A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer

NCT07741968 | Not Yet Recruiting DMC

• 4 other identifiers: 260057NCI-2026-04005P30CA033572R21CA293326
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial studies whether an intervention supported by technology (blended e-health intervention) works to improve fear of progression (FOP) in women with gynecologic or breast cancer. FOP is the fear patients experience from the possibility that their cancer could grow, spread, or get worse. Managing FOP is a leading unmet concern of cancer patients. High levels of FOP are associated with distress, depression, and increased health care costs, despite this, access to resources to address FOP remain limited. The blended e-health intervention in this trial offers remote group sessions along with online sessions to help patients access the information. Session content incorporates values-based goal setting and skills practices to manage unhelpful beliefs about worry and promote helpful coping behaviors. The sessions may help patients recognize unhelpful thoughts and behaviors which reinforce worry. A blended e-health intervention may be an effective way to improve FOP in women with gynecologic or breast cancer.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Breast Carcinoma; Endometrial Carcinoma; Ovarian Carcinoma; Ovarian Carcinosarcoma; Stage III Vaginal Cancer AJCC v8; Stage IV Cervical Cancer AJCC v8; Triple-Negative Breast Carcinoma; Uterine Corpus Carcinosarcoma; Malignant Female Reproductive System Neoplasm; Stage III Cervical Cancer AJCC v8; Stage III Vulvar Cancer AJCC v8; Stage IV Vaginal Cancer AJCC v8; Stage IV Vulvar Cancer AJCC v8; Breast Mixed Epithelial/Mesenchymal Metaplastic Carcinoma

Outcome Measures

Primary Outcomes (7)

• Recruitment rate (Feasibility of enrollment)

  Recruitment rate will be sufficient if at least 45% of invited patients complete the screening questionnaire and are enrolled. Descriptive statistics will be used to analyze feasibility measures.

  Up to 18 months

• Attrition rate (Intervention feasibility)

  Attrition will be acceptable if the percentage of enrolled subjects who drop out does not exceed 30% by week 6. Descriptive statistics will be used to analyze feasibility measures.

  Up to 6 weeks

• Percentage of Attendance/Sessions Completed

  Percentage of Attendance: Defined as the proportion of enrolled participants who attend the intervention sessions according to the study protocol. Feasibility will be evaluated based on participant attendance and will be considered successful if predefined feasibility criteria are met. Sessions Completed: Defined as the average number of intervention sessions completed by participants during the study period. This measure will be used to assess participant engagement with the intervention. Feasibility will be considered successful if predefined feasibility criteria are met.

  Up to 6 weeks

• System Usability Scale survey (Acceptability)

  The System Usability Scale is a validated measure of system usability with scores ranging from 0 to 100, where higher scores indicate greater perceived usability. The mean score will be calculated among participants who complete the assessment. Acceptability and usability will be considered successful if the mean score meets predefined study criteria.

  At week 6 (T2)

• Engagement measures

  Number of Log-ins: Defined as the average number of times participants log in to the study website during the study period. Page Views: Defined as the average number of website pages viewed by participants during the study period. Total Time on Site: Defined as the average total time participants spend on the study website during the study period. Skills Video Access: Defined as the average number of times participants access skills practice videos during the study period. Time Spent Viewing Skills Videos: Defined as the average total time participants spend viewing skills practice videos during the study period. Most Frequently Visited Content: Defined as the website content or pages accessed most frequently by participants during the study period, measured by access frequency.

  Up to 6 weeks

• Themes From Open-Ended System Usability Scale Responses and Open-Ended Exit Interview Questions

  Defined as themes identified from participants' responses to open-ended System Usability Scale questions. Qualitative data will be analyzed using conventional content analysis to identify common perceptions, experiences, and suggestions regarding website usability. Defined as themes identified from participants' responses to open-ended exit interview questions. Qualitative data will be analyzed using conventional content analysis to identify participants' experiences, perceived benefits, barriers to engagement, and recommendations for improvement.

  Up to 14 months

• Change in fear of progression

  Measured using the Fear of Progression Questionnaire. Total scores range from 12 to 60, with higher scores indicating greater fear of cancer progression. Change from baseline will be assessed.

  At baseline (T1), 6 weeks (T2), and 12 weeks (T3)

Secondary Outcomes (4)

• Change in cancer-specific distress

  At baseline (T1), 6 weeks (T2) and 12 weeks (T3).

• Change in Anxiety (PROMIS Anxiety 8a):

  At Baseline (T1), 6 weeks (T2) and 12 weeks (T3).

• Change in metacognitions

  At Baseline (T1), 6 weeks (T2) and 12 weeks (T3).

• Change in mindfulness

  At Baseline T1, 6 weeks (T2) and 12 weeks (T3)

Study Arms (2)

Arm I (Mindful Living Program)

EXPERIMENTAL

Patients participate in the Mindful Living Program over 6 weeks consisting of group sessions over 60 minutes each during weeks 1, 3, and 6 and online sessions during weeks 2, 4, and 5. Patients also practice skills related to attention training, detached mindfulness, worry postponement, guided imagery, and other mindfulness practices 10-12 minutes daily for 6 days a week. Additionally, patients receive a check-in call over 15-20 minutes at week 3-4 and access to videos as well as a website containing a journal, community forum, and resource library on study.

Other: Interview; Other: Supportive Care; Other: Survey Administration; Behavioral: Telephone-Based Intervention

Arm II (Navigating Cancer Program)

ACTIVE COMPARATOR

Patients participate in the Navigating Cancer Program over 6 weeks consisting of group sessions over 60 minutes each during weeks 1, 3, and 6 and online sessions during weeks 2, 4, and 5. Patients also receive a check-in call over 15-20 minutes at week 3-4.

Other: Best Practice; Other: Interview; Other: Survey Administration; Behavioral: Telephone-Based Intervention

Interventions

Best Practice OTHER

Participate in Navigating Cancer Program

Also known as: standard of care, standard therapy

Arm II (Navigating Cancer Program)

Interview OTHER

Ancillary studies

Arm I (Mindful Living Program); Arm II (Navigating Cancer Program)

Supportive Care OTHER

Participate in Mindful Living Program

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Arm I (Mindful Living Program)

Survey Administration OTHER

Ancillary studies

Arm I (Mindful Living Program); Arm II (Navigating Cancer Program)

Telephone-Based Intervention BEHAVIORAL

Receive check-in call

Arm I (Mindful Living Program); Arm II (Navigating Cancer Program)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with stage III or IV GYN (ovarian, endometrial, cervical, vulvar/vaginal) or breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with stage III or IV GYN (ovarian, endometrial, cervical, vulvar/vaginal) or breast cancer who are at least 2 months from initial diagnosis OR Women with stage I or II endometrial, ovarian, or breast cancer with carcinosarcoma histology OR Women with stage I or II triple negative breast cancer
• Score ≥ 34 on the Fear of Progression Short-Form, indicating dysfunctional levels
• Age 18 or older; able to read and understand English
• Patients can be on active treatment or surveillance. They can be no evidence of disease (NED), recurrent or with progressive disease

You may not qualify if:

• Enrolled in hospice
• Ongoing uncontrolled active psychiatric condition that, in the opinion of the investigator, would interfere in the conduct of the study (e.g., mood disorders, psychosis disorders, or substance use), Major depression as assessed by Patient Health Questionnaire-9 (PHQ-9)
• Non-English speaking
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
• Current participation in a mind-body or mindfulness education program within the past six weeks

Sponsors & Collaborators

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

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms; Triple Negative Breast Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Interviews as Topic; Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Cervical Diseases; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anne Reb

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The statistician will generate a password-protected randomization list to ensure blinding. The study team is blinded to assignment until this point. The study participants will be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): February 22, 2027
• Primary Completion (Estimated): January 16, 2028
• Study Completion (Estimated): January 16, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

US (2)