Clinical trial NCT05562570: Exercise and Pain in AYACS
Official title: Exercise Intervention Coupled With Standard Post-cancer Directed Treatment Care to Reduce Chronic Pain in Adolescents and Young Adult Cancer Survivors Who Have Completed Cancer-directed Therapy Less Than One Year
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AYA Cancer Survivors
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the intervention
timeFrame: Baseline
measure: Feasibility of the intervention
timeFrame: Baseline to week 16
Secondary outcomes:
measure: Measure changes in chronic pain levels
timeFrame: Baseline, week 8 and week 16
measure: Measure changes in cumulative dose of pain medications
timeFrame: Baseline, week 4, week 8, week 12 and week 16
measure: Measure changes in patient reported outcomes
timeFrame: Baseline, week 8 and week 16
measure: Measure changes in physical activity level (Godin-Shephard leisure-time physical activity questionnaire)
timeFrame: Baseline, week 8 and week 16
measure: Measure changes in physical activity level (International Physical Activity Questionnaire-Short Form)
timeFrame: Baseline, week 8 and week 16
measure: Measure changes in patient functional outcomes (6-min walking test)
timeFrame: Baseline and week 16
measure: Measure changes in patient functional outcomes (30-second chair stand test)
timeFrame: Baseline and week 16
measure: Measure changes in patient functional outcomes ("Timed Up and Go" test)
timeFrame: Baseline and week 16
measure: Measure changes in patient functional outcomes (grip strength test)
timeFrame: Baseline and week 16
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Children's Hospital
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Smita Dandekar, MD
role: PRINCIPAL_INVESTIGATOR
References: