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, Breast Mixed Epithelial/Mesenchymal Metaplastic Carcinoma, Endometrial Carcinoma, Malignant Female Reproductive System Neoplasm, Ovarian Carcinoma, Ovarian Carcinosarcoma, 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 Carcinoma, Uterine Corpus Carcinosarcoma
Conditions
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.
Detailed description
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.
Interventions
OTHERBest Practice
Participate in Navigating Cancer Program
OTHERInterview
Ancillary studies
OTHERSupportive Care
Participate in Mindful Living Program
OTHERSurvey Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Receive check-in call
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate (Feasibility of enrollment) | 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. |
| Attrition rate (Intervention feasibility) | 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. |
| Percentage of Attendance/Sessions Completed | 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. |
| System Usability Scale survey (Acceptability) | 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. |
| Engagement measures | 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. |
| Themes From Open-Ended System Usability Scale Responses and Open-Ended Exit Interview Questions | 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. |
| Change in fear of progression | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in cancer-specific distress | 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. |
| Change in Anxiety (PROMIS Anxiety 8a): | 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. |
| Change in metacognitions | 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 |
| Change in mindfulness | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnne Reb
City of Hope Medical Center
Outcome results
None listed