E-Interventions to Treat Fear of Cancer Recurrence for Patients With Localized Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Feasibility - completion of Interventions
研究概览
简要总结
This trial investigates whether an online intervention, iConquerFear, can reduce fear of cancer coming back (recurrence) and anxiety in patients with renal cell carcinoma that is restricted to the site of origin, without evidence of spread (localized). This intervention is an online adaptation of a highly effective face-to-face treatment for fear of recurrence that teaches strategies for: controlling worry and excessive threat monitoring, modifying unhelpful beliefs about worry, developing appropriate monitoring and screening behaviors, addressing cancer-related existential change, promoting values-based goal setting, and reducing uncertainty by providing information about cancer and treatment. The information learned may help others with renal cell carcinoma who also have a fear of cancer recurrence.
详细描述
PRIMARY OBJECTIVES:
I. To assess feasibility and acceptability of the iConquerFear program for patients with renal cell carcinoma (RCC).
II. To assess preliminary effects of the program on Fear of Cancer Recurrence-7 item scale (FCR-7), Patient-Reported Outcomes Measurement Information System (PROMIS)-anxiety, PROMIS-depression, and Functional Assessment of Chronic Illness Therapy-General (FACT-G).
III. Explore differences in feasibility and efficacy of iConquerFear by sociodemographic or clinical factors.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Sufficiently fluent in English
- •Cytologically or pathologically verified diagnosis of RCC
- •Undergone nephrectomy with negative margins (NOTE: Patients with other local definitive therapies, e.g., radiofrequency ablation or stereotactic ablative radiotherapy [SABR], would not be candidates for this protocol)
- •No evidence of metastatic disease (including at a minimum computed tomography [CT] of the chest, abdomen and pelvis for staging)
- •Internet access and basic computer skills
- •Moderate to severe fear of cancer recurrence (FCR)
排除标准
- 未提供
结局指标
主要结局
Feasibility - completion of Interventions
时间窗: 1 year
At least 70% of patients complete 3/5 intervention sessions, assessed as follows: i. ≥70% of patients complete first intervention session ii. ≥70% of patients complete second intervention session iii. ≥70% of patients complete third intervention session
Feasibility - retention/evaluation
时间窗: 1 year
≥70% of patients have at least 2 of 3 evaluable time points, assessed as follows: i. All patients will have timepoint 1 assessment, which is required at time of accession ii. ≥70% of patients must be evaluable at timepoint 2 or timepoint 3 \[in rare cases, patients will skip in intermediary time point but compelete a later timepoint evaluation\]
Feasibility - Accrual
时间窗: 1 year
at least 90% of the desired accrual goal is reached within 12 months
次要结局
- Preliminary effects of iConquerFear program - PROMIS -depression(Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)])
- Preliminary effects of iConquerFear program - FCR 7(Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)])
- Preliminary effects of iConquerFear program - (PROMIS)-Anxiety(Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)])
- Preliminary effects of iConquerFear program - FACT-G(Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)])