Telephone Support in Advanced Gastrointestinal Cancer
Telephone Support Program for Patients With Advanced Gastrointestinal Cancer and Their Family Caregivers
2 other identifiers
interventional
488
1 country
4
Brief Summary
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. The main questions it aims to answer are: Does our telephone counseling program lower the negative impact of patients' fatigue on their activities, emotions, and thinking abilities compared to a telephone program involving education and support? Does our telephone counseling program lower family caregivers' feelings of burden compared to a telephone program involving education and support? Participants in both study conditions will: Complete 6 weekly telephone sessions of counseling or education/support Complete a telephone booster session Complete 3 telephone interviews over about 5 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedStudy Start
First participant enrolled
August 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
January 23, 2026
January 1, 2026
4.5 years
July 29, 2024
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fatigue Interference Subscale of Fatigue Symptom Inventory
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.
2 weeks and 3 months post-intervention
Short-form of Zarit Burden Interview
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.
2 weeks and 3 months post-intervention
Secondary Outcomes (3)
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment
2 weeks and 3 months post-intervention
PROMIS Ability to Participate in Social Roles and Activities
2 weeks and 3 months post-intervention
PROMIS Global Health measure
2 weeks and 3 months post-intervention
Study Arms (2)
Acceptance and Commitment Therapy
EXPERIMENTALAcross six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that the team developed to guide mindfulness practices.
Education/Support
ACTIVE COMPARATORAcross six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- National Cancer Institute (NCI)collaborator
- Northwestern Universitycollaborator
- M.D. Anderson Cancer Centercollaborator
- Eskenazi Healthcollaborator
Study Sites (4)
Northwestern Medicine
Chicago, Illinois, 60611, United States
Eskenazi Health
Indianapolis, Indiana, 46202, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Mosher CE, Shinn EH, Addington EL, Wu W, Bricker JB, Helft PR, Turk AA, Vater LB, Masood A, Jalal SI, Loehrer PJ Sr, Champion VL, Johns SA. Protocol of a randomized trial of acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer. Contemp Clin Trials. 2026 Jan;160:108168. doi: 10.1016/j.cct.2025.108168. Epub 2025 Nov 26.
PMID: 41314597DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine E Mosher, Ph.D.
Indiana University Indianapolis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Research staff will be blind to study condition when administering assessments to participants via phone.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychology
Study Record Dates
First Submitted
July 29, 2024
First Posted
August 1, 2024
Study Start
August 21, 2024
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- The research community will have access to the data no later than the time of an associated publication or end of the performance period, whichever is first.
- Access Criteria
- Data will be findable for the research community through the Harvard Dataverse. A data digital object identifier (DOI) generated by the Harvard Dataverse will be referenced in all publications to allow the research community easy access to the exact data used in the publication. Access to the data will be restricted to qualified researchers to prevent misuse, misinterpretation, and confusion.
The dataset to be shared will include individual-level baseline, procedural-based (intervention session attendance, homework completion), and outcome data for approximately 244 patients and 244 family caregivers. Data will be collected from self-report surveys and the Electronic Medical Record (EMR). Data from scored assessments (e.g., psychosocial questionnaires) will include both raw data elements (e.g., individual item responses) and summary information (e.g., total scores) where feasible. To protect the privacy of study participants, the investigators will develop a plan for de-identification of this dataset, which will address participant identifiers, dates, variables that are administrative or sensitive in nature, unedited verbatim responses that are stored as text data, and variables with low frequencies for some values.