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

NCT ID: NCT03776253

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2024-08-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (CFS)

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).

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Attend CFS

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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

Attend CFS

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Conquer Fear Support

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Reb, NP, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2018-02405

Identifier Type: REGISTRY

Identifier Source: secondary_id

18305

Identifier Type: OTHER

Identifier Source: secondary_id

18305

Identifier Type: -

Identifier Source: org_study_id

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