Stem Cell Transplant PatientsACTivateNCT07516314
ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant Patients
A study testing ACTivate sessions in people with Stem Cell Transplant Patients, run by Anthony Sung, MD at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stem Cell Transplant Patients
- What is being tested?
- ACTivate sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2026to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 Exclusion Criteria:
- Patient unwilling to enroll
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Duke University
Durham, North Carolina, 27705
Dottie R Mayo, BA, 919-668-1935, dorothy.mayo@duke.edu
Rhonda M Merwin, PhD
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Anthony Sung, MD, 9135886030, asung2@kumc.edu
Anthony Sung, MD
About this study
Official title: ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients (ACTivate)
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.
- Conditions
- Stem Cell Transplant Patients
- Being tested
- ACTivate sessions
- Keywords
- Cognitive Behavioral Therapy, CBT, Hematopoietic Stem Cell Transplant, Acceptance and Commitment Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTivate sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education Control Arm | No intervention | Participants in the education control arm will not attend ACTivate sessions. |
| ACTivate Arm | Experimental | Participants in the ACTivate arm will attend ACTivate sessions. Receives: Behavioral: ACTivate sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 30
Secondary outcomes (10)
Length of Stay
The length of hospital stay measured in days from time of transplant to time of discharge.
Measured: Measured at Day 180
Effect on Clinical Outcomes (Treatment-related Mortality)
Effect on clinical outcomes as measured by treatment-related mortality.
Measured: Day -30, Day 30, Day 100, Year 1
Effect on Clinical Outcomes (Overall Survival)
Effect on clinical outcomes as measured by overall survival.
Measured: 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.
Measured: 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.
Measured: Day -30, Day 30, Day 100, Year 1
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (82)Papers the sponsor has linked to this study.
- Other trials for Stem Cell Transplant PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 arms in this study. Participants will be randomized to: * Education Control Arm * ACTivate Arm
- Masking
- None (open label)
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anthony Sung, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anthony Sung, MD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516314
- Sponsor's protocol ID
- IIT-2025-ACTivate
- Acronym
- ACTivate
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Oncology Center of Excellence (OCE). Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices Guidance for Industry - Draft Guidance. December 2024. Available from: https://www.fda.gov/media/184745/download . Accessed 01-21-2025.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry - E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1). January 2013. Available from: https://www.fda.gov/media/84857/download Accessed 01-21-2025.
Protocol Review & Monitoring Committee (PRMC) - About the PRMC. Cited 09-20-2024. Available from: https://kumed.sharepoint.com/sites/mykumc/prmc/Pages/default.aspx Accessed 09-20-2024.
The University of Kansas Cancer Center Clinical Trials Office Policy - Executive Resourcing Committee Submission Requirements. Version dated 08-03-2022. Cited 09-20-2024. Available from: https://kumed.sharepoint.com/sites/mykumc/cto/Documents/CTO%20Policy_ERC%20Submission.pdf#search=executive%20resource Accessed 09-20-2024.
The University of Kansas Cancer Center General Administration Guidance Document - Use of Investigator Initiated Steering Committee. Version dated 07-31-2023. Cited 09-20-2024. Available from: https://kumed.sharepoint.com/sites/mykumc/cto-training/Documents/Guidance_Use%20of%20Investigator%20Initiated%20Steering%20Committee.pdf#search=steering%20committee%20guidance%20document Accessed 09-20-2024.
Fitzmaurice, G., Laird, N.M., and Ware, J.H., Applied Longitudinal Analysis. Wiley Series in Probability and Statistics2004, New York: John Wiley & Sons.
Atkins DC. Using multilevel models to analyze couple and family treatment data: basic and advanced issues. J Fam Psychol. 2005 Mar;19(1):98-110. doi: 10.1037/0893-3200.19.1.98.
PubMed 15796656Adachi H. Cardiopulmonary Exercise Test. Int Heart J. 2017 Oct 21;58(5):654-665. doi: 10.1536/ihj.17-264. Epub 2017 Sep 30.
PubMed 28966333Vandekerckhove K, De Waele K, Minne A, Coomans I, De Groote K, Panzer J, Dhooge C, Bordon V, De Wolf D, Boone J. Evaluation of cardiopulmonary exercise testing, heart function, and quality of life in children after allogenic hematopoietic stem cell transplantation. Pediatr Blood Cancer. 2019 Jan;66(1):e27499. doi: 10.1002/pbc.27499. Epub 2018 Oct 14.
PubMed 30318730Hedeker, D., Gibbons, D. Longitudinal data analysis. New York, Wiley, 2006.
Franceschi C, Campisi J. Chronic inflammation (inflammaging) and its potential contribution to age-associated diseases. J Gerontol A Biol Sci Med Sci. 2014 Jun;69 Suppl 1:S4-9. doi: 10.1093/gerona/glu057.
PubMed 24833586Ariffin H, Azanan MS, Abd Ghafar SS, Oh L, Lau KH, Thirunavakarasu T, Sedan A, Ibrahim K, Chan A, Chin TF, Liew FF, Jeyamogan S, Rosli ES, Baharudin R, Yap TY, Skinner R, Lum SH, Hainaut P. Young adult survivors of childhood acute lymphoblastic leukemia show evidence of chronic inflammation and cellular aging. Cancer. 2017 Nov 1;123(21):4207-4214. doi: 10.1002/cncr.30857. Epub 2017 Jun 27.
PubMed 28654149Parker D, Sloane R, Pieper CF, Hall KS, Kraus VB, Kraus WE, Huebner JL, Ilkayeva OR, Bain JR, Newby LK, Cohen HJ, Morey MC. Age-Related Adverse Inflammatory and Metabolic Changes Begin Early in Adulthood. J Gerontol A Biol Sci Med Sci. 2019 Feb 15;74(3):283-289. doi: 10.1093/gerona/gly121.
PubMed 29985987Griesenauer B, Paczesny S. The ST2/IL-33 Axis in Immune Cells during Inflammatory Diseases. Front Immunol. 2017 Apr 24;8:475. doi: 10.3389/fimmu.2017.00475. eCollection 2017.
PubMed 28484466Adom D, Rowan C, Adeniyan T, Yang J, Paczesny S. Biomarkers for Allogeneic HCT Outcomes. Front Immunol. 2020 Apr 21;11:673. doi: 10.3389/fimmu.2020.00673. eCollection 2020.
PubMed 32373125
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients (ACTivate)
- ClinicalTrials.gov ID
- NCT07516314
- Acronym / sponsor ID
- ACTivate / IIT-2025-ACTivate
- Conditions
- Stem Cell Transplant Patients
- Keywords
- Cognitive Behavioral Therapy, CBT, Hematopoietic Stem Cell Transplant, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Anthony Sung, MDUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are 2 arms in this study. Participants will be randomized to: * Education Control Arm * ACTivate Arm
| Arm | Type | Receives |
|---|---|---|
| Education Control Arm | No intervention | –Participants in the education control arm will not attend ACTivate sessions. |
| ACTivate Arm | Experimental | Behavioral: ACTivate sessionsParticipants in the ACTivate arm will attend ACTivate sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTivate sessionsACTivate 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. | Behavioural | ACTivate Arm |
Primary outcome
Change in Physical Function (Six Minute Walk Test Distance)
Time frame: 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.
10 secondary outcomes
Length of Stay
Time frame: Measured at Day 180
Effect on Clinical Outcomes (Treatment-related Mortality)
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Clinical Outcomes (Overall Survival)
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (Short Physical Performance Battery)
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (30 Second Sit-to-Stand Test)
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (Lorig Self-Efficacy)
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (PROMIS-29+2 Profile)
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (FACT-BMT)
Time frame: Day -30, Day 30, Day 100, Year 1
Effect on Psychological Flexibility (CompACT-10 Questionnaire)
Time frame: Baseline, Year 1
Caregiver Self-Efficacy (Caregiver Inventory)
Time frame: Baseline, Year 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- BackgroundU.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Oncology Center of Excellence (OCE). Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices Guidance for Industry - Draft Guidance. December 2024. Available from: https://www.fda.gov/media/184745/download . Accessed 01-21-2025.
- BackgroundU.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry - E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1). January 2013. Available from: https://www.fda.gov/media/84857/download Accessed 01-21-2025.
- BackgroundProtocol Review & Monitoring Committee (PRMC) - About the PRMC. Cited 09-20-2024. Available from: https://kumed.sharepoint.com/sites/mykumc/prmc/Pages/default.aspx Accessed 09-20-2024.
- BackgroundThe University of Kansas Cancer Center Clinical Trials Office Policy - Executive Resourcing Committee Submission Requirements. Version dated 08-03-2022. Cited 09-20-2024. Available from: https://kumed.sharepoint.com/sites/mykumc/cto/Documents/CTO%20Policy_ERC%20Submission.pdf#search=executive%20resource Accessed 09-20-2024.
- BackgroundThe University of Kansas Cancer Center General Administration Guidance Document - Use of Investigator Initiated Steering Committee. Version dated 07-31-2023. Cited 09-20-2024. Available from: https://kumed.sharepoint.com/sites/mykumc/cto-training/Documents/Guidance_Use%20of%20Investigator%20Initiated%20Steering%20Committee.pdf#search=steering%20committee%20guidance%20document Accessed 09-20-2024.
- BackgroundFitzmaurice, G., Laird, N.M., and Ware, J.H., Applied Longitudinal Analysis. Wiley Series in Probability and Statistics2004, New York: John Wiley & Sons.
- Background: PubMed 15796656Atkins DC. Using multilevel models to analyze couple and family treatment data: basic and advanced issues. J Fam Psychol. 2005 Mar;19(1):98-110. doi: 10.1037/0893-3200.19.1.98.
- Background: PubMed 28966333Adachi H. Cardiopulmonary Exercise Test. Int Heart J. 2017 Oct 21;58(5):654-665. doi: 10.1536/ihj.17-264. Epub 2017 Sep 30.
- Background: PubMed 30318730Vandekerckhove K, De Waele K, Minne A, Coomans I, De Groote K, Panzer J, Dhooge C, Bordon V, De Wolf D, Boone J. Evaluation of cardiopulmonary exercise testing, heart function, and quality of life in children after allogenic hematopoietic stem cell transplantation. Pediatr Blood Cancer. 2019 Jan;66(1):e27499. doi: 10.1002/pbc.27499. Epub 2018 Oct 14.
- BackgroundHedeker, D., Gibbons, D. Longitudinal data analysis. New York, Wiley, 2006.
- Background: PubMed 24833586Franceschi C, Campisi J. Chronic inflammation (inflammaging) and its potential contribution to age-associated diseases. J Gerontol A Biol Sci Med Sci. 2014 Jun;69 Suppl 1:S4-9. doi: 10.1093/gerona/glu057.
- Background: PubMed 28654149Ariffin H, Azanan MS, Abd Ghafar SS, Oh L, Lau KH, Thirunavakarasu T, Sedan A, Ibrahim K, Chan A, Chin TF, Liew FF, Jeyamogan S, Rosli ES, Baharudin R, Yap TY, Skinner R, Lum SH, Hainaut P. Young adult survivors of childhood acute lymphoblastic leukemia show evidence of chronic inflammation and cellular aging. Cancer. 2017 Nov 1;123(21):4207-4214. doi: 10.1002/cncr.30857. Epub 2017 Jun 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTivate sessions in people with Stem Cell Transplant Patients, run by Anthony Sung, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Sung, MD (9135886030, asung2@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Function (Six Minute Walk Test Distance) (time frame: Baseline, Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07516314, which also lists 82 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.