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Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010227
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : April 14, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Catherine Mosher, Indiana University

Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date April 14, 2020
Actual Study Start Date  ICMJE August 26, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Fatigue Interference subscale of Fatigue Symptom Inventory [ Time Frame: 2 weeks post-intervention ]
    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. Higher scores indicate greater fatigue interference. This is the primary outcome for patients.
  • Short-form of Zarit Burden Interview [ Time Frame: 2 weeks post-intervention ]
    Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. Higher scores indicate greater caregiving burden. This is the primary outcome for caregivers.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • PROMIS Sleep-Related Impairment [ Time Frame: 2 weeks post-intervention ]
    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) with higher scores indicating greater sleep-related impairment. This is a secondary outcome for patients.
  • PROMIS Ability to Participate in Social Roles and Activities [ Time Frame: 2 weeks post-intervention ]
    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 such that a higher score indicates greater ability to participate in activities. This is a secondary outcome for both patients and caregivers.
  • Acceptance and Action Questionnaire-II [ Time Frame: 2 weeks post-intervention ]
    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). Higher scores indicate greater levels of psychological inflexibility. This is a secondary outcome for both patients and caregivers.
  • McGill Quality of Life Questionnaire-Revised [ Time Frame: 2 weeks post-intervention ]
    This 15-item measure evaluates physical, existential, and social well-being in patients with serious illnesses. Items are rated on 0 to 10 scales. This is a secondary outcome measure for patients.
  • PROMIS Global Health [ Time Frame: 2 weeks post-intervention ]
    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. This is a secondary outcome measure for caregivers.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers
Official Title  ICMJE Telephone Support for Advanced Gastrointestinal Cancer Patients and Their Family Caregivers
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 will be randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Dyads in both conditions will participate in six weekly 50-minute telephone sessions. Outcomes will be 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.
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 will recruit advanced GI cancer patients receiving care at the Indiana University Simon Cancer Center or Eskenazi Health hospital. Potentially eligible patients will be mailed an introductory letter signed by their oncologist and the PI along with a consent form. The letter will have a number to call if they do not wish to be contacted further. A research assistant (RA) will call all prospective participants who do not opt out approximately 1 to 2 weeks after the letter is mailed. The RA will describe the study as outlined in the consent form and answer any questions. Then the RA will administer an eligibility screening to those who consent to participate. Eligible and consenting patients will identify a potentially eligible family caregiver. If the family caregiver is eligible and consents to participate, then the patient and caregiver will each complete a baseline phone assessment. Following baseline assessments, patient-caregiver dyads (N = 40 dyads) will be 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 will complete 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 will be 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 will assess outcomes during follow-up phone assessments at 2 weeks and 3 months post-intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Advanced gastrointestinal cancer patient-family caregiver dyads (N = 40) will be 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).
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Gastrointestinal Neoplasms
Intervention  ICMJE
  • Behavioral: Acceptance and Commitment Therapy
    Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers will 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 will learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants will receive handouts on session topics and a CD that we developed to guide mindfulness practices.
  • Behavioral: Education/Support
    Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers will be directed to resources for practical and health information and contact information for psychosocial services. Sessions will 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 will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts summarizing session topics and will be asked to review them as homework.
Study Arms  ICMJE
  • Experimental: Acceptance and Commitment Therapy
    Patients and caregivers in the ACT arm will learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
    Intervention: Behavioral: Acceptance and Commitment Therapy
  • Active Comparator: Education/Support
    Patients and caregivers in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
    Intervention: Behavioral: Education/Support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Patient Inclusion Criteria:

  • Patient is at least 3 weeks post-diagnosis of 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 18 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Isabella Stuart, B.S. 317-278-4009 icstuart@iu.edu
Contact: Ellen Krueger, B.S. 317-278-2989 efkruege@iu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04010227
Other Study ID Numbers  ICMJE 1904388865
R21CA235788 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party Catherine Mosher, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Catherine E Mosher, Ph.D. Indiana University
PRS Account Indiana University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP