Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer
NCT ID: NCT03776253
Last Updated: 2025-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2018-11-15
2024-08-26
Brief Summary
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Detailed Description
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I. Assess the feasibility and acceptability of the CFS intervention in patients with advanced lung and gynecologic (GYN) cancer (stages III or IV) who have clinically significant levels of fear of cancer progression (FOP) or cancer-related distress.
SECONDARY OBJECTIVES:
I. Assess preliminary effects of the intervention on FOP, cancer-specific distress, anxiety, depression, overall symptom distress, metacognitions, and mindfulness.
OUTLINE:
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 sessions after each session.
After completion of study intervention, patients are followed up at week 12.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (CFS)
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).
Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components)
Attend CFS
Questionnaire Administration
Ancillary studies
Interventions
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Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components)
Attend CFS
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage III or IV disease
* At least 3 months from initial diagnosis
* Receiving disease-focused treatment or active surveillance mode
* A score of ≥ 34 on the Fear of Progression Questionnaire-Short Form (SF) or ≥ 24 on the Impact of Event Scale-Revised
* All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
* Patients enrolled in hospice care or who opt to receive no further disease-focused treatment
* Patients who are currently receiving ongoing psychiatric treatment
* Non-English speaking
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Anne Reb, NP, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2018-02405
Identifier Type: REGISTRY
Identifier Source: secondary_id
18305
Identifier Type: OTHER
Identifier Source: secondary_id
18305
Identifier Type: -
Identifier Source: org_study_id
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