Breast Cancer, Mental Health Issue
Conditions
Keywords
Depression, Anxiety, Well-Being
Brief summary
Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused on reducing symptoms of mental disorders. This is problematic given the range of psychosocial needs among breast cancer survivors, including those who may not have active mental health symptoms, yet could benefit from learning effective coping skills. Moreover, all of these interventions follow a "one size fits all" approach, lacking precision in terms of when, where, and to whom they should be given. The overarching goals of this project are to develop and pilot a variety of digital micro-interventions (DMIs) for breast cancer survivors - highly focused, technology-enabled interventions that can be delivered in the context of a person's daily life with little burden on the individual.
Interventions
BEHAVIORALDigital Micro-Interventions
Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement.
Sponsors
University of Virginia
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot study to test early stage digital micro-interventions (n=20 per micro-intervention)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age = 18 years. * 0-5 years post-diagnosis of Stage I, II, or III female breast cancer. * Elevated symptoms of depression and/or anxiety as measured by the PHQ-8 (score \> 9) or GAD-7 (score \> 7).
Exclusion criteria
* Receiving individual (1 on 1) treatment for depression and/or anxiety to avoid treatment interference (note, individuals will be permitted to enroll if they are taking antidepressant medication and have not had an appointment to adjust the dosage over the past 2 weeks) * Active suicidal ideation during the enrollment/screening call based on a trained staff member orally administering the suicidality item from the PHQ-9 to individuals on the phone ("In the last 2 weeks, have you had thoughts that you would be better off dead, or thoughts of hurting yourself in some way?"). If an individual responds in any way other than "not at all" based on the available response options (i.e., either "several days", "more than half the days", or "nearly every day"), or if they mention having suicidal ideation or thoughts of death during the enrollment/screening call, the Pitt-Optimum risk assessment tool will be administered. Only participants deemed low risk may proceed in enrollment; all will be given additional resources. * Do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later). * Cannot read and speak English (interventions only available in English).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Digital Micro-Intervention | Post 1 week | 12 item scale measuring satisfaction and acceptability. Each question is scored on a 0-4 scale with a total raw summed score range of 0-48. Higher scores indicate greater satisfaction and acceptability. Note, this measure could only be administered at post because it requires that participants used the intervention they were assigned, which was provided after they completed the baseline questionnaire battery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-29 Profile | Baseline | 24 items that measure various physical and mental health subdomains. Each question is scored on a 1-5 scale. The total raw score for Mental Health is composed of the 2 subdomains of Anxiety and Depression range from 8-40, where higher scores indicate worse overall mental health. The total raw score for Physical Health is composed of the 4 subdomains of Physical Function, Fatigue, Sleep Disturbance, and Ability to Participate in Social Activities, range from 16-80, where higher scores indicate worse overall physical health. The 4-item Pain Interference subscale and an item that assesses pain from 1-10 were omitted from the original PROMIS-29 Profile to limit redundancy with another pain measure. |
| Pain, Enjoyment of Life and General Activity (PEG) Scale | Baseline | Assesses chronic pain based on 3 items, each one ranging from 0-10. Scores range from 0-30, with higher scores indicating more pain severity and interference. |
| Emotion Regulation Questionnaire | Baseline | A 10 item scale to reassess for two emotion regulation strategies: cognitive reappraisal and expressive suppression. Participants rate each item on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Scores for each subscale range from 1-7 (after dividing by the number of items), with higher scores indicating a greater tendency to use that particular emotion regulation strategy. |
| Insomnia Severity Index | Baseline | A 7-item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms. |
| Patient Health Questionnaire-8 | Baseline | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. |
| Generalized Anxiety Disorder-7 | Baseline | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. |
Countries
United States
Participant flow
Pre-assignment details
No significant events occurred between the enrollment and assignment of participants.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 75 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 18 | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 19 | 0 / 20 |
Outcome results
None listed