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OncologyNCT03806140

Development and Evaluation of THRIVE

A study testing text messages in people with Oncology, run by Children's Hospital of Philadelphia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 25 years
Conditions the study is for
Oncology
What is being tested?
text messages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
No sites listed yet
Study dates
1 Jul 2014to 1 Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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)

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.

Read the 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.

Conditions
Oncology
Being tested
text messages
Keywords
Texting, mHealth, Adolescents and young adults transitioning of treatment
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • text messagesBehavioural

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

Study groups in NCT03806140
Study groupRoleWhat they receive
Intervention groupActive comparatorReceive daily text messages
Receives: Behavioral: text messages
Control groupNo interventionNo text messages, only written educational materials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 16 weeks

  2. Number of patients completed 16 week measures

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

    Measured: 16 weeks

  3. 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

    Measured: 16 weeks

Secondary outcomes (11)
  1. Health competence beliefs

    Health Competence Beliefs Inventory (HBCI) survey - The HCBI assess beliefs about the psychological and functional impact of past medical issues, perceived competence to manage current and future medical issues, perceived medical vulnerability now and in the future, and perceived connection to/communication with others about medical issues. HCBI includes 4 subscales (autonomy, health vulnerability, cognitive competence, and satisfaction with health care). For this study, we are omitting the cognitive competence subscale, resulting in 16 items.

    Measured: 16 weeks

  2. Engagement in health promoting behaviors

    Engagement in health promoting behaviors will be assessed using the Health Behavior Survey (HBS). This measure is composed of the 30-item Health Behavior Survey (HBS) that was developed for a previous study (Hocking, Schwartz, Hobbie et al., 2013). HBS alcoholic beverage consumption (4-items), smoking (2-items), other drug use (4-items), sunscreen use (1-item), health-screening (1-item), exercise (4-items), sexual behavior (3-items), and nutrition/weight (7-items). These items will be scored as either health promoting or health limiting (1 point for each health promoting behavior). The total score, as well as scores from each content area, will be used.

    Measured: 16 weeks

  3. Changes in health competence beliefs

    Perceived Health Competence Scale (PHCS) survey will be used to assess health competence beliefs. The survey is an 8-item instrument designed to assess perceived effectiveness carrying out health behaviors and influencing personal health outcomes. Participants rate each item on a 5-point Likert scale, from strongly disagree to strongly agree. Items yield a total score.

    Measured: 16 weeks

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

    Minneapolis-Manchester Quality of Life Instrument-adolescent (MMQL) survey will be used to measure health related quality of life in adolescent and young adult survivors of childhood cancer by assessing physical functioning, psychological functioning, social functioning, cognitive functioning, body image, outlook on life, and intimate relationships. Scores range from one to five, with a higher score indicating a better HRQL An overall QoL score is reached by finding the mean score for all the items.

    Measured: 16 weeks

  5. Patient adherence to clinic attendance

    Medical record review as well as completion of the Medical Adherence Measure (MAM) survey will be used to assess patient adherence to clinic attendance. The MAM assesses adherence. Patient adherence to medication and to clinic attendance are each rated on a 10-point scale (1 = never; 10 = always take medication). Participants also select barriers to adherence from a list of 12 and the option to write in another reason.

    Measured: 16 weeks

  6. Knowledge of health promoting behaviors

    Knowledge of health promoting behaviors will be assessed using the Knowledge Acquisition Measure questionnaire. The measure was developed by the research team for use in this study. The questionnaire consists of 23 multiple choice items regarding knowledge of basic health-promoting behaviors (e.g. recommended sunscreen use and maintenance of physical health) as well as five goal-specific questions that each participant will answer based on the goal he or she chose at the time of enrollment. All components of the Knowledge Acquisition Measure aim to assess the amount of health-related knowledge gained over the course of the intervention.

    Measured: 16 weeks

  7. Changes in sleep quality

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQUI) questionnaire- 19-item self-report questionnaire that measures subjective sleep quality and disturbance in adults over the past one-month period and discriminates "good" and "poor" sleepers (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989). The PSQI yields a global score (PSQI-G) and seven subscale scores consisting of Sleep Quality, Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disturbances, Sleep Medications, and Daytime Dysfunction, with a global score of > 5 thought to be suggestive of significant sleep disturbance.

    Measured: 16 weeks

  8. Medication adherence

    Medical adherence will be assessed by medical record review as well as Medical Adherence Measure (MAM) - Patient adherence to medication and to clinic attendance are each rated on a 10-point scale (1 = never; 10 = always take medication). Participants also select barriers to adherence from a list of 12 and the option to write in another reason.

    Measured: 16 weeks

  9. Fatigue

    Multidimensional fatigues scale (MFS) questionnaire will be used to assess fatigue. The measure is an 18- item questionnaire that yields a total score and three subscale scores: General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue. Items are answered on a 5-point Likert-type scale indicating how problematic each element of fatigue was over the past month. Lower scores indicate more fatigue

    Measured: 16 weeks

  10. Attainment of health related goals

    Goal Attainment Measure - was developed for this study, and assesses participants' expectation of (10-items) and progress related to achieving their chosen goal (9-items).

    Measured: week 1 and 16

  11. Patient adherence to medication compliance

    medical record review

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2019
  2. Study start1 Jul 2014
  3. Primary completion1 Jan 2016
  4. Study completion1 Jan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03806140
Sponsor's protocol ID
14-010834
Status last verified
Jan 2019
First submitted
10 Jan 2019
Last updated
16 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing text messages in people with Oncology, run by Children's Hospital of Philadelphia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of promoting a tailored text messaging intervention for AYA transitioning off active treatment (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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