Telephone Support in Advanced Gastrointestinal Cancer

Conditions

• Caregiver Burden
• Gastrointestinal Neoplasm Malignant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Acceptance and Commitment Therapy — BEHAVIORAL
  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 — BEHAVIORAL
  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.

Study Details

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

Key Dates

Start date

Aug 21, 2024

Status verified

Jan 2026

Primary completion

Feb 28, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

488 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: 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.
• Active Comparator: 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.

Primary Outcome Measure

Fatigue Interference Subscale of Fatigue Symptom Inventory [ Time Frame: 2 weeks and 3 months post-intervention ]

Central Contacts

• Hannah Mullin
  317-278-4005
  [email protected]

Locations (4)

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