QOL and GI Outcomes in Malignancies

NCT04815746 | Withdrawn

• 1 other identifier: 20190846
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Adaptation; Psychological Adjustment; Stress, Emotional

Keywords

Psychosocial Symptom Management; eHealth Intervention

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

• The Gastrointestinal Symptom Rating Scale (GSRS)

  GSRS (Scale of 0-78 with higher scores indicating worse gastrointestinal symptoms)

  Up to 10 weeks.

Study Arms (2)

Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm

EXPERIMENTAL

Participants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period.

Behavioral: Cognitive Behavioral Therapy (CBT)-based skills

Usual Clinical Care Control Arm

ACTIVE COMPARATOR

Participants in this group will receive standard education.

Behavioral: Standard Education

Interventions

Cognitive Behavioral Therapy (CBT)-based skills BEHAVIORAL

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.

Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm

Standard Education BEHAVIORAL

Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer.

Usual Clinical Care Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Frank Penedo, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: October 1, 2024
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)