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NCT03719677

Reducing Metabolic Syndrome Among Breast Cancer Survivors

Completed NA Results posted Last updated 20 November 2020
What this trial tests

NA trial testing Habit development intervention in Breast Cancer in 7 participants. Completed in 13 September 2020.

Timeline
6 November 2018
Primary endpoint
1 June 2020
13 September 2020

Quick facts

Lead sponsorBarbara Ann Karmanos Cancer Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment7
Start date6 November 2018
Primary completion1 June 2020
Estimated completion13 September 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Barbara Ann Karmanos Cancer Institute

Who can join

40 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self Reported Behavioral Automaticity Index Primary · From week 0-2

Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit

Baseline
GroupValue95% CI
Habit Development Intervention1.6± 1.3
Post test
GroupValue95% CI
Habit Development Intervention4.8± 2.1

Sponsor's own description

Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition. To determine the feasibility of the intervention 48 community-dwelling rural breast cancer survivors (BCS) (ages 40 and older) will receive the intervention. The 12-week intervention consists of three home-based face-to-face consultations with the therapist, 9 weekly habit tele phone coaching sessions, and the use of implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habit formation and address unmet needs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Barbara Ann Karmanos Cancer Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03719677.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing