Status:
COMPLETED
Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in advanced gastrointestinal (GI)...
Detailed Description
This trial evaluates the feasibility, acceptability, and preliminary efficacy of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in advanced gastrointestinal (GI) cance...
Eligibility Criteria
Inclusion
- Patient
- Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., anal, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving care at the Indiana University Simon Cancer Center or Eskenazi Health.
- Patient is at least 21 years of age.
- Patient can speak and read English.
- Patient has an eligible, consenting family caregiver (see criteria below).
- Patient has moderate to severe fatigue interference with functioning.
- Patient
Exclusion
- Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
- Patient reports being able to do little activity on a functional status measure.
- Patient is receiving hospice care at screening.
- Patient does not have working phone service.
- Patient has hearing impairment that precludes participation.
- Caregiver Inclusion Criteria:
- Family caregiver identified by a stage IV gastrointestinal cancer patient who meets the eligibility criteria.
- Caregiver has significant caregiving burden or distress
- Caregiver lives with the patient or has visited the patient in-person at least twice a week for the past month.
- Caregiver is at least 18 years of age.
- Caregiver can speak and read English.
- Caregiver
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04010227
Start Date
September 16 2019
End Date
June 8 2021
Last Update
December 22 2022
Active Locations (2)
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1
Eskenazi Health
Indianapolis, Indiana, United States, 46202
2
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202