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

NCT03776253 | Completed DMC

• 2 other identifiers: 18305NCI-2018-02405
• Study Type: interventional
• Target: 38
• 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

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

Outcome Measures

Primary Outcomes (3)

• Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking enrollment rate.

  Evaluate the enrollment (recruitment) rate over the study period. Feasibility will be deemed acceptable if at least 25 eligible participants are accrued within 9 months.

  Up to 9 months

• Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attrition.

  Evaluate attrition (drop-out rate) over time for enrolled participants. Feasibility will be deemed acceptable if the percentage of patients who drop-out does not exceed 20% by week 8 of the intervention and 50% by week 12 of the intervention.

  Up to week 12

• Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attendance.

  Evaluate the percentage of sessions attended. Feasibility will be deemed acceptable if participants attend an average of 5 of the 7 scheduled sessions.

  Up to week 12

Secondary Outcomes (7)

• Fear of progression (FOP) assessed using Fear of Progression Questionnaire-Short Form (SF)

  Up to week 12

• Cancer-specific distress assessed using the Impact of Event Scale-Revised (IES-R)

  Up to week 12

• Anxiety assessed using the PROMIS-Anxiety 8a

  Up to week 12

• Depression assessed using the Patient Health Questionnaire (PHQ-9)

  Up to week 12

• Overall symptom distress assessed using the Memorial Symptom Assessment Scale (MSAS)

  Up to 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

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)

Questionnaire Administration OTHER

Ancillary studies

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

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne Reb, NP, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

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: January 3, 2025

Record last verified: 2025-01

Locations

US (1)