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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Geriatric; Cancer; Fatigue

Treatments: Behavioral: Walk With Ease

Study type: Interventional

Funder types: Other

Identifiers

NCT02191982

LCCC1402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Walk With Ease

Wait List Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Walk With Ease