Clinical trial NCT01990066: 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
Overall status: TERMINATED
Phase: NA
Conditions: Cancer Related Fatigue
Keywords: Quality of Life
Physical Function
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Oncology Nursing Centers for Excellence
First posted: 2013-11-21
Enrollment: 8
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Reduction in Cancer Related Fatigue (CRF)
timeFrame: Baseline, +/- 7days of 4th chemo cycle (mid point), +/- 7 days of 3 weeks after 6th cycle (end point)
Secondary outcomes:
measure: Quality of Life Improvement (QOL)
timeFrame: Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point)
measure: Reduction in Physical Functional Decline
timeFrame: Baseline and +/- 7days of 3 weeks post 6th cycle (end point)
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Duke Raleigh Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Alicia S. Johnson, ADN-RN
role: PRINCIPAL_INVESTIGATOR
References: