Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Hematopoietic and Lymphoid Cell Neoplasm, Invasive Malignant Neoplasm, Leukemia, Lymphoma, Malignant Solid Neoplasm, Sarcoma, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Thyroid Gland Carcinoma
Conditions
Brief summary
This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors. By improving access to survivorship resources, health literacy, self-management skills, and support, an interactive survivorship program may help to improve adherence to adolescent and young adult healthcare guidelines and reduce cancer-related distress.
Detailed description
OUTLINE: Patients who have one or more elevated distress or low cardiometabolic or cancer health care adherence are randomized to Arm I or II. ARM I (INTERVENTION): Patients receive a personalized Survivorship Care Plan (SCP) and use the Interactive Survivorship Program to Improve Healthcare Resources (INSPIRE) mobile application. Patients may receive telehealth stepped care after 1 month. ARM II (CONTROL): Patients receive access to a study-specific control website that has annotated links to existing resources for adolescent and young adult (AYA) survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.
Interventions
Use INSPIRE mobile application
OTHERInternet-Based Intervention
Access to a study-specific control website
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURESupportive Care
Receive telehealth stepped care
OTHERInformational Intervention
Receive printed SCP materials
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with a first invasive malignancy of leukemia, lymphoma, melanoma, sarcoma, breast, thyroid, or colorectal cancer (stage 1-3 for solid tumors) between the ages of 15-39 years * Current age \>= 18 when approached * Currently within 1 to 5 years from the time of diagnosis * Completed active treatment for disease \>= 6 months previously * Received a therapeutic intervention (with curative intent if advanced stage disease) that included any of the following modalities: surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy * English proficiency adequate to complete assessments * Access to email and smartphone mobile app and or internet
Exclusion criteria
* Diagnosed with a subsequent invasive malignancy other than non-melanoma skin cancer * Received hematopoietic stem cell transplant * Health issues prohibiting computer use or ability to comply with study procedures * 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 |
|---|---|---|
| Change in distress score from baseline to 3 months | From baseline to 3 months | Will be assessed by Cancer and Treatment Distress (CTXD). The CTXD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience. Patients will meet the primary endpoint for lack of distress if they score \< 0.9 on the CTXD. |
| Change in distress score from baseline to 12 months | From baseline to 12 months | Will be assessed by Cancer and Treatment Distress (CTXD). The CTXD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience. Patients will meet the primary endpoint for lack of distress if they score \< 0.9 on the CTXD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of healthcare adherence (HCA)-all | At 12 months | Patients will meet HCA endpoint if their percent of recommended screenings obtained within the past 12 months is \>= 80% for HCA-all. |
| Proportion of HCA-cardiometabolic surveillance (CM) | At 12 months | Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is \>= 80% for HCA-CM. |
| Proportion of HCA-cancer surveillance (SM) | At 12 months | Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is \>= 80% for HCA-SM. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORK. Scott Baker
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed