Cooperative Extension and Cancer Survivorship: Supportive Care Via Cooperative Extension Services (SUCCESS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Participant attendance
研究概览
简要总结
The goal of this clinical trial is to learn if a cancer survivor program, delivered via Cooperative Extension, is feasible and if it can improve health outcomes in cancer survivors who are post-active treatment.
Aim 1: Evaluate the feasibility and acceptability of SUCCESS. Hypothesis 1: SUCCESS will be feasible and acceptable as evidenced by delivery of the intervention among Educators (implementation), including in agreement with the curriculum in Phase 1 (fidelity) with >85% attendance (demand) among participants with >80% rating the intervention as acceptable or highly acceptable on 5-point Likert-type scale (acceptability).
Aim 2: Determine the preliminary efficacy of SUCCESS for improving HRQOL (primary outcome) and other psychosocial and health-related endpoints (e.g., financial toxicity) (secondary outcomes). Hypothesis 2: Compared to matched controls, adults LWBC who complete SUCCESS will have significant improvements in HRQOL per the PROMIS Global Health v1.2 at follow-up (i.e., after 6 weeks).
Aim 3: Examine changes in conserved transcriptional response to adversity (CTRA) gene expression in a subset of interventions participants at follow-up. Hypothesis 3: Adults LWBC who complete SUCCESS will experience significant CTRA down-regulation.
This is a single arm trial and there is no comparison group.
Participants will be asked to do survey- and Zoom-based data collection before and after completing the 6-week program.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous adult-diagnosed cancer
- •Post active cancer treatment
- •No current active treatment, hormonal therapy permitted
- •Ability to get to group sessions
- •In Oklahoma
排除标准
- •Current palliative or hospice care
- •Surgical or medical history that precludes participation
- •Positive screen on the Physical Activity Readiness Questionnaire+ (PAR-Q+) without a doctor's note approving study participation
研究组 & 干预措施
SUCCESS Program
This includes our cancer survivorship program which entails 6 weekly group education sessions. Each session includes 25 minutes of didactic and discussion-based lecture, 25 minutes of facilitated support group, and 10 minutes of brief group-based exercise.
干预措施: SUCCESS (Behavioral)
结局指标
主要结局
Participant attendance
时间窗: Once per week for six weeks
We will measure how many enrolled participants attend each SUCCESS session
Delivery of sessions
时间窗: Once per week for six weeks
We will measure the percent of SUCCESS sessions delivered as planned by Educators
Fidelity to SUCCESS protocol
时间窗: Once per week for six weeks
We will measure what percentage of planned SUCCESS content is delivered as instructed.
Acceptability of SUCCESS
时间窗: Measured after SUCCESS (week 7-8 of the clinical trial)
We will administer a feasibility survey after SUCCESS for participants to rate how much they liked it. Rating will be on a 5-point Likert Scale ("How would you rate this program?" 1=poor, 5=excellent)
次要结局
- Physical function(Baseline (week 1) and post-SUCCESS (week 7-8))
- Financial Toxicity(Baseline (week 1) and post-SUCCESS (week 7-8))
- Depressive symptoms(Baseline (week 1) and post-SUCCESS (week 7-8))
- Diet quality(Baseline (week 1) and post-SUCCESS (week 7-8))
- Anxiety symptoms(Baseline (week 1) and post-SUCCESS (week 7-8))
- Loneliness(Baseline (week 1) and post-SUCCESS (week 7-8))
- Social isolation(Baseline (week 1) and post-SUCCESS (week 7-8))
- Health-related quality of life(Baseline (week 1) and post-SUCCESS (week 7-8))
- Food insecurity(Baseline (week 1) and post-SUCCESS (week 7-8))
- Basic psychological needs(Baseline (week 1) and post-SUCCESS (week 7-8))
- Self-reported pain(Baseline (week 1) and post-SUCCESS (week 7-8))
- Conserved Transcriptional Response to Adversity (CTRA) gene expression(Baseline (week 1) and post-SUCCESS (week 7-8))