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

N/ARecruitingNCT07741968

City of Hope Medical Center126 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Interventions

Best PracticeOTHER

Participate in Navigating Cancer Program

InterviewOTHER

Ancillary studies

Supportive CareOTHER

Participate in Mindful Living Program

Supportive CareOTHER

Complete skills practice

Supportive CareOTHER

Receive access to videos and website

Survey AdministrationOTHER

Ancillary studies

Telephone-Based InterventionBEHAVIORAL

Receive check-in call

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

City of Hope at Arcadia

Arcadia, California, United States

RECRUITING

City of Hope Medical Center

Duarte, California, United States

RECRUITING

City of Hope at Seacliff

Huntington Beach, California, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, United States

RECRUITING

City of Hope Antelope Valley

Lancaster, California, United States

RECRUITING

City of Hope at Long Beach Elm

Long Beach, California, United States

RECRUITING

City of Hope at Santa Clarita

Santa Clarita, California, United States

RECRUITING

City of Hope at Simi Valley

Simi Valley, California, United States

RECRUITING

City of Hope at South Pasadena

South Pasadena, California, United States

RECRUITING

City of Hope at Upland

Upland, California, United States

RECRUITING

...and 1 more locations

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

Change in cancer-specific distress

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.

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

Change in Anxiety (PROMIS Anxiety 8a):

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.

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

Change in metacognitions

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

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

Change in mindfulness

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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (11)

Outcomes

Primary Outcomes

Secondary Outcomes