E-Interventions to Treat Fear of Cancer Recurrence for Patients With Localized Renal Cell Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Cell Carcinoma
- Sponsor
- City of Hope Medical Center
- Primary Endpoint
- Feasibility - completion of Interventions
- Status
- Withdrawn
- Last Updated
- 10 months ago
Overview
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.
Investigators
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)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility - completion of Interventions
Time Frame: 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
Time Frame: 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
Time Frame: 1 year
at least 90% of the desired accrual goal is reached within 12 months
Secondary Outcomes
- 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)])