Trial Outcomes & Findings for In Person and mHealth Coping Skills Training for Symptom Management and Steps in Stem Cell Transplant Patients (NCT NCT03859765)
NCT ID: NCT03859765
Last Updated: 2024-03-22
Results Overview
Feasibility will be shown by meeting targeted study accrual (N=40) in the 16-month study period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
16 months (additional year granted due to COVID-19).
Results posted on
2024-03-22
Participant Flow
Participant milestones
| Measure |
HCT Symptoms and Steps
HCT Symptoms and Steps participants will complete in-person (3) and video-conferencing (4) coping skills training and activity coaching sessions teaching cognitive behavioral coping skills to manage pain, fatigue, and distress and increase activity. Participants will be given a wireless activity tracker and a smartphone for accessing the study mobile app.
HCT Symptoms and Steps: HCT Symptoms and Steps will provide patients with cognitive behavioral coping skills training and activity coaching sessions to enhance their ability to manage symptoms that interfere with activity.
|
HCT Education
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In Person and mHealth Coping Skills Training for Symptom Management and Steps in Stem Cell Transplant Patients
Baseline characteristics by cohort
| Measure |
HCT Symptoms and Steps
n=20 Participants
HCT Symptoms and Steps participants will complete in-person (3) and video-conferencing (4) coping skills training and activity coaching sessions teaching cognitive behavioral coping skills to manage pain, fatigue, and distress and increase activity. Participants will be given a wireless activity tracker and a smartphone for accessing the study mobile app.
HCT Symptoms and Steps: HCT Symptoms and Steps will provide patients with cognitive behavioral coping skills training and activity coaching sessions to enhance their ability to manage symptoms that interfere with activity.
|
HCT Education
n=20 Participants
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
60.59 years
STANDARD_DEVIATION 11.04 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 10.96 • n=7 Participants
|
59.32 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Cancer Type
Lymphoma
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Cancer Type
Multiple Myeloma
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Cancer Type
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
First cancer or recurrence
First Cancer
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
First cancer or recurrence
Recurrence
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Time since diagnosis (months)
|
33.46 Months
STANDARD_DEVIATION 65.08 • n=5 Participants
|
18.86 Months
STANDARD_DEVIATION 30.60 • n=7 Participants
|
26.16 Months
STANDARD_DEVIATION 50.73 • n=5 Participants
|
|
Number of participants receiving chemotherapy
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Number of participants receiving anti-cancer drug
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Time since transplant (days)
|
25.10 Days
STANDARD_DEVIATION 44.30 • n=5 Participants
|
14.20 Days
STANDARD_DEVIATION 10.98 • n=7 Participants
|
19.65 Days
STANDARD_DEVIATION 32.33 • n=5 Participants
|
PRIMARY outcome
Timeframe: 16 months (additional year granted due to COVID-19).Population: Total number screened
Feasibility will be shown by meeting targeted study accrual (N=40) in the 16-month study period.
Outcome measures
| Measure |
Screening
n=123 Participants
Potential participants who were screened prior to consent
|
HCT Education
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months
Number Ineligible
|
28 Participants
|
—
|
|
Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months
Number Eligible but Declined
|
51 Participants
|
—
|
|
Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months
Number Eligible but Unable to Consent
|
4 Participants
|
—
|
|
Feasibility as Measured by Number of Participants Accrued to the Study Within 16 Months
Number Accrued
|
40 Participants
|
—
|
PRIMARY outcome
Timeframe: approximately 20-24 weeksA measure of feasibility.
Outcome measures
| Measure |
Screening
n=20 Participants
Potential participants who were screened prior to consent
|
HCT Education
n=20 Participants
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Number of Participants Who Adhere to at Least 80% of the Study Protocol
|
17 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: approximately 20-24 weeksA measure of feasibility.
Outcome measures
| Measure |
Screening
n=20 Participants
Potential participants who were screened prior to consent
|
HCT Education
n=20 Participants
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Number of Participants Who do Not Complete the 3-month Post-treatment Follow-up Assessment
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: post-treatment (approximately 7-12 weeks)Population: Only applicable to the HCT Symptoms and Steps arm. Data not collected on two participants.
This questionnaire contains 8 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to sum CSQ answers resulting in a score range from 8 to 32. The intervention is considered acceptable if the mean value for acceptability across all participants is above 80% of max acceptability score (i.e., 25.6).
Outcome measures
| Measure |
Screening
n=18 Participants
Potential participants who were screened prior to consent
|
HCT Education
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) 8-item Version
|
27.89 units on a scale
Standard Deviation 3.46
|
—
|
SECONDARY outcome
Timeframe: pre-treatment (baseline), post-treatment (approximately 7-12 weeks)Population: Participants with data collected at both time points.
Physical Disability will be assessed using the Functional Assessment of Cancer Therapy 7-item physical well-being scale. Each item is scored 0=not at all to 4=very much as the statement applies to the past 7 days. The full range of the scale is 0 to 28, with a higher score indicating a better outcome.
Outcome measures
| Measure |
Screening
n=18 Participants
Potential participants who were screened prior to consent
|
HCT Education
n=18 Participants
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Change in Physical Disability as Measured by the the Functional Assessment of Cancer Therapy (FACT)
|
4.78 units on a scale
Standard Deviation 4.91
|
6.94 units on a scale
Standard Deviation 6.66
|
SECONDARY outcome
Timeframe: pre-treatment (baseline), post-treatment (approximately 7-12 weeks).Population: Participants with data collected at both time points.
Pain severity will be assessed with the Brief Pain Inventory (BPI). Patients will rate their "pain right now", "worst", "least" and "average" pain in the last week from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.
Outcome measures
| Measure |
Screening
n=18 Participants
Potential participants who were screened prior to consent
|
HCT Education
n=18 Participants
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Change in Pain Severity
|
-.79 units on a scale
Standard Deviation 2.19
|
.02 units on a scale
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: pre-treatment (baseline), post-treatment (approximately 7-12 weeks).Population: Participants with data collected at both time points.
Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) seven-item Fatigue Scale. For each item, the statement applies to the past 7 days: "never" (1), "rarely" (2), "sometimes" (3), "often" (4), or "always" (5). The summed score is then converted to a T-Score (0-100), where a higher T-Score indicates worse fatigue. 50 indicates the population mean with a standard deviation of 10. 50 and below is considered below average, 50-60 is mild, and 60 or greater is moderate/severe.
Outcome measures
| Measure |
Screening
n=18 Participants
Potential participants who were screened prior to consent
|
HCT Education
n=18 Participants
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Change in Fatigue
|
-2.62 units on a scale
Standard Deviation 6.98
|
-4.72 units on a scale
Standard Deviation 8.73
|
SECONDARY outcome
Timeframe: pre-treatment (baseline), post-treatment (approximately 7-12 weeks).Population: Participants with data collected at both time points.
Physical Activity will be assessed via step count with a wireless activity tracker (e.g., Fitbit). A distinct value pre and post treatment are reported, no averages were taken across multiple days.
Outcome measures
| Measure |
Screening
n=18 Participants
Potential participants who were screened prior to consent
|
HCT Education
n=18 Participants
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Change in Physical Activity
|
1686.35 steps
Standard Deviation 3894.57
|
1001.50 steps
Standard Deviation 2471.15
|
SECONDARY outcome
Timeframe: pre-treatment (baseline), post-treatment (approximately 7-12 weeks)Population: Participants with data collected at both time points.
Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). Each question rated 0-3, totaling 21 points.Total score of 0-7 = normal, 8-10 = borderline abnormal, 11-21 = abnormal.
Outcome measures
| Measure |
Screening
n=18 Participants
Potential participants who were screened prior to consent
|
HCT Education
n=18 Participants
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Change in Depression
|
-1.28 units on a scale
Standard Deviation 2.49
|
-2.72 units on a scale
Standard Deviation 5.26
|
SECONDARY outcome
Timeframe: pre-treatment (baseline), post-treatment (approximately 7-12 weeks)Population: Participants with data collected at both time points.
Anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS). Each question rated 0-3, totaling 21 points.Total score of 0-7 = normal, 8-10 = borderline abnormal, 11-21 = abnormal.
Outcome measures
| Measure |
Screening
n=18 Participants
Potential participants who were screened prior to consent
|
HCT Education
n=18 Participants
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Change in Anxiety.
|
-1.28 units on a scale
Standard Deviation 1.96
|
-1.22 units on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: pre-treatment (baseline), post-treatment (approximately 7-12 weeks)Population: Participants with data collected at both time points.
Change in self-efficacy as measured by the Self-Efficacy for Symptom Management scale: 1=not at all confident to 10=totally confident.
Outcome measures
| Measure |
Screening
n=18 Participants
Potential participants who were screened prior to consent
|
HCT Education
n=18 Participants
HCT Education participants will receive 1 brief in clinic session prior to discharge home providing education related to symptom management and physical activity, and a wireless activity tracker. HCT Education participants will also receive 6 brief phone calls upon return home.
|
|---|---|---|
|
Change in Self-Efficacy
|
-.98 units on a scale
Standard Deviation 2.47
|
.85 units on a scale
Standard Deviation 1.52
|
Adverse Events
HCT Symptoms and Steps
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HCT Education
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place