Childhood Cancer SurvivorsPAPAYANCT04947709
Physical Activity Post-Cancer for Adolescents and Young Adults
A study testing Physical Activity in people with Childhood Cancer Survivors, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA) trial aims to carry out a pilot randomized controlled trial among 10-17 year-old adolescents and young adults, at least 1 year and up to 5 years post-cancer treatment. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Childhood Cancer Survivors
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2022to 1 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescent and young adult inclusion criteria will be as follows:
- males and females diagnosed with cancer;
- treated at Penn State Health Children's Hospital or Penn State Cancer Institute, Milton S. Hershey Medical Center;
- at least 1 year and up to 5 years post-cancer treatment;
- being aged between 10 to 17 years old at enrollment;
- being able to speak, read and understand the English language;
Show all 10Show fewer
- adolescents and young adults have to be able to assent, and parents/guardians have to be able to consent to the study in an informed manner;
- Parent fluency in written and spoken English;
- Adolescents and young adults or their parents must have access to a phone or Zoom
- Note: The agreement of the attending oncologist will be required for the participation of adolescents and young adults eligible for this study.
Who cannot join
- Adolescent and young adult exclusion criteria will be as follows:
- Received follow-up at a location other than Penn State Health Children's Hospital or Penn State Cancer Institute, Milton S. Hershey Medical Center;
- Evidence in the medical record of an absolute contraindication for physical activity;
- cardiac exclusion criteria: Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system, history of acute coronary syndromes, uncertain or uncontrolled arrhythmia, uncontrolled hypertension, syncope, acute myocarditis, pericarditis, or endocarditis, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, pulmonary edema, respiratory failure, acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, mental impairment leading to inability to cooperate;
- History of refractory or recurrent diseases
- Already meeting physical activity guidelines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA)
The Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA) trial aims to carry out a pilot randomized controlled trial among 10-17 year-old adolescents and young adults, at least 1 year and up to 5 years post-cancer treatment. The trial will evaluate the effects of a 12 week physical activity intervention to improve patient reported outcomes and physical function, in comparison to a delayed-intervention control group.
Read the detailed description
The investigators will recruit 40 adolescents and young adults at least 1 year, and up to 5 years post-cancer treatment, and randomize them (20 randomized to each condition) to either a 12-week physical activity intervention to improve patient-reported outcomes and physical function, or delayed-intervention control group.
Participants randomized to the intervention group: The physical activity intervention will be structured to increase moderate-to-vigorous intensity aerobic physical activity, to achieve the 60 minute goal, five days per week. The intervention will also include weekly support calls from research staff. The physical activity intervention will be individualized by research staff according to the adolescents and young adults' health status, results from the physical fitness assessment, and most recent week's achieved minutes. The physical activity intervention will be modified during weekly support calls with a study team member, including frequency, intensity, time, and type, to maximize adherence and compliance
Participants randomized to the delayed-intervention control group: They will not receive the physical activity intervention, and they will not receive weekly support calls. Physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations will be offered to participants randomized to the delayed-intervention control group following completion of 12-week follow-up.
- Conditions
- Childhood Cancer Survivors
- Being tested
- Physical Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
The main structure of the physical activity program will focus on increasing physical activity. Physical activity will initially start at a duration of 15-30 minute bouts, and at rate of perceived exertion levels of 5-6 (somewhat hard). Over the course of the intervention, goals will be set to progress to 60 minutes of continuous physical activity, at a rate of perceived exertion level of 5-6 (somewhat hard). Participants will be instructed on the use of the ratings of the perceived exertion scale (Borg's RPE 1-10 scale). Participants will be instructed to walk, or engage in other forms of leisure-time physical activity to achieve these goals (cycling, running, swimming, etc). As the adolescent and young adults' health and fitness status improve, frequency, intensity, and session duration will be modified accordingly during weekly support calls. Moreover, goals will be responsive to the most recent week's achieved minutes and rate of perceived exertion.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention group | Experimental | The physical activity intervention will be structured to increase moderate-to-vigorous intensity aerobic physical activity, to achieve the 60-minute goal, five days per week. The intervention will also include weekly support calls from research staff to improve compliance to physical activity intervention. Receives: Behavioral: Physical Activity |
| Delayed-intervention control group | Other | Participants randomized to the delayed-intervention control group will serve as the control group for 12 weeks, and will not receive physical activity intervention during this time and will not receive weekly support calls. After completion of the control group, participants will be offered physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations. This delayed-intervention control group design is used not only to boost recruitment, but to eventually confer the benefits of physical activity to all those who enter the trial. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability-the proportion of adolescents and young adults who agree to participate
The proportion of adolescents and young adults who agree to participate among those deemed eligible by the attending oncologist
Range 0-100%-Higher scores indicate greater acceptability
Measured: Baseline
Feasibility-the proportion of adolescents and young adults who complete at least 50% of the physical activity intervention
The percentage of those randomized to the physical activity intervention that complete at least 50% of the physical activity intervention. Participants will be instructed by a project manager during weekly support calls to accumulate a specific amount of physical activity each week. Participants who self-report completing at least 50% of the physical activity, determined by the Godin-Shephard Leisure-Time Physical Activity Questionnaire, will be deemed compliant.
Range 0-100%-Higher scores indicate greater feasibility
Measured: Baseline to week 12
Secondary outcomes (26)
Patient reported outcomes-physical function mobility
the physical function mobility assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater physical function mobility
Measured: Baseline
Patient reported outcomes-physical function mobility
the physical function mobility assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater physical function mobility
Measured: week 12
Patient reported outcomes-anxiety
the anxiety assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater anxiety
Measured: Baseline
Patient reported outcomes-anxiety
the anxiety assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater anxiety
Measured: Week 12
Patient reported outcomes-depressive symptoms
the depressive symptoms assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater depressive symptoms
Measured: baseline
Patient reported outcomes-depressive symptoms
the depressive symptoms assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater depressive symptoms
Measured: Week 12
Patient reported outcomes-fatigue
the fatigue assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater fatigue
Measured: baseline
Patient reported outcomes-fatigue
the fatigue assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater fatigue
Measured: week 12
Patient reported outcomes-peer relationships
the peer relationships assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater peer relationships
Measured: baseline
Patient reported outcomes-peer relationships
the peer relationships assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater peer relationships
Measured: week 12
Patient reported outcomes-social isolation
the social isolation assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater social isolation
Measured: baseline
Patient reported outcomes-social isolation
the social isolation assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater social isolation
Measured: week 12
Patient reported outcomes-pain interference
the pain interference assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater pain interference
Measured: baseline
Patient reported outcomes-pain interference
the pain interference assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater pain interference
Measured: week 12
Patient reported outcomes-pain intensity
the pain intensity assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 0-10, higher scores indicate greater pain intensity
Measured: baseline
Patient reported outcomes-pain intensity
the pain intensity assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 0-10, higher scores indicate greater pain intensity
Measured: week 12
Patient reported outcomes-sleep disturbance
the sleep disturbance assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater sleep disturbance
Measured: baseline
Patient reported outcomes-sleep disturbance
the sleep disturbance assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 8-40, higher scores indicate greater sleep disturbance
Measured: week 12
Patient reported outcomes-cognitive function
the cognitive function assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 7-35, higher scores indicate greater cognitive function
Measured: baseline
Patient reported outcomes-cognitive function
the cognitive function assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49)
Range 7-35, higher scores indicate greater cognitive function
Measured: week 12
physical function-six minute walking test
The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes.
Further distances indicate greater physical function
Measured: baseline
physical function-six minute walking test
The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes.
Further distances indicate greater physical function
Measured: week 12
physical function-30 second chair stand
The 30 second chair stand test will be administered to assess physical function. Participants will aim to sit and rise out of a chair as many times as possible in 30 seconds.
Greater amounts of sit/stands indicate greater physical function
Measured: baseline
physical function-30 second chair stand
The 30 second chair stand test will be administered to assess physical function. Participants will aim to sit and rise out of a chair as many times as possible in 30 seconds.
Greater amounts of sit/stands indicate greater physical function
Measured: week 12
physical function-timed up and go
The timed up and go test will be administered to assess physical function. Participants will aim to stand up, walk 3 meters, turn around, and walk back to the chair as fast as possible.
Shorter durations indicate greater physical function
Measured: baseline
physical function-timed up and go
The timed up and go test will be administered to assess physical function. Participants will aim to stand up, walk 3 meters, turn around, and walk back to the chair as fast as possible.
Shorter durations indicate greater physical function
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start21 Jun 2022
- Primary completion27 Feb 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, utilizing a delayed-intervention control group.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Four Diamonds Research Fund at Penn State Health Childrens Hospital
- Responsible party
- Principal investigator, Smita Dandekar, Milton S. Hershey Medical Center
- Investigators
- Smita Dandekar, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947709
- Sponsor's protocol ID
- STUDY00018148
- Acronym
- PAPAYA
- Status last verified
- Aug 2023
- First submitted
- 9 Jun 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caru M, Dandekar S, Gordon B, Conroy DE, Barb ED, Doerksen SE, Smink GM, McKeone DJ, Shah NB, Greiner RJ, Schramm JW, Rao P, McGregor L, Schmitz KH. Implementing a behavioral physical activity program in children and adolescent survivors of childhood cancer: a pilot randomized controlled trial. J Behav Med. 2024 Oct;47(5):792-803. doi: 10.1007/s10865-024-00497-z. Epub 2024 May 12.
PubMed 38735024
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA)
- ClinicalTrials.gov ID
- NCT04947709
- Acronym / sponsor ID
- PAPAYA / STUDY00018148
- Conditions
- Childhood Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Four Diamonds Research Fund at Penn State Health Childrens Hospital
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 1 Jul 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.
The Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA) trial aims to carry out a pilot randomized controlled trial among 10-17 year-old adolescents and young adults, at least 1 year and up to 5 years post-cancer treatment. The trial will evaluate the effects of a 12 week physical activity intervention to improve patient reported outcomes and physical function, in comparison to a delayed-intervention control group.
Detailed description
The investigators will recruit 40 adolescents and young adults at least 1 year, and up to 5 years post-cancer treatment, and randomize them (20 randomized to each condition) to either a 12-week physical activity intervention to improve patient-reported outcomes and physical function, or delayed-intervention control group.
Participants randomized to the intervention group: The physical activity intervention will be structured to increase moderate-to-vigorous intensity aerobic physical activity, to achieve the 60 minute goal, five days per week. The intervention will also include weekly support calls from research staff. The physical activity intervention will be individualized by research staff according to the adolescents and young adults' health status, results from the physical fitness assessment, and most recent week's achieved minutes. The physical activity intervention will be modified during weekly support calls with a study team member, including frequency, intensity, time, and type, to maximize adherence and compliance
Participants randomized to the delayed-intervention control group: They will not receive the physical activity intervention, and they will not receive weekly support calls. Physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations will be offered to participants randomized to the delayed-intervention control group following completion of 12-week follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial, utilizing a delayed-intervention control group.
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention group | Experimental | Behavioral: Physical ActivityThe physical activity intervention will be structured to increase moderate-to-vigorous intensity aerobic physical activity, to achieve the 60-minute goal, five days per week. The intervention will also include weekly support calls from research staff to improve compliance to physical activity intervention. |
| Delayed-intervention control group | Other | Behavioral: Physical ActivityParticipants randomized to the delayed-intervention control group will serve as the control group for 12 weeks, and will not receive physical activity intervention during this time and will not receive weekly support calls. After completion of the control group, participants will be offered physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations. This delayed-intervention control group design is used not only to boost recruitment, but to eventually confer the benefits of physical activity to all those who enter the trial. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- males and females diagnosed with cancer;
- treated at Penn State Health Children's Hospital or Penn State Cancer Institute, Milton S. Hershey Medical Center;
- at least 1 year and up to 5 years post-cancer treatment;
- being aged between 10 to 17 years old at enrollment;
- being able to speak, read and understand the English language;
Key exclusion criteria (6 listed)
- Received follow-up at a location other than Penn State Health Children's Hospital or Penn State Cancer Institute, Milton S. Hershey Medical Center;
- Evidence in the medical record of an absolute contraindication for physical activity;
- cardiac exclusion criteria: Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system, history of acute coronary syndromes, uncertain or uncontrolled arrhythmia, uncontrolled hypertension, syncope, acute myocarditis, pericarditis, or endocarditis, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, pulmonary edema, respiratory failure, acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, mental impairment leading to inability to cooperate;
- History of refractory or recurrent diseases
- Already meeting physical activity guidelines.
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 |
|---|---|---|
| Physical ActivityThe main structure of the physical activity program will focus on increasing physical activity. Physical activity will initially start at a duration of 15-30 minute bouts, and at rate of perceived exertion levels of 5-6 (somewhat hard). Over the course of the intervention, goals will be set to progress to 60 minutes of continuous physical activity, at a rate of perceived exertion level of 5-6 (somewhat hard). Participants will be instructed on the use of the ratings of the perceived exertion scale (Borg's RPE 1-10 scale). Participants will be instructed to walk, or engage in other forms of leisure-time physical activity to achieve these goals (cycling, running, swimming, etc). As the adolescent and young adults' health and fitness status improve, frequency, intensity, and session duration will be modified accordingly during weekly support calls. Moreover, goals will be responsive to the most recent week's achieved minutes and rate of perceived exertion. | Behavioural | Delayed-intervention control group, Physical activity intervention group |
Primary outcome
Acceptability-the proportion of adolescents and young adults who agree to participate
Time frame: Baseline
The proportion of adolescents and young adults who agree to participate among those deemed eligible by the attending oncologist Range 0-100%-Higher scores indicate greater acceptability
Feasibility-the proportion of adolescents and young adults who complete at least 50% of the physical activity intervention
Time frame: Baseline to week 12
The percentage of those randomized to the physical activity intervention that complete at least 50% of the physical activity intervention. Participants will be instructed by a project manager during weekly support calls to accumulate a specific amount of physical activity each week. Participants who self-report completing at least 50% of the physical activity, determined by the Godin-Shephard Leisure-Time Physical Activity Questionnaire, will be deemed compliant. Range 0-100%-Higher scores indicate greater feasibility
26 secondary outcomes
Patient reported outcomes-physical function mobility
Time frame: Baseline
Patient reported outcomes-physical function mobility
Time frame: week 12
Patient reported outcomes-anxiety
Time frame: Baseline
Patient reported outcomes-anxiety
Time frame: Week 12
Patient reported outcomes-depressive symptoms
Time frame: baseline
Patient reported outcomes-depressive symptoms
Time frame: Week 12
Patient reported outcomes-fatigue
Time frame: baseline
Patient reported outcomes-fatigue
Time frame: week 12
Patient reported outcomes-peer relationships
Time frame: baseline
Patient reported outcomes-peer relationships
Time frame: week 12
Patient reported outcomes-social isolation
Time frame: baseline
Patient reported outcomes-social isolation
Time frame: week 12
Patient reported outcomes-pain interference
Time frame: baseline
Patient reported outcomes-pain interference
Time frame: week 12
Patient reported outcomes-pain intensity
Time frame: baseline
Patient reported outcomes-pain intensity
Time frame: week 12
Patient reported outcomes-sleep disturbance
Time frame: baseline
Patient reported outcomes-sleep disturbance
Time frame: week 12
Patient reported outcomes-cognitive function
Time frame: baseline
Patient reported outcomes-cognitive function
Time frame: week 12
physical function-six minute walking test
Time frame: baseline
physical function-six minute walking test
Time frame: week 12
physical function-30 second chair stand
Time frame: baseline
physical function-30 second chair stand
Time frame: week 12
physical function-timed up and go
Time frame: baseline
physical function-timed up and go
Time frame: week 12
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 14 Aug 2023.
- Derived from this study: PubMed 38735024Caru M, Dandekar S, Gordon B, Conroy DE, Barb ED, Doerksen SE, Smink GM, McKeone DJ, Shah NB, Greiner RJ, Schramm JW, Rao P, McGregor L, Schmitz KH. Implementing a behavioral physical activity program in children and adolescent survivors of childhood cancer: a pilot randomized controlled trial. J Behav Med. 2024 Oct;47(5):792-803. doi: 10.1007/s10865-024-00497-z. Epub 2024 May 12.
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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.
Smita Dandekar, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Childhood Cancer Survivors, run by Milton S. Hershey Medical 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 10 inclusion and 6 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 14 Aug 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?
Acceptability-the proportion of adolescents and young adults who agree to participate (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04947709, which also lists 1 linked publication.
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 14 Aug 2023.