Cancer, Fatigue, Geriatric
Conditions
Keywords
Cancer, Chemotherapy, Fatigue, Elderly, Geriatric, Any Cancer, Cancer Treatment, Weakness, Tiredness
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.
Interventions
BEHAVIORALWalk With Ease
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.
Sponsors
Breast Cancer Research Foundation
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure change in fatigue scores between intervention and wait list control arms from baseline to three months. | Three months | Change in fatigue will be measured using the FACIT-F. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 fatigue scores between intervention and WLC arms from baseline to 3 months | Three months | This outcome will be measured by the Brief Fatigue Inventory |
| To measure change in physical function over time from baseline to three months. | 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. | 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. | 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 engagement of walking over time from baseline to three months. | 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 |
Countries
United States
Outcome results
None listed