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

City of Hope Medical Center39 enrolled

Overview

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.

PRIMARY OBJECTIVES: 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Advanced Lung Carcinoma

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Number of Eligible Participants

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

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 12 weeks

Secondary Outcomes

Fear of Progression

Fear of progression was assessed using the Fear of Progression Questionnaire-Short Form (FOP-Q-SF). The total score ranges from 12 (minimum) to 60 (maximum), with higher scores indicating worse outcomes (i.e., greater fear of progression). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).