Childhood Cancer SurvivorsNCT04075734
Feasibility of a Self-Management + Peer Mentoring Intervention for Adolescent and Young Adult Childhood Cancer Survivors
A study testing Managing Your Health: Self-Management + Peer Mentoring in people with Childhood Cancer Survivors, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this project is to evaluate the feasibility of the "Managing Your Health" online self-management skills+peer mentoring intervention that focuses on overcoming survivor barriers to self-management of their survivorship care. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Childhood Cancer Survivors
- What is being tested?
- Managing Your Health: Self-Management + Peer Mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 26 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Young Adult Survivors:
- age 18-25;
- at least 2 years from treatment for any pediatric cancer diagnosed at age 0-19;
- low self-reported responsibility for healthcare as indicated by reporting parent is primarily responsible for healthcare or low score (1 or 2) on two or more items from Readiness for Transition Questionnaire - Survivor Version.
- Peer Mentor:
- age 21-29;
- at least 2 years from treatment for any pediatric cancer diagnosed at age 0-19;
- self-reported primary responsibility for healthcare and "complete" readiness to assume responsibility or high scores (3 or 4) on all items from Readiness for Transition Questionnaire - Survivor Version.
Who cannot join
- Documented or self-reported cognitive delay to prevent self-management of healthcare.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
The goal of this project is to evaluate the feasibility of the "Managing Your Health" online self-management skills+peer mentoring intervention that focuses on overcoming survivor barriers to self-management of their survivorship care. We will conduct a pilot randomized controlled trial (RCT) of the intervention versus usual care with adolescent and young adult survivors of childhood cancer ages 18-25 years. Participants will complete survey measures at baseline, Time 2 (about 2 months after baseline), Time 3 (about 5 months after baseline), and Time 4 (about 12 months after baseline).
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the feasibility of the online self-management+peer mentoring program in a pilot RCT.
II. Assess preliminary efficacy of the intervention.
- Conditions
- Childhood Cancer Survivors
- Being tested
- Managing Your Health: Self-Management + Peer Mentoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managing Your Health: Self-Management + Peer MentoringBehavioural
The online educational component consists of 5 self-management educational modules:
(1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy.
Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks. Receives: Behavioral: Managing Your Health: Self-Management + Peer Mentoring |
| Usual Care | No intervention | Participants are not receiving the tested intervention. They continue to receive standard or routine psychosocial or transition care available to them as part of the normal practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Measure: Enrollment (Young Adult Survivors) - Number of Eligible Patients Consented and Completing Baseline
Determined by number of eligible patients consented and completing baseline. Hypothesis: >50% of eligible will consent and complete the baseline.
Measured: Baseline
Feasibility Measure: Retention in Study (Young Adult Survivors): Percent of Consented Patients Who Are Retained in the Study and Complete Time 3 Follow-up
Retention in study (Young Adult Survivors). Determined by the percent of consented patients who are retained in the study and complete Time 3 follow-up. Hypothesis: >80%.
Measured: Time 3 at about 5 months since Baseline.
Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage
Mean percent completed per task: (a) On-line self-management educational modules and (b) Weekly calls with peer mentor.
Measured: Time 2, about 2 months since baseline.
Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean
Five items assess satisfaction with each aspect of the intervention: a. Overall program satisfaction; b. Content of online modules; c. Discussions with peer mentor; d. Frequency of calls with peer mentor; and e. Duration of program. First 3 items (a, b and c) were evaluated using a 5-point scale, (Minimum 1, Maximum 5) with higher scores indicating greater satisfaction. Item c evaluated on a scale from 1 "not frequent enough" to 3 "too frequent". Item d uses a 1 "way too short" to 5 "way too long" scale. The sample mean will be examined.
Measured: Time 2, about 2 months since baseline.
Feasibility: Utility of the Online Self-Management Modules (Young Adult Survivors): Questionnaire
The Utility Questionnaire is an 11-item scale that measures perceived ease of use and convenience of the online program using a 5-point scale, (minimum 1, maximum 5) with higher scores indicating greater perceived utility. An overall mean of all items will be calculated.
