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Rural Women Connecting for Better Health

22 november 2016 bijgewerkt door: University of Kansas Medical Center

Group Phone-Based Weight Control for Rural Breast Cancer Survivors

Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence and death compared to their normal weight counterparts. Moreover, weight gain and decreased physical activity are common after diagnosis and also increase the likelihood of breast cancer recurrence and death. Rural women suffer from health disparities in breast cancer diagnosis and treatment. Women of the most rural counties also have the highest prevalence of obesity compared to urban women. To address these disparities, the overarching objective of this proposal is to develop a clinically effective and cost efficient strategy for delivering a weight control intervention to rural breast cancer survivors. Group phone-based treatment via conference call is a novel treatment delivery approach that the investigators have shown to be effective for initial weight loss among rural breast cancer survivors and more effective than the standard individual phone-based approach among rural women. This innovative method of providing group treatment addresses access barriers in rural areas and may be especially ideal for rural breast cancer survivors because it provides social support in conjunction with a level of anonymity. However, the impact of group phone counseling during extended care for weight loss maintenance beyond 6 months remains unknown. Weight loss maintenance is the more challenging phase of treatment when weight regain is common, and this regain presents a potential risk for breast cancer recurrence. This randomized controlled trial will evaluate the effects of group phone-based treatment for weight loss maintenance among rural breast cancer survivors, compared to an established mail-based education comparison condition, subsequent to a 6 month group phone-based weight loss phase for both conditions. In addition to the intervention impact on weight loss maintenance, the study will provide estimates of incremental cost-effectiveness per kg loss between the two conditions and the impact on secondary outcomes including quality of life, breast cancer risk biomarkers, dietary intake, and physical activity.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Phase 1 - Weight Loss (0-6 months)

  • Weekly group phone counseling sessions for all participants (12-14 women per group) via conference call for 26 consecutive weeks
  • Low-calorie, low-fat diet recommended, including 2 pre-packaged entrees, five one-cup servings of fruits and vegetables and meal replacement shakes (provided free of charge)
  • Physical activity program program recommended, beginning with 15 minutes per day, 3 days a week, working toward a goal of 225 minutes a week
  • Experienced group counselor facilitates all sessions

Phase 2 - Weight Loss Maintenance (6-18 months)

  • Participants randomized to either group phone counseling or mail-based comparison with no phone counseling
  • Weight loss maintenance group condition includes 26 bi-weekly phone sessions, while mail-based comparison includes 26 bi-weekly newsletters in the mail
  • Focus is on problem-solving

Phase 3 - Transition to Self-Reliance (18-24 months)

  • Lasts from 18-24 months
  • No sessions or newsletter mailings
  • Participants are encouraged to continue to self-monitor throughout this period

Studietype

Ingrijpend

Inschrijving (Werkelijk)

210

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66160
        • University of Kansas Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 75 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • Breast cancer patients with a BMI 27-45 kg/m2
  • Diagnosis of Stage 0-IIIc disease within the past 10 years (except Stage 0, treated with mastectomy only)
  • Have completed all local and systemic therapy at least 3 months prior to entry
  • Have clearance from their oncologist or current medical provider to participate in a weight control study
  • Must be ≤ 75 years old
  • Post-menopausal
  • Participants must live in a rural area
  • Have access to a phone
  • Able to participate in the physical activity component of the intervention, i.e., be able to walk briskly unassisted and without serious medical risk
  • Weight stable within ten pounds three months prior to entry

Exclusion Criteria:

  • Women with insulin-dependent diabetes
  • Ongoing participation in a formal weight loss program
  • Ongoing use of pharmacotherapy for weight loss
  • Ongoing use of medications that seriously affect weight and metabolism (e.g., steroids, phentermine)
  • Positive screen for current substance abuse, major depression, or binge eating disorder
  • Any cardiac or pulmonary disease preventing participation
  • Treatment for any other cancers within the past year
  • Previous bariatric surgery

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group (GRP) phone counseling
The group phone counseling includes 26 bi-weekly phone sessions from 6 to 18 months and focuses on group problem-solving. Women continue in the same group as in weight loss intervention phase.
Gedragsmatig: Group phone counseling
Bi-weekly phone counseling sessions from 6 - 18 months
Actieve vergelijker: Mail-based Comparison Condition
Participants in this group will receive a newsletter by mail every other week for 12 months starting after the initial 6 month weight loss period. The newsletters will provide problem-solving tips and will review nutrition and physical activity information.
Gedragsmatig: Newsletter
Bi-weekly newsletter mailings from 6 - 18 months

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Weight loss maintenance
Tijdsspanne: 6 - 18 months
Examine the impact of group phone-based treatment on weight loss maintenance from 6 to 18 months, compared to a mail-based education COMPARISON condition, following a 6-month weight loss phase among obese rural breast cancer survivors.
6 - 18 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quality of life
Tijdsspanne: Baseline and 6, 12, 18, and 24 months
Compare the effects of treatment conditions on aspects of quality of life important for breast cancer survivorship, including general physical, social, and emotional well-being, fatigue, arthralgia, lymphedema symptoms, menopausal symptoms, and depressive symptoms.
Baseline and 6, 12, 18, and 24 months
Breast cancer risk biomarkers
Tijdsspanne: Baseline and 6 and 18 months
Examine the association of weight change with changes in selected breast cancer risk biomarkers, including bioavailable estradiol, testosterone, and fasting insulin. Examine whether modulation of biomarkers is sustained during weight loss maintenance.
Baseline and 6 and 18 months
Cost effectiveness
Tijdsspanne: 18 months
Compare the incremental cost-effectiveness of weight loss maintenance (kg below baseline) between group and control conditions. Costs include fixed and variable provider costs (facility, time, phone charges, supplies) and fixed and variable participant costs (time, out-of-pocket expenses).
18 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Kansas Medical Center

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Christie Befort, Ph.D., University of Kansas Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2011

Primaire voltooiing (Werkelijk)

1 april 2015

Studie voltooiing (Werkelijk)

1 oktober 2015

Studieregistratiedata

Eerst ingediend

23 september 2011

Eerst ingediend dat voldeed aan de QC-criteria

26 september 2011

Eerst geplaatst (Schatting)

27 september 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

23 november 2016

Laatste update ingediend die voldeed aan QC-criteria

22 november 2016

Laatst geverifieerd

1 november 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 12633
  • 1R01CA155014-01A1 (Subsidie/contract van de Amerikaanse NIH)

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