Trial Outcomes & Findings for Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant (NCT NCT03125070)
NCT ID: NCT03125070
Last Updated: 2025-01-29
Results Overview
Among those impaired at baseline, percent who are no longer impaired at 12 months (among those not missing either). Scores range from 0-3 and higher scores indicate higher distress. A cutoff of \>=.90 was used to categorize participants as high in distress. Participants with scores \<.90 were categorized as not distressed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
546 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2025-01-29
Participant Flow
Number analyzed excludes 34 participants determined to be ineligible after consent and 137 participants identified as not requiring the intervention due to lack of distress and adherence to healthcare screening reccomendations. This leaves 375 participants included in the final analyses.
Participant milestones
| Measure |
Group I (INSPIRE, Survivorship Care Plan)
Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Internet, Mobile app and Telehealth Intervention: Receive INSPIRE and survivorship care plan
Survey Administration: Ancillary studies
|
Group II (Usual Care)
Patients receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Patients may receive access to the INSPIRE online program after 12 months.
Best Practice and Internet site with links to existing resources: Receive usual care
Survey Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
191
|
|
Overall Study
COMPLETED
|
129
|
159
|
|
Overall Study
NOT COMPLETED
|
55
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Group I (INSPIRE, Survivorship Care Plan)
n=184 Participants
Participants receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Internet, Mobile app and Telehealth Intervention: Receive INSPIRE and survivorship care plan
Survey Administration: Ancillary studies
|
Group II (Usual Care)
n=191 Participants
Participants receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Participants may receive access to the INSPIRE online program after 12 months.
Best Practice and Internet site with links to existing resources: Receive usual care
Survey Administration: Ancillary studies
|
Total
n=375 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
|
117 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
67 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Age, Continuous
|
59.11 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
177 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
167 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
181 participants
n=5 Participants
|
190 participants
n=7 Participants
|
371 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Cancer and Treatment Distress
|
77 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Healthcare Adherence (HCA)
|
95 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Group that met criterion for highly distressed
Among those impaired at baseline, percent who are no longer impaired at 12 months (among those not missing either). Scores range from 0-3 and higher scores indicate higher distress. A cutoff of \>=.90 was used to categorize participants as high in distress. Participants with scores \<.90 were categorized as not distressed.
Outcome measures
| Measure |
Group I (INSPIRE, Survivorship Care Plan)
n=77 Participants
Participants receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Internet, Mobile app and Telehealth Intervention: Receive INSPIRE and survivorship care plan
Survey Administration: Ancillary studies
|
Group II (Usual Care)
n=93 Participants
Participants receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Participants may receive access to the INSPIRE online program after 12 months.
Best Practice and Internet site with links to existing resources: Receive usual care
Survey Administration: Ancillary studies
|
|---|---|---|
|
Cancer and Treatment Distress (CTXD)
|
23.4 percentage of participants
Interval 14.5 to 34.4
|
22.6 percentage of participants
Interval 14.6 to 32.4
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Those impaired at baseline
Assesses adherence to cardiometabolic surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months. Scores range from 0-1. Higher scores indicate high adherence. A cutoff of \<.80 was used to categorize participants as low in adherence. Scores higher than .80 were classified as being adherent to cardiometabolic surveillance.
Outcome measures
| Measure |
Group I (INSPIRE, Survivorship Care Plan)
n=95 Participants
Participants receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Internet, Mobile app and Telehealth Intervention: Receive INSPIRE and survivorship care plan
Survey Administration: Ancillary studies
|
Group II (Usual Care)
n=114 Participants
Participants receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Participants may receive access to the INSPIRE online program after 12 months.
Best Practice and Internet site with links to existing resources: Receive usual care
Survey Administration: Ancillary studies
|
|---|---|---|
|
Health Care Adherence (HCA)-Cardiometabolic
|
30.5 percentage of participants
Interval 21.5 to 40.8
|
27.2 percentage of participants
Interval 19.3 to 36.3
|
PRIMARY outcome
Timeframe: 6-weeks after enrollment.Population: Intervention participants who require telehealth stepped care at 6-weeks
Determine characteristics of participants who 1) do not meet criteria for adequate knowledge of cardiometabolic risks, or 2) do not report improved distress, or 3) have not logged in to the online program.
