Advanced Lung Carcinoma, Malignant Female Reproductive System Neoplasm, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
Conditions
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.
Interventions
BEHAVIORALPsychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components)
Attend CFS
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eligible Participants | Up to 9 months | Enrollment rate will be deemed sufficient if at least 33 eligible patients are accrued within 9 months. |
| Attrition | 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). |
| Number of Sessions Attended | 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. |
| Percentage of Participants Who Reported Home Practice | 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. |
| Percentage of Participants Who Completed All Assigned Home Practice | 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. |
| Percentage of Participants Who Reported Attention Training Practice for at Least One Week | 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
| Measure | Time frame | Description |
|---|---|---|
| Fear of Progression | 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). |
| Cancer-specific Distress | 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). |
| Anxiety | 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). |
| Depression | 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). |
| Overall Symptom Distress | 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). |
| Metacognitions | 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). |
| Mindfulness | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnne Reb, NP, PhD
City of Hope Medical Center
Participant flow
Recruitment details
Patients were recruited from the medical oncology outpatient clinics at the City of Hope National Medical Center. Advanced practice nurses screened the medical records and appointment schedules and confirmed eligibility with the oncology provider.
Pre-assignment details
Of the 48 patients who consented and completed the eligibility screening questionnaire, 39 met the eligibility criteria. Of those, 8 dropped before completing baseline data. Thirty-one participants were evaluable for the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Age | 58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 1 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
None listed