Telephone Support in Advanced Gastrointestinal Cancer

Telephone Support Program for Patients With Advanced Gastrointestinal Cancer and Their Family Caregivers

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

Study Overview

• Status: Recruiting
• Conditions: Caregiver Burden; Gastrointestinal Neoplasm Malignant
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy; Behavioral: Education/Support

Detailed Description

This trial tests the effects of telephone-delivered acceptance and commitment therapy (ACT) on patient fatigue interference with functioning and family caregiver burden in advanced gastrointestinal (GI) cancer (Aim 1) as well as secondary outcomes (Aim 2). This trial also examines increases in psychological flexibility as a hypothesized mediator of ACT's effects on patient fatigue interference and caregiver burden (Aim 3). Finally, two core aspects of psychological flexibility (i.e., mindfulness/acceptance and commitment/behavior change processes) are examined as exploratory mediators of ACT's effects on patient fatigue interference and caregiver burden (Aim 4). The investigators will recruit advanced GI cancer patients and caregivers from Indiana University Health, Eskenazi Health, MD Anderson Cancer Center, and Northwestern University hospitals. Potentially eligible patients will be mailed a study introductory letter along with a consent form. The letter will have a number to call if they do not wish to be contacted further. A research assistant will call all prospective participants who do not opt out approximately 1 to 2 weeks after the letter is mailed. The research assistant will describe the study as outlined in the consent form and answer any questions. Then the research assistant will administer an eligibility screening to those who consent to participate. With the patient's permission, the primary family caregiver will also be mailed a consent form and contacted via phone to screen for eligibility and obtain consent. Consenting patients and caregivers will complete a 35-minute individual phone assessment at baseline.

Following baseline assessments, patient-caregiver dyads (N = 244) will be randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by patient age (<65 vs. >=65 years) and performance status (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2). Dyads in both groups will complete six weekly 50-minute telephone sessions with the first session occurring one week after baseline. Blind interviewers will assess outcomes during 30-minute individual phone assessments at 2 weeks and 3 months post-intervention. Dyads in both conditions will also complete a 30-minute booster phone session one month after the 2-week follow-up. During the booster session, ACT therapists will reinforce and address any barriers to skill practice, and education/support therapists will review key medical center and community resources.

• Study Type: Interventional
• Enrollment (Estimated): 488
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah Mullin; Phone Number: 317-278-4005; Email: cancerq@iu.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medicine
      • Contact: Elizabeth Addington, Ph.D.
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Health
      • Contact: Hannah Mullin; Phone Number: 317-278-4005; Email: cancerq@iu.edu
    • Indianapolis, Indiana, United States, 46202
      • Not yet recruiting
      • Eskenazi Health
      • Contact: Hannah Mullin; Phone Number: 317-278-4005; Email: cancerq@iu.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Eileen Shinn, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Education/Support; Across 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.	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.
Experimental: Acceptance and Commitment Therapy; Across 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment	This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients.	2 weeks and 3 months post-intervention
PROMIS Ability to Participate in Social Roles and Activities	This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for both patients and caregivers.	2 weeks and 3 months post-intervention
PROMIS Global Health measure	This 10-item measure assesses participants' physical, mental, and social well-being. Items are rated on scales from 5 (excellent) to 1 (poor) and 5 (completely) to 1 (not at all). One item is rated on a scale from 5 (never) to 1 (always), and another item is rated on a scale from 5 (none) to 1 (very severe). Pain is rated on a scale from 0 (no pain) to 10 (worst pain imaginable) and recoded so that higher numbers indicate less pain. The items are then summed into Global Physical Health and Global Mental Health scores. The total scores are converted to T-scores with a range from 16.2 to 67.7 (Global Physical Health) and 21.2 to 67.6 (Global Mental Health), with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients and caregivers.	2 weeks and 3 months post-intervention

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: M.D. Anderson Cancer Center; National Cancer Institute (NCI); Northwestern University; Eskenazi Health
• Investigators: Principal Investigator: Catherine E Mosher, Ph.D., Indiana University Indianapolis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Fatigue; Caregiver Burden; Psychotherapy; Gastrointestinal Neoplasms; Family Caregivers
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Behavioral Symptoms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stress, Psychological; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Caregiver Burden; Fatigue; Gastrointestinal Neoplasms; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Palliative Care; Educational Status; Acceptance and Commitment Therapy
• Other Study ID Numbers: 21611; R01CA289486 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No