Clinical trial NCT04688333: iConquerFear Program for the Treatment of Fear of Cancer Recurrence in Patients With Localized Renal Cell Carcinoma
Official title: E-Interventions to Treat Fear of Cancer Recurrence for Patients With Localized Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Cell Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-12-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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)

Primary outcomes:
measure: Feasibility - Accrual
timeFrame: 1 year
measure: Feasibility - completion of Interventions
timeFrame: 1 year
measure: Feasibility - retention/evaluation
timeFrame: 1 year
Secondary outcomes:
measure: Preliminary effects of iConquerFear program - FCR 7
timeFrame: Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)]
measure: Preliminary effects of iConquerFear program - (PROMIS)-Anxiety
timeFrame: Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)]
measure: Preliminary effects of iConquerFear program - PROMIS -depression
timeFrame: Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)]
measure: Preliminary effects of iConquerFear program - FACT-G
timeFrame: Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)]
Other outcomes:
Locations:
Study officials:
affiliation: City of Hope Medical Center
name: Sumanta K Pal
role: PRINCIPAL_INVESTIGATOR
References: