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Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study

Primary Purpose

Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet Mobile Technology
Internet-Based Intervention
Questionnaire Administration
Supportive Care
Informational Intervention
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Clinical Stage I Cutaneous Melanoma AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with a first invasive malignancy of leukemia, lymphoma, colorectal cancer, melanoma, or sarcoma (stage 1-3 for solid tumors) between the ages of 15-39 years
  • 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
  • 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 exclusion criteria

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer CenterRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University of Pennsylvania/Abramson Cancer CenterRecruiting
  • Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (INSPIRE, telehealth care)

Arm II (control website)

Arm Description

Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.

Patients receive access to a study-specific control website that has annotated links to existing resources for AYA survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.

Outcomes

Primary Outcome Measures

Change in distress score 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
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.
Proportion of HCA-cardiometabolic surveillance (CM)
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)
Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-SM.

Secondary Outcome Measures

Proportion of healthcare adherence (HCA)-all
Patients will meet HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-all.

Full Information

First Posted
October 6, 2020
Last Updated
September 7, 2023
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04593277
Brief Title
Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study
Official Title
INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Thyroid Gland Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (INSPIRE, telehealth care)
Arm Type
Experimental
Arm Description
Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.
Arm Title
Arm II (control website)
Arm Type
Active Comparator
Arm Description
Patients receive access to a study-specific control website that has annotated links to existing resources for AYA survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.
Intervention Type
Other
Intervention Name(s)
Internet Mobile Technology
Other Intervention Name(s)
www-mobile
Intervention Description
Use INSPIRE mobile application
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Access to a study-specific control website
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Supportive Care
Other Intervention Name(s)
Supportive Therapy, Symptom Management, Therapy, Supportive
Intervention Description
Receive telehealth stepped care
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive printed SCP materials
Primary Outcome Measure Information:
Title
Change in distress score from baseline to 3 months
Description
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.
Time Frame
From baseline to 3 months
Title
Change in distress score from baseline to 12 months
Description
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.
Time Frame
From baseline to 12 months
Title
Proportion of HCA-cardiometabolic surveillance (CM)
Description
Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-CM.
Time Frame
At 12 months
Title
Proportion of HCA-cancer surveillance (SM)
Description
Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-SM.
Time Frame
At 12 months
Secondary Outcome Measure Information:
Title
Proportion of healthcare adherence (HCA)-all
Description
Patients will meet HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-all.
Time Frame
At 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 exclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Intake
Phone
888-344-5678
Email
inspire-aya@fredhutch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. Scott Baker
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia A. Ganz
First Name & Middle Initial & Last Name & Degree
Patricia A. Ganz
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann H. Partridge
First Name & Middle Initial & Last Name & Degree
Ann H. Partridge
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle N. Friedman
First Name & Middle Initial & Last Name & Degree
Danielle N. Friedman
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Jacobs
First Name & Middle Initial & Last Name & Degree
Linda Jacobs
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Intake
Phone
888-344-5678
Email
inspire-aya@fredhutch.org
First Name & Middle Initial & Last Name & Degree
K. Scott Baker

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study

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