Online Therapy for Gynecologic Cancer

(eSense-Cancer Trial)

Overseen By Kira McNamee

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Visual impairments, Poorly managed anxiety, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-16 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an online therapy program can address the sexual health needs of gynecologic cancer survivors. It tests two types of therapy: eSense-Cancer CBT (Cognitive Behavioral Therapy) and eSense-Cancer MBT (Mindfulness-Based Therapy), offered with or without a "navigator" (a support person). The goal is to determine if this online platform can assist survivors who live far away or face other obstacles to receiving treatment. Individuals who have had gynecologic cancer, experience sexual difficulties, and have internet access may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve access to care for many survivors.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, if you are in active treatment for cancer, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT) are generally safe and well-tolerated. These therapies improve sexual health and well-being.

The eSense-Cancer program offers these therapies online. Although specific data on side effects for the online version is unavailable, these therapies have proven safe in other settings, so similar results are expected online.

As the eSense-Cancer program is neither a medication nor a surgical treatment, the risk of side effects is much lower. This makes it a safe option for those seeking to improve sexual health after gynecologic cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because eSense-Cancer CBT and MBT offer innovative online therapy options for individuals with gynecologic cancer. Unlike traditional in-person therapy, these digital platforms provide cognitive behavioral therapy (CBT) and mindfulness-based therapy (MBT) that can be accessed remotely, making it more convenient and accessible. A unique feature of this trial is the inclusion of a "navigator" who can support participants through the therapy, potentially enhancing the effectiveness of the treatment. This approach could redefine how psychological support is provided to cancer patients, offering personalized, flexible, and potentially more engaging mental health care solutions.

What evidence suggests that this trial's treatments could be effective for gynecologic cancer survivors?

This trial will compare the effectiveness of cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT) in improving sexual health and well-being in women who have survived gynecologic cancer. Participants will be assigned to one of the treatment arms, either with or without support from a treatment "navigator." Research has shown that both CBT and MBT can improve emotional well-being and comfort in discussing sensitive issues. The benefits of these therapies have been observed to last even three months after the sessions ended. Both CBT and MBT have enhanced the overall quality of life for cancer survivors. These therapies are available online, making them more accessible for those who live far away or face other challenges in reaching treatment. ^{2 4 5 6 7}

Who Is on the Research Team?

Lori A Brotto, PhD, RPsych

Principal Investigator

University of British Columbia

Kyle Stephenson, PhD, RPsych

Principal Investigator

Xavier University of Louisiana.

Are You a Good Fit for This Trial?

This trial is for individuals with a history of any gynecologic cancer who are experiencing sexual health concerns. Participants must be fluent in English, able to commit to an 8-16 week program, have reliable internet access, and be comfortable using online platforms.

Inclusion Criteria

Are fluent in English (eSense content is delivered in English)

My gender does not affect my eligibility.

I have or had gynecological cancer.

Exclusion Criteria

I have visual impairments that affect my ability to read or use online materials.

Have poorly managed anxiety or mood disorder (assessed using the degree of life interference evaluation at screening)

I am currently undergoing treatment for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline questionnaires and undergo a 4-week waiting period before a second baseline assessment

4 weeks

Treatment

Participants are randomized to one of four arms and complete 8 modules of CBT or MBT with or without navigator support

8-16 weeks

Weekly/biweekly online module completion

Post-Treatment Assessment

Participants complete post-treatment questionnaires to assess various feasibility dimensions and clinical outcomes

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• eSense-Cancer CBT
• eSense-Cancer MBT

Trial Overview The study tests an adapted online intervention called eSense-Cancer aimed at addressing sexual health issues after gynecologic cancer. It involves navigator support and cognitive-behavioral therapy-based modules delivered over the web.

How Is the Trial Designed?

Group I: CBT - No navigator Active Control 1 Intervention

Participants will complete the CBT arm of eSense without support from a treatment "navigator"

Group II: MBT - No navigator Active Control 1 Intervention

Participants will complete the MBT arm of eSense without support from a treatment "navigator"

Group III: CBT - Navigator Active Control 2 Interventions

Participants will complete the CBT arm of eSense with support from a treatment "navigator"

Group IV: MBT - Navigator Active Control 2 Interventions

Participants will complete the MBT arm of eSense with support from a treatment "navigator"

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Xavier University of Louisiana.

Collaborator

Trials

9

Recruited

2,700+

Published Research Related to This Trial

A pilot study involving 27 gynecologic cancer patients showed that a 12-week web-based support group focusing on sexuality-related topics was both feasible and well-accepted, providing significant emotional support and improved body image.

Participants reported benefits such as increased emotional well-being and comfort in discussing sensitive topics, highlighting the effectiveness of online support groups in addressing psychosexual distress among gynecologic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study of an internet-based support group for women with sexual distress due to gynecologic cancer. Wiljer, D., Urowitz, S., Barbera, L., et al.[2022]

Internet-based cognitive behavioral therapy (iCBT) effectively reduces the perceived impact of hot flushes and night sweats in breast cancer survivors experiencing treatment-induced menopausal symptoms, based on a randomized controlled trial involving 235 women.

Women with lower education levels showed the most significant benefits from iCBT, and the development of healthier beliefs about hot flushes and their impact on daily life played a crucial role in the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioral therapy aimed at alleviating treatment-induced menopausal symptoms in breast cancer survivors: Moderators and mediators of treatment effects. Atema, V., van Leeuwen, M., Kieffer, JM., et al.[2020]

The BPSS app, designed to support breast cancer patients during chemotherapy, did not show significant improvements in anxiety, depression, or health literacy compared to patients who did not use the app, based on a study of 102 patients.

Despite the lack of improvement in psychological outcomes, the app effectively recorded a high number of side effects, revealing that medical staff often underestimated the severity of patients' symptoms, suggesting the app could enhance communication and care between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Smartphone Application as a Support Tool for Patients Undergoing Breast Cancer Chemotherapy: A Randomized Controlled Trial. Handa, S., Okuyama, H., Yamamoto, H., et al.[2021]

In a study of 122 patients with gynecologic cancers scheduled for radiotherapy, a significant number experienced emotional distress, with 57% reporting fear and 41% reporting worry before treatment.

Patients with five or more physical problems and those who did not undergo upfront surgery were particularly at risk for emotional distress, suggesting they may benefit from early psycho-oncological support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-treatment Emotional Distress in Patients Receiving Radiotherapy for Gynecologic Cancers. Rades, D., Al-Salool, A., Yu, NY., et al.[2023]

The coping and communication-enhancing intervention (CCI) significantly reduced depressive symptoms and cancer-specific distress in 352 women with gynecological cancer over the first six months compared to supportive counseling (SC) and usual care (UC).

Unlike SC, which showed no significant benefits, CCI improved emotional well-being and demonstrated that structured psychological interventions are essential for effectively addressing distress in newly diagnosed cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two psychological interventions for newly-diagnosed gynecological cancer patients. Manne, SL., Virtue, SM., Ozga, M., et al.[2018]

Online interventions have been found to significantly improve the quality of life and body image in patients with gynecological cancer, based on a review of 24 studies.

However, the effects of these interventions on symptom distress, social support, psychological distress, and sexual well-being remain inconclusive, indicating a need for further research with more rigorous study designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of online interventions for patients with gynecological cancer: An integrative review. Lin, H., Ye, M., Chan, SW., et al.[2021]

A study involving 60 breast cancer patients found that both cognitive-behavioral therapy (CBT) psychoeducational sessions and a self-managed informative guide improved psychological distress and quality of life after two months.

While both interventions were effective in reducing anxiety and distress, there were no significant differences in outcomes between the two groups, suggesting that self-managed resources can be as beneficial as structured therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Cognitive-Behavioral Approach and Psychoeducational Intervention in Breast Cancer Management: A Prospective Randomized Clinical Trial. Ardizzone, A., Bavetta, D., Garo, ML., et al.[2023]

The My Guide smartphone application significantly improved breast cancer knowledge among Latina breast cancer survivors, particularly for those who engaged with the app more frequently, compared to the attention-control group.

Participants using My Guide reported lower levels of self-blame than those using the My Health app, suggesting that culturally-informed interventions can promote better coping strategies in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of smartphone interventions on cancer knowledge and coping among Latina breast cancer survivors: Secondary analysis of a pilot randomized controlled trial. Oswald, LB., Baik, SH., Buscemi, J., et al.[2023]

A culturally sensitive telephone counseling intervention for 23 Latina-American cervical cancer survivors showed significant improvements in physical well-being and overall quality of life after 6 sessions.

The study indicates that such behavioral interventions are feasible and beneficial for this population, suggesting the need for further randomized controlled trials to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing physical well-being and overall quality of life among underserved Latina-American cervical cancer survivors: feasibility study. Ashing-Giwa, KT.[2021]

Internet-based cognitive behavioral therapy (iCBT) significantly reduced the perceived impact of hot flushes and night sweats in breast cancer survivors, with effect sizes of 0.63 for the guided group and 0.56 for the self-managed group, both statistically significant (P < .001).

Both iCBT groups also showed improvements in sleep quality, with effect sizes of 0.57 for the guided group and 0.41 for the self-managed group, indicating that iCBT can effectively address menopausal symptoms and enhance quality of life in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Internet-Based Cognitive Behavioral Therapy for Treatment-Induced Menopausal Symptoms in Breast Cancer Survivors: Results of a Randomized Controlled Trial. Atema, V., van Leeuwen, M., Kieffer, JM., et al.[2020]

The study evaluates the efficacy of an online Cognitive Behaviour Therapy (iCBT) program called 'Finding My Way' for reducing distress in 188 participants recently diagnosed with early-stage cancer, making it the first adequately powered trial of its kind.

If effective, this iCBT intervention could provide a cost-effective and accessible alternative to traditional face-to-face therapy, potentially improving quality of life and coping strategies for cancer patients during a critical time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding My Way: protocol of a randomised controlled trial evaluating an internet self-help program for cancer-related distress. Beatty, L., Kemp, E., Wade, T., et al.[2018]

An eight-lesson internet-delivered CBT program for anxiety and depression in early-stage cancer patients received high acceptability from participants, indicating it is user-friendly and engaging.

Participants supported the idea of combining resources for anxiety and depression, but suggested that a separate course should be developed for those with advanced-stage cancer, highlighting the need for tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of an internet cognitive behavioural therapy program for people with early-stage cancer and cancer survivors with depression and/or anxiety: thematic findings from focus groups. Karageorge, A., Murphy, MJ., Newby, JM., et al.[2018]

Blended cognitive behaviour therapy (bCBT) significantly reduced fear of cancer recurrence (FCR) in cancer survivors compared to care as usual (CAU), with a notable mean difference at the 15-month follow-up.

bCBT is a cost-effective intervention, costing €2049 per quality-adjusted life year (QALY) gained, and is comparable in total costs and QALYs to CAU, making it a viable long-term treatment option for managing FCR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy and cost-effectiveness of blended cognitive behavior therapy for high fear of recurrence in breast, prostate and colorectal Cancer survivors: follow-up of the SWORD randomized controlled trial. Burm, R., Thewes, B., Rodwell, L., et al.[2020]

The BREATH trial, involving 150 early breast cancer survivors, demonstrated that a web-based self-management intervention significantly reduced distress levels compared to standard care alone, with a small-to-medium effect size.

While the intervention improved distress, it did not have a lasting impact on empowerment, indicating that while immediate psychological support is beneficial, further strategies may be needed for sustained empowerment in survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BREATH: Web-Based Self-Management for Psychological Adjustment After Primary Breast Cancer--Results of a Multicenter Randomized Controlled Trial. van den Berg, SW., Gielissen, MF., Custers, JA., et al.[2022]

A study involving 179 primary breast cancer patients showed that psychosocial support interventions by trained nurses or psychologists significantly improved quality of life and reduced symptoms like insomnia and dyspnea compared to standard care.

Patients receiving the psychosocial support reported less need for additional hospital psychosocial services, suggesting that this intervention could be an effective and practical alternative in routine cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual psychosocial support for breast cancer patients: a randomized study of nurse versus psychologist interventions and standard care. Arving, C., Sjödén, PO., Bergh, J., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06619769

eSense-Cancer: Adapting an Online Intervention for ... This research aims to assess how well an adapted online health intervention meets the sexual health needs of gynecologic cancer survivors.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06619769/esense-cancer-adapting-an-online-intervention-for-sexual-health-concerns-to-gynecologic-cancer?country=Canada&city=Vancouver

eSense-Cancer: Adapting an Online Intervention for ... This research aims to assess how well an adapted online health intervention meets the sexual health needs of gynecologic cancer survivors and to ...

3. brottolab.med.ubc.ca brottolab.med.ubc.ca/studies/esense-cancer/

eSense Cancer | UBC Sexual Health Research Our research aims to assess how well eSense-Cancer, an adapted online health intervention, meets gynecologic cancer survivors' sexual health needs.

4. withpower.com withpower.com/trial/phase-gynecologic-cancers-9-2024-c3e4a

Online Therapy for Gynecologic Cancer (eSense-Cancer Trial) The eSense-Cancer online therapy is unique because it offers cognitive behavioral therapy (CBT) and mindfulness-based therapy (MBT) through an online platform, ...

5. app.trialscreen.org app.trialscreen.org/trials/esense-cancer-adapting-online-intervention-sexual-health-concerns-to-gynecologic-trial-nct06619769

Online Intervention for Sexual Health in Gynecologic Cancer This study aims to assess the effectiveness of an online program (eSense-Cancer) ... The program offers cognitive-behavioral therapy (CBT) or mindfulness-based ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06619769

eSense-Cancer: Adapting an Online Intervention for ... This research aims to assess how well an adapted online health intervention meets the sexual health needs of gynecologic cancer survivors and to test the ...

7. ctv.veeva.com ctv.veeva.com/study/esense-cancer-adapting-an-online-intervention-for-sexual-health-concerns-to-gynecologic-cancer

eSense-Cancer: Adapting an Online Intervention for Sexual ... This research aims to assess how well an adapted online health intervention meets the sexual health needs of gynecologic cancer survivors and to ...