 140 couples and assess outcomes such as Global Satisfaction with Sex Life and quality of life at multiple time points, potentially providing a new accessible resource for managing sexual side effects of prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TrueNTH sexual recovery study protocol: a multi-institutional collaborative approach to developing and testing a web-based intervention for couples coping with the side-effects of prostate cancer treatment in a randomized controlled trial. Wittmann, D., Mehta, A., Northouse, L., et al.[2019]

In a trial involving 60 female cancer survivors, an online self-help intervention significantly increased the number of sexually active participants at follow-up, indicating its potential effectiveness in improving sexual function (p < 0.001).

Participants also reported improved sexual function and increased use of sexual aids, suggesting that the intervention can positively impact sexual health, although high attrition rates highlight the need for better patient engagement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness trial of an online self-help intervention for sexual problems after cancer. Schover, LR., Strollo, S., Stein, K., et al.[2021]

The online intervention for couples recovering from prostate cancer treatment did not significantly improve overall satisfaction with sex life after 6 months, but it did encourage earlier engagement in sexual activities compared to the control group.

Participants found the intervention helpful, with over 73% reporting satisfaction with the content and more than 85% willing to recommend it to other couples, highlighting the value of sexual health support post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TrueNTH Sexual Recovery Intervention for couples coping with prostate cancer: Randomized controlled trial results. Wittmann, D., Mehta, A., Bober, SL., et al.[2023]

Internet-based cognitive behavioral therapy (CBT) significantly improved sexual satisfaction, intimacy, and relationship satisfaction for partners of breast cancer survivors, based on a study of 69 participants.

While the CBT program primarily targeted the sexual health of breast cancer survivors, it is suggested that future programs should also focus on the partners' needs to enhance overall sexual functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Functioning and Relationship Satisfaction of Partners of Breast Cancer Survivors Who Receive Internet-Based Sex Therapy. Hummel, SB., van Lankveld, JJDM., Oldenburg, HSA., et al.[2019]

Internet-based cognitive behavioral therapy (CBT) significantly improved sexual functioning in breast cancer survivors, with notable increases in sexual desire, arousal, and lubrication over a 24-week period, compared to a control group.

The intervention also positively affected body image and reduced menopausal symptoms, indicating that Internet-based CBT can be an effective therapeutic option for addressing sexual dysfunction in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Internet-Based Cognitive Behavioral Therapy in Improving Sexual Functioning of Breast Cancer Survivors: Results of a Randomized Controlled Trial. Hummel, SB., van Lankveld, JJDM., Oldenburg, HSA., et al.[2022]

A comprehensive review of 486 articles identified 257 studies that used psychometrically evaluated sexual function measures in cancer patients, highlighting a significant gap in widely tested measures for this population.

The findings support the development of the PROMIS-Sexual Function instrument, which aims to provide a flexible and robust tool for assessing sexual function in oncology, addressing the limitations of existing measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial report of the cancer Patient-Reported Outcomes Measurement Information System (PROMIS) sexual function committee: review of sexual function measures and domains used in oncology. Jeffery, DD., Tzeng, JP., Keefe, FJ., et al.[2021]

The Sexual Minorities and Prostate Cancer Scale (SMACS) was developed and validated with 401 sexual minority prostate cancer patients, providing a comprehensive tool to measure sexual functioning beyond just erectile function, addressing unique experiences of this population.

The SMACS demonstrated strong psychometric properties, including good internal consistency and construct validity, making it a reliable instrument for clinicians and researchers to assess sexual satisfaction, confidence, and urinary incontinence in sexual minority men post-prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creation and Psychometric Validation of the Sexual Minorities and Prostate Cancer Scale (SMACS) in Sexual Minority Patients-The Restore-2 Study. Polter, EJ., Kohli, N., Rosser, BRS., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11046581

Sexual Health and Rehabilitation (SHARE) - NIH RePORTER 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 ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/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 ...

3. withpower.com withpower.com/trial/phase-cancer-survivorship-8-2024-4dc59

Online Support for Sexual Dysfunction in Cancer Survivors Research shows that online self-help interventions can improve sexual function in cancer survivors, with some studies noting increased sexual activity among ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3831175/

EFFICACY TRIAL OF AN INTERNET-BASED ... This randomized trial suggests that an internet-based intervention can significantly improve sexual function and satisfaction in women with ...

5. academic.oup.com academic.oup.com/jsm/article/20/Supplement_2/qdad061.015/7165522

(015) Sexual Health and Relationship Enhancement (SHARE ... Most participants' improvement in sexual function (65.2%) and sexual distress (66.7%) was reliable. Almost half of participants reported ...

6. ascopubs.org ascopubs.org/doi/10.1200/EDBK-25-472856

Enhancing Sexual Health for Cancer Survivors Sexual health concerns are reported in up to 90% of gynecologic cancer survivors, 75%-90% of breast cancer survivors, 77% of female lung cancer ...

7. trialx.com trialx.com/clinical-trials/listings/318487/sexual-health-and-rehabilitation-online-shareonline/

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 ...