Telephone Support for Advanced Gastrointestinal Cancer Patients and Their Family Caregivers
Acceptance and Commitment Therapy
+ Education/Support
Digestive System Diseases+6
+ Digestive System Neoplasms
+ Fatigue
Supportive Care Study
Summary
Study start date: September 16, 2019
Actual date on which the first participant was enrolled.This trial evaluates the feasibility, acceptability, and preliminary efficacy of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in advanced gastrointestinal (GI) cancer patients and family caregiver burden as well as secondary outcomes. The study team recruited advanced GI cancer patients receiving care at the Indiana University Simon Cancer Center or Eskenazi Health hospital. Potentially eligible patients were mailed an introductory letter signed by their oncologist and the PI along with a consent form. The letter had a number to call if they did not wish to be contacted further. A research assistant (RA) called all prospective participants who did not opt out approximately 1 to 2 weeks after the letter was mailed. The RA described the study as outlined in the consent form and answered any questions. Then the RA administered an eligibility screening to those who consented to participate. Eligible and consenting patients identified a potentially eligible family caregiver. If the family caregiver was eligible and consented to participate, then the patient and caregiver each completed a baseline phone assessment. Following baseline assessments, patient-caregiver dyads (N = 40 dyads) were randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by patient performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2). Dyads in both study conditions completed six weekly 50-minute telephone sessions with the first session occurring one week after baseline. For ACT participants, adherence to home practice during the past week was assessed and recorded during each session. Feasibility will be examined via accrual, attrition, and adherence rates, and acceptability will be evaluated using a mixed methods approach (qualitative and quantitative). Blind interviewers assessed outcomes during follow-up phone assessments at 2 weeks and 3 months post-intervention.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.84 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Patient Inclusion Criteria: * Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., anal, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving care at the Indiana University Simon Cancer Center or Eskenazi Health. * Patient is at least 21 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. Caregiver Inclusion Criteria: * Family caregiver identified by a stage IV gastrointestinal cancer patient who meets the eligibility criteria. * Caregiver has significant caregiving burden or distress * 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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Indiana University Simon Comprehensive Cancer Center
Indianapolis, United States