Breast Cancer
Conditions
Keywords
Psychosocial Care, Wellness
Brief summary
Researchers are trying to see if proactive identification and team based individualized care of cancer patients having emotional difficulties can improve quality of life relative to treatment as usual. Also, to see if proactive approaches to maintain wellness can prevent grief among breast cancer patients, experiencing no emotional difficulties relative to treatment as usual.
Detailed description
Consented subjects will be randomized into two separate groups. Groups will be distressed and non-distressed subjects. Each group will be randomized into either intervention education training or standard of care. Both groups will be asked to fill out questionnaires during the duration of the study. Subjects will be remain in the study for up to one year.
Interventions
BEHAVIORALStandard of Care Distressed in study Arm Distressed
Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.
BEHAVIORALPsycho-Education
Mindfulness based stress reduction class, yoga and education material
BEHAVIORALTeam Based Care
Psychiatrist, Oncologist, clinical social worker, study coordinator
BEHAVIORALStandard of Care Non-Distressed
No psycho-education about wellness promotion or health. These patients will be monitored only.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Non-Distressed patients will be randomized to receive intervention or standard of care. Distressed patients will be randomized to receive intervention or standard of care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of breast cancer within last three years * Able to communicate in English or with the help of an interpreter. * Access to a device with internet connection
Exclusion criteria
* Breast cancer patients who are considered for hospice or expected survival of less than six months. * Presence of active suicidal ideations. * Presence of active psychosis. * Presence of dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wellness | baseline, 6 months | Subject wellness scores based on Short Warwick-Edinburgh Mental-Wellbeing Scale. This is a 7 item scale monitoring of mental wellbeing in subjects. Responses are based on a 1 to 5 item scale with 1 = None of the time, 2 = Rarely, 3 = Some of the Time, 4 = Often, 5 = All of the Time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in depression compared to baseline | one year | measured by using PHQ-8 (Patient Health Questionnaire); this is an 8 item scale. Scores of 5 or less are considered no depression, 5-10, mild depression, 11-15, moderate depression, 16-20 moderately severe and more than 20 is considered severe depression. |
| Improvement in anxiety compared to baseline | One Year | Will be measured by GAD-7 (Generalized Anxiety Disorder 7-item Scale). Its a 7 item scale. Cut points of 5, 10, 15 represent mild, moderate and severe levels of anxiety. |
Countries
United States
Outcome results
None listed