Stem Cell Transplant Patients
Conditions
Keywords
Cognitive Behavioral Therapy, CBT, Hematopoietic Stem Cell Transplant, Acceptance and Commitment Therapy
Brief summary
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.
Interventions
BEHAVIORALACTivate sessions
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.
Sponsors
Anthony Sung, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
There are 2 arms in this study. Participants will be randomized to: * Education Control Arm * ACTivate Arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Patient Inclusion Criteria: * Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE: Remote / electronic consent via REDCap consenting allowed per IRB policy and approval. * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study * Plan to undergo allogeneic HCT in approximately 30 days * Males and/or females age 18 - 80 years * Agreement to adhere to Lifestyle Considerations throughout study duration * Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access). NOTE: A smartphone will be provided to participants if needed. * Able to read/write English or Spanish (as we lack trained ACT interventionists in other languages) Caregiver Inclusion Criteria: * Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE: Remote / electronic consent via REDCap consenting allowed per IRB policy and approval. * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study * Males and/or females age 18-80 years * Agreement to adhere to Lifestyle Considerations throughout study duration * Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access). NOTE: A smartphone will be provided to participants if needed. * Able to read/write English or Spanish (as we lack trained ACT interventionists in other languages) Patient
Exclusion criteria
* Caregiver unwilling to enroll (as standard of care, all HCT patients are required to have a caregiver, but caregivers may decline to participate in this study which would make the patient ineligible for this study) * Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements * Concurrent participation in another behavioral intervention research study. * Activity restrictions that limit one's ability to engage in intense physical activity Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Function (Six Minute Walk Test Distance) | Baseline, Day 30 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Measured at Day 180 | The length of hospital stay measured in days from time of transplant to time of discharge. |
| Effect on Clinical Outcomes (Treatment-related Mortality) | Day -30, Day 30, Day 100, Year 1 | Effect on clinical outcomes as measured by treatment-related mortality. |
| Effect on Clinical Outcomes (Overall Survival) | Day -30, Day 30, Day 100, Year 1 | Effect on clinical outcomes as measured by overall survival. |
| Effect on Health-related Quality of Life (Short Physical Performance Battery) | Day -30, Day 30, Day 100, Year 1 | 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. |
| Effect on Health-related Quality of Life (30 Second Sit-to-Stand Test) | Day -30, Day 30, Day 100, Year 1 | 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. |
| Effect on Health-related Quality of Life (Lorig Self-Efficacy) | Day -30, Day 30, Day 100, Year 1 | 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. |
| Effect on Health-related Quality of Life (PROMIS-29+2 Profile) | Day -30, Day 30, Day 100, Year 1 | 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. |
| Effect on Health-related Quality of Life (FACT-BMT) | Day -30, Day 30, Day 100, Year 1 | 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. |
| Effect on Psychological Flexibility (CompACT-10 Questionnaire) | Baseline, Year 1 | 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. |
| Caregiver Self-Efficacy (Caregiver Inventory) | Baseline, Year 1 | 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. |
Countries
United States
Contacts
CONTACTAnthony Sung, MD
Outcome results
None listed