Measured: Time 2, about 2 months since baseline.
Feasibility: Impact of the Online Self-Management Modules (Young Adult Survivors): Questionnaire
The Impact Questionnaire is a 13-item scale that measures perceived effectiveness of the online program using a 5-point scale, (minimum 1, and maximum 5) with higher scores indicating greater perceived effectiveness. An overall mean of all items will be calculated.
Measured: Time 2, about 2 months since baseline.
Feasibility: Adherence Barriers to the Online Self-Management Modules (Young Adult Survivors): Questionnaire
The Adherence Barriers Questionnaire is a 6-item scale that measures perceived barriers to using the online program using a 5-point scale, (minimum 1 and maximum 5) with higher scores indicating greater perceived barriers. An overall mean of all items will be calculated.
Measured: Time 2, about 2 months since baseline.
Acceptance of Peer Mentors (Young Adult Survivors and Peer Mentors): Questionnaire
Acceptance will be evaluated by young adult survivors' and peer mentors' report on perceived alliance with each other using the Working Alliance Inventory - Short Form Revised (Hatcher \& Gillaspy, 2006), a validated measure of the quality and strength of the relationship. Items are rated on a 5-point scale. The measure yields 3 subscales summary scores that can range from 5 to 20, with higher scores indicating more positive relationships. Sum scores on each sub-scale with be calculated: Bond, Goal, and Task.
Measured: Time 2, about 2 months since baseline
Secondary outcomes (14)
Healthcare Responsibility (Young Adult Survivors)
The Readiness for Transition Questionnaire - Survivor Version (RTQ) assesses the degree to which survivors are responsible for 10 healthcare behaviors, including knowing their survivorship care plan, scheduling annual visits, scheduling specialist appointments, taking and filling medications (if prescribed), explaining medical history to others, knowing insurance coverage, attending appointments, communicating with providers, and calling providers, on a 4-point scale, with higher scores indicating higher levels of responsibility. The RTQ yields a total mean score for responsibility. It also has one item evaluating "overall readiness to assume complete responsibility for healthcare" with response options of Not at all ready, somewhat ready, mostly ready, or completely ready. The sample mean for the Total Responsibility score and overall readiness item will be calculated (range 1-4)
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Knowledge (Young Adult Survivors)
The knowledge subscale from the Transition Readiness Inventory (TRI) measures knowledge of survivorship care using a 5-point scale, with higher scores indicating greater knowledge. A mean score will be calculated (range 1-5).
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
Self-Management Skills/Self-Efficacy (Young Adult Survivors)
The Skills/Self-Efficacy sub-scale from the Transition Readiness Inventory (TRI) measures self-management skills and self-efficacy for survivorship care using a 5-point scale, with higher scores indicating greater skills/efficacy. A mean score will be calculated (range 1-5).
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
Self-Management Goals (Young Adult Survivors)
The Goals subscale from the Transition Readiness Inventory (TRI) measures self-management goals for survivorship care using a 5-point scale, with higher scores indicating greater goals. A mean score will be calculated (range 1-5).
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
Self-Management Beliefs (Young Adult Survivors)
The Beliefs/Expectations sub-scale from the Transition Readiness Inventory (TRI) measures self-management beliefs for survivorship care using a 5-point scale, with higher scores indicating more positive beliefs. A mean score will be calculated (range 1-5).
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
Self-efficacy for Communicating With Physician (Young Adult Survivors): Scale
This single item measures confidence in communicating with a physician about health concerns using a 10-point scale, with higher scores indicating greater confidence. Range is from 1-10.
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Self-efficacy for Communicating With Family About Healthcare (Young Adult Survivors): Scale
This scale measures confidence in communicating with family about healthcare concerns using a 5-point scale, with higher scores indicating greater confidence. A mean score is calculated (range from 1-5).
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Self-efficacy for Managing Late Effects (Young Adult Survivors): Scale
This scale consists of three items measuring confidence in managing late effects using a 5-point scale, with higher scores indicating higher confidence. A mean score is calculated (range 1-5).
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Self-efficacy for Survivorship Care Planning (Young Adult Survivors): Scale
This scale consists of three items measuring confidence in survivorship care planning using a 5-point scale, with higher scores indicating higher confidence. A mean score is calculated (range 1-5).
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Health Insurance Self-efficacy (Young Adult Survivors): Scale
This scale consists of seven items measuring confidence in managing health insurance using a 5-point scale, with higher scores indicating higher confidence. A mean score is calculated (range 1-5).
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Survivorship Care Attitudes (Young Adult Survivors)
This scale consists of four items measuring attitudes toward survivorship care using a 5-point scale, with higher scores indicating more positive attitudes. A mean score is calculated (range 1-5).
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Self-efficacy for Managing Emotions (Young Adult Survivors): Scale
The Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Emotions-Short Form is an 8-item measure of confidence in managing emotions. A mean score will be calculated (range 1-5). Higher scores indicate higher confidence in managing emotions.
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
Emotional Support (Young Adult Survivors)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support-Short Form is a 4-item measure of perceived emotional support. A mean score will be calculated (range 1-5), with higher scores indicative of having better perceived emotional support.
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Informational Support (Young Adult Survivors)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support-Short Form is a 4-item measure of perceived availability of helpful information or advice. A mean score will be calculated (range 1-5), with higher scores indicating higher perceived informational support.
Measured: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start1 Sep 2019
- Primary completion12 Oct 2020
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Katie Devine, PhD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Katie Devine, PhD, Principal investigator, Rutgers Cancer Inst. of NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075734
- Sponsor's protocol ID
- 20150001955
- Other IDs
- R21CA222936
- Status last verified
- May 2022
- First submitted
- 29 Aug 2019
- Last updated
- 31 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT04075734
- Acronym / sponsor ID
- 20150001955
- Conditions
- Childhood Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Posted 31 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to evaluate the feasibility of the "Managing Your Health" online self-management skills+peer mentoring intervention that focuses on overcoming survivor barriers to self-management of their survivorship care. We will conduct a pilot randomized controlled trial (RCT) of the intervention versus usual care with adolescent and young adult survivors of childhood cancer ages 18-25 years. Participants will complete survey measures at baseline, Time 2 (about 2 months after baseline), Time 3 (about 5 months after baseline), and Time 4 (about 12 months after baseline).
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the feasibility of the online self-management+peer mentoring program in a pilot RCT.
II. Assess preliminary efficacy of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Managing Your Health: Self-Management + Peer MentoringThe intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks. |
| Usual Care | No intervention | –Participants are not receiving the tested intervention. They continue to receive standard or routine psychosocial or transition care available to them as part of the normal practice |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- age 18-25;
- at least 2 years from treatment for any pediatric cancer diagnosed at age 0-19;
- low self-reported responsibility for healthcare as indicated by reporting parent is primarily responsible for healthcare or low score (1 or 2) on two or more items from Readiness for Transition Questionnaire - Survivor Version.
- age 21-29;
- at least 2 years from treatment for any pediatric cancer diagnosed at age 0-19;
Key exclusion criteria (1 listed)
- Documented or self-reported cognitive delay to prevent self-management of healthcare.
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 |
|---|---|---|
| Managing Your Health: Self-Management + Peer MentoringThe online educational component consists of 5 self-management educational modules: (1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy. Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call. | Behavioural | Intervention |
Primary outcome
Feasibility Measure: Enrollment (Young Adult Survivors) - Number of Eligible Patients Consented and Completing Baseline
Time frame: Baseline
Determined by number of eligible patients consented and completing baseline. Hypothesis: >50% of eligible will consent and complete the baseline.
Feasibility Measure: Retention in Study (Young Adult Survivors): Percent of Consented Patients Who Are Retained in the Study and Complete Time 3 Follow-up
Time frame: Time 3 at about 5 months since Baseline.
Retention in study (Young Adult Survivors). Determined by the percent of consented patients who are retained in the study and complete Time 3 follow-up. Hypothesis: >80%.
Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage
Time frame: Time 2, about 2 months since baseline.
Mean percent completed per task: (a) On-line self-management educational modules and (b) Weekly calls with peer mentor.
Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean
Time frame: Time 2, about 2 months since baseline.
Five items assess satisfaction with each aspect of the intervention: a. Overall program satisfaction; b. Content of online modules; c. Discussions with peer mentor; d. Frequency of calls with peer mentor; and e. Duration of program. First 3 items (a, b and c) were evaluated using a 5-point scale, (Minimum 1, Maximum 5) with higher scores indicating greater satisfaction. Item c evaluated on a scale from 1 "not frequent enough" to 3 "too frequent". Item d uses a 1 "way too short" to 5 "way too long" scale. The sample mean will be examined.
Feasibility: Utility of the Online Self-Management Modules (Young Adult Survivors): Questionnaire
Time frame: Time 2, about 2 months since baseline.
The Utility Questionnaire is an 11-item scale that measures perceived ease of use and convenience of the online program using a 5-point scale, (minimum 1, maximum 5) with higher scores indicating greater perceived utility. An overall mean of all items will be calculated.
Feasibility: Impact of the Online Self-Management Modules (Young Adult Survivors): Questionnaire
Time frame: Time 2, about 2 months since baseline.
The Impact Questionnaire is a 13-item scale that measures perceived effectiveness of the online program using a 5-point scale, (minimum 1, and maximum 5) with higher scores indicating greater perceived effectiveness. An overall mean of all items will be calculated.
Feasibility: Adherence Barriers to the Online Self-Management Modules (Young Adult Survivors): Questionnaire
Time frame: Time 2, about 2 months since baseline.
The Adherence Barriers Questionnaire is a 6-item scale that measures perceived barriers to using the online program using a 5-point scale, (minimum 1 and maximum 5) with higher scores indicating greater perceived barriers. An overall mean of all items will be calculated.
Acceptance of Peer Mentors (Young Adult Survivors and Peer Mentors): Questionnaire
Time frame: Time 2, about 2 months since baseline
Acceptance will be evaluated by young adult survivors' and peer mentors' report on perceived alliance with each other using the Working Alliance Inventory - Short Form Revised (Hatcher \& Gillaspy, 2006), a validated measure of the quality and strength of the relationship. Items are rated on a 5-point scale. The measure yields 3 subscales summary scores that can range from 5 to 20, with higher scores indicating more positive relationships. Sum scores on each sub-scale with be calculated: Bond, Goal, and Task.
14 secondary outcomes
Healthcare Responsibility (Young Adult Survivors)
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Knowledge (Young Adult Survivors)
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
Self-Management Skills/Self-Efficacy (Young Adult Survivors)
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
Self-Management Goals (Young Adult Survivors)
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
Self-Management Beliefs (Young Adult Survivors)
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
Self-efficacy for Communicating With Physician (Young Adult Survivors): Scale
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Self-efficacy for Communicating With Family About Healthcare (Young Adult Survivors): Scale
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Self-efficacy for Managing Late Effects (Young Adult Survivors): Scale
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Self-efficacy for Survivorship Care Planning (Young Adult Survivors): Scale
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Health Insurance Self-efficacy (Young Adult Survivors): Scale
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Survivorship Care Attitudes (Young Adult Survivors)
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Self-efficacy for Managing Emotions (Young Adult Survivors): Scale
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
Emotional Support (Young Adult Survivors)
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Informational Support (Young Adult Survivors)
Time frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Katie Devine, PhD principal investigator
Rutgers Cancer Inst. of NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managing Your Health: Self-Management + Peer Mentoring in people with Childhood Cancer Survivors, run by Rutgers, The State University of New Jersey 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 8 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 31 May 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility Measure: Enrollment (Young Adult Survivors) - Number of Eligible Patients Consented and Completing Baseline (time frame: Baseline). The study lists 8 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 31 May 2022.