QOL and GI Outcomes in Malignancies

Stress, Emotional Clinical Trial

Official title:

Psychosocial Determinants of Health-Related Quality of Life (QOL) and Gastrointestinal (GI) Functional Outcomes During Treatment for Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04815746
• Other study ID #: 20190846
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: Sara Fleszar-Pavlovic, PhD
• Phone: 8504456978
• Email: sarafleszarpavlovic[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychological Adaptation
• Psychological Adjustment
• Stress, Emotional
• Stress, Psychological

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

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