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Behavioral Intervention
Psychosocial Care for Advanced Cancer
N/A
Waitlist Available
Led By Anne Reb, NP, PhD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage III or IV disease
Must not have
Patients enrolled in hospice care or who opt to receive no further disease-focused treatment
Current severe depression or psychosis; significant cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new psychosocial intervention called Conquer Fear Support (CFS) in patients with stage III-IV lung or gynecologic cancer who are afraid of their cancer progressing. CFS is based on a program called "Conquer Fear" which was developed by researchers in Australia. It may help reduce worries, fears, and uncertainty in patients with advanced lung or gynecological cancer.
Who is the study for?
This trial is for English-speaking patients with stage III-IV lung or gynecologic cancer who have been diagnosed at least 3 months ago. They must be undergoing treatment or active surveillance and feel a strong fear of their cancer progressing, as measured by specific questionnaires.
What is being tested?
The Conquer Fear Support intervention is being tested to see if it can help reduce the fear and anxiety associated with advanced-stage lung or gynecological cancers. It includes psychoeducation, attention training, worry management, and detached mindfulness components.
What are the potential side effects?
Since this is a psychosocial intervention focusing on mental health support rather than medication, there are no typical drug side effects. However, participants may experience emotional discomfort while discussing fears and anxieties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is in stage III or IV.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am in hospice care or have chosen not to pursue further treatment for my condition.
Select...
I do not have severe depression, psychosis, or significant cognitive issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attendance.
Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attrition.
Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking enrollment rate.
Secondary study objectives
Anxiety assessed using the PROMIS-Anxiety 8a
Cancer-specific distress assessed using the Impact of Event Scale-Revised (IES-R)
Depression assessed using the Patient Health Questionnaire (PHQ-9)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (CFS)Experimental Treatment2 Interventions
Patients attend CFS psychosocial intervention consisting of 7 nurse-led sessions (session 1 in-person and sessions 2-7 via video conferencing) over 45 minutes each for 8 weeks. Patients also complete home practice assignments comprising attention training technique and mindfulness practice after each session.
Patients complete self-report questionnaires at baseline (T1), 8 weeks (T2) and 12 weeks (T3).
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Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
599 Previous Clinical Trials
1,923,509 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,111 Total Patients Enrolled
Anne Reb, NP, PhDPrincipal InvestigatorCity of Hope Medical Center
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