A Distress Screening and Intervention in Cancer Surgery

NCT ID: NCT03979794

Last Updated: 2024-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-17

Study Completion Date

2024-11-12

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial (intervention vs. standard care)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Be-WEL 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 Type EXPERIMENTAL

Behavioral Intervention for Wellness and Engaged Living (Be-WEL)

Intervention Type BEHAVIORAL

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.

Standard Care

Standard Care consists of the standard care patients typically receive from their medical team.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavioral 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Chelsea Ratcliff

Adjunct Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chelsea G Ratcliff, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine/Sam Houston State University

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-40276

Identifier Type: -

Identifier Source: org_study_id

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