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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-07274 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24425 | Other Identifier | CITY OF Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| R21CA293326 | U.S. NIH Grant/Contract | View source |
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slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial tests feasibility, acceptability and how well a virtual mental health intervention, compared to enhanced usual care consisting of an educational intervention, works to address fear of progression for women with high risk or stage III-IV gynecologic or breast cancer. Worrying about cancer coming back or progression is natural for cancer patients. Many cancer patients face stress and uncertainty as they live longer and attend regular check-ups. A supportive program can help to develop skills to feel calmer and more resilient during uncertain times and better manage feelings of fear. The virtual mental health intervention may be a feasible, acceptable and effective may to address fear of progression for women with high risk or stage III-IV gynecologic or breast cancer.
PRIMARY OBJECTIVE:
I. To determine the feasibility and acceptability of a blended e-health intervention to manage fear of progression (FOP) in patients with stage III or IV gynecologic (GYN) or breast cancer.
SECONDARY 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 receive access to the Day by Day platform that includes patient partner videos, testimonials, handouts and a community forum. Patients may optionally utilize these resources for 6 weeks. Patients attend online group sessions, over 60 minutes, for every other week for 3 sessions and complete online educational sessions on values clarification, managing worry and unhelpful thoughts, and skills practices to promote healthy coping on alternate weeks for 3 sessions. Patients complete a check in call, for 15-20 minutes, at week 3-4. Patients are asked to practice the skills including attention training, mindfulness, worry postponement, guided imagery and other practices from the intervention for 10-12 minutes, at least 6 days per week for and track their practice on the Day to Day platform for 6 weeks. Patients may be loaned a tablet if needed for 6 weeks.
ARM II: Patients receive access to the Empower Hope platform. Patients attend online group sessions, over 60 minutes, for every other week for 3 sessions and complete online educational sessions on clinical trial participation, identifying reliable online information, healthy living on nutrition and activity/exercise and coping with fatigue on alternate weeks for 3 sessions. Patients complete a check in call, for 15-20 minutes, at week 3-4. Patients may be loaned a tablet if needed for 6 weeks.
After completion of study intervention, patients are followed up at 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Fear of progression intervention) | Experimental | Patients receive access to the Day by Day platform that includes patient partner videos, testimonials, handouts and a community forum. Patients may optionally utilize these resources for 6 weeks. Patients attend online group sessions, over 60 minutes, for every other week for 3 sessions and complete online educational sessions on values clarification, managing worry and unhelpful thoughts, and skills practices to promote healthy coping on alternate weeks for 3 sessions. Patients complete a check in call, for 15-20 minutes, at week 3-4. Patients are asked to practice the skills including attention training, mindfulness, worry postponement, guided imagery and other practices from the intervention for 10-12 minutes, at least 6 days per week for and track their practice on the Day to Day platform for 6 weeks. Patients may be loaned a tablet if needed for 6 weeks. |
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| Arm II (Educational intervention) | Active Comparator | Patients receive access to the Empower Hope platform. Patients attend online group sessions, over 60 minutes, for every other week for 3 sessions and complete online educational sessions on clinical trial participation, identifying reliable online information, healthy living on nutrition and activity/exercise and coping with fatigue on alternate weeks for 3 sessions. Patients complete a check in call, for 15-20 minutes, at week 3-4. Patients may be loaned a tablet if needed for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Attend online group sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Fear of cancer progression (FOP-SF) | FOP-SF consists of 12 items pertaining to 4 subscales: affective reactions; partnership/family; occupation; loss of autonomy. Scores range from 12-60; higher levels indicate greater FOP; a cut-off of 34 and above indicates dysfunctional FOP levels. The FOP-SF has been validated in a large sample of breast and mixed cancer patients (a=.87) patients who completed a rehabilitation program (a=.90). The correlation between the long and short form of the questionnaires is r=0.92. Validity has been demonstrated by correlation with HADS anxiety (r=.65 to .71), GAD anxiety (r=.57) and depression (r=.49). In a descriptive FOP study in 135 English-speaking cancer survivors, the FOP-SF showed high internal consistency (a=0.88) and was correlated with similar constructs: Intrusions (r=.72), metacognitive beliefs (r=0.62); death anxiety (r=0.67) (Curran et al., 2020). | Baseline, 6 weeks, up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-related distress - Impact of Event Scale-R (IES-R) | The IES-R measures cancer-related distress. It consists of 22-likert-scale items representing 3 subscales: Intrusion; Avoidance; and Hyperarousal. Items are scored on a 0-4 response format. Total scores range from 0-88. A score of 24 or greater indicates clinical levels of distress. It demonstrates good internal consistency; a=.79-.92. The IES has been used in several studies with cancer patients. It has been found to be sensitive to change in these interventions (Butow et al. 2017). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Reb | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope at Arcadia | Arcadia | California | 91007 | United States | ||
| City of Hope Medical Center |
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Following completion of baseline questionnaires and the intake call, the clinical research assistant will be informed of the group assignment. The study team is blinded to assignment until this point. The study participants will be blinded to group assignment (single-blind).
