Hematopoietic and Lymphoid Cell Neoplasm
Conditions
Brief summary
This phase III trial investigates health informatics and a self-management program for improving the health of cancer survivors after stem cell transplant. After transplant many survivors may feel stressed or may be unsure of what health care they need. A self-management program called INSPIRE, along with a personalized survivorship care plan may improve stress and health care for transplant survivors.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan. GROUP II: Patients receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Patients receive access to the INSPIRE online program after 12 months.
Interventions
OTHERBest Practice and Internet site with links to existing resources
Receive usual care
OTHERInternet, Mobile app and Telehealth Intervention
Receive INSPIRE and survivorship care plan
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received \>= 1 autologous or allogeneic (related or unrelated) HCT with curative intent at a participating transplant center for a hematologic malignancy * Age 18 years of age or older at last transplant * Survival 2-5 years after last HCT when first approached for enrollment * In remission at time of study entry, may be receiving chemoprevention * Internet and email access * American and Canadian citizens, and/or those with mailing addresses in the United States (US)/Canada and/or temporarily residing anywhere outside the country (IE - military).
Exclusion criteria
* Development of invasive subsequent malignancy after HCT other than non-melanoma skin cancer, in the past two years * Medical or other issue prohibiting computer use, reading or ability to comply with all study procedures or unable to communicate via phone (e.g., significant vision, hearing or cognitive impairment, major illness, hospitalization) * Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility) * Does not complete baseline patient-reported outcome (PRO) assessment items required to determine stratification or whether the survivor meets inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | 6-weeks after enrollment. | 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. |
| Cancer and Treatment Distress (CTXD) | Up to 12 months | 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. |
| Health Care Adherence (HCA)-Cardiometabolic | Up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-8 Depression | Up to 12 months | Assessed by participant questionnaire.Among those impaired (PHQ≥10) at baseline, percent no longer impaired at 12 months |
| Health Care Adherence (HCA)-Subsequent Malignancy Screening | Up to 12 months | Assesses adherence to subsequent malignancy surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of Survivorship Needs and Health Related Self-efficacy | Up to 12 months | Mediators of primary outcomes: assessed by patient questionnaires. |
| Cost and Resources to Maintain Program | 12 months | Determine resources that would be needed to sustain the intervention as a national HCT survivorship program if implemented through the CIBMTR/NMDP. |
| Reach, Engagement and Fidelity of Web-based Intervention | Up to 12 months | Process 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group I (INSPIRE, Survivorship Care Plan) 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 | 184 |
| Group II (Usual Care) 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 | 191 |
| Total | 375 |
Baseline characteristics
| Characteristic | Group I (INSPIRE, Survivorship Care Plan) | Group II (Usual Care) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 67 Participants | 59 Participants | 126 Participants |
| Age, Categorical Between 18 and 65 years | 117 Participants | 132 Participants | 249 Participants |
| Age, Continuous | 59.11 years STANDARD_DEVIATION 12.8 | 57.3 years STANDARD_DEVIATION 12.5 | 58.2 years STANDARD_DEVIATION 12.6 |
| Cancer and Treatment Distress | 77 Participants | 93 Participants | 170 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 177 Participants | 186 Participants | 363 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Healthcare Adherence (HCA) | 95 Participants | 114 Participants | 209 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 11 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) White | 167 Participants | 163 Participants | 330 Participants |
| Region of Enrollment Canada | 3 participants | 1 participants | 4 participants |
| Region of Enrollment United States | 181 participants | 190 participants | 371 participants |
| Sex: Female, Male Female | 85 Participants | 99 Participants | 184 Participants |
| Sex: Female, Male Male | 99 Participants | 92 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 184 | 1 / 191 |
| other Total, other adverse events | 0 / 184 | 0 / 191 |
| serious Total, serious adverse events | 0 / 184 | 0 / 191 |
Outcome results
Primary
Cancer and Treatment Distress (CTXD)
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.
Time frame: Up to 12 months
Population: Group that met criterion for highly distressed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I (INSPIRE, Survivorship Care Plan) | Cancer and Treatment Distress (CTXD) | 23.4 percentage of participants |
| Group II (Usual Care) | Cancer and Treatment Distress (CTXD) | 22.6 percentage of participants |
p-value: 0.9Chi-squared
Primary
Characteristics of 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.
Time frame: 6-weeks after enrollment.
