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

Conditions

• Stem Cell Transplant Patients

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

May 31, 2026

Status verified

Mar 2026

Primary completion

Jan 31, 2030

Completion

Apr 30, 2031

Study Design

Enrollment

476 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• No Intervention: Education Control Arm
  Participants in the education control arm will not attend ACTivate sessions.
• Experimental: ACTivate Arm
  Participants in the ACTivate arm will attend ACTivate sessions.

Primary Outcome Measure

Change in Physical Function (Six Minute Walk Test Distance) [ Time Frame: Baseline, Day 30 ]

Central Contacts

• Anthony Sung, MD
  9135886030
  [email protected]

Locations (2)

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