Development and Evaluation of THRIVE

NCT03806140 | Completed

• 1 other identifier: 14-010834
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigators will test the feasibility and acceptability, as well as efficacy (exploratory aim) of a text messaging intervention for Adolescents and young adults (AYA) transitioning off active treatment for cancer. Texting Health Resources to Inform, motiVate, and Engage (THRIVE) is intended to improve knowledge about health promotion and health vulnerability and importance of continued engagement in care, while also providing support and improving efficacy to achieve health-related goals.

Conditions

Oncology

Keywords

Texting; mHealth; Adolescents and young adults transitioning of treatment

Outcome Measures

Primary Outcomes (3)

• Acceptability of promoting a tailored text messaging intervention for AYA transitioning off active treatment

  All patients will complete a measure of acceptability at the outcome data collection-. The questionnaire consists of 27 items for the control group and 31 items for the intervention group. Items will be answered on a Likert-scale and one open-ended question intended to elicit suggestions for improving the intervention. Items pertain to perceived value, appropriateness, convenience and helpfulness of the intervention.

  16 weeks

• Number of patients completed 16 week measures

  Completion of follow-up measures which will be logged by research team for feasibility

  16 weeks

• Number of patient-reported barriers to technology of text messages

  Number of participants who report barriers or issues with the text messages and technology for feasibility

  16 weeks

Secondary Outcomes (11)

• Health competence beliefs

  16 weeks

• Engagement in health promoting behaviors

  16 weeks

• Changes in health competence beliefs

  16 weeks

• Changes in health related quality of life (HRQL) in adolescent and young adult survivors of childhood cancer

  16 weeks

• Patient adherence to clinic attendance

  16 weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Receive daily text messages

Behavioral: text messages

Control group

NO INTERVENTION

No text messages, only written educational materials

Interventions

text messages BEHAVIORAL

receive about one health-related text message a day for 16 weeks

Intervention group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with cancer
• Males or females between the ages of 12 and 25
• In remission (per documentation in chart)
• Within 12 months of completing active treatment for cancer
• Cognitively capable to complete measures (per documentation in chart of impairment or parent or provider report).
• Able to read and speak English.
• Parent available to provide consent for those ages 12 to 17

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lisa Schwartz, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 16, 2019
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share