Clinical trial NCT04815746: QOL and GI Outcomes in Malignancies
Official title: Psychosocial Determinants of Health-Related Quality of Life (QOL) and Gastrointestinal (GI) Functional Outcomes During Treatment for Malignancies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Psychological Adaptation
Psychological Adjustment
Stress, Emotional
Keywords: Psychosocial Symptom Management
eHealth Intervention
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Health Related Quality of Life as Measured by Perceived Stress Scale
timeFrame: Up to 10 weeks.
measure: Health Related Quality of Life as Measured by University of California, Los Angeles (UCLA) Loneliness Scale
timeFrame: Up to 10 weeks.
measure: Health Related Quality of Life as Measured by Interpersonal Support Evaluation List
timeFrame: Up to 10 weeks.
measure: Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7)
timeFrame: Up to 10 weeks.
measure: Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy (FACT) Hepatobiliary-Pancreatic Symptom Index (FHSI)-18
timeFrame: Up to 10 weeks.
measure: The Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Up to 10 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Frank Penedo, PhD
role: PRINCIPAL_INVESTIGATOR
References: