Online Support for Sexual Dysfunction in Cancer Survivors

Overseen By Sharon Bober, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Never sexually active, Impairments, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the SHAREonline Intervention treatment 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 participants. Additionally, internet-based cognitive behavioral therapy (CBT) has been found to enhance sexual satisfaction and intimacy for partners of breast cancer survivors. ^{1 2 3 4 5}

Is the online support for sexual dysfunction in cancer survivors safe for humans?

The research does not specifically mention safety concerns for the online interventions, suggesting they are generally considered safe for human use. However, the studies focus more on effectiveness rather than detailed safety data. ^{1 5 6 7 8}

How is the SHAREonline Intervention treatment for sexual dysfunction in cancer survivors different from other treatments?

The SHAREonline Intervention is unique because it is an online, self-help program designed to improve sexual function in cancer survivors without the need for extensive clinician guidance, making it more scalable and accessible compared to traditional treatments that often require direct professional involvement. ^{1 2 6 9 10}

Research Team

Sharon Bober, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

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

I haven't had cancer treatment in the last 4 months and none is planned.

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.

Trial Timeline

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

Treatment Details

Interventions

• SHAREonline Intervention (Behavioral 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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness trial of an online self-help intervention for sexual problems after cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Sexual Functioning and Relationship Satisfaction of Partners of Breast Cancer Survivors Who Receive Internet-Based Sex Therapy. [2019]

3. United States 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. [2021]

4. Netherlands 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Self-Reported Sexual Function Measures Administered to Female Cancer Patients: A Systematic Review, 2008-2014. [2018]

6. England 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. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. [2023]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Can sexual outcomes be enhanced after cancer using online technology? [2016]

10. United States pubmed.ncbi.nlm.nih.gov

TrueNTH Sexual Recovery Intervention for couples coping with prostate cancer: Randomized controlled trial results. [2023]