Population: Intervention participants who require telehealth stepped care at 6-weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Age at baseline <70 | 54 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | PHQ score <10 (no depression) | 56 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Education: High school diploma or less | 6 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | PHQ 10-14 (mild depression) | 6 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | White/non-Hispanic | 61 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | PHQ 15-19 (moderate depression) | 5 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Sex-Female | 35 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | PHQ >=20 (severe depression) | 1 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Education: At least some college or vocational/technical program | 62 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | PHQ score unknown | 0 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Sex-Male | 33 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | CTXD <0.9 (not distressed) | 26 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Education level unknown | 0 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | CTXD >=0.9 (distressed) | 42 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | BIPOC | 6 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | CTXD score unknown | 0 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Income: <$100,000 | 39 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | HCU-C >.80 (normal adherence) | 13 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Age at baseline >=70 | 14 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | HCU-C <.80 (low adherence) | 53 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | HCU-C unknown | 2 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Income: >=$100,000 | 26 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | HCU-SM >=.80 (normal adherence) | 45 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Race/ethnicity unknown | 1 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | HCU-SM <.80 (low adherence) | 23 Participants |
| Group I (INSPIRE, Survivorship Care Plan) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Income unknown | 3 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | PHQ 15-19 (moderate depression) | 2 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | HCU-C <.80 (low adherence) | 78 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Sex-Female | 50 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Sex-Male | 66 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Age at baseline <70 | 91 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Age at baseline >=70 | 25 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | White/non-Hispanic | 103 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | BIPOC | 10 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Race/ethnicity unknown | 3 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Education: High school diploma or less | 18 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Education: At least some college or vocational/technical program | 97 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Education level unknown | 1 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Income: <$100,000 | 75 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Income: >=$100,000 | 34 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Income unknown | 7 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | PHQ score <10 (no depression) | 98 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | PHQ 10-14 (mild depression) | 13 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | PHQ >=20 (severe depression) | 2 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | PHQ score unknown | 1 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | CTXD <0.9 (not distressed) | 52 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | CTXD >=0.9 (distressed) | 62 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | CTXD score unknown | 2 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | HCU-C >.80 (normal adherence) | 35 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | HCU-C unknown | 3 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | HCU-SM >=.80 (normal adherence) | 85 Participants |
| Group II (Usual Care) | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | HCU-SM <.80 (low adherence) | 31 Participants |
Comparison: Secondary cancer screening healthcare utilization (HCU-SM) at baseline: \>=.80 versus \<.80p-value: 0.31Chi-squared
Comparison: PHQ score at baseline: no depression (\<10), mild depression (10-14), moderate depression (15-19), severe depression (\>=20)p-value: 0.28Chi-squared
Comparison: CTXD score at baseline \<0.9 (not distressed) or \>=0.9 (distressed)p-value: 0.33Chi-squared
Comparison: Cardiometabolic Healthcare Utilization (HCU-C) score at baseline: \>.80 versus \<.80p-value: 0.1Chi-squared
Comparison: Sex: Female vs. Malep-value: 0.27Chi-squared
Comparison: Age \<70 vs. \>=70p-value: 0.88Chi-squared
Comparison: Race and ethnicity: white AND non-Hispanic versus any other combination of race and ethnicity (BIPOC)p-value: 0.98Chi-squared
Comparison: Education: High school or less versus at least some college or vocational/technical programp-value: 0.19Chi-squared
Comparison: Income: \<$100,000 annual versus \>=$100,000 annualp-value: 0.24Chi-squared
Primary
Health Care Adherence (HCA)-Cardiometabolic
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.
Time frame: Up to 12 months
Population: Those impaired at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I (INSPIRE, Survivorship Care Plan) | Health Care Adherence (HCA)-Cardiometabolic | 30.5 percentage of participants |
| Group II (Usual Care) | Health Care Adherence (HCA)-Cardiometabolic | 27.2 percentage of participants |
p-value: 0.6Chi-squared
Secondary
Health Care Adherence (HCA)-Subsequent Malignancy Screening
Assesses adherence to subsequent malignancy surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months.
Time frame: Up to 12 months
Population: Participants impaired at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I (INSPIRE, Survivorship Care Plan) | Health Care Adherence (HCA)-Subsequent Malignancy Screening | 4.8 percentage of participants |
| Group II (Usual Care) | Health Care Adherence (HCA)-Subsequent Malignancy Screening | 4.2 percentage of participants |
p-value: 0.89Chi-squared
Secondary
PHQ-8 Depression
Assessed by participant questionnaire.Among those impaired (PHQ≥10) at baseline, percent no longer impaired at 12 months
Time frame: Up to 12 months
Population: Participants impaired at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I (INSPIRE, Survivorship Care Plan) | PHQ-8 Depression | 28.6 percentage of participants |
| Group II (Usual Care) | PHQ-8 Depression | 39.5 percentage of participants |
p-value: 0.4Chi-squared
Other Pre-specified
Cost and Resources to Maintain Program
Determine resources that would be needed to sustain the intervention as a national HCT survivorship program if implemented through the CIBMTR/NMDP.
Time frame: 12 months
Other Pre-specified
Knowledge of Survivorship Needs and Health Related Self-efficacy
Mediators of primary outcomes: assessed by patient questionnaires.
Time frame: Up to 12 months
Other Pre-specified
Reach, Engagement and Fidelity of Web-based Intervention
Process 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.
Time frame: Up to 12 months