QOL and GI Outcomes in Malignancies

University of Miami

Status: Withdrawn

Conditions: Stress, Emotional; Psychological Adaptation; Psychological Adjustment

Treatments: Behavioral: Standard Education; Behavioral: Cognitive Behavioral Therapy (CBT)-based skills

Study type: Interventional

Funder types: Other

Identifiers

NCT04815746

20190846

Details and patient eligibility

About

The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Greater than 18 years of age
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

1. Patients unable to read Spanish or English, as they will be unable to complete surveys.
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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm

Experimental group

Description:

Participants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period.

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)-based skills

Usual Clinical Care Control Arm

Active Comparator group

Description:

Participants in this group will receive standard education.

Treatment:

Behavioral: Standard Education