Exercise Intervention for Cancer Survivors and Caregivers

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University of Rochester

Status and phase

Completed
Phase 1

Conditions

Cancer

Treatments

Behavioral: Dyadic progressive walking and resistance exercise
Behavioral: Survivor-only progressive walking and resistance exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT01883635
46413

Details and patient eligibility

About

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.

Full description

This was a pilot feasibility study to refine our methodology before a larger Phase II trial.

Enrollment

44 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Individual Exercise Intervention
Active Comparator group
Description:
Survivor-only progressive walking and resistance exercise
Treatment:
Behavioral: Survivor-only progressive walking and resistance exercise
Dyadic Exercise Intervention
Experimental group
Description:
Dyadic progressive walking and resistance exercise
Treatment:
Behavioral: Dyadic progressive walking and resistance exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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