Advanced Lung CarcinomaNCT03776253

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

A study testing Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components) and Questionnaire Administration in people with Advanced Lung Carcinoma and Malignant Female Reproductive System Neoplasm, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Advanced Lung Carcinoma, Malignant Female Reproductive System Neoplasm, Stage III Lung Cancer AJCC v8
What is being tested?: Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components) and Questionnaire Administration
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2018to 26 Aug 2024
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91010

Other trials in United States

About this study

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

Read the detailed description

PRIMARY OBJECTIVES:

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:

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.

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
Being tested: Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components), Questionnaire Administration
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components)Behavioural
Also called Conquer Fear Support
Attend CFS
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT03776253
Study group	Role	What they receive
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). Receives: Behavioral: Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components); Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Eligible Participants
Enrollment rate will be deemed sufficient if at least 33 eligible patients are accrued within 9 months.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks

Secondary outcomes (7)

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).
Measured: T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Cancer-specific Distress
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).
Measured: T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Anxiety
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).
Measured: T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Depression
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).
Measured: T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Overall Symptom Distress
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).
Measured: T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Metacognitions
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).
Measured: T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Mindfulness
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).
Measured: T1 (Baseline), T2 (Week 8), and T3 (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201826 Aug 2024

First posted14 Dec 2018
Study start15 Nov 2018
Primary completion26 Jul 2024
Study completion26 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Lung CarcinomaStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03776253
Sponsor's protocol ID: 18305
Other IDs: NCI-2018-02405, 18305
Status last verified: Jul 2026
First submitted: 31 Oct 2018
Last updated: 6 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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