| Behavioral Intervention | Behavioral | Complete online educational sessions |
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| Behavioral Intervention | Behavioral | Complete check in call |
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| Behavioral Intervention | Behavioral | Complete daily skills practice |
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| Educational Intervention | Other | Receive access to patient partner videos, testimonials, handouts and a community forum |
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| Educational Intervention | Other | Attend online group sessions |
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| Educational Intervention | Other | Complete online education sessions |
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| Internet-Based Intervention | Other | Receive access to Day to Day platform |
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| Internet-Based Intervention | Other | Receive access to the Empower Hope platform |
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| Interview | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Virtual Technology Intervention | Other | Receive a tablet |
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| Baseline, 6 weeks, Up to 12 weeks |
| Anxiety - PROMIS - Anxiety 8-a | This measures fear, worry, hyperarousal, and related somatic symptoms (Cella et al., 2010). It consists of 8 items scored on a 0-5 response format. Scores are standardized to continuous T scores with a mean of 50 and SD of 10; higher scores reflect higher distress. PROMIS T score thresholds for anxiety are less than 55 normal; 55-64 mild; 65-74 moderate; greater than or equal to 75 severe. Validity was established in a large sample of patients with chronic illnesses, including cancer. Construct validity was demonstrated using the anxiety scale from the MASQ as the convergent measure (r=.80) and the CES-D as the divergent measure (r=.75). | Baseline, 6 weeks, Up to 12 weeks |
| Metacognitive Beliefs - Metacognitions questionnaire (MCQ-18) | The MCQ assesses different beliefs about worry. We will use 18 items from three subscales of the parent MCQ-30 questionnaire a) positive beliefs about worry; b) negative beliefs about worry; and c) need to control thoughts. Items are scored on a 1-4 Likert scale. Subscale scores range from 6-24. Higher scores indicate more dysfunctional metacognitions. Internal consistency was a=.93 for the total score and ranged from .72-.93 for the subscale scores. It has been validated in cancer patients showing good convergent validit7 (Cook et al., 2014). Internal consistency of the subscales ranged from .73-.89 (pre-treatment) and .79-.91 (post-treatment). | Baseline, 6 weeks, Up to 12 weeks |
| Mindfulness - Five Facet Mindfulness Questionnaire (FFMQ-15) | FFMQ-15 assesses 5 facets of mindfulness: Observing, Describing, Acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Items are rated on a 5-point Likert scale ranging from 1-5 scale (never/ rarely to very often). Three items comprise each subscale. Subscale scores range from 3-15. Higher scores indicate greater mindfulness skills engagement. The measure is sensitive to change over the course of mindfulness-based cognitive therapy (Chambers et al., 2017). For scoring, the Observing subscale score is excluded based on psychometric testing data from previous research. The total FFMQ score is calculated by summing the 4 subscale scores. For the subscales, internal consistency is adequate (a=.66-.83) (Baer et al., 2006). The FFMQ has been used in studies of advanced cancer patients. | Baseline, 6 weeks, Up to 12 weeks |
| Duarte |
| California |
| 91010 |
| United States |
| City of Hope at Irvine Lennar | Irvine | California | 92618 | United States |
| City of Hope Antelope Valley | Lancaster | California | 93534 | United States |
| City of Hope at Long Beach Worsham | Long Beach | California | 90808 | United States |
| City of Hope at Long Beach Elm | Long Beach | California | 90813 | United States |
| City of Hope Mission Hills | Mission Hills | California | 91345 | United States |
| City of Hope - Santa Clarita | Santa Clarita | California | 91355 | United States |
| City of Hope at Simi Valley | Simi Valley | California | 93065 | United States |
| City of Hope at Thousand Oaks | Thousand Oaks | California | 91361 | United States |
| City of Hope South Bay | Torrance | California | 90503 | United States |
| City of Hope Upland | Upland | California | 91786 | United States |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D010051 | Ovarian Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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