eSense-Cancer: Adapting an Online Intervention for Sexual Health Concerns to Gynecologic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- A change in sexual distress (FSDS-R)
研究概览
简要总结
Sexual health is a vital component of gynecologic cancer treatment and survivorship. Unfortunately, most gynecologic cancer survivors lack sufficient information about the impact of cancer on sexual health and treatment opportunities. 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 efficacy of the new platform. If successful, eSense-Cancer may increase access to treatment for gynecologic cancer survivors, including those living in remote areas or facing other accessibility barriers. It may also fill healthcare gaps for survivors of varying ethnicity, sexual orientation, socioeconomic status, and gender.
详细描述
Once participants have consented to participate in the study, they will complete baseline questionnaires, then undergo a 4-week waiting period. After this 4 week waiting period, they will complete a second baseline questionnaire, and then be randomized to one of four arms:
- CBT with navigator support (n=15)
- CBT with no navigator support (n=15)
- MBT with navigator support (n=15)
- MBT with no navigator support (n=15)
Participants will receive an online link to complete the questionnaires consisting of demographics, primary outcomes (sexual distress; FSDS-R, and sexual function; PROMIS SexFS measure adapted for cancer survivors). For those in the navigator support arms, before beginning the eSense-Cancer modules, participants will have an initial 15-30 minute conversation via the UBC-hosted version of Zoom with their assigned navigator, who will explain their role.
Following this meeting, participants will gain access to the CBT or MBT arm of eSense-Cancer and receive an individualized link to access eSense-Cancer. They will work through one module weekly/biweekly (on their own time) and complete the related exercise during that week. This process should take 8-16 weeks. After each module, they will complete a questionnaire to assess usability of the module just completed.
For those in the navigator arms, when participants complete a module, they will fill out their calendar preferences to find a day and time to meet with their navigator over the next week. The navigator will receive an automatic email when their assigned participant has finished a module. If a week has passed and participants have not scheduled a time to meet with their navigator, the navigator will email the participant to schedule their meeting. These meetings will entail 2-3 minutes of general introduction, 10-15 minutes to check in on any eSense-Cancer-related concerns or questions that arose over the week, and 2-3 minutes to close and schedule their next session, for a total of 15-25 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •self-report a current or history of gynecologic cancer of any subtype
- •self-report symptoms of sexual difficulties and score of greater than 11 on the Female Sexual Distress Scale-Revised
- •are fluent in English (eSense content is delivered in English)
- •have reliable internet access and basic competency in using online platforms (individuals will self-report)
- •are available for 8 - 16 weeks and able to complete eSense modules and associated questionnaires
- •any gender
排除标准
- •have visual impairments or disabilities interfering with reading and ability to interact with online materials
- •have poorly managed anxiety or mood disorder (assessed using the degree of life interference evaluation at screening)
- •individuals who are in active treatment for their cancer (including radiation, chemotherapy and any planned surgeries).
结局指标
主要结局
A change in sexual distress (FSDS-R)
时间窗: Assessed at enrolment (T1), treatment start (T2) and treatment end (T3). Time between T1 and T2: 4 weeks. Time between T2 and T3: 8-16 weeks
Sexual distress will be measured using the Female Sexual Distress Scale-Revised (FSDS-R). This scale is measured on a scale of 0-52 with higher values representing more distress.
A change in sexual function and satisfaction (PROMIS SexFs)
时间窗: Assessed at enrolment (T1), treatment start (T2) and treatment end (T3). Time between T1 and T2: 4 weeks. Time between T2 and T3: 8-16 weeks
The PROMIS SexFS scale will be used to measure sexual function and satisfaction. The scale consists of 14 questions with higher scores indicating greater levels of sexual function and satisfaction. Scores are differentially calculated for those who are sexually active versus not sexually active.
次要结局
- Treatment satisfaction as assessed by the adapted Erectile Dysfunction Inventory of Treatment Satisfaction(Assessed at post-treatment (T3): 8-16 weeks after treatment start)
- Global Impressions of eSense-Cancer(Assessed at post-treatment (T3): 8-16 weeks after treatment start)
- Usability of each module(Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.)
- Treatment satisfaction of each module(Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.)
研究者
Lori Brotto
Professor
University of British Columbia