Cancer, Stress
Conditions
Brief summary
The goal of this project is to examine initial effectiveness of a brief (2 preoperative, 2 postoperative session) cognitive behaviorally-based telephone intervention compared to standard care on postoperative outcomes for patients who are scheduled to undergo a cancer-related surgery in 12 or more days and screen positive for distress (4 or higher on 0-10 Distress Thermometer). The intervention focuses on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care. Participants will be randomly assigned to receive the intervention or to receive standard care. Outcomes assessed 4 and 6 weeks post-operatively will include: Depression (Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7), health-related QOL (SF-36 MCS and PCS), number and type of complications, length of stay, and 30-day readmission.
Interventions
BEHAVIORALBehavioral Intervention for Wellness and Engaged Living (Be-WEL)
Behavioral Intervention for Wellness and Engaged Living (Be-WEL) is a 4-session (2 preoperative, 2 postoperative) telephone intervention focused on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial (intervention vs. standard care)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ADULT (18 years of age or older) * SCHEDULED FOR SURGERY FOR CANCER (excluding non-melanoma skin cancer) 12 OR MORE DAYS IN ADVANCE OF CONSENT * SIGNIFICANTLY DISTRESSED (\>4 on the 0-10 Distress Thermometer) * ABLE TO SPEAK ENGLISH
Exclusion criteria
* COGNITIVE IMPAIRMENT : \<4 on baseline Mini Cog measure * SERIOUS MENTAL ILLNESS: a diagnosis of a bipolar or psychotic disorder (noted in medical record) * NON-ENGLISH SPEAKING: This study only involves participants who can speak English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-8 | 4-weeks post-operation (+/-1 week) | PHQ-8 assesses depression symptoms; A total score (range: 0-24) will be used with higher scores representing more depressive symptoms. |
| Generalized Anxiety Disorder-7 | 4-weeks post-operation (+/-1 week) | The GAD-7 measures anxiety symptoms; A total score (range: 0-21) will be used with higher scores representing more anxiety symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Complications | 30 days post-operation | Occurrence of: perioperative mortality, cardiac complications, postoperative pneumonia, intubation for \>48-hours postoperatively unplanned reintubation, venous thromboembolic events, renal dysfunction, or surgical-site infections |
| Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS) | 4-weeks post-operation (+/-1 week) | The SF-36 PCS assesses physical health-related quality of life (QOL) on a 0-100 scale (with a mean of 50 and standard deviation of 10 for general population). Higher scores represent higher physical health-related QOL. |
| Hospital Readmission | 30 days post-operation | Number of times readmitted to a hospital after operation |
| Length of post-operative hospital stay | 30 days post-operation | Number of days inpatient hospital stay after operation |
| Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS) | 4-weeks post-operation (+/-1 week) | The SF-36 MCS assesses mental health-related quality of life (QOL) on a 0-100 scale (with a mean of 50 and standard deviation of 10 for general population). Higher scores represent higher mental health-related QOL. |
Countries
United States
Outcome results
None listed