Outcome measures
| Measure |
Group I (INSPIRE, Survivorship Care Plan)
n=68 Participants
Participants receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Internet, Mobile app and Telehealth Intervention: Receive INSPIRE and survivorship care plan
Survey Administration: Ancillary studies
|
Group II (Usual Care)
n=116 Participants
Participants receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Participants may receive access to the INSPIRE online program after 12 months.
Best Practice and Internet site with links to existing resources: Receive usual care
Survey Administration: Ancillary studies
|
|---|---|---|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Sex-Female
|
35 Participants
|
50 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Sex-Male
|
33 Participants
|
66 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Age at baseline <70
|
54 Participants
|
91 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Age at baseline >=70
|
14 Participants
|
25 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
White/non-Hispanic
|
61 Participants
|
103 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
BIPOC
|
6 Participants
|
10 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Race/ethnicity unknown
|
1 Participants
|
3 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Education: High school diploma or less
|
6 Participants
|
18 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Education: At least some college or vocational/technical program
|
62 Participants
|
97 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Education level unknown
|
0 Participants
|
1 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Income: <$100,000
|
39 Participants
|
75 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Income: >=$100,000
|
26 Participants
|
34 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Income unknown
|
3 Participants
|
7 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
PHQ score <10 (no depression)
|
56 Participants
|
98 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
PHQ 10-14 (mild depression)
|
6 Participants
|
13 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
PHQ 15-19 (moderate depression)
|
5 Participants
|
2 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
PHQ >=20 (severe depression)
|
1 Participants
|
2 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
PHQ score unknown
|
0 Participants
|
1 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
CTXD <0.9 (not distressed)
|
26 Participants
|
52 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
CTXD >=0.9 (distressed)
|
42 Participants
|
62 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
CTXD score unknown
|
0 Participants
|
2 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
HCU-C >.80 (normal adherence)
|
13 Participants
|
35 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
HCU-C <.80 (low adherence)
|
53 Participants
|
78 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
HCU-C unknown
|
2 Participants
|
3 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
HCU-SM >=.80 (normal adherence)
|
45 Participants
|
85 Participants
|
|
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
HCU-SM <.80 (low adherence)
|
23 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants impaired at baseline
Assesses adherence to subsequent malignancy surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months.
Outcome measures
| Measure |
Group I (INSPIRE, Survivorship Care Plan)
n=42 Participants
Participants receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Internet, Mobile app and Telehealth Intervention: Receive INSPIRE and survivorship care plan
Survey Administration: Ancillary studies
|
Group II (Usual Care)
n=48 Participants
Participants receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Participants may receive access to the INSPIRE online program after 12 months.
Best Practice and Internet site with links to existing resources: Receive usual care
Survey Administration: Ancillary studies
|
|---|---|---|
|
Health Care Adherence (HCA)-Subsequent Malignancy Screening
|
4.8 percentage of participants
Interval 0.6 to 16.2
|
4.2 percentage of participants
Interval 0.5 to 14.3
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants impaired at baseline
Assessed by participant questionnaire.Among those impaired (PHQ≥10) at baseline, percent no longer impaired at 12 months
Outcome measures
| Measure |
Group I (INSPIRE, Survivorship Care Plan)
n=21 Participants
Participants receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Internet, Mobile app and Telehealth Intervention: Receive INSPIRE and survivorship care plan
Survey Administration: Ancillary studies
|
Group II (Usual Care)
n=38 Participants
Participants receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Participants may receive access to the INSPIRE online program after 12 months.
Best Practice and Internet site with links to existing resources: Receive usual care
Survey Administration: Ancillary studies
|
|---|---|---|
|
PHQ-8 Depression
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
39.5 percentage of participants
Interval 24.0 to 56.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 monthsMediators of primary outcomes: assessed by patient questionnaires.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 monthsProcess Measures: Rates of participants approached versus registering, rates of visits to the web site, pages viewed, types of modalities used, attrition rates and support requests.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsDetermine resources that would be needed to sustain the intervention as a national HCT survivorship program if implemented through the CIBMTR/NMDP.
Outcome measures
Outcome data not reported
Adverse Events
Group I (INSPIRE, Survivorship Care Plan)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Group II (Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 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