The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older

Cancer Clinical Trial

— S-PACT  

Official title:

A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191982
• Other study ID #: LCCC1402
• Status: Completed
• Phase: N/A
• First received: June 20, 2014
• Last updated: September 11, 2017
• Start date: June 2014
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.

Description:

The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Men and women age 65 years and older

• Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD

• Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)

• Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)

• Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer

• Moderate to severe fatigue (>4 on BFI)

• Less than 120 minutes/week of physical activity

• English speaking

• Signed IRB approved written informed consent

• Approval from their treating physician to engage in moderate-intensity physical activity

• Patient-assessed ability to walk and engage in moderate physical activity

• Willing and able to meet all study requirements.

Exclusion Criteria:

• Receiving hormonal therapy for prostate cancer

• Unable to walk or engage in moderate-intensity physical activity

• Have BFI=3.

• Report more than 120 minutes/week of physical activity

Related Conditions & MeSH terms

• Cancer
• Fatigue
• Geriatric

Intervention

Behavioral:
• Walk With Ease
Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.	Change in fatigue will be measured using the FACIT-F.	Three months
Secondary	To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months	This outcome will be measured by the Brief Fatigue Inventory	Three months
Secondary	To report recruitment and retention in the study at 3 months		Three months
Secondary	To report recruitment and retention in the study at 6 months		Six months
Secondary	To measure implementation of and adherence to WWE		Six months
Secondary	To count the number of adverse events	To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.	Six months
Secondary	To measure change in engagement of walking over time from baseline to three months.	To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.; Engagement in walking (total minutes per week) as measured by engagement in physical activity questions	Three Months
Secondary	To measure change in physical function over time from baseline to three months.	To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.; Physical function as measured by SPPB	Three Months
Secondary	To measure change in quality of life over time from baseline to three months.	To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.; Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression.	Three Months
Secondary	To measure change in self-efficacy over time from baseline to three months.	To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.; Engagement in walking (total minutes per week) as measured by engagement in physical activity questions	Three Months

External Links

•   UNC Geriatric Oncology Program