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Study Summary
No. 2007-0754:.......Breast; Colorectal; Prostate......Wendy Demark-Wahnefried......Behavioral Science
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Study Summary Title
Study Summary
Number:
2007-0754
Study Title:Reach-out to ENhancE Wellness in Older Survivors
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Physician New Patient Referral
Name:Wendy Demark-WahnefriedPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-7366
Contact us about clinical trials
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General Information
Disease Group:Breast
Colorectal
Prostate
Supported By:NIH/NCI
Phase of Study:Phase II/Phase IIIReturn
Visit:
This protocol is totally home-based, no visits are required
Treatment
Agents:
Behavioral InterventionHome Care:The diet (portion-controlled, low fat, high fruit and vegetable, low energy
density diet) and exercise (lower body resistance training exercises + walking)
intervention is being delivered via mailed materials and telephone counseling
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes

The overall objective of this trial is to test whether a distance medicine-based diet and exercise program will improve physical functioning, overall health and quality of life, and health behaviors among older cancer survivors who are >5 years out from a diagnosis of colorectal, breast or prostate cancer.


Specific aims:
1) To determine the efficacy of the intervention in reorienting the physical function trajectory among elders who are long term survivors of cancer;
2) To determine differences between arms with regard to other endpoints (physical activity, diet quality, BMI, depression, etc.);
3) To identify factors that influence program efficacy (self-efficacy, etc.); and
4) To characterize functional decline over a 2-year period in survivors who receive the initial intervention vs those who are intervened upon after a 1-year delay.

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Study Status Information
Study Activation / Registration Date:02/22/2008
IRB Review and Approval Date:02/22/2008
Study Type:Behavioral
Recruitment Status:Terminated
Projected Accrual:641
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Individuals diagnosed with colorectal, prostate or female breast cancer at least 5 years ago

2) Age 65 or older

3) Body Mass Index of at least 25, but less than 40

4) Able to read, write and speak English

5) Has telephone access

6) Community dwelling

Exclusion Criteria:1) Evidence of progressive cancer or second primaries (not including non-melanoma skin cancers)

2) Has an intercurrent illness or condition that precludes adherence to an unsupervised exercise program, e.g., severe orthopedic conditions or paralysis that requires mobility aid other than a cane; scheduled for a hip or knee replacement within 6 months; end-stage renal disease; dementia; unstable angina; and/or heart attack, congestive heart failure or pulmonary conditions that require oxygen or hospitalization within 6 months.

3) Currently taking pharmacologic doses of warfarin (coumadin).

4) Currently exercises at least 150 minutes per week

5) Currently residing in a skilled nursing facility

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Links
Registration Number: NCT00303875
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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