Reducing Metabolic Syndrome Among Breast Cancer Survivors

• Sponsor: Barbara Ann Karmanos Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03719677
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: Habit development intervention	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Reducing Metabolic Syndrome and Unmet Needs Among Rural Breast Cancer Survivors During the Survivorship Transition
• Actual Study Start Date: Nov 6, 2018
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Sep 13, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

1. Self Reported Behavioral Automaticity Index [From week 0-2]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201

Sponsors and Collaborators

• Barbara Ann Karmanos Cancer Institute

Investigators

• Principal Investigator: Heather Fritz, PhD, Wayne State University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 22, 2019

More Information

Publications

None provided.

• Responsible Party: Heather Fritz, Principal Investigator, Barbara Ann Karmanos Cancer Institute
• ClinicalTrials.gov Identifier: NCT03719677
• Other Study ID Numbers: 2018-062
• First Posted: Oct 25, 2018
• Last Update Posted: Nov 20, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Metabolic Syndrome

Study Results

Participant Flow

Arm/Group Title	Habit Development Intervention
Arm/Group Description	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. Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
Period Title: Overall Study
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Habit Development Intervention
Arm/Group Description	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. Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
Overall Participants	7
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.5 (10.8)
Sex: Female, Male (Count of Participants)
Female	7 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 28.6%
White	5 71.4%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Self Reported Behavioral Automaticity Index
Description	Measures changes in habit strength, scores range from 1-7 with higher scores indicating a stronger habit
Time Frame	From week 0-2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Habit Development Intervention
Arm/Group Description	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. Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
Measure Participants	7
Baseline	1.6 (1.3)
Post test	4.8 (2.1)

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	The treatment involved providing education and counseling about how to develop healthy dietary and physical activity habits. No invasive procedures or hands on treatments or pharmacological agents were included in the study. There are no known risks for serious adverse events, or all cause mortality from health coaching interventions limited to diet and physical activity. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were monitored/assessed at each study visit.
Arm/Group Title	Habit Development Intervention
Arm/Group Description	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. Habit development intervention: Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
All Cause Mortality
	Habit Development Intervention
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Serious Adverse Events
	Habit Development Intervention
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Habit Development Intervention
	Affected / at Risk (%)	# Events
Total	0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.