WithdrawnNot Applicable

QOL and GI Outcomes in Malignancies

Stopped: We have decided to withdraw this research study due to the receipt of funding for a similar study that aligns more closely with our current research priorities and available resources.

United States0Started 2024-10-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Greater than 18 years of age
✓. Spanish or English speaker with ability to read one of these languages
✓. Diagnosis of pancreatic cancer .
✓. 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

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

What they're measuring

Health Related Quality of Life as Measured by Perceived Stress Scale

Timeframe: Up to 10 weeks.

Health Related Quality of Life as Measured by University of California, Los Angeles (UCLA) Loneliness Scale

Timeframe: Up to 10 weeks.

Health Related Quality of Life as Measured by Interpersonal Support Evaluation List

Timeframe: Up to 10 weeks.

Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7)

Timeframe: Up to 10 weeks.

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.

The Gastrointestinal Symptom Rating Scale (GSRS)

Timeframe: Up to 10 weeks.

Trial details

NCT IDNCT04815746

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-08

View on ClinicalTrials.gov More Psychological Adaptation trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Greater than 18 years of age
✓. Spanish or English speaker with ability to read one of these languages
✓. Diagnosis of pancreatic cancer .
✓. 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

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

What they're measuring

Health Related Quality of Life as Measured by Perceived Stress Scale

Timeframe: Up to 10 weeks.

Health Related Quality of Life as Measured by University of California, Los Angeles (UCLA) Loneliness Scale

Timeframe: Up to 10 weeks.

Health Related Quality of Life as Measured by Interpersonal Support Evaluation List

Timeframe: Up to 10 weeks.

Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7)

Timeframe: Up to 10 weeks.

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.

The Gastrointestinal Symptom Rating Scale (GSRS)

Timeframe: Up to 10 weeks.