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Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors (VCC0910)

14. januar 2013 oppdatert av: Kim Dittus, University of Vermont

Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese. The American Cancer Society has called for weight loss treatment to be standard of care for overweight women with breast cancer. During therapy women with breast cancer often gain weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have their cancer come back. The reason why overweight breast cancer survivors are more likely to re-occur has not been well studied, but changes in how insulin works may contribute. Overweight survivors are also at risk for the other chronic diseases associated with obesity. Fortunately, weight losses of as little as 5-7% of baseline body weight can improve risk of chronic disease. An effective behaviorally-based, lifestyle intervention delivered via the internet has been developed at the University of Vermont. This successful intervention has not been tested among breast cancer survivors. Given that women tend to lose muscle mass during cancer therapy the addition of a resistance training component to the weight loss intervention may be important. Therefore the overall goal of this project is to pilot test a proven distantly- delivered behavioral weight loss intervention among overweight breast cancer survivors and to evaluate whether a resistance program results in improvements in lean body mass, while studying how both interventions change insulin sensitivity.

Specifically, this project is a randomized, controlled clinical trial designed to test the effectiveness and acceptability of a 6-month behavioral weight loss intervention with and without resistance training. Participants will be randomized to one of two groups: 1) behavioral weight control treatment via the Internet; or 2) behavioral weight control treatment via the Internet plus a resistance training program. Women eligible to participate include overweight breast cancer survivors who are age 50 or older and 6-36 months past receiving chemotherapy. Assessments will be conducted at baseline and six months and will include measures of body weight, muscle mass, adherence to treatment, and insulin sensitivity.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

72

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Vermont
      • Burlington, Vermont, Forente stater, 05405
        • Vermont Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Post-menopausal (last period 12 mos prior to study enrollment or oophorectomy)
  • Age 40-65
  • DCIS, Stage I, II, III Breast Cancer
  • BMI between 27-50
  • Completed chemotherapy to treat early stage breast cancer (Stage I-III) no less then 6 months and no more than 48 months from start of study or for specific aim 3 Diagnosis of DCIS or Stage I breast cancer who did not receive chemotherapy.

Exclusion Criteria:

  • Participant can not have a psychotic or central nervous system impairment that would limit compliance with study requirements
  • Evidence of metastatic disease
  • Chemotherapy for cancer other than breast cancer
  • Diabetes mellitus, uncontrolled hypo or hyper thyroidism, liver failure
  • Celiac sprue, inflammatory bowel disease
  • Inability to walk for exercise
  • Lymphedema as indicated by a 2 cm circumference difference at the elbow
  • weight loss in the previous 6 months of 10 lbs or greater

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: weight loss intervention
Behavioral weight loss intervention
Atferdsmessig: weight loss intervention
Behavioral weight loss intervention
Eksperimentell: Weight Loss plus Resistance Training
Behavioral weight loss intervention with the addition of resistance training
Atferdsmessig: Weight Loss
Behavioral weight loss intervention
Aktiv komparator: Comparator
Group of women who did not receive chemotherapy
Atferdsmessig: Weight Loss
Behavioral weight loss intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Identify changes in energy balance and insulin sensitivity parameters in overweight breast cancer survivors after a behavioral weight loss intervention.
Tidsramme: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Primary outcome measures include weight, fat free mass, fat mass, total and active energy expenditure, calorie intake and oral glucose tolence test
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Determine whether the addition of resistance training to a behavioral weight loss intervention preserves muscle mass and improves weight loss or insulin sensitivity in breast cancer survivors.
Tidsramme: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Outcomes include weight, fat free mass, fat mass, strength (upper extremity and lower extremity) and oral glucose tolerence test
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Identify differences in weight loss and energy balance between post menopausal breast cancer survivors who received chemotherapy and those who did not receive chemotherapy as part of their oncologic management.
Tidsramme: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Outcomes: weight, fat mass, Fat free mass, total and active energy expenditure, calorie intake
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Determine differences in insulin sensitivity parameters between post menopausal breast cancer survivors who received chemotherapy and those who did not.
Tidsramme: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Oral glusoe tolerence test
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Determine feasibility, acceptability, and safety of weight loss intervention without resistance training for breast cancer survivors.
Tidsramme: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Outcomes include compliance as determined by percent of indiviudals completing each lesson and completing the program. Saftery is assessed by identifying injury or worsening lymphedema. Acceptability is determined with a survey.
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Assess changes in health-related quality of life after a weight loss intervention.
Tidsramme: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Outcomes include SF-36 and FACT-fatigue surveys
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Determine feasibility, acceptability, and safety of weight loss intervention with resistance training for breast cancer survivors.
Tidsramme: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Outcomes include compliance as determined by percent of indiviudals completing each lesson and completing the program. Saftery is assessed by identifying injury or worsening lymphedema. Acceptability is determined with a survey.
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.

Samarbeidspartnere og etterforskere

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Sponsor

University of Vermont

Samarbeidspartnere

University of Vermont Medical Center

Etterforskere

  • Hovedetterforsker: Kim L Dittus, MD, PhD, University of Vermont/ Fletcher Allen Health Care

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2009

Primær fullføring (Faktiske)

1. januar 2012

Studiet fullført (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først innsendt

12. april 2010

Først innsendt som oppfylte QC-kriteriene

28. november 2011

Først lagt ut (Anslag)

30. november 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. januar 2013

Sist bekreftet

1. januar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 10-031

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