NCT03719677

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

November 6, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

November 20, 2020

Completed
Last Updated

November 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

October 22, 2018

Results QC Date

October 5, 2020

Last Update Submit

October 29, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Self Reported Behavioral Automaticity Index

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

    From week 0-2

Study Arms (1)

Habit development intervention

EXPERIMENTAL

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.

Behavioral: Habit development intervention

Interventions

Habit development interventionBEHAVIORAL

Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning

Habit development intervention

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Heather Fritz
Organization
Wayne State University
Heather.fritz@wayne.edu
313-664-2627

Study Officials

  • Heather Fritz, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 25, 2018

Study Start

November 6, 2018

Primary Completion

June 1, 2020

Study Completion

September 13, 2020

Last Updated

November 20, 2020

Results First Posted

November 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)