Phone therapy may ease fatigue and caregiver strain in advanced GI cancer
NCT ID NCT06532877
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tests whether a telephone-based counseling program can help patients with advanced gastrointestinal cancer and their family caregivers feel better. The program teaches strategies to manage stress and symptoms, and is compared to a standard education and support program. About 488 patient-caregiver pairs will take part in six weekly phone sessions and three interviews over five months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Acceptance and Commitment Therapy (behavioral intervention)
- What this could lead to
- If successful, this could provide a practical, low-cost way to help patients and caregivers cope with fatigue and stress during advanced cancer.
- What could go wrong
- This is a behavioral study, not a drug trial, so benefits may be modest. Results depend on participant engagement and may not apply to all cancer types or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 488 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Patient 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Eskenazi Health
RECRUITINGIndianapolis, Indiana, 46202, United States
Contact Email: •••••@•••••
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Indiana University Health
RECRUITINGIndianapolis, Indiana, 46202, United States
Contact Email: •••••@•••••
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Northwestern Medicine
RECRUITINGChicago, Illinois, 60611, United States
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