CancerNCT03979794
A Distress Screening and Intervention in Cancer Surgery
A study testing Behavioral Intervention for Wellness and Engaged Living (Be-WEL) in people with Cancer and Stress, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Behavioral Intervention for Wellness and Engaged Living (Be-WEL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2020to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Behavioral Intervention for Wellness and Engaged Living (Be-WEL)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Intervention for Wellness and Engaged Living (Be-WEL)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Be-WEL Intervention | Experimental | 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. Receives: Behavioral: Behavioral Intervention for Wellness and Engaged Living (Be-WEL) |
| Standard Care | No intervention | Standard Care consists of the standard care patients typically receive from their medical team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-8
PHQ-8 assesses depression symptoms; A total score (range: 0-24) will be used with higher scores representing more depressive symptoms.
Measured: 4-weeks post-operation (+/-1 week)
Generalized Anxiety Disorder-7
The GAD-7 measures anxiety symptoms; A total score (range: 0-21) will be used with higher scores representing more anxiety symptoms.
Measured: 4-weeks post-operation (+/-1 week)
Secondary outcomes (5)
Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS)
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.
Measured: 4-weeks post-operation (+/-1 week)
Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS)
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.
Measured: 4-weeks post-operation (+/-1 week)
Number of Complications
Occurrence of: perioperative mortality, cardiac complications, postoperative pneumonia, intubation for >48-hours postoperatively unplanned reintubation, venous thromboembolic events, renal dysfunction, or surgical-site infections
Measured: 30 days post-operation
Length of post-operative hospital stay
Number of days inpatient hospital stay after operation
Measured: 30 days post-operation
Hospital Readmission
Number of times readmitted to a hospital after operation
Measured: 30 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start17 Dec 2020
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Why it stopped: Insufficient funding for research personnel prevented adequate recruitment and retention of research participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (intervention vs. standard care)
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chelsea Ratcliff, Baylor College of Medicine
- Investigators
- Chelsea G Ratcliff, PhD, Principal investigator, Baylor College of Medicine/Sam Houston State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979794
- Sponsor's protocol ID
- H-40276
- Status last verified
- Nov 2024
- First submitted
- 28 May 2019
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not currently a plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Distress Screening and Intervention in Cancer Surgery
- ClinicalTrials.gov ID
- NCT03979794
- Acronym / sponsor ID
- H-40276
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding for research personnel prevented adequate recruitment and retention of research participants.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (intervention vs. standard care)
| Arm | Type | Receives |
|---|---|---|
| Be-WEL Intervention | Experimental | Behavioral: 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. |
| Standard Care | No intervention | –Standard Care consists of the standard care patients typically receive from their medical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Be-WEL Intervention |
Primary outcome
Patient Health Questionnaire-8
Time frame: 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
Time frame: 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.
5 secondary outcomes
Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS)
Time frame: 4-weeks post-operation (+/-1 week)
Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS)
Time frame: 4-weeks post-operation (+/-1 week)
Number of Complications
Time frame: 30 days post-operation
Length of post-operative hospital stay
Time frame: 30 days post-operation
Hospital Readmission
Time frame: 30 days post-operation
Results and safety
The study was stopped early (reason given: Insufficient funding for research personnel prevented adequate recruitment and retention of research participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No. There is not currently a plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chelsea G Ratcliff, PhD principal investigator
Baylor College of Medicine/Sam Houston State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention for Wellness and Engaged Living (Be-WEL) in people with Cancer and Stress, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient funding for research personnel prevented adequate recruitment and retention of research participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-8 (time frame: 4-weeks post-operation (+/-1 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.