Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer

NCT03776253 | Completed Results DMC

• 2 other identifiers: 18305NCI-2018-02405
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will pilot a psychosocial intervention called Conquer Fear Support (CFS) in patients with stage III-IV lung or gynecologic cancer who are experiencing fear of cancer progression. The intervention is adapted from a novel program called "Conquer Fear" which was developed by researchers in Australia. CFS may help in reducing worries, fears, and uncertainty in patients with advanced lung or gynecological cancer.

Conditions

Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Advanced Lung Carcinoma; Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (6)

• Number of Eligible Participants

  Enrollment rate will be deemed sufficient if at least 33 eligible patients are accrued within 9 months.

  Up to 9 months

• Attrition

  Feasibility of the Conquer Fear SUPPORT (CFS) intervention will be assessed by tracking attrition. Attrition is defined as the percentage of participants who withdraw from the study among enrolled participants who completed the baseline questionnaire (i.e., evaluable participants). Feasibility will be evaluated based on whether attrition remains within the prespecified study thresholds at Week 8 (T2) and Week 12 (T3).

  Up to Week 12

• Number of Sessions Attended

  Attendance was assessed as the number of intervention sessions attended by each participant. Seven intervention sessions were offered during the study period.

  Up to 12 weeks

• Percentage of Participants Who Reported Home Practice

  Home practice was assessed by participant self-report during the intervention period. The outcome reflects the percentage of participants who reported engaging in assigned home practice activities.

  Up to 12 weeks

• Percentage of Participants Who Completed All Assigned Home Practice

  Completion of assigned home practice was assessed by participant self-report during the intervention period. The outcome reflects the percentage of participants who reported completing all assigned home practice activities.

  Up to 12 weeks

• Percentage of Participants Who Reported Attention Training Practice for at Least One Week

  Attention training practice was assessed by participant self-report during the intervention period. The outcome reflects the percentage of participants who reported engaging in attention training practice for at least one week.

  Up to 12 weeks

Secondary Outcomes (7)

• Fear of Progression

  T1 (Baseline), T2 (Week 8), and T3 (Week 12)

• Cancer-specific Distress

  T1 (Baseline), T2 (Week 8), and T3 (Week 12)

• Anxiety

  T1 (Baseline), T2 (Week 8), and T3 (Week 12)

• Depression

  T1 (Baseline), T2 (Week 8), and T3 (Week 12)

• Overall Symptom Distress

  T1 (Baseline), T2 (Week 8), and T3 (Week 12)

Study Arms (1)

Supportive care (CFS)

EXPERIMENTAL

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).

Behavioral: Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components); Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Ancillary studies

Supportive care (CFS)

Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components) BEHAVIORAL

Attend CFS

Also known as: Conquer Fear Support

Supportive care (CFS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with gynecologic (GYN) and lung cancer will be recruited
• 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

You may not qualify if:

• Current severe depression or psychosis; significant cognitive impairment
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Links

• A nurse-led intervention for fear of cancer progression in advanced cancer: A pilot feasibility study

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Anne Reb
• Organization: City of Hope Medical Center

areb@coh.org

6263598111

Study Officials

• Anne Reb, NP, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: December 14, 2018
• Study Start: November 15, 2018
• Primary Completion: July 26, 2024
• Study Completion: August 26, 2024
• Last Updated: August 6, 2026
• Results First Posted: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)