Text-Messaging Communication Micro-Intervention for Couples Coping With Advanced GI Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Changes in constructive communication
研究概览
简要总结
The purpose of this study is to develop, refine, and pilot test a text-messaging micro-intervention focused on improving communication skills for couples in which one partner has gastrointestinal cancer.
For the pilot testing portion of the study, couples will be randomized (1:1) to receive the text-messaging communication micro-intervention or to a waitlist control group. All couples will be asked to complete questionnaires before randomization and 30 days post-randomization. Couples in the waitlist control group will be offered the text-messaging micro-intervention after completing the second set of surveys (30-days post-randomization).
详细描述
A cancer diagnosis requires patients and their intimate partners to communicate effectively to navigate illness-related challenges. Research indicates that couples who use effective communication strategies have better individual psychological adjustment and higher relationship satisfaction. However, many couples have difficulty communicating about cancer-related issues which can lead to poorer individual, relationship, and patient health outcomes.
While dyadic interventions to improve couple communication have proven efficacious, they are often time intensive and have limited reach. The challenges of recruiting couples into dyadic interventions are well-documented, with low recruitment rates especially among underserved couples.
Micro-interventions, which consist of brief educational materials and short activities delivered via text message or a mobile application, have significant potential to increase reach and participation in diverse groups of couples by increasing flexibility and reducing barriers to access. Previous studies have found micro-interventions to be effective in promoting health behavior change in a wide range of individuals and in enhancing dyadic functioning in community couples.
The proposed project aims to develop, test, and examine the feasibility, acceptability, and efficacy of a text-messaging communication micro-intervention for couples coping with advanced GI cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In a committed relationship
- •Both members of the couple must read and speak fluent English
- •One partner must be diagnosed with advanced (Stage III or IV) gastrointestinal cancer and undergoing systemic therapy (e.g., chemotherapy)
- •One or both partners must score ≥1.0 on the holding back screen
排除标准
- •Patient or partner who is unable to provide informed consent as assessed by the oncologist or research staff
- •Patient or partner is physically impaired in such a way that precludes the use of a mobile device
- •Patient or partner who do not have a mobile device
- •Patient or partner who is too sick to participate, as judged by the oncologist or research staff.
结局指标
主要结局
Changes in constructive communication
时间窗: Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)
Changes in constructive communication measured by the Communication Patterns Questionnaire (CPQ-Short Form)
Assessment of acceptability of micro-Intervention
时间窗: Post-Intervention (30 days post randomization)
Acceptability of treatment will be measured using the Client Satisfaction Questionnaire (CSQ-8); higher scores indicate higher satisfaction
Changes in relationship satisfaction
时间窗: Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)
Changes in relationship satisfaction measured by the Couples Satisfaction Index (CSI-4); higher scores indicate higher relationship satisfaction
次要结局
未报告次要终点