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Trial Outcomes & Findings for ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients (NCT NCT04423939)

NCT ID: NCT04423939

Last Updated: 2025-11-25

Results Overview

The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

Baseline (~30 days before HCT), Signoff (~10 days before HCT), Day 90 post-HCT

Results posted on

2025-11-25

Participant Flow

Participants were recruited from the Duke Adult Bone Marrow Transplant program between August 2020 and September 2022. The first subject was consented on October 14, 2020 and the last subject was consented on June 7, 2022.

Five subjects consented to the study but were excluded before starting intervention. One patient's caregiver declined to participate and lack of caregiver participation is an exclusion criteria for this study. One patient was no longer scheduled to receive an allogeneic transplant and they and their caregiver were excluded. One patient relapsed and was no longer getting a transplant and they and their caregiver were excluded.

Participant milestones

Participant milestones
Measure
Hematopoietic Stem Cell Transplantation (HCT) Patients
HCT patients at Duke Acceptance and Commitment Therapy (ACT): The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.
Caregivers
HCT patient caregivers at Duke Acceptance and Commitment Therapy (ACT): The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.
Overall Study
STARTED
14
14
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
14
14

Reasons for withdrawal

Reasons for withdrawal
Measure
Hematopoietic Stem Cell Transplantation (HCT) Patients
HCT patients at Duke Acceptance and Commitment Therapy (ACT): The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.
Caregivers
HCT patient caregivers at Duke Acceptance and Commitment Therapy (ACT): The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.
Overall Study
Still on study (but completed primary endpoint)
8
8
Overall Study
Death
3
0
Overall Study
Withdrawal by Subject
3
0
Overall Study
Caregiver to patient who died
0
3
Overall Study
Caregiver to patient who withdrew
0
3

Baseline Characteristics

Caregivers are not included in the diagnosis category

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Caregivers
n=14 Participants
14 HCT patients' caregivers at Duke Acceptance and Commitment Therapy (ACT): The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the patient and caregiver.
Total
n=28 Participants
Total of all reporting groups
Hematopoietic Stem Cell Transplantation (HCT) Patients
n=14 Participants
14 HCT patients at Duke Acceptance and Commitment Therapy (ACT): The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the patient and caregiver.
Age, Continuous
58.1 years
STANDARD_DEVIATION 11.9 • n=14 Participants
55.7 years
STANDARD_DEVIATION 13.3 • n=28 Participants
53.3 years
STANDARD_DEVIATION 14.6 • n=14 Participants
Sex: Female, Male
Female
8 Participants
n=14 Participants
15 Participants
n=28 Participants
7 Participants
n=14 Participants
Sex: Female, Male
Male
6 Participants
n=14 Participants
13 Participants
n=28 Participants
7 Participants
n=14 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=14 Participants
1 Participants
n=28 Participants
1 Participants
n=14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
n=14 Participants
24 Participants
n=28 Participants
13 Participants
n=14 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=14 Participants
3 Participants
n=28 Participants
0 Participants
n=14 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=14 Participants
0 Participants
n=28 Participants
0 Participants
n=14 Participants
Race (NIH/OMB)
Asian
0 Participants
n=14 Participants
0 Participants
n=28 Participants
0 Participants
n=14 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=14 Participants
0 Participants
n=28 Participants
0 Participants
n=14 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=14 Participants
4 Participants
n=28 Participants
2 Participants
n=14 Participants
Race (NIH/OMB)
White
9 Participants
n=14 Participants
21 Participants
n=28 Participants
12 Participants
n=14 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=14 Participants
0 Participants
n=28 Participants
0 Participants
n=14 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=14 Participants
3 Participants
n=28 Participants
0 Participants
n=14 Participants
Diagnosis
Acute myeloid leukemia
—
6 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
6 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
Diagnosis
Myeloproliferative neoplasm
—
3 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
3 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
Diagnosis
Myelodysplastic syndrome
—
2 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
2 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
Diagnosis
Diffuse large B cell lymphoma
—
1 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
1 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
Diagnosis
Acute lymphoblastic leukemia
—
1 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
1 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
Diagnosis
Chronic myeloid leukemia
—
1 Participants
n=14 Participants • Caregivers are not included in the diagnosis category
1 Participants
n=14 Participants • Caregivers are not included in the diagnosis category

PRIMARY outcome

Timeframe: Baseline (~30 days before HCT), Signoff (~10 days before HCT), Day 90 post-HCT

The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Outcome measures

Outcome measures
Measure
Hematopoietic Stem Cell Transplantation (HCT) Patients
n=14 Participants
14 HCT patients at Duke Acceptance and Commitment Therapy (ACT): The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.
Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT)
Baseline (~30 days before HCT)
449 meters
Interval 421.0 to 477.0
Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT)
Sign off (~10 days before HCT)
468 meters
Interval 439.0 to 496.0
Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT)
Day 90
478 meters
Interval 447.0 to 509.0

