Clinical trial NCT03806140: Development and Evaluation of THRIVE
Official title: Proof-of-Concept of an Infrastructure for Text Messaging Interventions at CHOP: Development and Evaluation of THRIVE (Texting Health Resources to Inform, motiVate, and Engage)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Keywords: Texting
mHealth
Adolescents and young adults transitioning of treatment
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Adolescents and young adults (AYA) with cancer are recognized as an understudied and underserved population in oncology. AYA engagement in ongoing disease management is compromised by lack of awareness of their continued health vulnerabilities and need for continued care, their desire to be "normal" and remove themselves from the cancer experience, and lack of AYA-appropriate support and services. Thus, AYA with cancer, especially those completing active treatment, are extremely vulnerable and in need of support to maintain remission and assure optimal health into adulthood. To address the immediate need for innovative interventions targeting AYA completing cancer treatment, the proposed study will test the efficacy, feasibility, and acceptability of a tailored text messaging intervention for AYA transitioning off active treatment called THRIVE (Texting Health Resources to Inform, motiVate, and Engage).

A pilot randomized controlled trial testing the acceptability and feasibility (primary) and initial efficacy (secondary) of a health promoting mobile health texting intervention with AYA transitioning off active cancer treatment to follow-up care.

The intervention compares a texting intervention to a receipt of an AYA survivorship handbook. Acceptability and feasibility are primary outcomes. Efficacy outcomes include measures of knowledge, healthcare utilization, adherence, engagement in care, and psychosocial well-being measures.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1)Subjects that do not meet inclusion criteria described above will be excluded.

Primary outcomes:
measure: Acceptability of promoting a tailored text messaging intervention for AYA transitioning off active treatment
timeFrame: 16 weeks
measure: Number of patients completed 16 week measures
timeFrame: 16 weeks
measure: Number of patient-reported barriers to technology of text messages
timeFrame: 16 weeks
Secondary outcomes:
measure: Health competence beliefs
timeFrame: 16 weeks
measure: Engagement in health promoting behaviors
timeFrame: 16 weeks
measure: Changes in health competence beliefs
timeFrame: 16 weeks
measure: Changes in health related quality of life (HRQL) in adolescent and young adult survivors of childhood cancer
timeFrame: 16 weeks
measure: Patient adherence to clinic attendance
timeFrame: 16 weeks
measure: Knowledge of health promoting behaviors
timeFrame: 16 weeks
measure: Changes in sleep quality
timeFrame: 16 weeks
measure: Medication adherence
timeFrame: 16 weeks
measure: Fatigue
timeFrame: 16 weeks
measure: Attainment of health related goals
timeFrame: week 1 and 16
measure: Patient adherence to medication compliance
timeFrame: 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Lisa Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
References: