Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers

Telephone Support for Advanced Gastrointestinal Cancer Patients and Their Family Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Neoplasms
• Intervention / Treatment: Behavioral: Education/Support; Behavioral: Acceptance and Commitment Therapy

Detailed Description

This trial evaluates the feasibility, acceptability, and preliminary efficacy of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in advanced gastrointestinal (GI) cancer patients and family caregiver burden as well as secondary outcomes. The study team recruited advanced GI cancer patients receiving care at the Indiana University Simon Cancer Center or Eskenazi Health hospital. Potentially eligible patients were mailed an introductory letter signed by their oncologist and the PI along with a consent form. The letter had a number to call if they did not wish to be contacted further. A research assistant (RA) called all prospective participants who did not opt out approximately 1 to 2 weeks after the letter was mailed. The RA described the study as outlined in the consent form and answered any questions. Then the RA administered an eligibility screening to those who consented to participate. Eligible and consenting patients identified a potentially eligible family caregiver. If the family caregiver was eligible and consented to participate, then the patient and caregiver each completed a baseline phone assessment. Following baseline assessments, patient-caregiver dyads (N = 40 dyads) were randomly assigned in equal numbers to 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). Dyads in both study conditions completed six weekly 50-minute telephone sessions with the first session occurring one week after baseline. For ACT participants, adherence to home practice during the past week was assessed and recorded during each session. Feasibility will be examined via accrual, attrition, and adherence rates, and acceptability will be evaluated using a mixed methods approach (qualitative and quantitative). Blind interviewers assessed outcomes during follow-up phone assessments at 2 weeks and 3 months post-intervention.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Health
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Simon Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Patient Inclusion Criteria:

• 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.

Patient Exclusion Criteria:

• 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.

Caregiver Inclusion Criteria:

• 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 Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and Commitment Therapy; 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; 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.
Active Comparator: 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.	Behavioral: Education/Support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment	This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients.	2 weeks and 3 months post-intervention
PROMIS Ability to Participate in Social Roles and Activities	This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for both patients and caregivers.	2 weeks and 3 months post-intervention
Acceptance and Action Questionnaire-II	This 7-item measure assesses psychological flexibility, or the ability to fully experience the present moment while persisting in actions aligned with personal values. Each item is rated on a scale from 1 (never true) to 7 (always true). The seven items are summed with higher total scores indicating greater levels of psychological inflexibility. The total score range is 7 to 49. This is a secondary outcome for both patients and caregivers.	2 weeks and 3 months post-intervention
McGill Quality of Life Questionnaire-Revised	This 15-item measure evaluates physical, psychological, existential, and social quality of life in patients with serious illnesses. Each of the 4 subscale scores (i.e., physical, psychological, existential, and social quality of life) is the sum of the items with higher scores indicating better quality of life. Items are rated on 0 to 10 scales. The physical quality of life subscale is the sum of 3 items (2 items reverse-coded) with a range of 0 to 30. The psychological quality of life subscale is the sum of 4 items (all items reverse-coded) with a range of 0 to 40. The existential quality of life subscale is the sum of 4 items (1 item reverse-coded) with a range of 0 to 40. The social quality of life subscale is the sum of 3 items (none reverse-coded) with a range of 0 to 30. This is a secondary outcome measure for patients.	2 weeks and 3 months post-intervention
PROMIS Global Health	This 10-item measure assesses global health, including physical, mental, and social well-being. With the exception of pain, which is rated on a 0 to 10 scale, all items are rated on 5-point scales from 1 to 5. The item on pain is recoded from a 0-10 to a 1-5 scale and reverse-scored. Two additional items are reverse-scored. Then four of the items are summed, with higher physical quality of life subscale scores indicating better physical quality of life. Four other items are also summed with higher psychological quality of life subscale scores indicating better psychological quality of life. The subscale scores are converted to T-scores with a range from 16.2 to 67.7 for physical quality of life and a range from 21.2 to 67.6 for psychological quality of life. Higher T-scores for the physical and psychological quality of life subscales indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome measure for caregivers.	2 weeks and 3 months post-intervention
Value Progress Subscale of the Valuing Questionnaire.	This 5-item subscale assesses progress in living according to one's personal values, a construct related to activity engagement. Items are rated on 0 to 6 scales. The 5 items are summed with higher total subscale scores indicating greater progress in living according to one's personal values. The total subscale score range is 0 to 30. This is a secondary outcome measure for patients and caregivers.	2 weeks and 3 months post-intervention

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Catherine E Mosher, Ph.D., Indiana University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): June 8, 2021
• Study Completion (Actual): June 8, 2021

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Fatigue; Psychotherapy; Family Caregivers
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: 1904388865; R21CA235788 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Results of this trial will be presented at professional meetings and published in peer-reviewed journals. The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. The data set will contain necessary identifiers, excluding those prohibited by HIPAA. The investigators will be required to sign a data use agreement and obtain Institutional Review Board (IRB) approval before receiving the data set.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No