Phase 1
N=44
Exercise Intervention for Cancer Survivors and Caregivers
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01883635 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Psychological Distress — 2.25; -.65 units on a scale — p=0.14
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Survivor-only progressive walking and resistance exercise (Behavioral); Dyadic progressive walking and resistance exercise (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psychological Distress |
2.25; -.65 | 0.14 |
| SECONDARY Immune Biomarkers |
1.17; 1.42 | 0.65 |
Summary
The purpose of the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers.
Eligibility Criteria
Inclusion Criteria for Cancer Survivors:
- Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin cancers) and have received surgery, chemotherapy, and/or radiation therapy within the last 1-12 months.
- Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or physicians designee) following cancer treatments
- Have a caregiver willing to participate int he study
- Be able to read English
- Be 21 years of age or older
- Give written informed consent
Inclusion Criteria for Caregivers:
- Be nominated by a cancer survivor
- Be able to read English
- Be 21 years of age or older
- Give written informed consent
Exclusion Criteria
- have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating participation in a low to moderate intensity home based walking and progressive resistance program, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor.
- For caregivers, be currently undergoing active treatment for cancer
Data sourced from ClinicalTrials.gov (NCT01883635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.