Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers

NCT04010227 | Completed Results DMC

• 2 other identifiers: 1904388865R21CA235788
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in advanced gastrointestinal (GI) cancer patients and family caregiver burden. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, spirituality), and engaging in activities consistent with these values. A total of 40 patient-caregiver dyads were randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Dyads in both conditions participated in six weekly 50-minute telephone sessions. Outcomes were assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. Study findings will inform a large-scale trial of intervention efficacy.

Conditions

Gastrointestinal Neoplasms

Keywords

Acceptance and Commitment Therapy; Fatigue; Family Caregivers; Psychotherapy

Outcome Measures

Primary Outcomes (2)

• Fatigue Interference Subscale of Fatigue Symptom Inventory

  Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients.

  2 weeks and 3 months post-intervention

• Short-form of Zarit Burden Interview

  Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers.

  2 weeks and 3 months post-intervention

Secondary Outcomes (6)

• Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment

  2 weeks and 3 months post-intervention

• PROMIS Ability to Participate in Social Roles and Activities

  2 weeks and 3 months post-intervention

• Acceptance and Action Questionnaire-II

  2 weeks and 3 months post-intervention

• McGill Quality of Life Questionnaire-Revised

  2 weeks and 3 months post-intervention

• PROMIS Global Health

  2 weeks and 3 months post-intervention

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).

Behavioral: Acceptance and Commitment Therapy

Education/Support

ACTIVE COMPARATOR

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.

Behavioral: Education/Support

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

Across six weekly 50-minute sessions, advanced GI 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 we developed to guide mindfulness practices.

Acceptance and Commitment Therapy

Education/Support BEHAVIORAL

Across six weekly 50-minute sessions, advanced GI 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 care at the Indiana University Simon Cancer Center or Eskenazi Health.
• Patient is at least 21 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.

You may not qualify if:

• 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.
• Family caregiver identified by a stage IV gastrointestinal cancer patient who meets the eligibility criteria.
• Caregiver has significant caregiving burden or distress
• 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 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.

Sponsors & Collaborators

• Indiana University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Mosher CE, Secinti E, Kroenke K, Helft PR, Turk AA, Loehrer PJ Sr, Sehdev A, Al-Hader AA, Champion VL, Johns SA. Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Apr 20;7(1):99. doi: 10.1186/s40814-021-00837-9.

  PMID: 33879253 BACKGROUND

• Mosher CE, Secinti E, Wu W, Kashy DA, Kroenke K, Bricker JB, Helft PR, Turk AA, Loehrer PJ, Sehdev A, Al-Hader AA, Champion VL, Johns SA. Acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer: Results of a pilot randomized trial. Palliat Med. 2022 Jul;36(7):1104-1117. doi: 10.1177/02692163221099610. Epub 2022 May 30.

  PMID: 35637615 RESULT

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Fatigue

Interventions

Acceptance and Commitment Therapy; Educational Status; Palliative Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Catherine Mosher
• Organization: Indiana University

cemosher@iupui.edu

3172746769

Study Officials

• Catherine E Mosher, Ph.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Advanced gastrointestinal cancer patient-family caregiver dyads (N = 40) were 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 performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2).

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: September 16, 2019
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. Data will be available for at least 6 years.
• Access Criteria: The data set and supporting information will be made available to qualified investigators to allow replication of analyses or secondary data analyses. The PI will review requests for data access. The investigators will be required to sign a data use agreement and obtain IRB approval before receiving the data set. The mechanism for data sharing will be reviewed by the IRB.

Locations

US (2)