A Nurse-Led Intervention for Fear of Progression in Advanced Cancer

NCT04819997 | Active Not Recruiting DMC

• 3 other identifiers: 20594NCI-2021-01138P30CA033572
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. This study may help patients learn more effective ways to cope and respond to your concerns and any unhelpful thoughts.

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; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (3)

• Feasibility of recruitment

  Defined by enrollment rate. Enrollment rate will be calculated as number of enrolled divided by the number of eligible patients.

  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.

  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.

  Up to 10 weeks

Other Outcomes (6)

• Fear of progression (FOP)

  Up to 10 weeks

• Cancer-specific distress

  Up to 10 weeks

• Anxiety

  Up to 10 weeks

Study Arms (1)

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.

Other: Educational Intervention

Interventions

Educational Intervention OTHER

Participate in videoconference session

Also known as: Education for Intervention

Supportive care (videoconference, questionnaire, survey)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe mental illness (e.g. psychosis)
• Hospice enrolled
• Non-English speaking

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Anne Reb

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 29, 2021
• Study Start: March 8, 2021
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)