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NCT Number: NCT07516314

ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant Patients

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.

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Key information

Conditions

Stem Cell Transplant Patients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Cancer Center, Kansas City, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTivate sessions

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Length of Stay

    Time frame: Measured at Day 180

    The length of hospital stay measured in days from time of transplant to time of discharge.

  2. Effect on Clinical Outcomes (Treatment-related Mortality)

    Time frame: Day -30, Day 30, Day 100, Year 1

    Effect on clinical outcomes as measured by treatment-related mortality.

  3. Effect on Clinical Outcomes (Overall Survival)

    Time frame: Day -30, Day 30, Day 100, Year 1

    Effect on clinical outcomes as measured by overall survival.

  4. 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 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.

  5. 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 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.

  6. 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 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.

  7. 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 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.

  8. Effect on Health-related Quality of Life (FACT-BMT)

    Time frame: 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.

  9. Effect on Psychological Flexibility (CompACT-10 Questionnaire)

    Time frame: 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.

  10. Caregiver Self-Efficacy (Caregiver Inventory)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Sung, MD

CONTACT

[email protected]

9135886030

Sponsors and collaborators

Lead sponsor

Anthony Sung, MD

Other

Registry information

Official study title

ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients (ACTivate)

Acronym: ACTivate

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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