Survivors of Childhood CancerEarly Phase 1NCT05000359
A Mobile Phone Intervention to Promote Adherence to Survivorship Care Among Adolescent and Young Adult Cancer Survivors
A Early Phase 1 study testing text messaging intervention in people with Survivors of Childhood Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
Adolescents and young adults (AYA) survivors of childhood cancer receive inadequate surveillance for treatment-related late effects. This study evaluates the acceptability and feasibility of a mobile phone messaging intervention targeting behavior changes related to receiving survivorship care among AYA survivors. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Survivors of Childhood Cancer
- What is being tested?
- text messaging intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 3 Jul 2023
- Phase
- Early Phase 1
- 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 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must be between the ages of 18 to 39 years at the time of enrollment
- Patient must reside in the greater Los Angeles area.
- Patients must have received survivorship care at the University of California at Los Angeles (UCLA)
- Patients must be fluent in English.
- Patients must be off cancer therapy for at least one year.
- Patients must have personal access to a smart phone with text messaging and internet and/or data capability.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Los Angeles
Los Angeles, California, 90095
About this study
Adolescents and young adults (AYA) survivors of childhood cancer receive inadequate surveillance for treatment-related late effects. This study evaluates the acceptability and feasibility of a mobile phone messaging intervention targeting behavior changes related to receiving survivorship care among AYA survivors.
Content from an existing text-messaging survivorship education intervention will be adapted to a novel text-messaging platform, Chorus. Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention. In-depth interviews will be conducted with each participant during the study, and a focus group with all participants will be conducted at the end of the study. Qualitative analysis will determine areas for improvement in the text messaging intervention in order to ensure acceptability and feasibility in AYA survivors. The text messaging intervention on Chorus will be adapted to better suit the needs of AYA survivors based on the results of the qualitative analysis. Mobile phone interventions offer a cost-effective, age-appropriate approach to AYA survivorship care education. If effective, the text-messaging intervention will be evaluated in a randomized, controlled pilot trial to improve rates of survivorship care and clinical outcomes for AYA survivors.
Read the detailed description
Aim 1: To adapt and enhance an existing text messaging intervention to an expanded two-way multi-media mobile phone messaging platform (Chorus) that will improve knowledge regarding the risk of late effects among AYA survivors, intent to seek recommended survivorship care, and completion of standard survivorship care goals. a. both two-way text messaging to improve Children?s Oncology Group (COG) survivorship guideline adherence b. web-based educational content for survivors of key survivorship messages regarding risk for late effects and need for ongoing survivorship care c. Monthly peer navigation phone calls to address barriers and promote retention d. utilization of pre and post-test questionnaires for participants to access and complete within the Chorus platform Aim 2: To test the acceptability and feasibility of the expanded mobile phone intervention content to improve messaging and strategies for survivorship care using qualitative methodologies and applying the Technology Acceptance Model (TAM) within a sample of AYA survivors. a. perceived usefulness of the text messaging system b. perceived ease of use of the text messaging system c. effect of the text messaging system on health-related behavior intent
- Conditions
- Survivors of Childhood Cancer
- Being tested
- text messaging intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text messaging interventionBehavioural
Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.
| Study group | Role | What they receive |
|---|---|---|
| AYA Text messaging intervention | Other | Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention. Receives: Behavioral: text messaging intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobil Phone Muti-Media messaging
Acceptability and feasibility of an expanded mobile phone intervention as assessed by key informant interview questions and a focus group discussion developed based on the Technology Acceptance Model: (a) perceived usefulness of the text messaging system for completing ASAP goals, (b) perceived ease of use of the text messaging system for completing ASAP goals, and (c) effect of the text messaging system on intent to complete ASAP goals. The assessment will be qualitative only.
The Technology Acceptance Model (TAM) evaluates how likely a user of new technology will accept and continue to use the new technology. TAM posits that if the technology is perceived as useful, easy to use, and increases intent to use - then the technology is more likely to be accepted. Interview questions and focus group discussion points will ask about these criteria. If responses satisfy the TAM criteria, this supports mobile phone intervention as acceptable and feasible for use in AYA cancer survivors.
Measured: one month
Secondary outcomes (2)
Key Informant Interview regarding risk for late effects due to prior cancer treatment and intent to seek survivorship care.
Themes for refinement of the text messaging intervention as assessed by key informant interview questions designed to elicit feedback on features of the mobile phone intervention that could improve knowledge regarding risk for late effects and intent to seek survivorship care.
Hypothetical example: Collectively, participants believed that the intervention's incorporation of weblinks and phone numbers to community resources clarified their risk for late effects as a cancer survivor.
Measured: up to 1 year
Key Informant Interview to identify themes from which the mobile phone intervention will be refined in order to improve its potential impact on the completion of participants' Adolescent and Young Adult Survivorship Action Plan (ASAP) goals.
