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The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older (S-PACT)

Primary Purpose

Cancer, Geriatric, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walk With Ease
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, Chemotherapy, Fatigue, Elderly, Geriatric, Any Cancer, Cancer Treatment, Weakness, Tiredness

Eligibility Criteria

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

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

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Wait List Control

Arm Description

This arm will begin the Walk With Ease program after the completion of chemotherapy.

The arm will begin the Walk With Ease program three months after completion of chemotherapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
To report recruitment and retention in the study at 3 months
To report recruitment and retention in the study at 6 months
To measure implementation of and adherence to WWE
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.
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
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
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.
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

Full Information

First Posted
June 20, 2014
Last Updated
September 11, 2017
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Breast Cancer Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02191982
Brief Title
The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Breast Cancer Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Geriatric, Fatigue
Keywords
Cancer, Chemotherapy, Fatigue, Elderly, Geriatric, Any Cancer, Cancer Treatment, Weakness, Tiredness

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
This arm will begin the Walk With Ease program after the completion of chemotherapy.
Arm Title
Wait List Control
Arm Type
Active Comparator
Arm Description
The arm will begin the Walk With Ease program three months after completion of chemotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Walk With Ease
Other Intervention Name(s)
WWE
Intervention Description
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.
Primary Outcome Measure Information:
Title
To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
Description
Change in fatigue will be measured using the FACIT-F.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months
Description
This outcome will be measured by the Brief Fatigue Inventory
Time Frame
Three months
Title
To report recruitment and retention in the study at 3 months
Time Frame
Three months
Title
To report recruitment and retention in the study at 6 months
Time Frame
Six months
Title
To measure implementation of and adherence to WWE
Time Frame
Six months
Title
To count the number of adverse events
Description
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.
Time Frame
Six months
Title
To measure change in engagement of walking over time from baseline to three months.
Description
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
Time Frame
Three Months
Title
To measure change in physical function over time from baseline to three months.
Description
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
Time Frame
Three Months
Title
To measure change in quality of life over time from baseline to three months.
Description
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.
Time Frame
Three Months
Title
To measure change in self-efficacy over time from baseline to three months.
Description
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
Time Frame
Three Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyman B Muss, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Links:
URL
https://unclineberger.org/patientcare/programs/geriatric
Description
UNC Geriatric Oncology Program

Learn more about this trial

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

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