URCC 08106

KCCOP Protocol Summary

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full protocol.
Members may follow the "Full Protocol" link or contact KCCOP for complete protocol information.

Full Protocol

(members only)

Consent Form

HIPAA

URCC 08106 - "A Study of the Effects of Exercise on Cancer-Related Fatigue"

NOTES:

1) Exercise kits provided - contact KCCOP.

2) CRAs/RNs administering the exercise intervention must be trained (in person or via phone) & approved by URCC.

Treatment Plan (Supplied Drug: N/A)

CRF = Cancer Related Fatigue

AC = Aerobic Capacity

QOL = Quality of Life

NOTES: 1) MUST CONCEAL RANDOMIZATION ARM FROM THE PT UNTIL DAY 0.

2) IF CHEMO IS DELAYED, PARTICIPANT SHOULD CONTINUE w/STUDY REQUIREMENTS AS IF CHEMO HAD STARTED.

Schema for 2-wk Cycle Chemo Regimens

Baseline

Eligibility, Consent, & Register pt on or b/f Day -4

Daily Diary & Pedometer Asmts (Days -4 to -1)

Assess AC & strength between Day -4 to 0 (must be done prior to receiving 1st chemo tx)

Assess CRF & QOL on Day -1 (pts complete questionnaires at home the night b/f 1st chemo tx)

Tx Cycle 1 (Days 0-13)

Study Day 0 (day pt receives 1st chemo tx)

RANDOMIZE (Day 0), tell pt which arm they are on, & explain program

Arm 1 = Standard Chemo

Arm 2 = Exercise + Standard Chemo

Tx Cycle 2 (Days 14-27)

Tx Cycle 3 (Days 28-41)

Start end of study pedometer in Standard Care (no exercise) condition (Day 38)

Assess CRF & QOL (Day 41): Pts complete at home on night b/f chemo tx

Tx Cycle 4 (Day 42)

Assess AC & strength (Day 42): Tests must be done prior to chemo

Collect all daily diaries & questionnaires (Day 42)

Administer & collect feedback questionnaire

Schema for 3-wk Cycle Chemo Regimens

Pts receiving oral chemo (i.e., Xeloda) will most closely follow this schema. All pts receiving oral chemo must be consented & enrolled prior to receiving any chemo tx.

Baseline

Eligibility, Consent, & Register pt on or b/f Day -4

Daily Diary & Pedometer Asmts (Days -4 to -1)

Assess AC & strength between Day -4 to 0 (must be done prior to receiving 1st chemo tx)

Assess CRF & QOL on Day -1 (pts complete questionnaires at home the night b/f 1st chemo tx)

Tx Cycle 1 (Days 0-20)

Study Day 0 (day pt receives 1st chemo tx)

RANDOMIZE (Day 0), tell pt which arm they are on, & explain program

Arm 1 = Standard Chemo

Arm 2 = Exercise + Standard Chemo

Tx Cycle 2 (Days 21-41)

Start end of study pedometer in Standard Care (no exercise) condition (Day 38)

Assess CRF & QOL (Day 41): Pts complete at home on night b/f chemo tx

Tx Cycle 3 (Day 42)

Assess AC & strength (Day 42): Tests must be done prior to chemo

Collect all daily diaries & questionnaires (Day 42)

Administer & collect feedback questionnaire

Schema for 4-wk Cycle Chemo Regimens

Baseline

Eligibility, Consent, & Register pt on or b/f Day -4

Daily Diary & Pedometer Asmts (Days -4 to -1)

Assess AC & strength between Day -4 to 0 (must be done prior to receiving 1st chemo tx)

Assess CRF & QOL on Day -1 (pts complete questionnaires at home the night b/f 1st chemo tx)

Tx Cycle 1 (Days 0-27)

Study Day 0 (day pt receives 1st chemo tx)

RANDOMIZE (Day 0), tell pt which arm they are on, & explain program

Arm 1 = Standard Chemo

Arm 2 = Exercise + Standard Chemo

Tx Cycle 2 (Days 28-42)

Start end of study pedometer in Standard Care (no exercise) condition (Day 38)

Assess CRF & QOL (Day 41): Pts complete at home on night b/f end of study visit

Study Ends (Day 42)

Study ends on Day 42 in middle of Tx Cycle 2

Assess AC & strength (Day 42)

Collect all daily diaries & questionnaires (Day 42)

Administer & collect feedback questionnaire

Eligibility

Prim dx of cancer (no leukemia), no distant mets.
Chemo naive.
Must be starting chemo for >6 wks w/tx cycles of either 2, 3, or 4 wks. Oral chemo (i.e., Xeloda) is allowed & will most closely follow the 3-wk cycle schema.
Karnofsky perf status >70 (assessed by med onc at start of chemo txs).
Able to read English.
Age >21.
No concurrent RT.
No physical limitations to contraindicate low-moderate intensity home-based walking & progressive resistance program (med onc's decision).
Must not be in active or maintenance stage of exercise behavior as determined by 1-item Exercise Stages of Change Short Form (included in the "On Study Data / Participant Form", Ques. 7).
PRESTUDY REQUIREMENTS:
- Participant Contact Form for Future Research*
- On Study Data / Participant Form*
- Clinical Record Information*
- Chemo Flowsheet &/or RT Tx Summary (copy from chart)*
- Lab tests (w/i last 3 mos)**
- Meds & CAM usage**
- Brief Fatigue Inventory**
- Multidimensional Fatigue Symptom Inventory**
- Fitness Testing (6-Min. Walk Test, Handgrip Dynamometer Test)**
- Pedometer (4 consecutive days: Days -4 to -1)**
- Functional Asmt of Chronic Illness Therapy, - Fatigue, & - Cognition**
- Aerobic Center Longitudinal Study Physical Activity Questionnaire**
- Daily Diary (including hot flashes, begin on same day Pedometer commences during baseline)**
- Center for Epidemiological Studies Depression Scale**
- State Trait Anxiety Inventory**
- Profile of Mood States**
- Pittsburgh Sleep Quality Inventory**
- Symptom Inventory**
- Walking & Resistance Exercise Prescription Sheets (EXCAP Pt Manual)*
* On Study (at time of consent)

** Baseline Asmt (Days -4 to 0)
Signed informed consent.