Home Based Exercise Program for Elderly Cancer Patients

Cancer Related Fatigue Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01990066
• Other study ID #: Pro00046121
• Status: Terminated
• Phase: N/A
• First received: November 15, 2013
• Last updated: December 23, 2014
• Start date: March 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer Related Fatigue
• Fatigue

Intervention

Behavioral:
• Home Based Exercise
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.

Locations

Country	Name	City	State
United States	Duke Raleigh Cancer Center	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Oncology Nursing Centers for Excellence

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Cancer Related Fatigue (CRF)	CRF will be evaluated using the FACIT-F tool.	Baseline, +/- 7days of 4th chemo cycle (mid point), +/- 7 days of 3 weeks after 6th cycle (end point)	No
Secondary	Quality of Life Improvement (QOL)	QOL will be evaluated using the NHANES and FACIT-F tools.	Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point)	No
Secondary	Reduction in Physical Functional Decline	Physical function will be evaluated using the Berg Balance Test and 6 Min Walk Test	Baseline and +/- 7days of 3 weeks post 6th cycle (end point)	No