NCT00548236

Brief Summary

This study is being done to determine whether a telephone-based counseling intervention can help survivors of breast and colorectal cancer increase their weekly physical activity. Observational evidence suggests that physical activity after breast and colorectal cancer diagnosis decreases recurrence rates. Unfortunately, many people become less active during cancer therapy, and a substantial proportion never return to pre-diagnosis levels of physical activity. This study looks to see if people who have recently finished chemotherapy for breast, colon or rectal cancer can be motivated to increase their exercise by talking to an exercise specialist over the phone. The study also looks at changes in mood, fatigue, fitness, fat distribution and weight.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
7mo left

Started Oct 2007

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

9 active sites

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 Progress97%
Oct 2007Dec 2026

Study Start

First participant enrolled

October 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
17.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

October 22, 2007

Last Update Submit

February 20, 2026

Conditions

Keywords

exercise interventionAACT

Outcome Measures

Primary Outcomes (1)

  • To evaluate the ability of a multi-center, telephone-based physical activity intervention to increase weekly physical activity levels in sedentary patients treated with adjuvant chemotherapy for Stage I-III breast or colorectal cancer.

    months

Secondary Outcomes (1)

  • To evaluate the impact of a physical activity intervention upon fitness, exercise self-efficacy, anthropometric measures, and quality of life in a group of patients with stage I-III breast or colorectal cancer.

    months

Study Arms (2)

1

EXPERIMENTAL

Immediate participation in a 16-week exercise program

Behavioral: Telephone-Based exercise intervention

2

NO INTERVENTION

Control population; will receive exercise plan after 16-week control period

Interventions

Exercise counselling offered via telephone calls

1

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed stage I-III breast or colorectal cancer
  • years of age or older
  • Completed adjuvant treatment(for current malignancy)
  • Completion of all adjuvant chemotherapy and radiation (with the exception of adjuvant herceptin and/or tamoxifen/aromatase inhibitor therapy for breast cancer patients) between 2 and 36 months prior to enrollment
  • Ability to speak and read English
  • Willingness to be randomized
  • Medical clearance from an oncologist or primary care physician stating the participant is able to participate in an unsupervised, moderate-intensity physical activity program
  • No major surgery within 2 months of study enrollment or planned during study period

You may not qualify if:

  • Metastatic cancer
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
  • Plans to have hip or knee replacement within a year
  • Participation in more than 60 minutes a week of moderate-intensity recreational activity as assessed by the International Physical Activity Questionnaire Short Form
  • BMI \>47

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of California at San Diego

La Jolla, California, 92093, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

New Hampshire Oncology Hematology

Concord, New Hampshire, 03106, United States

Location

Lakes Regional Healthcare Hematology Oncology

Hooksett, New Hampshire, 03106, United States

Location

Rosewell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Hematology Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jennifer Ligibel, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 23, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2009

Study Completion (Estimated)

December 1, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations