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Completed

NCT Number: NCT03776253

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

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.

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Key information

Conditions

Advanced Lung Carcinoma Lung Diseases Lung Neoplasms Malignant Female Reproductive System Neoplasm Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms 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 Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

Attend CFS

Other names: Conquer Fear Support

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Number of Eligible Participants

    Time frame: Up to 9 months

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

  2. Attrition

    Time frame: Up to Week 12

    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).

  3. Number of Sessions Attended

    Time frame: Up to 12 weeks

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

  4. Percentage of Participants Who Reported Home Practice

    Time frame: Up to 12 weeks

    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.

  5. Percentage of Participants Who Completed All Assigned Home Practice

    Time frame: Up to 12 weeks

    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.

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

    Time frame: Up to 12 weeks

    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.

Secondary outcomes

  1. Fear of Progression

    Time frame: T1 (Baseline), T2 (Week 8), and T3 (Week 12)

    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).

  2. Cancer-specific Distress

    Time frame: T1 (Baseline), T2 (Week 8), and T3 (Week 12)

    Cancer-specific distress was assessed using the Impact of Event Scale-Revised (IES-R). The total score ranges from 0 (minimum) to 88 (maximum), with higher scores indicating worse outcomes (i.e., greater cancer-specific distress). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).

  3. Anxiety

    Time frame: T1 (Baseline), T2 (Week 8), and T3 (Week 12)

    Anxiety was assessed using the Patient-Reported Outcomes Measurement Information System Anxiety Short Form 8a (PROMIS-Anxiety 8a). Raw scores range from 8 (minimum) to 40 (maximum) and were converted to standardized T-scores (mean = 50, standard deviation = 10). In both scoring metrics, higher scores indicate worse outcomes (i.e., greater anxiety). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).

  4. Depression

    Time frame: T1 (Baseline), T2 (Week 8), and T3 (Week 12)

    Depression was assessed using the Patient Health Questionnaire-9 (PHQ-9). The total score ranges from 0 (minimum) to 27 (maximum), with higher scores indicating worse outcomes (i.e., more severe depressive symptoms). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).

  5. Overall Symptom Distress

    Time frame: T1 (Baseline), T2 (Week 8), and T3 (Week 12)

    Overall symptom distress was assessed using the Memorial Symptom Assessment Scale (MSAS). The total MSAS score (TMSAS) ranges from 0 (minimum) to 4 (maximum), with higher scores indicating worse outcomes (i.e., greater symptom severity and distress). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).

  6. Metacognitions

    Time frame: T1 (Baseline), T2 (Week 8), and T3 (Week 12)

    Metacognitions were assessed using the Metacognitions Questionnaire-30 (MCQ-30). The total score ranges from 30 (minimum) to 120 (maximum), with higher scores indicating worse outcomes (i.e., more dysfunctional metacognitions). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).

  7. Mindfulness

    Time frame: T1 (Baseline), T2 (Week 8), and T3 (Week 12)

    Mindfulness was assessed using the Five Facet Mindfulness Questionnaire-15 (FFMQ-15), excluding the Observing subscale per scoring instructions. The total score ranges from 12 (minimum) to 60 (maximum), with higher scores indicating better outcomes (i.e., greater mindfulness). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Conquer Fear SUPPORT: A Psychosocial Intervention in Patients With Advanced Cancer

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2018
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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