Exercise Intervention for Cancer Survivors and Caregivers

NCT ID: NCT01883635

Last Updated: 2016-02-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Individual Exercise Intervention

Survivor-only progressive walking and resistance exercise

Group Type ACTIVE_COMPARATOR

Survivor-only progressive walking and resistance exercise

Intervention Type BEHAVIORAL

Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only

Dyadic Exercise Intervention

Dyadic progressive walking and resistance exercise

Group Type EXPERIMENTAL

Dyadic progressive walking and resistance exercise

Intervention Type BEHAVIORAL

Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Survivor-only progressive walking and resistance exercise

Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only

Intervention Type BEHAVIORAL

Dyadic progressive walking and resistance exercise

Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EXCAP EXCAP-PA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Charles Kamen

Assistant Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Charles Kamen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Rochester

Rochester, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

46413

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Senior Adult Hepatobiliary Prehab Study
NCT05921552 ACTIVE_NOT_RECRUITING NA
Researching the Effect of Aerobic Exercise on Cancer
NCT03996239 ACTIVE_NOT_RECRUITING NA