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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Attend online group sessions
Complete online educational sessions
Complete check in call
Complete daily skills practice
Receive access to patient partner videos, testimonials, handouts and a community forum
Attend online group sessions
Complete online education sessions
Receive access to Day to Day platform
Receive access to the Empower Hope platform
Ancillary studies
Ancillary studies
Receive a tablet
City of Hope at Arcadia
Arcadia, California, United States
City of Hope Medical Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
City of Hope at Long Beach Worsham
Long Beach, California, United States
City of Hope at Long Beach Elm
Long Beach, California, United States
City of Hope Mission Hills
Mission Hills, California, United States
City of Hope - Santa Clarita
Santa Clarita, California, United States
City of Hope at Simi Valley
Simi Valley, California, United States
City of Hope at Thousand Oaks
Thousand Oaks, California, United States
...and 2 more locations
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).
Time frame: Baseline, 6 weeks, up to 12 weeks
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 6 weeks, Up to 12 weeks
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