Clinical trial NCT03776253: Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer
Official title: Conquer Fear SUPPORT: A Psychosocial Intervention in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Stage IV Lung Cancer AJCC v8
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-12-14
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. CFS may help in reducing worries, fears, and uncertainty in patients with advanced lung or gynecological cancer.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking enrollment rate.
timeFrame: Up to 9 months
measure: Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attrition.
timeFrame: Up to week 12
measure: Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attendance.
timeFrame: Up to week 12
Secondary outcomes:
measure: Fear of progression (FOP) assessed using Fear of Progression Questionnaire-Short Form (SF)
timeFrame: Up to week 12
measure: Cancer-specific distress assessed using the Impact of Event Scale-Revised (IES-R)
timeFrame: Up to week 12
measure: Anxiety assessed using the PROMIS-Anxiety 8a
timeFrame: Up to week 12
measure: Depression assessed using the Patient Health Questionnaire (PHQ-9)
timeFrame: Up to week 12
measure: Overall symptom distress assessed using the Memorial Symptom Assessment Scale (MSAS)
timeFrame: Up to week 12
measure: Metacognitions (MCQ-30) assessed using the Metacognitions Questionnaire
timeFrame: Up to week 12
measure: Mindfulness assessed using the Five Facet Mindfulness Questionnaire (FFMQ-15)
timeFrame: Up to week 12
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Anne Reb, NP, PhD
role: PRINCIPAL_INVESTIGATOR
References: