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Home Based Exercise Program for Elderly Cancer Patients

Primary Purpose

Cancer Related Fatigue

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Based Exercise
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Related Fatigue focused on measuring Quality of Life, Physical Function

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Endometrial, Ovarian, Cervix, Vaginal Cancer Initiating Chemotherapy
  • Age greater than or equal to 65yrs
  • ECOG (Eastern Cooperative Oncology Group) performance status less than 3
  • No current physical therapy intervention
  • English speaking

Exclusion Criteria:

  • Non-gynecologic malignancy
  • Recurrent cancer
  • Receiving radiation alone
  • Gait or balance disturbance

Sites / Locations

  • Duke Raleigh Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Observation

Arm Description

Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching. They will receive a home exercise DVD and flip ring of exercises. Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer. Subjects will record their exercise on a log and return on day 1 of every cycle.

Subjects randomized to observation will only have physical therapy assessment using the Berg Balance Test and 6min Walk Test at baseline and end point. These subjects will not receive any exercise teaching.

Outcomes

Primary Outcome Measures

Reduction in Cancer Related Fatigue (CRF)
CRF will be evaluated using the FACIT-F tool.

Secondary Outcome Measures

Quality of Life Improvement (QOL)
QOL will be evaluated using the NHANES and FACIT-F tools.
Reduction in Physical Functional Decline
Physical function will be evaluated using the Berg Balance Test and 6 Min Walk Test

Full Information

First Posted
November 15, 2013
Last Updated
December 23, 2014
Sponsor
Duke University
Collaborators
Oncology Nursing Centers for Excellence
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1. Study Identification

Unique Protocol Identification Number
NCT01990066
Brief Title
Home Based Exercise Program for Elderly Cancer Patients
Official Title
Single Institution Randomized Controlled Study of a Home Based Exercise Program to Reduce Functional Decline, Cancer Related Fatigue (CRF and Improve Quality of Life for the Elderly Gynecologic Oncology Patient)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting adequate enrollment
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Oncology Nursing Centers for Excellence

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Implementation of a home based exercise program to reduce functional decline, cancer related fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient Problem: Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology patient undergoing chemotherapy? Support: Fatigue and its impact on QOL is a major concern with the elderly patient receiving chemotherapy. When compared to younger adults QOL is more important than gain in survival for elderly patients. (Eyigor, et al., 2010). The National Comprehensive Cancer Network recommends exercise as the most effective intervention for cancer related fatigue. Methods: This is a single institution randomized controlled study to evaluate a home based exercise program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be randomized to the intervention group or to the control group receiving usual care. Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to assist with compliance. The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6 minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following cycle 6 (completion). Conclusion: PT directed home exercise program may improve CRF, functional decline, and QOL in elderly gynecologic oncology patients undergoing chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Related Fatigue
Keywords
Quality of Life, Physical Function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching. They will receive a home exercise DVD and flip ring of exercises. Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer. Subjects will record their exercise on a log and return on day 1 of every cycle.
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Subjects randomized to observation will only have physical therapy assessment using the Berg Balance Test and 6min Walk Test at baseline and end point. These subjects will not receive any exercise teaching.
Intervention Type
Behavioral
Intervention Name(s)
Home Based Exercise
Intervention Description
Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching. They will receive a home exercise DVD and flip ring of exercises. Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer. Subjects will record their exercise on a log and return on day 1 of every cycle.
Primary Outcome Measure Information:
Title
Reduction in Cancer Related Fatigue (CRF)
Description
CRF will be evaluated using the FACIT-F tool.
Time Frame
Baseline, +/- 7days of 4th chemo cycle (mid point), +/- 7 days of 3 weeks after 6th cycle (end point)
Secondary Outcome Measure Information:
Title
Quality of Life Improvement (QOL)
Description
QOL will be evaluated using the NHANES and FACIT-F tools.
Time Frame
Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point)
Title
Reduction in Physical Functional Decline
Description
Physical function will be evaluated using the Berg Balance Test and 6 Min Walk Test
Time Frame
Baseline and +/- 7days of 3 weeks post 6th cycle (end point)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endometrial, Ovarian, Cervix, Vaginal Cancer Initiating Chemotherapy Age greater than or equal to 65yrs ECOG (Eastern Cooperative Oncology Group) performance status less than 3 No current physical therapy intervention English speaking Exclusion Criteria: Non-gynecologic malignancy Recurrent cancer Receiving radiation alone Gait or balance disturbance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia S. Johnson, ADN-RN
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Raleigh Cancer Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States

12. IPD Sharing Statement

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Home Based Exercise Program for Elderly Cancer Patients

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