OncologyNCT03806140
Development and Evaluation of THRIVE
A study testing text messages in people with Oncology, run by Children's Hospital of Philadelphia.
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
- Type of treatment
- Lifestyle or therapy programme
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Receive daily text messages Receives: Behavioral: text messages |
| Control group | No intervention | No text messages, only written educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Number of patients completed 16 week measures
Completion of follow-up measures which will be logged by research team for feasibility
Measured: 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
Measured: 16 weeks
Secondary outcomes (11)
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
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
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
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
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
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
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
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
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
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
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.
- First posted16 Jan 2019
- Study start1 Jul 2014
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Schwartz, PhD, Principal investigator, Children's Hospital of Philadelphia
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03806140
- Acronym / sponsor ID
- 14-010834
- Conditions
- Oncology
- Keywords
- Texting, mHealth, Adolescents and young adults transitioning of treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: text messagesReceive daily text messages |
| Control group | No intervention | –No text messages, only written educational materials |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (1 listed)
- 1)Subjects that do not meet inclusion criteria described above will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| text messagesreceive about one health-related text message a day for 16 weeks | Behavioural | Intervention group |
Primary outcome
Acceptability of promoting a tailored text messaging intervention for AYA transitioning off active treatment
Time frame: 16 weeks
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.
Number of patients completed 16 week measures
Time frame: 16 weeks
Completion of follow-up measures which will be logged by research team for feasibility
Number of patient-reported barriers to technology of text messages
Time frame: 16 weeks
Number of participants who report barriers or issues with the text messages and technology for feasibility
11 secondary outcomes
Health competence beliefs
Time frame: 16 weeks
Engagement in health promoting behaviors
Time frame: 16 weeks
Changes in health competence beliefs
Time frame: 16 weeks
Changes in health related quality of life (HRQL) in adolescent and young adult survivors of childhood cancer
Time frame: 16 weeks
Patient adherence to clinic attendance
Time frame: 16 weeks
Knowledge of health promoting behaviors
Time frame: 16 weeks
Changes in sleep quality
Time frame: 16 weeks
Medication adherence
Time frame: 16 weeks
Fatigue
Time frame: 16 weeks
Attainment of health related goals
Time frame: week 1 and 16
Patient adherence to medication compliance
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Oncology
Recruiting
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
Pediatric Oncology Patients With Risk for Infections
RecruitingObservational study
Efficacy and Safety of Ivonescimab Monotherapy as First-Line Treatment for PD-L1-Positive, Driver Gene-Negative, Locally Advanced or Metastatic NSCLC: A Multicenter, Prospective, Real-World Cohort Study
Patients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC, EGFR Mutation-negative and ALK Rearrangement-negative
Enrolling by invitation
Clinical Alternatives for Reducing Harm Using E-cigarettes
Smoking, E-Cig Use
Recruiting
Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments
Sarcopenia, Oncology
Recruiting
Development of a Digital Personalised Nutrition Tool for Adolescents Undergoing Cancer Treatment
Paediatric Oncology, Malnutrition in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Schwartz, PhD principal investigator
Children's Hospital of Philadelphia
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.