Renal Cell CarcinomaNCT04688333
iConquerFear Program for the Treatment of Fear of Cancer Recurrence in Patients With Localized Renal Cell Carcinoma
An observational study of Renal Cell Carcinoma, run by City of Hope Medical Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Internet-Based Intervention - Complete iConquerFear program, Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2022to 27 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal Cell Carcinoma
Who may be able to join
- 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)
Who cannot join
None listed.
About this study
Official title: E-Interventions to Treat Fear of Cancer Recurrence for Patients With Localized Renal Cell Carcinoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Internet-Based Intervention - Complete iConquerFear program, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based Intervention - Complete iConquerFear programOther
Online adaptation of a highly effective face-to-face treatment for fear of recurrence.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Internet-Based Intervention - Complete iConquerFear program; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Accrual
at least 90% of the desired accrual goal is reached within 12 months
Measured: 1 year
Feasibility - completion of Interventions
At least 70% of patients complete 3/5 intervention sessions, assessed as follows:
- ≥70% of patients complete first intervention session ii. ≥70% of patients complete second intervention session iii. ≥70% of patients complete third intervention session
Measured: 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]
Measured: 1 year
Secondary outcomes (4)
Preliminary effects of iConquerFear program - FCR 7
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start20 Aug 2022 (estimated)
- Primary completion27 Aug 2023 (estimated)
- Study completion27 Aug 2023 (estimated)
Why it stopped: Feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sumanta K Pal, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688333
- Sponsor's protocol ID
- 20133
- Other IDs
- NCI-2020-04378, 20133, P30CA033572
- Status last verified
- Jun 2025
- First submitted
- 10 Sep 2020
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-Interventions to Treat Fear of Cancer Recurrence for Patients With Localized Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04688333
- Acronym / sponsor ID
- 20133
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Aug 2022 (estimated)
- Primary completion
- 27 Aug 2023 (estimated)
- Study completion
- 27 Aug 2023 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (iConquerFear program, questionnaires) | – | Other: Internet-Based Intervention - Complete iConquerFear program, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients complete 5 sessions of iConquerFear program online over 5 weeks. Patients also complete questionnaires at baseline, after the intervention, and 2 months later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal Cell Carcinoma
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based Intervention - Complete iConquerFear programOnline adaptation of a highly effective face-to-face treatment for fear of recurrence. | Other | Supportive care (iConquerFear program, questionnaires) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (iConquerFear program, questionnaires) |
| Questionnaire AdministrationComplete questionnaires | Other | Supportive care (iConquerFear program, questionnaires) |
Primary outcome
Feasibility - Accrual
Time frame: 1 year
at least 90% of the desired accrual goal is reached within 12 months
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]
4 secondary outcomes
Preliminary effects of iConquerFear program - FCR 7
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (T1), immediately after the intervention expected at 5 weeks after baseline (T2), and at 2 months follow-up (T3, 2 months following T2)]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumanta K Pal principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by City of Hope Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Accrual (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.