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

City of Hope

Status: Withdrawn

Conditions: Renal Cell Carcinoma

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04688333

20133 (Other Identifier)

NCI-2020-04378 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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)

Trial design

0 participants in 1 patient group

Supportive care (iConquerFear program, questionnaires)

Description:

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

Treatment:

Other: Quality-of-Life Assessment

Other: Internet-Based Intervention - Complete iConquerFear program

Other: Questionnaire Administration