QOL and GI Outcomes in Malignancies

Not Applicable

Withdrawn

• Conditions: Stress, Emotional; Psychological Adaptation; Psychological Adjustment
• Interventions: Behavioral: Standard Education; Behavioral: Cognitive Behavioral Therapy (CBT)-based skills

• Registration Number: NCT04815746
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-25
• Study Start: 2024-10-01
• Primary Completion: 2024-10-08
• Study Completion: 2024-10-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Clinical Care Control Arm	Standard Education	Participants in this group will receive standard education.
Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm	Cognitive Behavioral Therapy (CBT)-based skills	Participants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period.

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life as Measured by Perceived Stress Scale	Up to 10 weeks.	Perceived Stress Scale (Scale of 1-40 with higher scores indicating higher stress)
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7)	Up to 10 weeks.	FACT-G7 (Scale of 0-28 with higher scores indicating better quality of life)
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy (FACT) Hepatobiliary-Pancreatic Symptom Index (FHSI)-18	Up to 10 weeks.	FACT FHSI-18 (Scale of 0-72 with lower scores indicating better quality of life)
The Gastrointestinal Symptom Rating Scale (GSRS)	Up to 10 weeks.	GSRS (Scale of 0-78 with higher scores indicating worse gastrointestinal symptoms)
Health Related Quality of Life as Measured by University of California, Los Angeles (UCLA) Loneliness Scale	Up to 10 weeks.	UCLA Loneliness Scale (Scale of 20-80 with higher scores indicating higher loneliness)
Health Related Quality of Life as Measured by Interpersonal Support Evaluation List	Up to 10 weeks.	Interpersonal Support Evaluation List (12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support).

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States