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Exercise and Pain in AYACS

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Penn State Health

Status

Completed

Conditions

AYA Cancer Survivors

Treatments

Behavioral: Physical activity intervention coupled with standard post-cancer directed treatment care
Other: Standard post-cancer directed treatment care control

Study type

Interventional

Funder types

Other

Identifiers

NCT05562570
STUDY00020904

Details and patient eligibility

About

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 adolescents and young adults (AYA). 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male and female AYA cancer survivors diagnosed with any type of cancer between the ages of 15 and 39 years old
  2. AYA cancer survivors who have completed all standard/planned cancer treatment and are stable at the time of recruitment
  3. AYA cancer survivors are < 1-year post cancer therapy
  4. AYA cancer survivors 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)
  5. AYA cancer survivors who are age ≥18 years old at the time of enrollment
  6. AYA cancer survivors who are and who are not non-ambulatory/wheelchair bound.
  7. AYA cancer survivors must be able to speak, read and understand the English language
  8. AYA cancer survivors must be able to provide and understand informed consent
  9. AYA cancer survivors must be able to attend three visits (baseline, 8 and 16-week follow-up) at the Penn State Health Milton S. Hershey Medical Center
  10. AYA cancer survivors must have access to a computer with wifi, smartphone with wifi or tablet with wifi

Note: The agreement of the attending oncologist will be required for the participation of AYA cancer survivors eligible for this study.

Exclusion criteria

  1. AYA cancer survivors who have not completed all standard/planned cancer treatment and/or not in complete remission at the time of recruitment
  2. AYA cancer survivors who are > 1-year post cancer therapy
  3. AYA cancer survivors who are < 18 years old at the time of enrollment
  4. cancer survivors who have evidence 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.
  5. AYA cancer survivors who have history of refractory or recurrent cancer
  6. AYA cancer survivors who are unable to speak, read, and understand the English language

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Physical activity intervention coupled with standard post-cancer directed treatment care group
Experimental group
Treatment:
Behavioral: Physical activity intervention coupled with standard post-cancer directed treatment care
Standard post-cancer directed treatment care control group
Other group
Treatment:
Other: Standard post-cancer directed treatment care control

Trial contacts and locations

1

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Central trial contact

Maxime Caru, PhD, PhD

Data sourced from clinicaltrials.gov

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