Key informant interviews with YA survivors regarding their experience during the mobile phone intervention will identify themes from which the mobile phone intervention will be refined in order to improve its potential impact on the completion of participants' Adolescent and Young Adult Survivorship Action Plan (ASAP) goals.
Theoretical example: Collectively, participants believed the appointment reminders provided by the mobile phone intervention made it more likely for them to attend their survivorship care clinic appointment and, thus, complete their ASAP goal (adherence to survivorship care).
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start12 Jul 2021
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivors of Childhood CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark C Garcia, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000359
- Sponsor's protocol ID
- 21-000440
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2021
- Last updated
- 12 Jul 2023
- 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Phone Intervention to Promote Adherence to Survivorship Care Among Adolescent and Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT05000359
- Acronym / sponsor ID
- 21-000440
- Conditions
- Survivors of Childhood Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 11 Aug 2021 (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.
Adolescents and young adults (AYA) survivors of childhood cancer receive inadequate surveillance for treatment-related late effects. This study evaluates the acceptability and feasibility of a mobile phone messaging intervention targeting behavior changes related to receiving survivorship care among AYA survivors.
Content from an existing text-messaging survivorship education intervention will be adapted to a novel text-messaging platform, Chorus. Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention. In-depth interviews will be conducted with each participant during the study, and a focus group with all participants will be conducted at the end of the study. Qualitative analysis will determine areas for improvement in the text messaging intervention in order to ensure acceptability and feasibility in AYA survivors. The text messaging intervention on Chorus will be adapted to better suit the needs of AYA survivors based on the results of the qualitative analysis. Mobile phone interventions offer a cost-effective, age-appropriate approach to AYA survivorship care education. If effective, the text-messaging intervention will be evaluated in a randomized, controlled pilot trial to improve rates of survivorship care and clinical outcomes for AYA survivors.
Detailed description
Aim 1: To adapt and enhance an existing text messaging intervention to an expanded two-way multi-media mobile phone messaging platform (Chorus) that will improve knowledge regarding the risk of late effects among AYA survivors, intent to seek recommended survivorship care, and completion of standard survivorship care goals. a. both two-way text messaging to improve Children?s Oncology Group (COG) survivorship guideline adherence b. web-based educational content for survivors of key survivorship messages regarding risk for late effects and need for ongoing survivorship care c. Monthly peer navigation phone calls to address barriers and promote retention d. utilization of pre and post-test questionnaires for participants to access and complete within the Chorus platform Aim 2: To test the acceptability and feasibility of the expanded mobile phone intervention content to improve messaging and strategies for survivorship care using qualitative methodologies and applying the Technology Acceptance Model (TAM) within a sample of AYA survivors. a. perceived usefulness of the text messaging system b. perceived ease of use of the text messaging system c. effect of the text messaging system on health-related behavior intent
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.
| Arm | Type | Receives |
|---|---|---|
| AYA Text messaging intervention | Other | Behavioral: text messaging interventionTen AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients must be between the ages of 18 to 39 years at the time of enrollment
- Patient must reside in the greater Los Angeles area.
- Patients must have received survivorship care at the University of California at Los Angeles (UCLA)
- Patients must be fluent in English.
- Patients must be off cancer therapy for at least one year.
Key exclusion criteria (1 listed)
- -
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 messaging interventionTen AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention. | Behavioural | AYA Text messaging intervention |
Primary outcome
Mobil Phone Muti-Media messaging
Time frame: one month
Acceptability and feasibility of an expanded mobile phone intervention as assessed by key informant interview questions and a focus group discussion developed based on the Technology Acceptance Model: (a) perceived usefulness of the text messaging system for completing ASAP goals, (b) perceived ease of use of the text messaging system for completing ASAP goals, and (c) effect of the text messaging system on intent to complete ASAP goals. The assessment will be qualitative only. The Technology Acceptance Model (TAM) evaluates how likely a user of new technology will accept and continue to use the new technology. TAM posits that if the technology is perceived as useful, easy to use, and increases intent to use - then the technology is more likely to be accepted. Interview questions and focus group discussion points will ask about these criteria. If responses satisfy the TAM criteria, this supports mobile phone intervention as acceptable and feasible for use in AYA cancer survivors.
2 secondary outcomes
Key Informant Interview regarding risk for late effects due to prior cancer treatment and intent to seek survivorship care.
Time frame: up to 1 year
Key Informant Interview to identify themes from which the mobile phone intervention will be refined in order to improve its potential impact on the completion of participants' Adolescent and Young Adult Survivorship Action Plan (ASAP) goals.
Time frame: up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Mark C Garcia, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing text messaging intervention in people with Survivors of Childhood Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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 6 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: withdrawn, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mobil Phone Muti-Media messaging (time frame: one month). 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 12 Jul 2023.