Telephone Support in Advanced Gastrointestinal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Acceptance and Commitment Therapy
BehavioralPatients 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).
Education/Support
BehavioralPatients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Treatment groups
488 Participants
are divided into 2 treatment groupsGroup A: Acceptance and Commitment TherapyExperimental treatment 1 intervention
Group B: Education/SupportActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 weeks and 3 months post-intervention2
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.
Time frame
2 weeks and 3 months post-interventionSecondary outcomes
1
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.
Time frame
2 weeks and 3 months post-intervention2
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.
Time frame
2 weeks and 3 months post-intervention3
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.
Time frame
2 weeks and 3 months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Northwestern University
Collaborator
M.D. Anderson Cancer Center
Collaborator
Eskenazi Health
Collaborator
Source ClinicalTrials.gov