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 eligibility & treatment information in the protocol.
Please 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, actigraphs, & blood draw kits are 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, Actigraphy, & Pedometer Asmts (Days -4 to -1)

Collect fasting blood draw & assess AC & strength between Day -4 to 0 (blood draw & tests 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)

Actigraphy in exercise & standard care conditions (Days 17-20)

Tx Cycle 3 (Days 28-41)

Start end of study actigraphy in exercise & standard care conditions (Day 38)

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)

Collect fasting blood draw & assess AC & strength (Day 42): Blood draw & tests must be done prior to chemo

Collect all daily diaries, questionnaires, & actigraph (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, Actigraphy, & Pedometer Asmts (Days -4 to -1)

Collect fasting blood draw, assess AC, & strength between Day -4 to 0 (blood draw & tests 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

Actigraphy in exercise & standard care conditions (Days 17-20)

Arm 1 = Standard Chemo

Arm 2 = Exercise + Standard Chemo

Tx Cycle 2 (Days 21-41)

Start end of study actigraphy in exercise & standard care conditions (Day 38)

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)

Collect fasting blood draw, assess AC & strength (Day 42): Blood draw & tests must be done prior to chemo

Collect all daily diaries, questionnaires, & actigraph (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, Actigraphy, & Pedometer Asmts (Days -4 to -1)

Collect fasting blood draw, 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

Actigraphy in exercise & standard care conditions (Days 17-20)

Arm 1 = Standard Chemo

Arm 2 = Exercise + Standard Chemo

Tx Cycle 2 (Days 28-42)

Start end of study actigraphy in exercise & standard care conditions (Day 38)

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

Collect fasting blood draw, assess AC, & strength (Day 42): Blood draw & tests must be done prior to chemo

Collect all daily diaries, questionnaires, & actigraph (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)*
- Blood draw**#
*       On Study (at time of consent)

**     Baseline Asmt (Days -4 to 0)
#      6 tubes (approx 50ml): 2 red-tops for serum, 2 purple-top EDTA-heparin (1 for plasma & 1 for DNA), & 2 Paxgene tubes for RNA. Samples may be stored & frozen (see protocol for time limitations & storage requirements). Contact KCCOP for kit.
Signed informed consent.