This study is a phase 2, multicenter, randomized controlled trial to test the application of Acceptance and Commitment Therapy (ACT) in HCT patients. ACT is an evidence-based cognitive behavioral therapy intervention that emphasizes psychological flexibility and behaviors, helping transplant patients focus on actions that may help maintain adequate physical activity despite physical and emotional discomfort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
476
ACTivate sessions are based on ACT and train psychological flexibility skills to help patients and caregivers adhere to recommendations for physical activity and nutrition in the face of an uncertain and difficult treatment course, side effects and complications. Sessions will be conducted conjointly (include both the patient and caregiver). . Interventionists will be master's level psychology professionals. All sessions will be conducted remotely and audiotaped.
University of Kansas Cancer Center
Kansas City, Kansas, United States
Duke University
Durham, North Carolina, United States
Change in Physical Function (Six Minute Walk Test Distance)
The change in physical function as measured by the difference in six minute walk test distance in meters from baseline to Day 30; a greater number of meters walked indicates a higher level of physical fitness.
Time frame: Baseline, Day 30
Length of Stay
The length of hospital stay measured in days from time of transplant to time of discharge.
Time frame: Measured at Day 180
Effect on Clinical Outcomes (Treatment-related Mortality)
Effect on clinical outcomes as measured by treatment-related mortality.
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Clinical Outcomes (Overall Survival)
Effect on clinical outcomes as measured by overall survival.
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (Short Physical Performance Battery)
Effect on health-related quality of life as measured by performance on the Short Physical Performance Battery, which results in a score from 0 to 12 points, with a higher number indicating better physical function.
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (30 Second Sit-to-Stand Test)
Effect on the health-related quality of life as measured by the 30-second Sit-to-Stand Test, which measures the number of times an individual can stand up from a chair and sit back down within 30 seconds, with higher number indicating greater fitness.
Time frame: Day -30, Day 30, Day 100, Year 1
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Effect on Health-related Quality of Life (Lorig Self-Efficacy)
Effect on health-related quality of life as measured by Lorig Self-Efficacy for Managing Chronic Disease Scale, which results in a numerical score between 1 and 10, with a higher number indicating higher self-efficacy.
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (PROMIS-29+2 Profile)
Effect on health-related quality of life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile, which results in a numerical score between 0 and 100, with a higher number indicating better physical function.
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (FACT-BMT)
Effect on health-related quality of life as measured by the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) questionnaire, which results in a numerical score between 0 and 148, with a higher number indicating a better quality of life.
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Psychological Flexibility (CompACT-10 Questionnaire)
Effect on psychological flexibility as measured by the CompACT-10 Questionnaire, which assess three key factors - openness to experience, behavioral awareness, and valued action - with higher total scores indicating higher psychological flexibility.
Time frame: Baseline, Year 1
Caregiver Self-Efficacy (Caregiver Inventory)
Caregiver self-efficacy as measured by the Caregiver Inventory (CGI), which results in a numerical score between 9 and 189, with a higher number indicating greater caregiver self-efficacy.
Time frame: Baseline, Year 1