- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03719677
Reducing Metabolic Syndrome Among Breast Cancer Survivors
Reducing Metabolic Syndrome and Unmet Needs Among Rural Breast Cancer Survivors During the Survivorship Transition
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The objective of the present study is to determine the feasibility of a manual, theory based, occupational therapist delivered, preventative intervention to increase habit development (HD) of healthy dietary and physical activity behaviors, and reduce metabolic syndrome (MetS) among high-risk, rural breast cancer survivors (BCS). 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 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 telephone 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. Feasibility metrics will be collected throughout the intervention. The one specific aim is:
Aim 1. To determine the feasibility and acceptability of the intervention for rural BCS. Investigators will evaluate recruitment, trial engagement and retention rates, treatment satisfaction, and the feasibility of the data collection processes for the primary behavioral measures of HD.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Michigan
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Detroit, Michigan, Forente stater, 48201
- Barbara Ann Karmanos Cancer Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- English speaking
- Diagnosis of stage 1-3 histologically confirmed first cancer of the breast
- Reside in a zip code designated as rural by the United States Department of Agriculture Economic Research Service
- Be within the initial 12 months following the end of primary treatment and meet 3 of the following 5 criteria for MetS confirmed via point-of-care testing or documentation in their medical record:
A large waistline > 35 inches Blood pressure > 130/85; HbA1c of 5.7%-6.4%; Triglyceride levels > 150 mg/dL; HDL cholesterol levels < 50 mg/dL
Exclusion Criteria:
- Will not exclude participants based on hormone receptivity, one exception is that we will exclude HER2 positive BCS
- Pregnant patients
- Resistant Hypertension
- Steroid-dependent asthma or Chronic obstructive pulmonary disease
- Cirrhosis or hepatic failure
- A major cardiovascular event (e.g., stroke, myocardial infarction) within the previous 90 days
- Chronic kidney disease on renal replacement therapy
- Type one or two diabetes
- Stage 4 cancer; those with a secondary cancer (except for nonmelanomatous skin cancers and carcinoma of the cervix in situ)
- Taking weight loss medications
- Current involvement in a behavioral program
- Neuropsychiatric disorder or dementia
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Habit development intervention
Treatment includes occupational therapy evaluation and consultation to address any deficits in physical function, safety, social participation and/or life roles.
After the occupational therapy evaluation, the therapist delivers education on physical activity and dietary recommendations and habit development techniques, and uses behavioral skills training to develop habit plans, as well as prompts/cues, environmental modifications, and reminder text messages to reinforce engagement in the plan.
The intervention is delivered through 3 face to face sessions, 9 tele coaching calls, and text messages.
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Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Self Reported Behavioral Automaticity Index
Tidsramme: From week 0-2
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Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit
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From week 0-2
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Heather Fritz, PhD, Wayne State University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2018-062
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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