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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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.