Childhood Cancer SurvivorsNCT05562193
Exercise and Pain in CCS
A study testing Physical activity intervention coupled with standard post-cancer directed treatment care in people with Childhood Cancer Survivors, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in children and… 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 intervention coupled with standard post-cancer directed treatment care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 11 Mar 2025
- 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
- Male and female CCS diagnosed with any type of cancer
- CCS who have completed all standard/planned cancer treatment and are stable at the time of recruitment
- CCS are < 1-year post cancer therapy
- CCS who have chronic pain (pain will be self-reported by the participant, will have to be ≥1 on a scale of 10 and lasting for 3 months or longer)
- CCS who are age between 10 and 17 years old at the time of enrollment
- CCS who are and who are not non-ambulatory/wheelchair bound.
Show all 12Show fewer
- CCS and parent/legal guardian must be able to speak, read and understand the English language
- CCS's parent or legal guardian must be able to provide and understand informed consent
- CCS must be able to provide and understand assent
- CCS must be able to attend three visits (baseline, 8 and 16-week follow-up) at the Penn State Health Children's Hospital
- CCS and parent/legal guardian must have access to a computer, smartphone or tablet
- Note: The agreement of the attending oncologist will be required for the participation of CCS eligible for this study.
Who cannot join
- CCS who have not completed all standard/planned cancer treatment and/or not in complete remission at the time of recruitment
- CCS who are > 1-year post cancer therapy
- CCS who are < 10 years old and > 17 years old at the time of enrollment
- CCS who have evidence in their medical record of an absolute contraindication to complete any of the physical assessments in their medical record. This exclusion criterion is at the oncologist's discretion when research staff will contact the medical oncologist via secure email or secure message through the electronic medical record for approval to approach their patients for the study and for medical clearance. The oncologists can update this information at any time during the study if there is evidence of an absolute contraindication to complete any of the physical assessments.
- CCS who have history of refractory or recurrent cancer
- CCS or their parent/legal guardian who are unable to speak, read, and understand the English language
- CCS who are unable to access and complete online questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Children's Hospital
Hershey, Pennsylvania, 17033
About this study
Official title: Exercise Intervention Coupled With Standard Post-cancer Directed Treatment Care to Reduce Chronic Pain in Childhood Cancer Survivors Who Have Completed Cancer-directed Therapy Less Than One Year
The purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in children and adolescents. Our central hypothesis is that integration of exercise interventions into standard post-cancer directed treatment care will be acceptable and feasible while improving patients' pain, decreasing the cumulative dose of pain medication and improving patients' functional and psychosocial outcomes as compared to patients who only receive standard post-cancer directed treatment care.
- Conditions
- Childhood Cancer Survivors
- Being tested
- Physical activity intervention coupled with standard post-cancer directed treatment care, Standard post-cancer directed treatment care control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity intervention coupled with standard post-cancer directed treatment careBehavioural
CCS will participate in a 16-week physical activity program. CCS will be instructed to start with a session duration of <15-min, three days per week at low intensity (e.g., activities expending >1.5 to 3 METs or intensity <5 on a scale of 0 to 10). Any type of physical activity will be acceptable. The program will be individualized, and activity increased according to patients' health status, results from the physical function assessment, and most recent week's achieved physical activities. The program will include support calls and texts from research staff (exercise physiologist). The program will be modified and adapted during support calls or texts, including frequency, intensity, time and type to maximize CCS' success. CCS will receive a Fitbit at the beginning of the intervention.
Standard post-cancer directed treatment care controlOther
CCS in the control group will not participate in a 16-week physical activity program and will not receive support calls or texts. Physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations and the International Pediatric Oncology Exercise Guidelines will be offered to CCS following completion of 16-week follow-up. Moreover, CCS will receive a Fitbit following completion of 16-week follow-up
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention coupled with standard post-cancer directed treatment care group | Experimental | Not described Receives: Behavioral: Physical activity intervention coupled with standard post-cancer directed treatment care |
| Standard post-cancer directed treatment care control group | Other | Not described Receives: Other: Standard post-cancer directed treatment care control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention
The number of participants approached who agree to participate in the study
Measured: Baseline
Feasibility of the intervention
The number of participants randomized to the physical activity program intervention coupled with standard post-cancer directed treatment care who complete at least 50% of the physical activity intervention.
Measured: Baseline to week 16
Secondary outcomes (8)
Measure changes in chronic pain levels
Self-reported chronic pain questionnaire using the PedsQL pediatric pain questionnaire. The parent proxy-report format is used to assess the parent's perceptions of their child's pain.
Range 0-100, Higher score indicates higher pain intensity
Measured: Baseline, week 8 and week 16
Measure changes in cumulative dose of pain medications
- Chart review: number of pain medications prescribed, total dosage and length of time prescribed.
- Self-reported pain medication: usage of prescription medication and information about the use of non-prescription pain medications (e.g., over the counter oral and topical pain medications).
- The Prescription Drug Monitoring Program will be accessed to gather information on all filled prescriptions for controlled substances within the state of Pennsylvania.
- Morphine equivalent dose will be calculated for each patient after looking at the total daily amount of each opioid the patient is taking. Using the standard conversion factors developed by the CDC, the Morphine milligram equivalent equates the many different opioids into a standard value that is based on morphine and its potency providing an easily interpretable metric for representing opioid utilization
Measured: Baseline, week 4, week 8, week 12 and week 16
Measure changes in patient reported outcomes
Psychosocial questionnaires using the NIH developed PROMIS pediatric questionnaires, which are validated for pediatric oncology, including: Self-reported physical function mobility, Anxiety, Depressive symptoms, Fatigue, Peer relationships, Social isolation, Pain interference, Pain intensity, Sleep disturbance, Cognitive function.
PROMIS pediatric questionnaires assessing PROs on 5 point Likert scale responses
Measured: Baseline, week 8 and week 16
Measure changes in physical activity level
Self-reported physical activity questionnaire using the Godin-Shephard leisure-time physical activity questionnaire.
- Less than 14 units: Insufficiently active
- 14 to 23 units: Moderately active
- 24 units or more: Active
Measured: Baseline, week 8 and week 16
Measure changes in patient functional outcomes (6-min walking test)
Validated physical function tests for pediatric patients, including the 6-min walking test Further distances indicate greater physical function
Measured: Baseline and week 16
Measure changes in patient functional outcomes (30-second chair stand test)
Validated physical function tests for pediatric patients, including the 30-second chair stand test Greater amounts of sit/stands indicate greater physical function
Measured: Baseline and week 16
Measure changes in patient functional outcomes ("Timed Up and Go" test)
Validated physical function tests for pediatric patients, including the "Timed Up and Go" test Shorter durations indicate greater physical function
Measured: Baseline and week 16
Measure changes in patient functional outcomes (grip strength test)
Validated physical function tests for pediatric patients, including the grip strength test Greater grip strength indicate greater physical function
Measured: Baseline and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start30 Sep 2022
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 20 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, Penn State Health Milton S Hershey Medical Center
- Investigators
- Smita Dandekar, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562193
- Sponsor's protocol ID
- STUDY00020762
- Status last verified
- May 2025
- First submitted
- 26 Sep 2022
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention Coupled With Standard Post-cancer Directed Treatment Care to Reduce Chronic Pain in Childhood Cancer Survivors Who Have Completed Cancer-directed Therapy Less Than One Year
- ClinicalTrials.gov ID
- NCT05562193
- Acronym / sponsor ID
- STUDY00020762
- Conditions
- Childhood Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 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
- 30 Sep 2022 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 30 Sep 2022 (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 purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in children and adolescents. Our central hypothesis is that integration of exercise interventions into standard post-cancer directed treatment care will be acceptable and feasible while improving patients' pain, decreasing the cumulative dose of pain medication and improving patients' functional and psychosocial outcomes as compared to patients who only receive standard post-cancer directed treatment care.
