NCT02191982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

3.2 years

First QC Date

June 20, 2014

Last Update Submit

September 11, 2017

Conditions

CancerGeriatricFatigue

Keywords

CancerChemotherapyFatigueElderlyGeriatricAny CancerCancer TreatmentWeaknessTiredness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months

    Three months

  • To report recruitment and retention in the study at 3 months

    Three months

  • To report recruitment and retention in the study at 6 months

    Six months

  • To measure implementation of and adherence to WWE

    Six months

  • To count the number of adverse events

    Six months

  • +4 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Walk With Ease

Wait List Control

ACTIVE COMPARATOR

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

Behavioral: Walk With Ease

Interventions

Walk With EaseBEHAVIORAL

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.

Also known as: WWE
InterventionWait List Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsFatigueAsthenia

Interventions

Walkingmethyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Hyman B Muss, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2014

First Posted

July 16, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 12, 2017

Record last verified: 2017-09

Locations

US(1)