NCT02194387

Brief Summary

This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at high risk for cancer. Increasing exercise and eating healthy foods may help reduce the risk of cancer. Studying how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices may help doctors plan the most effective motivational program for cancer prevention.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
337

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Sep 2014Sep 2027

First Submitted

Initial submission to the registry

July 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 17, 2014

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

13 years

First QC Date

July 16, 2014

Last Update Submit

March 5, 2026

Conditions

Body Mass Index 25 or GreaterBRCA1 Gene MutationBRCA2 Gene MutationBreast CarcinomaCancer SurvivorChronic Lymphocytic LeukemiaFatigueHealth Status UnknownLynch SyndromeOvarian CarcinomaOverweight

Outcome Measures

Primary Outcomes (2)

  • Change in waist circumference (Pilot I)

    Expressed as the mean difference.

    Baseline to 4 months post-intervention

  • Change in waist circumference (Pilot II)

    Expressed as the mean difference.

    Baseline to 4 months post-intervention

Study Arms (1)

Supportive care (energy balance interventions)

EXPERIMENTAL

TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing. TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages. SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking. SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.

Dietary Supplement: Dietary InterventionOther: Internet-Based InterventionOther: Laboratory Biomarker AnalysisOther: Questionnaire AdministrationBehavioral: Telephone-Based Intervention

Interventions

Dietary InterventionDIETARY_SUPPLEMENT

Record dietary intake 4-7 days per week

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Supportive care (energy balance interventions)
Internet-Based InterventionOTHER

Receive email coaching

Supportive care (energy balance interventions)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Supportive care (energy balance interventions)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive care (energy balance interventions)
Telephone-Based InterventionBEHAVIORAL

Receive telephone coaching

Supportive care (energy balance interventions)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PILOTS I, II AND III: Body mass index (BMI) of 25 or higher OR \< 150 minutes of moderate to vigorous exercise per week OR \< 5 servings of fruit and vegetables per day
  • PILOTS I, II AND III: Capable of participating in moderate-vigorous unsupervised exercise
  • PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and receive text messages
  • PILOTS I, II AND III: Able to read and write English
  • PILOTS I, II AND III: Have access to internet
  • PILOT II: BRCA positive OR Lynch syndrome positive individuals
  • PILOT II (FAMILY MEMBER): Female and male biological and non-biological family members of BRCA-positive individuals OR Lynch syndrome positive individuals
  • PILOT III: CLL survivors
  • PILOT III: Has experienced fatigue within the past seven days

You may not qualify if:

  • PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other assistive device
  • PILOTS I, II AND III: Women who are pregnant (by self-report)
  • PILOTS I, II AND III: Less than 3 months post-surgery
  • PILOTS II and III: Currently receiving radiation therapy or cytotoxic chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Crane JC, Gordon MJ, Basen-Engquist K, Ferrajoli A, Markofski MM, Lee CY, Fares S, Simpson RJ, LaVoy EC. Relationships between T-lymphocytes and physical function in adults with chronic lymphocytic leukemia: Results from the HEALTH4CLL pilot study. Eur J Haematol. 2023 Jun;110(6):732-742. doi: 10.1111/ejh.13958. Epub 2023 Mar 31.

    PMID: 36946440DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellFatigueColorectal Neoplasms, Hereditary NonpolyposisOvarian NeoplasmsOverweight

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersOvernutritionNutrition DisordersBody Weight

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Karen M Basen-Engquist

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 18, 2014

Study Start

September 17, 2014

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

US(1)