Clinical trial · Interventional
A Distress Screening and Intervention in Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient funding for research personnel prevented adequate recruitment and retention of research participants.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Stress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Intervention for Wellness and Engaged Living (Be-WEL) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Be-WEL Intervention
- description
- 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.
- interventionNames
- Behavioral: Behavioral Intervention for Wellness and Engaged Living (Be-WEL)
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- Standard Care consists of the standard care patients typically receive from their medical team.
Primary outcomes (2)
- measure
- Patient Health Questionnaire-8
- timeFrame
- 4-weeks post-operation (+/-1 week)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available