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

City of Hope

Status: Completed

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03776253

18305 (Other Identifier)

NCI-2018-02405 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Supportive care (CFS)

Experimental group

Description:

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).

Treatment:

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

Other: Questionnaire Administration