Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09186 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10784 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA263144 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
This clinical trial evaluates several behavioral interventions for the improvement of physical activity in cancer patients. Childhood and adolescent/young adult cancer survivors have been reported to have poor diet quality and rarely meet recommended physical activity guidelines. This trial aims to see whether a tailored intervention based on self-determination theory may help to improve physical activity and dietary change.
OUTLINE: Patients are randomized to Arms 1, 2, or 3.
ARM 1: Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 6 months.
ARM 2: Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated every 2 months) after 6 months.
ARM 3: Patients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months.
ARM 4: If Arms 1 or 2 patients have poor response after 3 months, patients may be re-randomized to Arm 4. Patients receive remote sessions with a health coach every 1-2 weeks for 3 months. Patients may continue to receive remote sessions once a month after 3 months, during the maintenance phase (months 6-12).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (personalized clinician-led self-management telehealth) | Experimental | Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 6 months. |
|
| Arm 2 (personalized goal setting) | Experimental | Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated monthly) after 6 months. |
|
| Arm 3 (waitlist) | Active Comparator | Patients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months. |
|
| Arm 4 (remote sessions with a health coach) | Experimental | Arm 1 and 2 patients with poor response after 3 months can be re-randomized to Arm 4. Patients receive remote sessions with a health coach every 1-2 weeks for 3 months. Patients may continue to receive remote sessions once a month after 3 months, during the maintenance phase (months 6-12). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Receive personalized clinician-led self-management telehealth sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sedentary time | <100 counts/minute as measured by research-grade accelerometry | Up to 12 months |
| Healthy Eating Index (HEI)-2015 score | On a scale of 100 (perfect score) as measured by Food Frequency Questionnaire | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant engagement | As measured by: 1) response to clinician action plans [score of 0-10; 10 being most engaged]; 2) use of mHealth apps [e.g., number of days with daily steps ≥500; number of days with recorded calories ≥500; social media interactions counting viewing, liking, or posting comments]; and 3) number of sessions completed with lifestyle health coach and coach's rating of engagement [score of 0-10; 10 being most engaged] |
Not provided
Inclusion Criteria:
Childhood Cancer Survivor Study (CCSS) participant who is between age 18 to < 55 years at time of initial approach
Moderate to high CV risk status based on CCSS risk prediction models for cardiomyopathy and ischemic heart disease
Able to read, write, and speak English
Ability to understand and the willingness to provide informed consent
At least one of the following:
Be free of any known (self-reported) ischemic heart disease or cardiomyopathy
Have internet access (can be via smartphone or computer; if neither device is available, the study can loan participants a Wi-Fi enabled device, but participant will need to have access to the internet)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric J. Chow | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States | ||
| Fred Hutch/University of Washington Cancer Consortium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2025 | Oct 6, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Behavioral Intervention | Behavioral | Receive personalized goal setting for daily steps and activity and dietary goals |
|
|
| Behavioral Intervention | Behavioral | Remote sessions with a health coach |
|
|
| Survey Administration | Other | Ancillary studies |
|
| Interview | Other | Ancillary studies |
|
| Up to 12 months |
| Health-related self-efficacy scale | Per Schwarzer R, et al. and converted to T-score (higher equaling greater self-efficacy) | Up to 12 months |
| Multidimensional Health Locus of Control Scale | Per Wallston KA, et al. with 3 subscales: internal, chance, and powerful others (each scored from 6-36, with higher values indicating greater agreement with that subscale's locus on control beliefs) | Up to 12 months |
| Seattle |
| Washington |
| 98109 |
| United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided