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Behavioral Intervention
Behavioral Intervention for Wellness and Engaged Living (Be-WEL) for Cancer
N/A
Recruiting
Led By Chelsea G Ratcliff, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-weeks post-operation (+/-1 week)
Awards & highlights
Study Summary
This trial is examining whether a brief cognitive behaviorally-based telephone intervention can improve postoperative outcomes for cancer patients compared to standard care. The intervention focuses on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care.
Who is the study for?
This trial is for English-speaking adults (18+) who are scheduled for cancer surgery in at least 12 days and are feeling significantly distressed, scoring more than 4 on a distress scale. It's not open to those with cognitive impairment, serious mental illnesses like bipolar or psychotic disorders, or non-English speakers.Check my eligibility
What is being tested?
The study tests a brief telephone intervention called Be-WEL against standard care. The program includes preoperative and postoperative sessions focusing on relaxation, activity increase, and adherence to medication/wound care. Outcomes like depression, anxiety, quality of life, complications, hospital stay length, and readmission rates will be measured.See study design
What are the potential side effects?
Since the intervention is behavioral with no medications involved directly from the trial itself—focusing on emotional support and lifestyle changes—the side effects may include discomfort from discussing personal issues but typically do not involve physical drug-related side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-weeks post-operation (+/-1 week)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-weeks post-operation (+/-1 week)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Generalized Anxiety Disorder-7
Patient Health Questionnaire-8
Secondary outcome measures
Hospital Readmission
Length of post-operative hospital stay
Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Be-WEL InterventionExperimental Treatment1 Intervention
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.
Group II: Standard CareActive Control1 Intervention
Standard Care consists of the standard care patients typically receive from their medical team.
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,172 Total Patients Enrolled
Chelsea G Ratcliff, PhDPrincipal InvestigatorBaylor College of Medicine/Sam Houston State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You feel very upset or distressed and scored above 4 on a scale of 0 to 10.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Care
- Group 2: Be-WEL Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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