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Behavioral Intervention

Acceptance and Commitment Therapy for Caregiver Burden

N/A
Waitlist Available
Led By Catherine E Mosher, Ph.D.
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks and 3 months post-intervention
Awards & highlights

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

Who is the study for?
This trial is for patients with advanced gastrointestinal cancer and their family caregivers. Participants must be willing to engage in weekly telephone sessions and interviews over approximately 5 months. Specific eligibility criteria are not provided, but typically include factors like age, health status, and the stage of cancer.
What is being tested?
The study compares two types of telephone support: one offers counseling with stress management strategies (Acceptance and Commitment Therapy), while the other provides education on quality-of-life issues. The aim is to see which program better reduces patient fatigue impact and caregiver burden.
What are the potential side effects?
Since this trial involves non-medical interventions such as counseling and education via phone calls, there are no direct medical side effects expected from participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks and 3 months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks and 3 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fatigue Interference Subscale of Fatigue Symptom Inventory
Short-form of Zarit Burden Interview
Secondary study objectives
PROMIS Ability to Participate in Social Roles and Activities
PROMIS Global Health measure
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Acceptance and Commitment TherapyExperimental Treatment1 Intervention
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.
Group II: Education/SupportActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acceptance and Commitment Therapy
2010
Completed Phase 1
~1490

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,789 Previous Clinical Trials
40,985,807 Total Patients Enrolled
2 Trials studying Caregiver Burden
703 Patients Enrolled for Caregiver Burden
Northwestern UniversityOTHER
1,616 Previous Clinical Trials
931,330 Total Patients Enrolled
1 Trials studying Caregiver Burden
29 Patients Enrolled for Caregiver Burden
Indiana UniversityLead Sponsor
1,007 Previous Clinical Trials
1,102,354 Total Patients Enrolled
8 Trials studying Caregiver Burden
3,606 Patients Enrolled for Caregiver Burden
~325 spots leftby Feb 2029
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