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NCT Number: NCT07741968

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

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.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Adnexal Diseases Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Breast Carcinoma Breast Diseases Breast Mixed Epithelial/Mesenchymal Metaplastic Carcinoma Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Malignant Female Reproductive System Neoplasm Neoplasms Neoplasms by Site Ovarian Carcinoma Ovarian Carcinosarcoma Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stage III Cervical Cancer AJCC v8 Stage III Vaginal Cancer AJCC v8 Stage III Vulvar Cancer AJCC v8 Stage IV Cervical Cancer AJCC v8 Stage IV Vaginal Cancer AJCC v8 Stage IV Vulvar Cancer AJCC v8 Triple Negative Breast Neoplasms Triple-Negative Breast Carcinoma Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Corpus Carcinosarcoma Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center, Duarte, California, United States

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About this study

PRIMARY OBJECTIVE:

I. To determine the feasibility and acceptability of a blended e-health intervention to manage FOP in patients with stage III or IV gynecologic (GYN) or breast cancer.

SECONDARY (EXPLORATORY) OBJECTIVE:

I. To determine the effects of the intervention on reducing fear of cancer progression (FOP) (primary outcome) and improving secondary outcomes of distress, anxiety, metacognitions, and mindfulness.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: 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.

After completion of study intervention, patients are followed up at week 12.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Best Practice

Other

Participate in Navigating Cancer Program

Other names: standard of care, standard therapy

interview

Other

Ancillary studies

Supportive Care

Other

Participate in Mindful Living Program

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Survey Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Receive check-in call

Primary outcomes

  1. Recruitment rate (Feasibility of enrollment)

    Time frame: Up to 18 months

    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.

  2. Attrition rate (Intervention feasibility)

    Time frame: Up to 6 weeks

    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.

  3. Percentage of Attendance/Sessions Completed

    Time frame: Up to 6 weeks

    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.

  4. System Usability Scale survey (Acceptability)

    Time frame: At week 6 (T2)

    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.

  5. Engagement measures

    Time frame: Up to 6 weeks

    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.

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

    Time frame: Up to 14 months

    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.

  7. Change in fear of progression

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

    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.

Secondary outcomes

  1. Change in cancer-specific distress

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

    Measured using a cancer-specific distress instrument. Total scores range from 0 to 88, with higher scores indicating greater cancer-related distress. Change from baseline will be assessed.

  2. Change in Anxiety (PROMIS Anxiety 8a):

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

    Measured using the PROMIS Anxiety 8a scale. Scores range from 37.1 to 83.1, with higher scores indicating greater anxiety. Change from baseline will be assessed.

  3. Change in metacognitions

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

    Measured using the Metacognitions Questionnaire. Subscale scores range from 6 to 24, with higher scores indicating more dysfunctional beliefs about worry and metacognitive processes. Change from baseline will be assessed

  4. Change in mindfulness

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

    Measured using the Five Facet Mindfulness Questionnaire (FFMQ). Total scores range from 12 to 60, with higher scores indicating greater engagement with mindfulness skills and mindful awareness. Change from baseline will be assessed.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

An e-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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