At-Home Support for Rural Women Using Group Video Calling
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Feasibility of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data
研究概览
简要总结
This randomized phase I trial studies at-home group video calling sessions in quality of life in rural patients with breast cancer. At-home group video calling support sessions may improve the well-being and quality of life of women who have breast cancer
详细描述
PRIMARY OBJECTIVES:
I. To examine whether delivering at-home professionally-led breast cancer support using group video calling is feasible, acceptable and satisfactory for women in rural northern California.
II. To evaluate the feasibility of using on-line tools to recruit, screen, treat, and assess this population for a subsequent randomized clinical trial.
III. Assess whether the rate of recruitment of women in this region in this study using predominantly on-line means of recruitment can be improved over that of the previous study using predominantly face-to-face means of recruitment.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be eligible for this study, the participant must have been diagnosed with breast cancer within the previous 5 years prior to study entry; individuals who have been diagnosed with any stage of breast cancer are eligible
- •There are no limitations regarding allowable type and amount of prior therapy
- •There are no race/ethnic restrictions
- •There are no life expectancy restrictions
- •Neither Eastern Cooperative Oncology Group (ECOG) nor Karnofsky performance status will be employed
- •There are no requirements for organ and marrow function
- •Ability to understand and the willingness to sign a written informed consent document; this will be assessed in the telephone screen conducted by Lisa Frankel as she will review each section of the consent form with the participant and ask if she has any questions about it; this telephone screen will have been approved by the Stanford University Institutional Review Board (IRB), and Lisa Frankel will conduct the interviews in a private location to ensure confidentiality
- •Eligibility for this study requires that a woman be a resident of one of 27 rural counties in California (Alpine, Amador, Butte, Calaveras, Colusa, Del Norte, El Dorado, Glenn, Imperial, Inyo, Lake, Lassen, Madera, Mariposa, Modoc, Mono, Nevada, Placer, Plumas, Shasta, Sierra, Siskiyou, Sutter, Tehama, Trinity, Tuolumne, or Yuba, except we will not include women living within the following cities: Chico, Madera, Redding, Rocklin, Roseville or Yuba City, due to this study's more rural focus)
- •Eligibility for this study requires that a woman has sufficient hearing to be able to engage in conversation over the phone
- •Eligibility for this study requires that a woman has a private place available where she can access the internet
- •Eligibility for this study requires that a woman is potentially available to meet at the day of the week and time of the day that the group intervention is scheduled â in the event that she is randomly assigned to receive the at-home group calling intervention
- •Eligibility for this study requires that women have broadband or digital subscriber line (DSL) internet access
- •Eligibility for this study requires that women have a computer with a webcam and either a microphone or a phone available to call into the video conference
排除标准
- •There are no therapy restrictions
- •There are no restrictions regarding use of other investigational agents
- •There are no exclusion requirements due to co-morbid disease or incurrent illness
- •Requirements regarding history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent or device are not applicable to this study
- •There are no exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent
- •There are no other agent-specific exclusion criteria
- •Pregnancy or nursing patients will not be excluded from the study
- •Patients who are cancer survivors or those who are human immunodeficiency virus (HIV)-positive will not be excluded from the study
结局指标
主要结局
Feasibility of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data
时间窗: At 1 week post-intervention
The major criterion for determining feasibility is to determine whether we can recruit rural women with breast cancer more rapidly using predominantly on-line procedures in this study than in our previous study that predominantly used face-to-face procedures. The qualitative data for determining the feasibility will be collected during the at-home group video calling sessions and from women's interviews conducted at the end of the study. Will be assessed using mixed methods.
Acceptability of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data
时间窗: At 1 week post-intervention
The qualitative data for determining the acceptability will be collected during the at-home group video calling sessions and from women's interviews conducted at the end of the study. Will be assessed using mixed methods.
次要结局
- Changes in quality of life (posttraumatic stress, depression symptoms, perceived stress, and positive states of mind)(From baseline to 1 week post-intervention)
- Changes in satisfaction with social support(From baseline to 1 week post-intervention)
- Changes in self-efficacy for coping with cancer(From baseline to 1 week post-intervention)
研究者
Cheryl Koopman
Professor (Research) of Psychiatry and Behavioral Sciences
Stanford University