Trial Outcomes & Findings for Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer (NCT NCT03776253)
NCT ID: NCT03776253
Last Updated: 2026-08-06
Results Overview
Enrollment rate will be deemed sufficient if at least 33 eligible patients are accrued within 9 months.
COMPLETED
NA
39 participants
Up to 9 months
2026-08-06
Participant Flow
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.
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.
Participant milestones
| Measure |
A Single Group Mixed Methods Study
The Day by Day intervention was adapted from the Conquer Fear Intervention. Adaptations were made to tailor the content to individuals with advanced cancer and to shorten each session. The intervention teaches skills to reduce worry and unhelpful coping behaviors. Sessions focused on values clarification, skills practices (attention training, detached mindfulness, worry postponement), and surveillance/lifestyle education.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer
Baseline characteristics by cohort
| Measure |
A Single Group Mixed Methods Study
n=31 Participants
Participants attended the Day by Day intervention to address fear of cancer progression, consisting of seven nurse-led, one-on-one sessions over eight weeks. The first session was conducted in person followed by six sessions via Zoom. The program included a values-based goal setting activity, experiential activities, and skills practice including attention training technique, detached mindfulness, and worry postponement.
Patients complete self-report questionnaires at baseline (T1), 8 weeks (T2) and 12 weeks (T3) and an exit interview.
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Age, Continuous
Age
|
58 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: Of the 99 individuals approached, 51 declined participation. Forty- eight participants consented and completed the eligibility screening questionnaire. Among those, 39 met the eligibility criteria. Of those eligible, 31 completed baseline questionnaires and were considered evaluable.
Enrollment rate will be deemed sufficient if at least 33 eligible patients are accrued within 9 months.
Outcome measures
| Measure |
Evaluable Participants.
n=99 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Number of Eligible Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Thirty-one participants completed baseline questionnaires and were considered evaluable. Among these 31 participants, 9 dropped out by T2. Of the 22 remaining at T2, 3 withdrew by T3.
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).
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Attrition
Dropped T2
|
9 Participants
|
|
Attrition
Dropped between T2 and T3
|
3 Participants
|
|
Attrition
Completed study
|
19 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
Attendance was assessed as the number of intervention sessions attended by each participant. Seven intervention sessions were offered during the study period.
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Number of Sessions Attended
|
5.3 Sessions
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Up to 12 weeksHome 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.
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Percentage of Participants Who Reported Home Practice
|
26 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksCompletion 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.
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Percentage of Participants Who Completed All Assigned Home Practice
|
18 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
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.
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Percentage of Participants Who Reported Attention Training Practice for at Least One Week
|
17 Participants
|
SECONDARY outcome
Timeframe: T1 (Baseline), T2 (Week 8), and T3 (Week 12)Population: Least squares means and standard errors (SE) of FOP-Q-SF scores were estimated for 31 evaluable participants at T1 (Baseline), T2 (Week 8), and T3 (Week 12) using a linear mixed model for repeated measures.
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).
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Fear of Progression
T1 (Baseline)
|
41.1 FOP-Q-SF score
Standard Error 1.3
|
|
Fear of Progression
T2 (Week 8)
|
33.1 FOP-Q-SF score
Standard Error 1.5
|
|
Fear of Progression
T3 (Week 12)
|
31.3 FOP-Q-SF score
Standard Error 1.5
|
SECONDARY outcome
Timeframe: T1 (Baseline), T2 (Week 8), and T3 (Week 12)Population: IES-R least square mean for 31 evaluable participants was calculated at T1 (Baseline), T2 (Week 8), and T3 (Week 12) using Linear Mixed Model for repeated-measure design.
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).
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Cancer-specific Distress
T2 (Week 8)
|
15.8 IES-R score
Standard Error 3.0
|
|
Cancer-specific Distress
T1 (Baseline)
|
34.9 IES-R score
Standard Error 2.5
|
|
Cancer-specific Distress
T3 (Week 12)
|
16.6 IES-R score
Standard Error 3.1
|
SECONDARY outcome
Timeframe: T1 (Baseline), T2 (Week 8), and T3 (Week 12)Population: PROMIS Anxiety- 8a least square mean (standard error) for 31 evaluable participants was calculated at T1 (Baseline), T2 (Week 8), and T3 (Week 12) using Linear Mixed Model for repeated-measure design.
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).
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Anxiety
T1 (Baseline)
|
59.1 PROMIS Anxiety- 8a score
Standard Error 1.5
|
|
Anxiety
T2 (Week 8)
|
52.0 PROMIS Anxiety- 8a score
Standard Error 1.8
|
|
Anxiety
T3 (Week 12)
|
51.4 PROMIS Anxiety- 8a score
Standard Error 1.9
|
SECONDARY outcome
Timeframe: T1 (Baseline), T2 (Week 8), and T3 (Week 12)Population: PHQ-9 least square mean (standard error) for 31 evaluable participants was calculated at T1 (Baseline), T2 (Week 8), and T3 (Week 12) using Linear Mixed Model for repeated-measure design.
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).
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Depression
T1 (Baseline)
|
8.6 PHQ-9 depression score
Standard Error 0.9
|
|
Depression
T2 (Week 8)
|
3.9 PHQ-9 depression score
Standard Error 1.0
|
|
Depression
T3 (Week 12)
|
4.2 PHQ-9 depression score
Standard Error 1.1
|
SECONDARY outcome
Timeframe: T1 (Baseline), T2 (Week 8), and T3 (Week 12)Population: MSAS least square mean (standard error) for 31 evaluable participants was calculated at T1, T2, and T3 using Linear Mixed Model for repeated-measure design.
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).
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Overall Symptom Distress
T1 (Baseline)
|
0.8 MSAS score
Standard Error 0.1
|
|
Overall Symptom Distress
T2 (Week 8)
|
0.5 MSAS score
Standard Error 0.1
|
|
Overall Symptom Distress
T3 (Week 12)
|
0.5 MSAS score
Standard Error 0.1
|
SECONDARY outcome
Timeframe: T1 (Baseline), T2 (Week 8), and T3 (Week 12)Population: MCQ-30 least square mean (standard error) for 31 evaluable participants was calculated at T1 (Baseline), T2 (Week 8), and T3 (Week 12) using Linear Mixed Model for repeated-measure design.
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).
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Metacognitions
T1 (Baseline)
|
53.0 MCQ-30 score
Standard Error 2.0
|
|
Metacognitions
T2 (Week 8)
|
49.4 MCQ-30 score
Standard Error 2.2
|
|
Metacognitions
T3 (Week 12)
|
46.9 MCQ-30 score
Standard Error 2.2
|
SECONDARY outcome
Timeframe: T1 (Baseline), T2 (Week 8), and T3 (Week 12)Population: FFMQ-15 least square mean (standard error) for 31 evaluable participants was calculated at T1 (Baseline), T2 (Week 8), and T3 (Week 12) using Linear Mixed Model for repeated-measure design.
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).
Outcome measures
| Measure |
Evaluable Participants.
n=31 Participants
Thirty-one participants who completed the baseline questionnaire were considered evaluable for the intervention.
|
|---|---|
|
Mindfulness
T1 (Baseline)
|
43.9 FFMQ-15 score
Standard Error 1.2
|
|
Mindfulness
T2 (Week 8)
|
47.0 FFMQ-15 score
Standard Error 1.3
|
|
Mindfulness
T3 (Week 12)
|
47.9 FFMQ-15 score
Standard Error 1.3
|
Adverse Events
Enrolled Participants.
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enrolled Participants.
n=39 participants at risk
Adverse events for 39 enrolled participants were collected up to week 12.
|
|---|---|
|
Psychiatric disorders
Referred to psychiatry services
|
2.6%
1/39 • Up to week 12
Adverse events for enrolled participants will be collected up to week 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place