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Behavioral Intervention

Telephone Support for Advanced Gastrointestinal Cancer

N/A

Recruiting

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 18 years of age

Be older than 18 years old

Must not have

Caregiver has hearing impairment that precludes participation

Patient is receiving hospice care at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks and 3 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a new telephone counseling program can help patients and their family caregivers cope better with advanced gastrointestinal cancer. They will compare this new program, which teaches stress management strategies, with a

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My caregiver cannot participate due to hearing impairment.

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I am currently receiving hospice care.

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I am able to understand and consent to participate in the study.

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I do not wish to participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks and 3 months post-intervention

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met