An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Sexual Function Questionnaire for Men and Women (SFQ-W, SFW-M) scores from pre (0 weeks) to post-treatment (6 weeks), and 3 month follow-up
研究概览
简要总结
Diagnosis and treatment of breast cancer often leads to lower levels of sexual desire, decreased sexual arousal, painful intercourse, and difficulties achieving orgasm, and thus adversely impacts sexual functioning and intimacy. Despite the overwhelming evidence that many couples experience sexual distress following breast cancer, very few interventions have been designed exclusively to address these concerns. The purpose of this study is to develop and evaluate an online psychosexual program geared to the unique needs of couples experiencing sexual distress after breast cancer. This study will utilize a web-based approach, allowing couples to participate in the program from the privacy and comfort of their homes, and providing a resource to couples who may not otherwise be able to readily access support. Accordingly, this project has the potential for widespread positive impact for couples affected by breast cancer.
详细描述
Many couples experience sexual problems following breast cancer treatment, and difficulties with intimacy and sexuality tend to extend past the 1 year post-treatment point. Given that resources available for couples who experience sexual distress after breast cancer are virtually non-existent, there is a need to develop and empirically evaluate psychosexual interventions for breast cancer patients and their partners.
The purpose of this study is to evaluate the feasibility, process, and outcomes of an online, couples-based intervention designed to address sexual problems encountered by many couples facing breast cancer. The intervention will take place in the form of six E-therapy sessions delivered via secure, encrypted videoconferencing software commonly used by health care providers practicing telemedicine. Each session will be supplemented by psychoeducational materials (i.e. reading and/or video) available through a privately accessed homepage for the study.
Thirty couples will participate in the study, and will be be randomized to either the treatment condition or the wait-list control condition. Participants assigned to the wait-list will have the option of receiving the online program once they have completed their commitment to the study (approximately 5 months later). In addition to completing standardized questionnaires, couples will participate in pre- and post-treatment interviews, which will be analyzed thematically in order to improve the intervention and its delivery.
The proposed project builds upon existing research pertaining to the sexual health implications of female cancer survivorship, and will fill a gap both in the literature and support available to breast cancer survivors experiencing sexual distress. Given that sexual distress is such a crucial concern for women with breast cancer, and that the majority of couples experiencing sexual difficulties may not receive adequate support in this regard, the goal of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help improve the quality of life of couples affected by breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient has received a diagnosis within the last 5 years of invasive breast carcinoma (non- metastatic), or ductal carcinoma in-situ
- •Patient has received a mastectomy or lumpectomy and undergone adjuvant therapy (i.e.
- •chemotherapy, radiation, tamoxifen)
- •Patient is at least 1 month post-treatment.
- •Couples are in a committed relationship of at least 3 months duration at the time of diagnosis
- •Participants must be fluent in English
- •Participants must be 80 years of age or younger
- •Participants will require convenient access to a computer with a reliable internet connection in a private setting and have access to videoconferencing software (available for download at no cost).
排除标准
- •One or both of the partners are currently struggling with any mental illness that would interfere with the ability to participate (e.g. actively suicidal; currently psychotic
- •Couples who plan to participate in couples or sex counselling during the study
- •Couples experiencing significant levels of relationship distress (e.g. presence of violence or abuse), in which case they will be referred for couple counseling
结局指标
主要结局
Change in Sexual Function Questionnaire for Men and Women (SFQ-W, SFW-M) scores from pre (0 weeks) to post-treatment (6 weeks), and 3 month follow-up
时间窗: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
The SFQ assesses couples' sexual satisfaction and functioning. The SFQ will be used to assess change in couples' level of sexual functioning.
次要结局
- Centre for Epidemiological Studies Depression Scale(pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up)
- Breast Cancer Prevention Trial Symptom Checklist(pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up)
- Profile of Mood States Short Form (POMS-SF)(pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up)
- Revised Dyadic Adjustment Scale (RDAS)(pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up)
- Generalized Anxiety Disorder Assessment (GAD-7)(pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up)
- Maudsley Marital Questionnaire (marital sub-scale only)(pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up)
- Spousal Skills Checklist(pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up)
研究者
Karen Fergus
Principal Investigator
Sunnybrook Health Sciences Centre