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

ConditionsAnatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Breast CarcinomaBreast Mixed Epithelial/Mesenchymal Metaplastic CarcinomaEndometrial CarcinomaMalignant Female Reproductive System NeoplasmOvarian CarcinomaOvarian CarcinosarcomaStage III Cervical Cancer AJCC v8Stage III Vaginal Cancer AJCC v8Stage III Vulvar Cancer AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Vaginal Cancer AJCC v8Stage IV Vulvar Cancer AJCC v8Triple-Negative Breast CarcinomaUterine Corpus Carcinosarcoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Participate in Navigating Cancer Program

  • Interview

    Other intervention

    Ancillary studies

  • Supportive Care

    Other intervention

    Participate in Mindful Living Program

  • Supportive Care

    Other intervention

    Complete skills practice

  • Supportive Care

    Other intervention

    Receive access to videos and website

  • Survey Administration

    Other intervention

    Ancillary studies

  • Telephone-Based Intervention

    Behavioral

    Receive check-in call

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Arm I (Mindful Living Program)Experimental treatment 4 interventions
Group B: Arm II (Navigating Cancer Program)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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)

Secondary outcomes

1

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).
2

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).
3

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).
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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