iConquerFear Program for the Treatment of Fear of Cancer Recurrence in Patients With Localized Renal Cell Carcinoma

NCT04688333 | Withdrawn DMC

• 3 other identifiers: 20133NCI-2020-04378P30CA033572
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Feasibility - Accrual

  at least 90% of the desired accrual goal is reached within 12 months

  1 year

• Feasibility - completion of Interventions

  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

  1 year

• Feasibility - retention/evaluation

  ≥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 \[in rare cases, patients will skip in intermediary time point but compelete a later timepoint evaluation\]

  1 year

Secondary Outcomes (4)

• 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 - 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 - 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)]

Study Arms (1)

Supportive care (iConquerFear program, questionnaires)

Patients complete 5 sessions of iConquerFear program online over 5 weeks. Patients also complete questionnaires at baseline, after the intervention, and 2 months later.

Other: Internet-Based Intervention - Complete iConquerFear program; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Internet-Based Intervention - Complete iConquerFear program OTHER

Online adaptation of a highly effective face-to-face treatment for fear of recurrence.

Supportive care (iConquerFear program, questionnaires)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (iConquerFear program, questionnaires)

Questionnaire Administration OTHER

Complete questionnaires

Supportive care (iConquerFear program, questionnaires)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Renal Cell Carcinoma

You may qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Sumanta K Pal

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: December 30, 2020
• Study Start: August 20, 2022
• Primary Completion: August 27, 2023
• Study Completion: August 27, 2023
• Last Updated: June 26, 2025

Record last verified: 2025-06