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
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention coupled with standard post-cancer directed treatment care group | Experimental | Behavioral: Physical activity intervention coupled with standard post-cancer directed treatment care |
| Standard post-cancer directed treatment care control group | Other | Other: Standard post-cancer directed treatment care control |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Male and female CCS diagnosed with any type of cancer
- CCS who have completed all standard/planned cancer treatment and are stable at the time of recruitment
- CCS are < 1-year post cancer therapy
- CCS who have chronic pain (pain will be self-reported by the participant, will have to be ≥1 on a scale of 10 and lasting for 3 months or longer)
- CCS who are age between 10 and 17 years old at the time of enrollment
Key exclusion criteria (7 listed)
- CCS who have not completed all standard/planned cancer treatment and/or not in complete remission at the time of recruitment
- CCS who are > 1-year post cancer therapy
- CCS who are < 10 years old and > 17 years old at the time of enrollment
- CCS who have evidence in their medical record of an absolute contraindication to complete any of the physical assessments in their medical record. This exclusion criterion is at the oncologist's discretion when research staff will contact the medical oncologist via secure email or secure message through the electronic medical record for approval to approach their patients for the study and for medical clearance. The oncologists can update this information at any time during the study if there is evidence of an absolute contraindication to complete any of the physical assessments.
- CCS who have history of refractory or recurrent cancer
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 activity intervention coupled with standard post-cancer directed treatment careCCS will participate in a 16-week physical activity program. CCS will be instructed to start with a session duration of <15-min, three days per week at low intensity (e.g., activities expending >1.5 to 3 METs or intensity <5 on a scale of 0 to 10). Any type of physical activity will be acceptable. The program will be individualized, and activity increased according to patients' health status, results from the physical function assessment, and most recent week's achieved physical activities. The program will include support calls and texts from research staff (exercise physiologist). The program will be modified and adapted during support calls or texts, including frequency, intensity, time and type to maximize CCS' success. CCS will receive a Fitbit at the beginning of the intervention. | Behavioural | Physical activity intervention coupled with standard post-cancer directed treatment care group |
| Standard post-cancer directed treatment care controlCCS in the control group will not participate in a 16-week physical activity program and will not receive support calls or texts. Physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations and the International Pediatric Oncology Exercise Guidelines will be offered to CCS following completion of 16-week follow-up. Moreover, CCS will receive a Fitbit following completion of 16-week follow-up | Other | Standard post-cancer directed treatment care control group |
Primary outcome
Acceptability of the intervention
Time frame: Baseline
The number of participants approached who agree to participate in the study
Feasibility of the intervention
Time frame: Baseline to week 16
The number of participants randomized to the physical activity program intervention coupled with standard post-cancer directed treatment care who complete at least 50% of the physical activity intervention.
8 secondary outcomes
Measure changes in chronic pain levels
Time frame: Baseline, week 8 and week 16
Measure changes in cumulative dose of pain medications
Time frame: Baseline, week 4, week 8, week 12 and week 16
Measure changes in patient reported outcomes
Time frame: Baseline, week 8 and week 16
Measure changes in physical activity level
Time frame: Baseline, week 8 and week 16
Measure changes in patient functional outcomes (6-min walking test)
Time frame: Baseline and week 16
Measure changes in patient functional outcomes (30-second chair stand test)
Time frame: Baseline and week 16
Measure changes in patient functional outcomes ("Timed Up and Go" test)
Time frame: Baseline and week 16
Measure changes in patient functional outcomes (grip strength test)
Time frame: Baseline and week 16
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 May 2025.
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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
Penn State College of Medicine
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 intervention coupled with standard post-cancer directed treatment care 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 12 inclusion and 7 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 May 2025. 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 of the intervention (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?
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 May 2025.