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Completed

NCT Number: NCT02191982

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

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.

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Key information

Conditions

Cancer Asthenia Fatigue Geriatric Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walk With Ease

Behavioral

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.

Other names: WWE

Primary outcomes

  1. To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.

    Time frame: Three months

    Change in fatigue will be measured using the FACIT-F.

Secondary outcomes

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

    Time frame: Three months

    This outcome will be measured by the Brief Fatigue Inventory

  2. To report recruitment and retention in the study at 3 months

    Time frame: Three months

  3. To report recruitment and retention in the study at 6 months

    Time frame: Six months

  4. To measure implementation of and adherence to WWE

    Time frame: Six months

  5. To count the number of adverse events

    Time frame: Six months

    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.

  6. To measure change in engagement of walking over time from baseline to three months.

    Time frame: 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

  7. To measure change in physical function over time from baseline to three months.

    Time frame: 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

  8. To measure change in quality of life over time from baseline to three months.

    Time frame: 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.

  9. To measure change in self-efficacy over time from baseline to three months.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Official study 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)

Acronym: S-PACT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 16, 2014
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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