- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01441011
Rural Women Connecting for Better Health
22. November 2016 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Interventionell
Einschreibung (Tatsächlich)
210
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Kansas
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Kansas City, Kansas, Vereinigte Staaten, 66160
- University of Kansas Medical Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
Nicht älter als 75 Jahre (Kind, Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
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Bi-weekly phone counseling sessions from 6 - 18 months
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Aktiver Komparator: 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.
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Bi-weekly newsletter mailings from 6 - 18 months
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Weight loss maintenance
Zeitfenster: 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.
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6 - 18 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Quality of life
Zeitfenster: 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.
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Baseline and 6, 12, 18, and 24 months
|
|
Breast cancer risk biomarkers
Zeitfenster: 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.
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Baseline and 6 and 18 months
|
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Cost effectiveness
Zeitfenster: 18 months
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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).
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18 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Christie Befort, Ph.D., University of Kansas Medical Center
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Fazzino TL, Fabian C, Befort CA. Change in Physical Activity During a Weight Management Intervention for Breast Cancer Survivors: Association with Weight Outcomes. Obesity (Silver Spring). 2017 Nov;25 Suppl 2(Suppl 2):S109-S115. doi: 10.1002/oby.22007.
- Fazzino TL, Fleming K, Befort C. Alcohol Intake Among Breast Cancer Survivors: Change in Alcohol Use During a Weight Management Intervention. JMIR Cancer. 2016 Nov 9;2(2):e15. doi: 10.2196/cancer.6295.
- Fazzino TL, Sporn NJ, Befort CA. A qualitative evaluation of a group phone-based weight loss intervention for rural breast cancer survivors: Themes and mechanisms of success. Support Care Cancer. 2016 Jul;24(7):3165-73. doi: 10.1007/s00520-016-3149-7. Epub 2016 Mar 2.
- Befort CA, Klemp JR, Fabian C, Perri MG, Sullivan DK, Schmitz KH, Diaz FJ, Shireman T. Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors. Contemp Clin Trials. 2014 Mar;37(2):261-71. doi: 10.1016/j.cct.2014.01.010. Epub 2014 Jan 31.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. August 2011
Primärer Abschluss (Tatsächlich)
1. April 2015
Studienabschluss (Tatsächlich)
1. Oktober 2015
Studienanmeldedaten
Zuerst eingereicht
23. September 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. September 2011
Zuerst gepostet (Schätzen)
27. September 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
23. November 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. November 2016
Zuletzt verifiziert
1. November 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 12633
- 1R01CA155014-01A1 (US NIH Stipendium/Vertrag)
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