Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
488 participants
INTERVENTIONAL
2024-08-21
2029-02-28
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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).
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.
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
M.D. Anderson Cancer Center
OTHER
Eskenazi Health
OTHER
Indiana University
OTHER
Responsible Party
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Catherine Mosher
Professor of Psychology
Principal Investigators
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Catherine E Mosher, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Indiana University Indianapolis
Locations
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Northwestern Medicine
Chicago, Illinois, United States
Eskenazi Health
Indianapolis, Indiana, United States
Indiana University Health
Indianapolis, Indiana, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Elizabeth Addington, Ph.D.
Role: primary
Hannah Mullin
Role: primary
Hannah Mullin
Role: primary
Eileen Shinn, Ph.D.
Role: primary
Other Identifiers
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21611
Identifier Type: -
Identifier Source: org_study_id