Home Based Exercise Program for Elderly Cancer Patients

NCT01990066 | Terminated DMC

• 1 other identifier: Pro00046121
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Related Fatigue

Keywords

Quality of Life; Physical Function

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Quality of Life Improvement (QOL)

  Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point)

• Reduction in Physical Functional Decline

  Baseline and +/- 7days of 3 weeks post 6th cycle (end point)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Home Based Exercise

Observation

NO INTERVENTION

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.

Interventions

Home Based Exercise BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Oncology Nursing Centers for Excellence: collaborator

Study Sites (1)

Duke Raleigh Cancer Center

Raleigh, North Carolina, 27609, United States

Location

Study Officials

• Alicia S. Johnson, ADN-RN

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 24, 2014

Record last verified: 2014-11

Locations

US (1)