Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2024-10-01
2024-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm
Participants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period.
Cognitive Behavioral Therapy (CBT)-based skills
The CBT skills target reducing anxiety, (e.g., relaxation), changing negative appraisals (e.g., cognitive restructuring), coping skills training (e.g., enhancing adaptive skills), behavioral activation, interpersonal skills (e.g., communication skills) and building or enhancing social networks. The intervention will be administered online, and each module will last about 1-hour.
Usual Clinical Care Control Arm
Participants in this group will receive standard education.
Standard Education
Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer.
Interventions
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Cognitive Behavioral Therapy (CBT)-based skills
The CBT skills target reducing anxiety, (e.g., relaxation), changing negative appraisals (e.g., cognitive restructuring), coping skills training (e.g., enhancing adaptive skills), behavioral activation, interpersonal skills (e.g., communication skills) and building or enhancing social networks. The intervention will be administered online, and each module will last about 1-hour.
Standard Education
Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer.
Eligibility Criteria
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Inclusion Criteria
2. Spanish or English speaker with ability to read one of these languages
3. Diagnosis of pancreatic cancer .
4. Willingness to be assessed at diagnosis, during neoadjuvant chemotherapy (if applicable), preoperatively (if applicable - unless time of diagnosis is preoperative visit), and postoperatively for up to two years following surgery.
Exclusion Criteria
2. History of previous invasive cancer or treatment with chemotherapy, as they may have a different baseline functional status, quality of life, and gastrointestinal function compared to the normal healthy population, per principal investigator discretion, based on a case-by-case review.
3. Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months as these conditions can interfere with adequate participation in assessments, per principal investigator discretion, based on a case-by-case review.
4. Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Frank Penedo
Professor
Principal Investigators
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Frank Penedo, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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20190846
Identifier Type: -
Identifier Source: org_study_id
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