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

Not Applicable

Withdrawn

• Conditions: Renal Cell Carcinoma
• Interventions: Other: Internet-Based Intervention - Complete iConquerFear program; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT04688333
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09
• Study Start: 2022-08-20
• Primary Completion: 2023-08-27
• Study Completion: 2023-08-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (iConquerFear program, questionnaires)	Quality-of-Life Assessment	Patients complete 5 sessions of iConquerFear program online over 5 weeks. Patients also complete questionnaires at baseline, after the intervention, and 2 months later.
Supportive care (iConquerFear program, questionnaires)	Internet-Based Intervention - Complete iConquerFear program	Patients complete 5 sessions of iConquerFear program online over 5 weeks. Patients also complete questionnaires at baseline, after the intervention, and 2 months later.
Supportive care (iConquerFear program, questionnaires)	Questionnaire Administration	Patients complete 5 sessions of iConquerFear program online over 5 weeks. Patients also complete questionnaires at baseline, after the intervention, and 2 months later.

Primary Outcome Measures

Name	Time	Method
Feasibility - completion of Interventions	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	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	1 year	at least 90% of the desired accrual goal is reached within 12 months

Secondary Outcome Measures

Name	Time	Method
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)]	Analysis of Variance (ANOVA) will be used to explore changes in scores over time, separately for the metrics obtained from Patient-Reported Outcome Measurement Information System (PROMIS)-depression.; All instruments will be scored according to validated instructions. All available time points will be used in each analysis.; PROMIS Emotional Distress: Depression. This 8-item measure assesses symptoms of depression on a 5-point scale (1=never, 5=always). Scores range from 8-40 with higher scores indicating greater severity of depression.
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)]	Analysis of Variance (ANOVA) will be used to explore changes in scores over time, separately for the metrics obtained from Fear of Cancer Recurrence-7 item scale (FCR-7); All instruments will be scored according to validated instructions. All available time points will be used in each analysis.; Fear of Cancer Recurrence-7. This is a 7-item scale that assesses the degree of FCR, with a cutoff score of 17 or above indicative of moderate and a cutoff score of 27 or above indicative of severe FCR.
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)]	Analysis of Variance (ANOVA) will be used to explore changes in scores over time, separately for the metrics obtained from Patient-Reported Outcome Measurement Information System (PROMIS)-Anxiety.; All instruments will be scored according to validated instructions. All available time points will be used in each analysis.; PROMIS Emotional Distress: Anxiety. This 8-item measure assesses symptoms of anxiety on a 5-point scale (1=never, 5=always). Scores range from 7-35 with higher scores indicating greater severity of anxiety.
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)]	Analysis of Variance (ANOVA) will be used to explore changes in scores over time, separately for the metrics obtained from Functional Assessment of Chronic Illness Therapy-General (FACT-G).; All instruments will be scored according to validated instructions. All available time points will be used in each analysis.; Functional Assessment of Chronic Illness Therapy-General (FACT-G). A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-28 for the physical, social/family and functional subscales, 0-24 for the emotional subscale and 0-108 for the total score. Higher scores indicate higher quality of life.