Telephone Support in Advanced Gastrointestinal Cancer
NCT Number: NCT06532877
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastrointestinal Neoplasm Malignant|Caregiver Burden
Interventions: BEHAVIORAL: Acceptance and Commitment Therapy|BEHAVIORAL: Education/Support
Sponsor: Indiana University
Collaborators: National Cancer Institute (NCI)|Northwestern University|M.D. Anderson Cancer Center|Eskenazi Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 488
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2029-02
Locations: 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

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

Primary Outcome Measures: 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: 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