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Breast CancerPhase 2NCT00303875

Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight

A Phase 2 study testing behavioral dietary and exercise intervention in people with Breast Cancer and Colorectal Cancer, run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight. PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving… Read more about this study

Who is it for?
Ages 65 to 120 years
Conditions the study is for
Breast Cancer, Colorectal Cancer, Prostate Cancer
What is being tested?
behavioral dietary and exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
641 participants
Where
2 sitesUnited States
Study dates
Dec 2003to May 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 120 years
  • All sexes
  • No healthy volunteers
  • Older adult

DISEASE CHARACTERISTICS:

  • Diagnosed colorectal, prostate, or female breast cancer
  • At least 5 years beyond date of diagnosis with no clinical evidence of progressive disease or second primaries
  • Body mass index ≥ 25 kg/m^2 and < 40 kg/m^2
  • Currently exercising < 150 minutes/week
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • No serious intercurrent medical condition or disability that could preclude study treatment, including any of the following:
  • Severe orthopedic condition or scheduled hip or knee replacement within the next 6 months
  • Paralysis
  • End-stage renal disease
  • Dementia
  • Unstable angina
  • Heart attack, congestive heart failure, or pulmonary condition that required oxygen or hospitalization within the past 6 months
  • Ability to read, write, and speak English

PRIOR CONCURRENT THERAPY:

  • No concurrent warfarin

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: RENEW: Reach Out to Enhance Wellness in Older Survivors

RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the physical function over 1 year of overweight older long-term cancer survivors assigned to immediate vs delayed exercise and dietary counseling.

Secondary

  • Compare physical activity, saturated fat and vegetable and fruit intake, body mass index, depression, and general health and well being of experimental arm patients vs control arm patients.
  • Evaluate self-efficacy, social support, comorbidity, cancer-type, and gender as factors associated with program efficacy.
  • Determine the functional decline over a 2-year period in patients who undergo immediate vs delayed intervention.
  • Characterize the mathematical form, over a 2-year period, of physical functioning trajectories among older cancer survivors, including determining if the intervention effects are durable in those who receive the intervention initially and whether "catch-up" is possible in the delayed intervention arm.

OUTLINE: This is a randomized study. Patients are stratified according to cancer type (colorectal vs breast or prostate), sex, age (65-74 years vs 75 years and over), and race (white vs non-white). Patients are randomized to 1 of 2 intervention arms.

  • Arm I (immediate intervention): Patients receive a personalized notebook of diet and exercise information, exercise equipment, and logbooks to record food intake and exercise behaviors. Patients undergo 20-minute telephone discussions with a health counselor once weekly for 3 weeks, every 2 weeks for 2 months, and then monthly for up to 1 year for a total of 15 sessions. Patients also undergo a 5-minute telephone survey to assess health every 3 months.
  • Arm II (delayed intervention): Patients undergo intervention as in arm I after a 1-year waiting period.

After completion of study intervention, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 640 patients will be accrued for this study.

Being tested
behavioral dietary and exercise intervention
Keywords
recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent colon cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage I rectal cancer
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • behavioral dietary and exercise interventionBehavioural

Study groups in NCT00303875
Study groupRoleWhat they receive
Wait-list controlNo interventionWait-list control received diet \& exercise counseling during year 2 as a courtesy
Lifestyle counselingExperimentalsubjects randomized to receive diet \& exercise counseling for one year
Receives: Behavioral: behavioral dietary and exercise intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion

    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

    Measured: one year

Secondary outcomes (7)

  1. Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion

    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

    Measured: one year

  2. Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion

    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

    Measured: one year

  3. Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion

    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

    Measured: one year

  4. Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion

    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

    Measured: one year

  5. Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion

    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

    Measured: one year

  6. Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion

    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

    Measured: one year

  7. Stage of readiness for exercise and dietary change as assessed by the stage of change algorithms at baseline and years 1 and 2 following study completion

    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study startDec 2003
  3. Primary completionJun 2008
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
641 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303875
Sponsor's protocol ID
Pro00012963
Other IDs
DUMC-5477-03-12R0ER, DUMC-5477-04-12R1ER, CDR0000460231
Status last verified
Feb 2013
First submitted
15 Mar 2006
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Miller PE, Hartman TJ, Cohen HJ. Reach out to enhance wellness home-based diet-exercise intervention promotes reproducible and sustainable long-term improvements in health behaviors, body weight, and physical functioning in older, overweight/obese cancer survivors. J Clin Oncol. 2012 Jul 1;30(19):2354-61. doi: 10.1200/JCO.2011.40.0895. Epub 2012 May 21.

    PubMed 22614994

  • Miller PE, Morey MC, Hartman TJ, Snyder DC, Sloane R, Cohen HJ, Demark-Wahnefried W. Dietary patterns differ between urban and rural older, long-term survivors of breast, prostate, and colorectal cancer and are associated with body mass index. J Acad Nutr Diet. 2012 Jun;112(6):824-31, 831.e1. doi: 10.1016/j.jand.2012.02.021.

    PubMed 22709810

  • Mosher CE, Sloane R, Morey MC, Snyder DC, Cohen HJ, Miller PE, Demark-Wahnefried W. Associations between lifestyle factors and quality of life among older long-term breast, prostate, and colorectal cancer survivors. Cancer. 2009 Sep 1;115(17):4001-9. doi: 10.1002/cncr.24436.

    PubMed 19637244

  • Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.

    PubMed 19436015

  • Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39. doi: 10.1002/pon.1491.

    PubMed 19117329

  • Morey MC, Blair CK, Sloane R, Cohen HJ, Snyder DC, Demark-Wahnefried W. Group trajectory analysis helps to identify older cancer survivors who benefit from distance-based lifestyle interventions. Cancer. 2015 Dec 15;121(24):4433-40. doi: 10.1002/cncr.29684. Epub 2015 Oct 29.

    PubMed 26512712

  • Winger JG, Mosher CE, Rand KL, Morey MC, Snyder DC, Demark-Wahnefried W. Diet and exercise intervention adherence and health-related outcomes among older long-term breast, prostate, and colorectal cancer survivors. Ann Behav Med. 2014 Oct;48(2):235-45. doi: 10.1007/s12160-014-9598-7.

    PubMed 24648018

  • Blair CK, Morey MC, Desmond RA, Cohen HJ, Sloane R, Snyder DC, Demark-Wahnefried W. Light-intensity activity attenuates functional decline in older cancer survivors. Med Sci Sports Exerc. 2014 Jul;46(7):1375-83. doi: 10.1249/MSS.0000000000000241.

    PubMed 24389524

  • Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Cohen HJ. Promoting healthy lifestyles in older cancer survivors to improve health and preserve function. J Am Geriatr Soc. 2009 Nov;57 Suppl 2(Suppl 2):S262-4. doi: 10.1111/j.1532-5415.2009.02507.x.

    PubMed 20122025

  • Miller P, Demark-Wahnefried W, Snyder DC, Sloane R, Morey MC, Cohen H, Kranz S, Mitchell DC, Hartman TJ. Dietary supplement use among elderly, long-term cancer survivors. J Cancer Surviv. 2008 Sep;2(3):138-48. doi: 10.1007/s11764-008-0060-3. Epub 2008 Jul 11.

    PubMed 18792788

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing behavioral dietary and exercise intervention in people with Breast Cancer and Colorectal Cancer, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303875, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.

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