Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 4:38 PM
Study NCT ID:
NCT04688333
Status:
WITHDRAWN
Last Update Posted:
2025-06-26
First Post:
2020-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iConquerFear Program for the Treatment of Fear of Cancer Recurrence in Patients With Localized Renal Cell Carcinoma
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
E-Interventions to Treat Fear of Cancer Recurrence for Patients With Localized Renal Cell Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Feasibility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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:
Patients complete 5 sessions of iConquerFear program online over 5 weeks. Patients also complete questionnaires at baseline, after the intervention, and 2 months later.
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:
Patients complete 5 sessions of iConquerFear program online over 5 weeks. Patients also complete questionnaires at baseline, after the intervention, and 2 months later.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-04378 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 20133 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |