Pediatric CancerNCT04839952
Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer
A study testing Healthy Lifestyles in people with Pediatric Cancer, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial summary
This is a feasibility and acceptability trial to test a newly developed healthy lifestyle intervention for adolescent and young adult survivors of pediatric cancer. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Healthy Lifestyles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2020to 31 Aug 2023
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants will be adolescents and young adults (15-25 years of age) who have completed cancer treatment at Johns Hopkins All Children's Hospital any time in the last five years. This age range was chosen because it corresponds to the recommended age range for cancer-related adolescents and young adult studies38.
- If the adolescent or young adult patient lives with a parent, other adult family member, or adult romantic/platonic partner, that person will also be invited to participate in the intervention as a support to the patient.
- If the adolescent or young adult patient lives with a parent or romantic partner, the parent or romantic partner will also be invited to participate in the intervention as a support to the patient. A parent or romantic partner is eligible to participate if the patient lives with them at least 50% of the time. The parent or romantic partner will not receive separate financial compensation for participation. Herein, we use the word "parent" only because we expect the vast majority of patients will live with a parent instead of a romantic partner. Patients who do not live with a parent or romantic partner will participate alone.
- The patient's cancer treatment must have included chemotherapy and/or radiation.
- If a patient's cancer relapses during the study period, the patient's oncologist must agree to the patient continuing in this intervention.
Who cannot join
- Potential participants who appear to have cognitive, motor, or language delays, as observed by research personnel or documented in the medical record, will be excluded from this study if delays preclude informed consent and/or study completion. Participants may request that research personnel read all assessment, education, and intervention materials aloud in a structured interview format, in which case participants could respond to items verbally and/or by pointing to visual aids. Because of this option, participants' ability to read and write are not requirements for participation.
- Because the motivational interviewing component of the intervention is language-dependent and requires significant time and training for certification in another language, non-English speaking patients will only be included in this study if the psychology postdoctoral fellow hired in this study is a native Spanish speaker and can demonstrate motivational interviewing proficiency in Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
This is a feasibility and acceptability trial to test a newly developed healthy lifestyle intervention for adolescent and young adult survivors of pediatric cancer.
- Conditions
- Pediatric Cancer
- Being tested
- Healthy Lifestyles, Education-Only Control
- Keywords
- Pediatric cancer, Survivorship, Child, Adolescent, Weight, Obesity, Physical activity, Motivational interviewing, Problem solving, Culture, Exercise, Nutrition
- Medical subject headings
- Neoplasms, Body Weight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy LifestylesBehavioural
12 telehealth sessions. The first 5 visits include psycho/medical education plus a motivational interviewing component. The second 7 sessions include psycho/medical education plus a problem solving training component.
Education-Only ControlBehavioural
This control condition includes meeting with a clinician for one telehealth visit to review nutrition and physical activity recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Lifestyles Intervention Arm | Experimental | Participants will receive the healthy lifestyles intervention. Receives: Behavioral: Healthy Lifestyles |
| Education-Only Control Arm | Active comparator | Participants will receive the education-only intervention. Receives: Behavioral: Education-Only Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nutrition knowledge as assessed by the General Nutrition Knowledge Questionnaire
Knowledge of nutrition recommendations, as evidenced by scores on the General Nutrition Knowledge Questionnaire - Revised (higher scores indicate greater knowledge).
Measured: Pre-intervention and 2 months after the intervention concludes
Change in Physical activity knowledge as assessed by the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire
Knowledge of physical activity recommendations, as evidenced by scores on the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire (higher scores indicate greater knowledge).
Measured: Pre-intervention and 2 months after the intervention concludes
Change in Physical activity as assessed by Fitbit data
Physical activity total weekly minutes, as evidenced by weekly Fitbit data (activity measured in minutes).
Measured: Pre-intervention and 2 months after the intervention concludes
Change in Nutrition as assessed by the Rapid Eating Assessment for Patients score
Adherence to United States Department of Agriculture recommendations, as evidenced by the Rapid Eating Assessment for Patients (higher scores indicate better adherence to recommendations).
Measured: Pre-intervention and 2 months after the intervention concludes
Intervention feasibility as assessed by the fidelity rating
Feasibility of conducting the intervention with high clinician fidelity, as evidenced by fidelity ratings for each session (fidelity represented as a percentage based on the extent to which the clinician covered all planned information for each session). Average intervention fidelity ratings should meet or exceed 80% fidelity.
Measured: Immediately following intervention
Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile
Patient and caregiver acceptability of the newly developed intervention, as evidenced by the Abbreviated Acceptability Rating Profile (higher scores indicate greater acceptability, with scores equal to or greater than 30 indicating good acceptability per published standards).
Measured: Immediately following intervention
Secondary outcomes (6)
Change in Healthy lifestyle self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire Short Form
Self-efficacy managing weight, as evidenced on scores on the Weight Efficacy Lifestyle Questionnaire Short Form (greater scores indicate greater self-efficacy).
Measured: Pre-intervention and 2 months after the intervention concludes
Change in Healthy lifestyle self-efficacy as assessed by the Healthy Promoting Lifestyle Profile II
Self-efficacy maintaining healthy lifestyle behaviors, as evidenced by scores on the Healthy Promoting Lifestyle Profile II ((greater scores indicate greater self-efficacy).
Measured: Pre-intervention and 2 months after the intervention concludes
Change in Body satisfaction as assessed by the Body Esteem Scale for Adults and Adolescents
Body satisfaction, as evidenced by scores on the Body Esteem Scale for Adults and Adolescents (higher scores indicate greater body satisfaction).
Measured: Pre-intervention and 2 months after the intervention concludes
Change in Depression as assessed by the PROMIS Depressive Symptoms-Short Form
Depressive symptoms, as evidenced by scores on the PROMIS Pediatric Depressive Symptoms-Short Form or PROMIS Adult Depressive Symptoms-Short Form (greater scores indicate greater depressive symptoms).
Measured: Pre-intervention and 2 months after the intervention concludes
Change in Anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form
PROMIS Pediatric Anxiety Symptoms- Short Form or PROMIS Adult Anxiety Symptoms Short Form (greater scores indicate greater anxiety symptoms).
Measured: Pre-intervention and 2 months after the intervention concludes
Change in Self-esteem as assessed by the Rosenberg Self Esteem Scale
Self-esteem, as evidenced by scores on the Rosenberg Self Esteem Scale (greater scores indicate greater self-esteem).
Measured: Pre-intervention and 2 months after the intervention concludes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start11 Jun 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a small feasibility study. We will enroll 24 participants on the intervention arm and 12 participants to an education-only control arm.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa A. Faith, Ph.D., ABPP, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839952
- Sponsor's protocol ID
- IRB00238848
- Status last verified
- Aug 2023
- First submitted
- 8 Apr 2021
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer
- ClinicalTrials.gov ID
- NCT04839952
- Acronym / sponsor ID
- IRB00238848
- Conditions
- Pediatric Cancer
- Keywords
- Pediatric cancer, Survivorship, Child, Adolescent, Weight, Obesity, Physical activity, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 9 Apr 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.
This is a feasibility and acceptability trial to test a newly developed healthy lifestyle intervention for adolescent and young adult survivors of pediatric cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a small feasibility study. We will enroll 24 participants on the intervention arm and 12 participants to an education-only control arm.
| Arm | Type | Receives |
|---|---|---|
| Healthy Lifestyles Intervention Arm | Experimental | Behavioral: Healthy LifestylesParticipants will receive the healthy lifestyles intervention. |
| Education-Only Control Arm | Active comparator | Behavioral: Education-Only ControlParticipants will receive the education-only intervention. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Participants will be adolescents and young adults (15-25 years of age) who have completed cancer treatment at Johns Hopkins All Children's Hospital any time in the last five years. This age range was chosen because it corresponds to the recommended age range for cancer-related adolescents and young adult studies38.
- If the adolescent or young adult patient lives with a parent, other adult family member, or adult romantic/platonic partner, that person will also be invited to participate in the intervention as a support to the patient.
- If the adolescent or young adult patient lives with a parent or romantic partner, the parent or romantic partner will also be invited to participate in the intervention as a support to the patient. A parent or romantic partner is eligible to participate if the patient lives with them at least 50% of the time. The parent or romantic partner will not receive separate financial compensation for participation. Herein, we use the word "parent" only because we expect the vast majority of patients will live with a parent instead of a romantic partner. Patients who do not live with a parent or romantic partner will participate alone.
- The patient's cancer treatment must have included chemotherapy and/or radiation.
- If a patient's cancer relapses during the study period, the patient's oncologist must agree to the patient continuing in this intervention.
Key exclusion criteria (2 listed)
- Potential participants who appear to have cognitive, motor, or language delays, as observed by research personnel or documented in the medical record, will be excluded from this study if delays preclude informed consent and/or study completion. Participants may request that research personnel read all assessment, education, and intervention materials aloud in a structured interview format, in which case participants could respond to items verbally and/or by pointing to visual aids. Because of this option, participants' ability to read and write are not requirements for participation.
- Because the motivational interviewing component of the intervention is language-dependent and requires significant time and training for certification in another language, non-English speaking patients will only be included in this study if the psychology postdoctoral fellow hired in this study is a native Spanish speaker and can demonstrate motivational interviewing proficiency in Spanish.
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 |
|---|---|---|
| Healthy Lifestyles12 telehealth sessions. The first 5 visits include psycho/medical education plus a motivational interviewing component. The second 7 sessions include psycho/medical education plus a problem solving training component. | Behavioural | Healthy Lifestyles Intervention Arm |
| Education-Only ControlThis control condition includes meeting with a clinician for one telehealth visit to review nutrition and physical activity recommendations. | Behavioural | Education-Only Control Arm |
Primary outcome
Change in Nutrition knowledge as assessed by the General Nutrition Knowledge Questionnaire
Time frame: Pre-intervention and 2 months after the intervention concludes
Knowledge of nutrition recommendations, as evidenced by scores on the General Nutrition Knowledge Questionnaire - Revised (higher scores indicate greater knowledge).
Change in Physical activity knowledge as assessed by the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire
Time frame: Pre-intervention and 2 months after the intervention concludes
Knowledge of physical activity recommendations, as evidenced by scores on the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire (higher scores indicate greater knowledge).
Change in Physical activity as assessed by Fitbit data
Time frame: Pre-intervention and 2 months after the intervention concludes
Physical activity total weekly minutes, as evidenced by weekly Fitbit data (activity measured in minutes).
Change in Nutrition as assessed by the Rapid Eating Assessment for Patients score
Time frame: Pre-intervention and 2 months after the intervention concludes
Adherence to United States Department of Agriculture recommendations, as evidenced by the Rapid Eating Assessment for Patients (higher scores indicate better adherence to recommendations).
Intervention feasibility as assessed by the fidelity rating
Time frame: Immediately following intervention
Feasibility of conducting the intervention with high clinician fidelity, as evidenced by fidelity ratings for each session (fidelity represented as a percentage based on the extent to which the clinician covered all planned information for each session). Average intervention fidelity ratings should meet or exceed 80% fidelity.
Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile
Time frame: Immediately following intervention
Patient and caregiver acceptability of the newly developed intervention, as evidenced by the Abbreviated Acceptability Rating Profile (higher scores indicate greater acceptability, with scores equal to or greater than 30 indicating good acceptability per published standards).
6 secondary outcomes
Change in Healthy lifestyle self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire Short Form
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Healthy lifestyle self-efficacy as assessed by the Healthy Promoting Lifestyle Profile II
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Body satisfaction as assessed by the Body Esteem Scale for Adults and Adolescents
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Depression as assessed by the PROMIS Depressive Symptoms-Short Form
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Self-esteem as assessed by the Rosenberg Self Esteem Scale
Time frame: Pre-intervention and 2 months after the intervention concludes
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 5 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Melissa A. Faith, Ph.D., ABPP principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyles in people with Pediatric Cancer, run by Johns Hopkins All Children's Hospital 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 5 inclusion and 2 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 5 Sep 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.
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?
Change in Nutrition knowledge as assessed by the General Nutrition Knowledge Questionnaire (time frame: Pre-intervention and 2 months after the intervention concludes). The study lists 6 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 5 Sep 2023.