Trial Title:
Telephone Support in Advanced Gastrointestinal Cancer
NCT ID:
NCT06532877
Condition:
Gastrointestinal Neoplasm Malignant
Caregiver Burden
Conditions: Official terms:
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Caregiver Burden
Conditions: Keywords:
Gastrointestinal Neoplasms
Family Caregivers
Acceptance and Commitment Therapy
Fatigue
Psychotherapy
Caregiver Burden
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Advanced gastrointestinal cancer patient-family caregiver dyads (N = 244) will be
randomly assigned in equal numbers to Acceptance and Commitment Therapy (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).
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
Research staff will be blind to study condition when administering assessments to
participants via phone.
Intervention:
Intervention type:
Behavioral
Intervention name:
Acceptance and Commitment Therapy
Description:
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).
Arm group label:
Acceptance and Commitment Therapy
Intervention type:
Behavioral
Intervention name:
Education/Support
Description:
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.
Arm group label:
Education/Support
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
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.
Criteria for eligibility:
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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwestern Medicine
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Elizabeth Addington, Ph.D.
Facility:
Name:
Eskenazi Health
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Hannah Mullin
Phone:
317-278-4005
Email:
cancerq@iu.edu
Facility:
Name:
Indiana University Health
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hannah Mullin
Phone:
317-278-4005
Email:
cancerq@iu.edu
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eileen Shinn, Ph.D.
Start date:
August 21, 2024
Completion date:
February 2029
Lead sponsor:
Agency:
Indiana University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Northwestern University
Agency class:
Other
Collaborator:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Eskenazi Health
Agency class:
Other
Source:
Indiana University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06532877