PRIMARY outcome

Timeframe: Up to Day 90

Hospital length of stay in days

Outcome measures

Outcome measures
Measure
Hematopoietic Stem Cell Transplantation (HCT) Patients
n=14 Participants
14 HCT patients at Duke Acceptance and Commitment Therapy (ACT): The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.
Hospital Length of Stay, as Measured by Medical Record Review
31.4 days
Standard Deviation 27.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 90

Stool samples assessed by 16s rRNA sequencing

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, D0, D7, D14, D21, Day 30, Day 60, Day 180, Year 1, Year 2, and Year 3

Stool samples assessed by 16s rRNA sequencing

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Hospital length of stay in days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3

The baseline for each patient is made through an algorithm that factors the patients age and gender. The patient's score is compared to what a person that is the patient's same age and gender would get. This comparison is then used as a tool to assess aerobic capacity or endurance.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Continuous from baseline

Post-HCT clinical outcomes (i.e. GVHD)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Exit interviews to assess patients' opinion on the ACT program

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, at each ACT session time point

6-item survey to assess patients' opinion on the ACT program

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Whole blood samples, will be analyzed and monitored for outcomes such as immune cell differentiation, immune response and development of GVHD. Flow cytometry will be performed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Approximately 1ml of plasma from the EDTA tube will be used for metabolomics analysis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 14, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Skin swab samples batch sequenced and microbiome analyzed

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, Year 1

Assessing changes in severity of core symptoms that are typically associated with HCT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

9-item questionnaire to assess preparedness for caregiving

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The Self-Efficacy to Manage Chronic Disease Scale is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The 5D represents 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Five levels of severity are measured, as indicated by the "5L," ranging from "no problems" to "extreme problems." All scores are converted into a summary index.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

21 item assessment scored on a 5-point Likert scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

50 item assessment. Higher total and domain scores indicate greater quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The scores of all of the sections are added and if the patient has a score greater or equal to three this assessment deems that the patients is frail. If the patient has a score between 1-2 the patient is deemed pre-frail.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

22-item questionnaire to assess how a patient's care as affected their finances

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, D180, Year 1, Year 2, and Year 3

Questionnaire to assess caregiver socioeconomic status

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

COST-FACIT is an 11-item questionnaire that assesses a patient's financial toxicity

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

CMS SDOH is a 10 item survey that assesses 5 domains of social needs

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

ASA-24 is a self-administered 24-hour diet recall

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Scores for each section can range from 0-4 depending on severity and nutritional impact. The sum of all scores provides the Total PG-SGA score, which can be used to indicate the need for intervention (Bauer et al., 2002)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Continuous from baseline

BMI can be associated with a patient's nutritional health

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Albumin levels can be associated with a patient's nutritional health

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The HHI-12 is an adapted 12 question version of the Hearth Hope Scale that assesses a patient's sense of hope

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

PC-PTSD is a 5 item screen to identify patients with probable PTSD. If the patient screens positive, they then take the PCL-5. The PCL-5 is a 20 item screen to assess symptoms of PTSD.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 90

The VQ is a 10-item self-report questionnaire that assesses how closely a person is living in align with their values over the last week. Progress (range = 0 to 30) is defined as enactment and perseverance in living consistently with one's values; higher scores represent a closer alignment between one's internal values and one's actions. Obstruction (range = 0 to 30) represents the extent to which various disruptions got in the way of valued living; higher scores represent more interference with living consistently with one's values. The baseline and day 90 VQ scores are reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

This administered assessment is subdivided into visuospatial/executive (5pts), naming (3pts), memory (no points), attention(5pts), language(3pts), abstraction(2pts), delayed recall(5pts), and orientation(6pts). All the subdivided sections have as many questions as they have points. For analysis, the cut point is if the patient has less than 26 points.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Participants will answer Yes/No to whether they have had any falls in the preceding 6 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Continuous from baseline up to 3 years

Activity tracker tracks number of steps per day

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Subjects will sit in a chair with their arms crossed over their chest and rise to a standing position, then return to seated position. They will repeat this as many times as they can in 30 seconds.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

All the task points are added which make the SPPB score. The cut-point for the SPPB is a score of 10. The cumulative and sections scores are assessed individually and comprehensively. This assessment score will be used as a tool for evaluating lower extremity functioning in older persons.

Outcome measures

Outcome data not reported

Adverse Events

Hematopoietic Stem Cell Transplantation (HCT) Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths

Caregivers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anthony Sung

Duke University Medical Center

Phone: 919-668-1000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place