NCT06532877 · Indiana University
Telephone Support in Advanced Gastrointestinal Cancer
What this study is about
The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer. A new telephone counseling program that involves practicing strategies for managing stress and symptoms will be compared to a telephone program involving education on quality-of-life issues and psychosocial support.
View original scientific description
The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer. A new telephone counseling program that involves practicing strategies for managing stress and symptoms will be compared to a telephone program involving education on quality-of-life issues and psychosocial support.
Interventions
BEHAVIORAL
Acceptance and Commitment Therapy
Patients and caregivers in the acceptance and commitment therapy arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
BEHAVIORAL
Education/Support
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Primary outcome measures
Fatigue Interference Subscale of Fatigue Symptom Inventory
Time frame: 2 weeks and 3 months post-intervention
Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients.
Short-form of Zarit Burden Interview
Time frame: 2 weeks and 3 months post-intervention
Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., ampullary, anal, appendix, bile duct, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving cancer care at one of the study sites.
- Patient is at least 18 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 criteria
- 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.
- Patient participated in the pilot trial testing the same intervention. Caregiver Inclusion Criteria:
- Family caregiver identified by a gastrointestinal cancer patient who meets the eligibility criteria.
- Caregiver has significant caregiving burden.
- 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 Exclusion Criteria:
- Caregiver shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
- Caregiver does not have working phone service.
- Caregiver has hearing impairment that precludes participation.
- Patient declines study participation.
Where
- Chicago, Illinois
- Indianapolis, Indiana
- Houston, Texas
Collaborators
National Cancer Institute (NCI), Northwestern University, M.D. Anderson Cancer Center, Eskenazi Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations