Condition or disease | Intervention/treatment | Phase |
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Gastrointestinal Neoplasms | Behavioral: Acceptance and Commitment Therapy Behavioral: Education/Support | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Advanced gastrointestinal cancer patient-family caregiver dyads (N = 42) 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 |
Official Title: | Telephone Support for Advanced Gastrointestinal Cancer Patients and Their Family Caregivers |
Actual Study Start Date : | August 26, 2019 |
Estimated Primary Completion Date : | July 2, 2021 |
Estimated Study Completion Date : | July 2, 2021 |
Arm | Intervention/treatment |
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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).
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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.
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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.
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
United States, Indiana | |
Eskenazi Health | |
Indianapolis, Indiana, United States, 46202 | |
Indiana University Simon Cancer Center | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Catherine E Mosher, Ph.D. | Indiana University |
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | July 3, 2019 | ||||||||||||||||||
First Posted Date ICMJE | July 8, 2019 | ||||||||||||||||||
Last Update Posted Date | April 8, 2021 | ||||||||||||||||||
Actual Study Start Date ICMJE | August 26, 2019 | ||||||||||||||||||
Estimated Primary Completion Date | July 2, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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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 42 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 = 42 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 = 42) 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 |
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Condition ICMJE | Gastrointestinal Neoplasms | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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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. | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||
Actual Enrollment ICMJE |
84 | ||||||||||||||||||
Original Estimated Enrollment ICMJE |
80 | ||||||||||||||||||
Estimated Study Completion Date ICMJE | July 2, 2021 | ||||||||||||||||||
Estimated Primary Completion Date | July 2, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE |
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
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 ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Catherine Mosher, Indiana University | ||||||||||||||||||
Study Sponsor ICMJE | Indiana University | ||||||||||||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | Indiana University | ||||||||||||||||||
Verification Date | April 2021 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |