Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
fatigue, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Physical activity may help lessen fatigue caused by cancer in patients receiving chemotherapy. It is not yet known whether a home-based walking and resistance-band exercise program is effective in lessening fatigue. PURPOSE: This randomized phase III trial is studying how well exercise works in lessening fatigue caused by cancer in patients undergoing chemotherapy.
Detailed description
OBJECTIVES: Primary * Determine the efficacy of a home-based walking and progressive-resistance exercise program in reducing cancer-related fatigue (CRF) in patients undergoing chemotherapy. OUTLINE: This is a multicenter study. Patients are stratified according to participating site, chemotherapy course length (2 weeks vs 3 weeks), gender, and degree of fatigue reported on the study assessment questionnaire (≤ 5 vs \> 5). Patients are randomized to 1 of 2 intervention arms. * Arm I: Patients receive standard chemotherapy. * Arm II: Patients receive a home-based walking kit comprising an Exercise for Cancer Patients Manual, a pedometer, and therapeutic resistance bands. Patients undergo moderately intense aerobic exercise (walking) monitored by a pedometer, and low to moderately intense progressive-resistance exercise using therapeutic resistance bands for 6 weeks. Patients also receive standard chemotherapy. Patients in both arms undergo assessment of their aerobic capacity and strength by the 6-minute walk test and handgrip dynamometry at baseline and at day 41. They also have a fasting blood draw and wear an actigraph for one week at baseline and week 6. Patients complete Functional Assessment of Chronic Illness Therapy-Fatigue and -Cognitive Subscales, Brief Fatigue Inventory, Multidimensional Fatigue Symptom Inventory, Center for Epidemiological Studies-Depression Scale State Trait Anxiety Inventory, Pittsburgh Sleep Quality Inventory, Profile of Mood States, Aerobic Center Longitudinal Study Physical Activity, and Symptom Inventory questionnaires at baseline and at day 41 and keep a daily exercise diary during study intervention.
Interventions
BEHAVIORALexercise
home based walking and progressive resistance training exercise
Sponsors
National Cancer Institute (NCI)
Gary Morrow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* primary diagnosis of cancer other than leukemia, with no distant metastasis * chemotherapy naïve * starting chemotherapy treatments for cancer and scheduled for at least 6 weeks of treatments with treatment cycles of either 2, 3 or 4 weeks. Oral chemotherapy (e.g., Xeloda) is acceptable * Karnofsky Performance level of 70 or greater * able to read English
Exclusion criteria
* diagnosis of leukemia * metastatic disease * receiving concurrent radiation therapy * physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance program * identified as in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention) | 41 days: Day 0 (before intervention) Day 41 (post intervention) | BFI has nine items. Three items ask patients to rate the severity of their fatigue at its worst, usual, and now during normal waking hours, with 0 being no fatigue and 10 being fatigue as bad as you can imagine. Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being does not interfere and 10 being completely interferes. BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue). The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care + EXCAP Personalized exercise prescription
exercise: home based walking and progressive resistance training exercise | 331 |
| Standard Care Wait list control | 312 |
| Total | 643 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Changed Mind | 10 | 1 |
| Overall Study | Chemo started too soon | 2 | 3 |
| Overall Study | Incomplete Form | 2 | 1 |
| Overall Study | Medical | 1 | 3 |
| Overall Study | Noncompliant | 1 | 4 |
| Overall Study | No Reason | 3 | 7 |
| Overall Study | Overwhelmed | 6 | 6 |
Baseline characteristics
| Characteristic | Standard Care | Standard Care + EXCAP | Total |
|---|---|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 10.1 | 57.1 years STANDARD_DEVIATION 11.9 | 56.8 years STANDARD_DEVIATION 11.1 |
| Body Mass Index (BMI) | 30.2 kg / m^2 STANDARD_DEVIATION 6.4 | 30.1 kg / m^2 STANDARD_DEVIATION 6.7 | 30.1 kg / m^2 STANDARD_DEVIATION 6.5 |
| Cancer Stage Stage I | 84 Participants | 80 Participants | 164 Participants |
| Cancer Stage Stage II | 139 Participants | 150 Participants | 289 Participants |
| Cancer Stage Stage III | 77 Participants | 84 Participants | 161 Participants |
| Cancer Stage Stage IV | 5 Participants | 6 Participants | 11 Participants |
| Cancer Stage Unknown | 7 Participants | 11 Participants | 18 Participants |
| Cancer Type Breast | 267 Participants | 271 Participants | 538 Participants |
| Cancer Type Colon | 15 Participants | 20 Participants | 35 Participants |
| Cancer Type Lung | 9 Participants | 6 Participants | 15 Participants |
| Cancer Type Lymphoma | 7 Participants | 17 Participants | 24 Participants |
| Cancer Type Other | 14 Participants | 17 Participants | 31 Participants |
| Currently Employed Employed outside the house | 184 Participants | 184 Participants | 368 Participants |
| Currently Employed Home-Maker with >= 1 dependents | 23 Participants | 32 Participants | 55 Participants |
| Currently Employed Self-Employed | 16 Participants | 11 Participants | 27 Participants |
| Currently Employed Unemployed | 89 Participants | 104 Participants | 193 Participants |
| Education 2 or 4 degree or Some college | 165 Participants | 165 Participants | 330 Participants |
| Education Graduate degree | 46 Participants | 67 Participants | 113 Participants |
| Education High school / GED degree | 86 Participants | 88 Participants | 174 Participants |
| Education No high school or GED degree | 14 Participants | 10 Participants | 24 Participants |
| Education Unknown | 1 Participants | 1 Participants | 2 Participants |
| Exercise Stages of Change Exercising and have been for less than 6 months | 1 Participants | 0 Participants | 1 Participants |
| Exercise Stages of Change Exercising and have been for more than 6 months | 0 Participants | 0 Participants | 0 Participants |
| Exercise Stages of Change Not exercising and don't intend to in next 6 month | 36 Participants | 43 Participants | 79 Participants |
| Exercise Stages of Change Not exercising but do intend to in next 6 months | 83 Participants | 89 Participants | 172 Participants |
| Exercise Stages of Change Not exercising but intend to in next 30 days | 192 Participants | 199 Participants | 391 Participants |
| Karnofsky Performance Status (KPS) | 94.8 Karnofsky Performance Scale STANDARD_DEVIATION 6.8 | 94.2 Karnofsky Performance Scale STANDARD_DEVIATION 7.1 | 94.5 Karnofsky Performance Scale STANDARD_DEVIATION 7 |
| Marital Status Divorced or separated | 40 Participants | 24 Participants | 64 Participants |
| Marital Status Married or long-term committed relationship | 214 Participants | 236 Participants | 450 Participants |
| Marital Status Single | 36 Participants | 44 Participants | 80 Participants |
| Marital Status Widowed | 22 Participants | 27 Participants | 49 Participants |
| Previous Treatment - Chemotherapy No | 308 Participants | 329 Participants | 637 Participants |
| Previous Treatment - Chemotherapy Yes | 4 Participants | 2 Participants | 6 Participants |
| Previous Treatment - Hormone Therapy No | 304 Participants | 318 Participants | 622 Participants |
| Previous Treatment - Hormone Therapy Yes | 8 Participants | 13 Participants | 21 Participants |
| Previous Treatment - Radiation Therapy No | 306 Participants | 323 Participants | 629 Participants |
| Previous Treatment - Radiation Therapy Yes | 6 Participants | 8 Participants | 14 Participants |
| Previous Treatment - Surgery No | 37 Participants | 35 Participants | 72 Participants |
| Previous Treatment - Surgery Yes | 275 Participants | 296 Participants | 571 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Black | 30 Participants | 30 Participants | 60 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Other | 17 Participants | 16 Participants | 33 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized White | 265 Participants | 285 Participants | 550 Participants |
| Sex: Female, Male Female | 298 Participants | 306 Participants | 604 Participants |
| Sex: Female, Male Male | 14 Participants | 25 Participants | 39 Participants |
| Time since end of first cancer treatment, weeks | 6.8 weeks STANDARD_DEVIATION 23.7 | 14.5 weeks STANDARD_DEVIATION 72.9 | 10.8 weeks STANDARD_DEVIATION 55.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 331 | 3 / 312 |
| serious Total, serious adverse events | 4 / 331 | 1 / 312 |
Outcome results
Primary
Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention)
BFI has nine items. Three items ask patients to rate the severity of their fatigue at its worst, usual, and now during normal waking hours, with 0 being no fatigue and 10 being fatigue as bad as you can imagine. Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being does not interfere and 10 being completely interferes. BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue). The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention).
Time frame: 41 days: Day 0 (before intervention) Day 41 (post intervention)
Population: Subjects completing both BFI at day 0 and day 41
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care + EXCAP | Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention) | 0.9 units on a scale | Standard Deviation 2.4 |
| Standard Care | Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention) | 0.7 units on a scale | Standard Deviation 2.3 |
p-value: 0.914895% CI: [-0.371, 0.3327]ANCOVA