Stick Together - a Dyadic Web-intervention for Younger Patients with Breast Cancer and Their Partners
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Participation (Acceptability 1)
研究概览
简要总结
This pilot study investigates the acceptability and feasibility of 'Stick Together', a self-guided online intervention, for younger women with breast cancer and their cohabiting partners.
详细描述
This one-arm feasibility study pilots the 'Stick Together' intervention among 20 women newly diagnosed with breast cancer at age 25-49 and their cohabiting partners. The intervention aims to strengthen couples' positive dyadic coping and communication, as well as participants mental health and quality of life, as well as quality of life of underage children.
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
- 25 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(patients):
- •women newly diagnosed with first primary breast cancer, treated with curative intent at Department of breast surgery, Gentofte Hospital
- •living with a romantic partner
- •Inclusion Criteria (partners):
- •living in romantic partnership with a patient eligible for the intervention
排除标准
- •(both patients and partners):
- •severe relationship difficulties or current couples counselling
- •severe, untreated mental illness in one or both partners
- •capable of participating (mastery of Danish language, available smartphone, tablet or other device, no cognitive impairment)
研究组 & 干预措施
Intervention group (Stick Together)
Intervention group (all participants)
干预措施: Stick Together (Behavioral)
结局指标
主要结局
Participation (Acceptability 1)
时间窗: baseline
Percentage of eligible participants consenting to participate
Completion (Feasibility)
时间窗: Post-intervention (7-9 months post diagnosis)
Percentage of participants completing the intervention (65% completion)
Participants satisfaction (Acceptability 2)
时间窗: Post-intervention follow-up (7-9 months post diagnosis)
Percentage of participants satisfied with the intervention
次要结局
- Change from baseline to post-intervention in negative dyadic coping(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in satisfaction with dyadic coping(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in psychological quality of life(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in supportive dyadic coping(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in joint dyadic coping(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in perceived stress(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in active engagement(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in overprotection(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in physical quality of life(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in social quality of life(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in children's quality of life(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in anxiety(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in protective buffering(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in delegated dyadic coping(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in depression(Baseline, after intervention completion (average 8 months after diagnosis))
- Change from baseline to post-intervention in stress communication(Baseline, after intervention completion (average 8 months after diagnosis))
研究者
Annika von Heymann
Post.doc.
Rigshospitalet, Denmark