Advanced Lung CarcinomaNCT04819997
A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
A study testing Educational Intervention in people with Advanced Lung Carcinoma and Metastatic Malignant Female Reproductive System Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This clinical trial focuses on a nurse-led program that is designed to help patients cope with worries, fears, and uncertainty about the future. The purpose of this study is to understand if the program is helpful and practical to carry out at medical centers and community clinics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Lung Carcinoma, Metastatic Malignant Female Reproductive System Neoplasm, Stage III Lung Cancer AJCC v8
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 stage III or IV gynecologic (GYN) or lung cancer
- At least 3 months from initial diagnosis
- Score >= 34 on the Fear of Progression-short form (SF) questionnaire
Who cannot join
- Severe mental illness (e.g. psychosis)
- Hospice enrolled
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
This clinical trial focuses on a nurse-led program that is designed to help patients cope with worries, fears, and uncertainty about the future. The purpose of this study is to understand if the program is helpful and practical to carry out at medical centers and community clinics. This study may help patients learn more effective ways to cope and respond to your concerns and any unhelpful thoughts.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility and acceptability of the revised day by day (DBD) intervention in an academic and community settings.
II. To assess the preliminary effects of the revised DBD intervention for reducing fear of progression (FOP) and improving distress, anxiety, depression, metacognitions (beliefs about worry), and mindfulness.
OUTLINE:
Patients participate in 5 videoconference sessions over 30 minutes each over 6 weeks focused on worry management skills, values-based goal setting, and brief mindfulness-based practices, then complete patient workbook activities after each session over 15-20 minutes per day. Patients also complete a survey over 8 minutes at 6 weeks, an exit interview at 7 weeks, and questionnaires over 25 minutes each at baseline, 6 weeks, and 10 weeks.
- Conditions
- Advanced Lung Carcinoma, Metastatic 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
- Educational Intervention
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention
Participate in videoconference session
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (videoconference, questionnaire, survey) | Experimental | Patients participate in 5 videoconference sessions over 30 minutes each over 6 weeks focused on worry management skills, values-based goal setting, and brief mindfulness-based practices, then complete patient workbook activities after each session over 15-20 minutes per day. Patients also complete a survey over 8 minutes at 6 weeks, an exit interview at 7 weeks, and questionnaires over 25 minutes each at baseline, 6 weeks, and 10 weeks. Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Defined by enrollment rate. Enrollment rate will be calculated as number of enrolled divided by the number of eligible patients.
Measured: Up to 10 weeks
Feasibility of the intervention
Defined by attrition, attendance, and adherence with home practice activities. Attrition rate will be calculated as number of patients who drop out patients divided by number of enrolled patients. Adherence will be assessed based on the completion rate of home practice activities.
Measured: Up to 10 weeks
Acceptability
Will be assessed based on 1) responses to open-ended questions on the exit interview response asking about participants' experience with the intervention and delivery platforms; and 2) a self-report evaluation survey rating usefulness of the session content, home practice activities, testimonials, and delivery platforms. Survey items are rated on a 1-5 Likert scale. An average score of 3 or above will indicate good acceptability.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start15 Mar 2021
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anne Reb, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819997
- Sponsor's protocol ID
- 20594
- Other IDs
- NCI-2021-01138, 20594, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
- ClinicalTrials.gov ID
- NCT04819997
- Acronym / sponsor ID
- 20594
- Conditions
- Advanced Lung Carcinoma, Metastatic 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial focuses on a nurse-led program that is designed to help patients cope with worries, fears, and uncertainty about the future. The purpose of this study is to understand if the program is helpful and practical to carry out at medical centers and community clinics. This study may help patients learn more effective ways to cope and respond to your concerns and any unhelpful thoughts.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility and acceptability of the revised day by day (DBD) intervention in an academic and community settings.
II. To assess the preliminary effects of the revised DBD intervention for reducing fear of progression (FOP) and improving distress, anxiety, depression, metacognitions (beliefs about worry), and mindfulness.
OUTLINE:
Patients participate in 5 videoconference sessions over 30 minutes each over 6 weeks focused on worry management skills, values-based goal setting, and brief mindfulness-based practices, then complete patient workbook activities after each session over 15-20 minutes per day. Patients also complete a survey over 8 minutes at 6 weeks, an exit interview at 7 weeks, and questionnaires over 25 minutes each at baseline, 6 weeks, and 10 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (videoconference, questionnaire, survey) | Experimental | Other: Educational InterventionPatients participate in 5 videoconference sessions over 30 minutes each over 6 weeks focused on worry management skills, values-based goal setting, and brief mindfulness-based practices, then complete patient workbook activities after each session over 15-20 minutes per day. Patients also complete a survey over 8 minutes at 6 weeks, an exit interview at 7 weeks, and questionnaires over 25 minutes each at baseline, 6 weeks, and 10 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stage III or IV gynecologic (GYN) or lung cancer
- At least 3 months from initial diagnosis
- Score >= 34 on the Fear of Progression-short form (SF) questionnaire
Key exclusion criteria (3 listed)
- Severe mental illness (e.g. psychosis)
- Hospice enrolled
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for InterventionParticipate in videoconference session | Other | Supportive care (videoconference, questionnaire, survey) |
Primary outcome
Feasibility of recruitment
Time frame: Up to 10 weeks
Defined by enrollment rate. Enrollment rate will be calculated as number of enrolled divided by the number of eligible patients.
Feasibility of the intervention
Time frame: Up to 10 weeks
Defined by attrition, attendance, and adherence with home practice activities. Attrition rate will be calculated as number of patients who drop out patients divided by number of enrolled patients. Adherence will be assessed based on the completion rate of home practice activities.
Acceptability
Time frame: Up to 10 weeks
Will be assessed based on 1) responses to open-ended questions on the exit interview response asking about participants' experience with the intervention and delivery platforms; and 2) a self-report evaluation survey rating usefulness of the session content, home practice activities, testimonials, and delivery platforms. Survey items are rated on a 1-5 Likert scale. An average score of 3 or above will indicate good acceptability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Reb principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Advanced Lung Carcinoma and Metastatic Malignant Female Reproductive System Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Up to 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.