Clinical trial NCT02191982: The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older
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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Geriatric
Fatigue
Keywords: Cancer
Chemotherapy
Fatigue
Elderly
Geriatric
Any Cancer
Cancer Treatment
Weakness
Tiredness
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2014-07-16
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
timeFrame: Three months
Secondary outcomes:
measure: To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months
timeFrame: Three months
measure: To report recruitment and retention in the study at 3 months
timeFrame: Three months
measure: To report recruitment and retention in the study at 6 months
timeFrame: Six months
measure: To measure implementation of and adherence to WWE
timeFrame: Six months
measure: To count the number of adverse events
timeFrame: Six months
measure: To measure change in engagement of walking over time from baseline to three months.
timeFrame: Three Months
measure: To measure change in physical function over time from baseline to three months.
timeFrame: Three Months
measure: To measure change in quality of life over time from baseline to three months.
timeFrame: Three Months
measure: To measure change in self-efficacy over time from baseline to three months.
timeFrame: Three Months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Hyman B Muss, MD
role: PRINCIPAL_INVESTIGATOR
References: