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Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: Exercise Behavior Change

Study type

Interventional

Funder types

Other

Identifiers

NCT00640666
ROG-SIU.003

Details and patient eligibility

About

It is important to confirm health benefits experienced by breast cancer survivors after participation in a physical activity behavior change intervention. One such potential benefit is a reduction in harmful inflammation that might lead to increased symptoms or cancer risk. Because little is known about how physical activity behavior change interventions influence inflammation in breast cancer survivors, the investigators study will measure inflammation with blood markers known as cytokines among breast cancer survivors before and after a physical activity intervention. Such information has the potential to lead to improved physical functioning, reduction in bothersome symptoms (e.g., fatigue), and reduced cancer risk in breast cancer survivors.

Enrollment

30 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of Stage I, II, or IIIA breast cancer who are not currently receiving (and do not plan to receive during the study duration) chemotherapy or radiation therapy. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.
  • If the patient has undergone a surgical procedure, must be at least 8 weeks post-procedure.
  • English speaking.
  • Medical clearance for participation provided by primary care physician or oncologist.

Exclusion criteria

  • Diagnosis of dementia or organic brain syndrome.
  • Medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
  • Contraindication to participation in a regular physical activity program.
  • Metastatic or recurrent disease
  • Inability to ambulate
  • Engaged in ≥ 60 minutes of vigorous physical activity or ≥ 150 minutes of moderate plus vigorous activity per week during the past month.
  • Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
  • Participant does not live or work within 50 miles of the study site.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Physical activity intervention
Experimental group
Description:
Behavior change intervention
Treatment:
Behavioral: Exercise Behavior Change
Standard of care with written materials
No Intervention group
Description:
Written materials

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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