Trial Outcomes & Findings for Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA) (NCT NCT05358951)
NCT ID: NCT05358951
Last Updated: 2026-02-27
Results Overview
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
COMPLETED
NA
56 participants
Baseline to 8-weeks post-intervention session
2026-02-27
Participant Flow
Participant milestones
| Measure |
NON-COACHING CONDITION STEP-YA
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
COACHING CONDITION STEP-YA
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
|---|---|---|
|
Intervention Session and Evaluation
STARTED
|
27
|
29
|
|
Intervention Session and Evaluation
COMPLETED
|
27
|
29
|
|
Intervention Session and Evaluation
NOT COMPLETED
|
0
|
0
|
|
Required Follow-up
STARTED
|
27
|
29
|
|
Required Follow-up
COMPLETED
|
27
|
28
|
|
Required Follow-up
NOT COMPLETED
|
0
|
1
|
|
Optional Follow-up
STARTED
|
27
|
25
|
|
Optional Follow-up
COMPLETED
|
18
|
19
|
|
Optional Follow-up
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
NON-COACHING CONDITION STEP-YA
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
COACHING CONDITION STEP-YA
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
|---|---|---|
|
Required Follow-up
Withdrawal by Subject
|
0
|
1
|
|
Optional Follow-up
Lost to Follow-up
|
9
|
6
|
Baseline Characteristics
One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample.
Baseline characteristics by cohort
| Measure |
NON-COACHING CONDITION STEP-YA
n=27 Participants
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
COACHING CONDITION STEP-YA
n=28 Participants
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.67 Years
STANDARD_DEVIATION 6.10 • n=24 Participants • One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample.
|
29.29 Years
STANDARD_DEVIATION 5.28 • n=20 Participants • One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample.
|
29.96 Years
STANDARD_DEVIATION 5.69 • n=40 Participants • One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample.
|
|
Sex/Gender, Customized
Female
|
21 Participants
n=24 Participants
|
16 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Male
|
6 Participants
n=24 Participants
|
10 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Not Specified
|
0 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=24 Participants
|
22 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=24 Participants
|
25 Participants
n=20 Participants
|
49 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Insomnia Severity Index
|
15.11 Units on a scale
STANDARD_DEVIATION 3.34 • n=24 Participants
|
15.17 Units on a scale
STANDARD_DEVIATION 3.58 • n=20 Participants
|
15.14 Units on a scale
STANDARD_DEVIATION 3.43 • n=40 Participants
|
|
Profile of Mood States - Short Form (Total Mood Disturbance)
|
23.37 Units on a scale
STANDARD_DEVIATION 15.64 • n=24 Participants
|
34.14 Units on a scale
STANDARD_DEVIATION 21.31 • n=20 Participants
|
28.85 Units on a scale
STANDARD_DEVIATION 19.35 • n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8-weeks post-intervention sessionPopulation: One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample.
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Outcome measures
| Measure |
COACHING CONDITION STEP-YA
n=28 Participants
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
NON-COACHING CONDITION STEP-YA
n=27 Participants
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
|---|---|---|
|
Insomnia Severity Change at 8 Weeks
|
5.67 Units on a scale
Standard Deviation 3.26
|
7.25 Units on a scale
Standard Deviation 3.47
|
SECONDARY outcome
Timeframe: Baseline to 8-weeks post-intervention sessionPopulation: One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample.
The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.
Outcome measures
| Measure |
COACHING CONDITION STEP-YA
n=28 Participants
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
NON-COACHING CONDITION STEP-YA
n=27 Participants
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
|---|---|---|
|
Profile of Mood States Change at 8 Weeks
|
7.75 Units on a scale
Standard Deviation 13.40
|
4.07 Units on a scale
Standard Deviation 13.37
|
SECONDARY outcome
Timeframe: Baseline to 4-weeks post-intervention sessionPopulation: One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample.
The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.
Outcome measures
| Measure |
COACHING CONDITION STEP-YA
n=28 Participants
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
NON-COACHING CONDITION STEP-YA
n=27 Participants
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
|---|---|---|
|
Profile of Mood States Change at 4 Weeks
|
12.00 Units on a scale
Standard Deviation 17.07
|
9.48 Units on a scale
Standard Deviation 14.32
|
SECONDARY outcome
Timeframe: Baseline to 4-weeks post-intervention sessionPopulation: One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample.
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Outcome measures
| Measure |
COACHING CONDITION STEP-YA
n=28 Participants
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
NON-COACHING CONDITION STEP-YA
n=27 Participants
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
|---|---|---|
|
Insomnia Severity Change at 4 Weeks
|
8.28 Units on a scale
Standard Deviation 3.92
|
9.51 Units on a scale
Standard Deviation 4.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeks post-intervention sessionThe Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Outcome measures
| Measure |
COACHING CONDITION STEP-YA
n=19 Participants
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
NON-COACHING CONDITION STEP-YA
n=18 Participants
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
|
|---|---|---|
|
Insomnia Severity at 16 Weeks (Optional)
|
5.47 Units on a scale
Standard Deviation 2.50
|
7.00 Units on a scale
Standard Deviation 4.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks post-interventionStudy specific questionnaire assessing intervention acceptability, credibility and participant satisfaction
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks post-interventionStudy specific questionnaire describing satisfaction with coaching sessions
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 Weeks post-intervention sessionStudy specific questionnaire asking about participant satisfaction with the intervention
Outcome measures
Outcome data not reported
Adverse Events
NON-COACHING CONDITION STEP-YA
COACHING CONDITION STEP-YA
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