A Home-based Physical Activity Intervention in Breast Cancer Survivors

NCT02408107 | Completed Phase 3

• 1 other identifier: ID800
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this current study was to investigate the effects of a pragmatic home-based physical activity programme on primarily physical activity levels and secondarily weight maintenance, health-related quality of life (HRQoL), insulin resistance (IR) and lipid concentrations in post-adjuvant therapy breast cancer survivors.

Conditions

Breast Cancer

Keywords

Physical activity; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Physical activity questionnaire (International Physical Activity Questionnaire)

  Change in self-reported physical activity (MET-min/wk) from baseline to post-intervention at 6 months in all 80 participants.

  Baseline and 6 months

Secondary Outcomes (16)

• Health-related quality of life questionnaire (Functional Assessment of Cancer Therapy (FACT) - Breast)

  Baseline and 6 months

• Body mass

  Baseline and 6 months

• Body Mass Index

  Baseline and 6 months

• Body fat percentage via bioelectrical impedance analysis

  Baseline and 6 months

• Glucose via venepuncture blood samples

  Baseline and 6 months

Study Arms (2)

Physical activity intervention

EXPERIMENTAL

Received a 30 min physical activity counselling session which employed motivational interviewing to encourage the adoption of current recommended physical activity guidelines. This arm also received 3 support phone calls (1 at the end of months 1, 2 and 3) and a physical activity reminder postcard on months 4 and 5.

Behavioral: Physical activity

Usual care

NO INTERVENTION

This arm received usual care (i.e. no physical activity counselling, support phone calls or post-cards).

Interventions

Physical activity BEHAVIORAL

Physical activity (PA) intervention participants received a 30-45 min face-to-face consultation (1st visit), followed by 15-20 min support telephone calls (end of months 1, 2 and 3). During months 4 and 5 patients received reminder leaflets. Consultations were conducted by the primary researcher after baseline measurements and were based on the four core motivational interviewing principles. The topics covered in the consultation (e.g. goal setting, overcoming barriers, health and safety advice) were similar to other trials that incorporated a PA counselling component. The focus of the follow-up phone calls (end of months 1-3) was to prevent relapse and/or improve maintenance of PA. The intervention participants were encouraged to work towards accumulating at least 30min of moderate-intensity PA on 5-7 days/week.

Physical activity intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female 18 y and over,
• Diagnosed with invasive breast cancer (Stage I-III) within two years of enrolment and no evidence, or clinical suspicion, of metastatic disease,
• Post-surgery and had no surgery planned for the next six months at least,
• Had fully completed adjuvant therapy (radiotherapy and/or chemotherapy) not including hormonal therapy,
• No previous malignancy except in the case of ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years,
• No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up,
• Willing to be randomised, and willing to maintain contact with the investigators over the six months

You may not qualify if:

• No evidence of invasive breast cancer (i.e. only pre-invasive disease identified),
• Previous invasive breast cancer (surgically treated DCIS or LCIS is allowed),
• Inability to participate in PA because of severe disability (e.g. severe arthritic conditions), psychiatric illness and vulnerable subjects, such as pregnant women.
• Any other patient where PA was not approved by their oncologist due to the presence of one or more contraindications to exercise in cancer patients.

Sponsors & Collaborators

• Dudley Group NHS Foundation Trust: lead

Related Publications (9)

• Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity levels in women attending breast screening, receiving chemotherapy and post-breast cancer treatment; a cross-sectional study. Int J Environ Res Public Health. 2014 May 20;11(5):5487-96. doi: 10.3390/ijerph110505487.

  PMID: 24852599 BACKGROUND

• Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity, risk of death and recurrence in breast cancer survivors: A systematic review and meta-analysis of epidemiological studies. Acta Oncol. 2015 May;54(5):635-54. doi: 10.3109/0284186X.2014.998275. Epub 2015 Mar 9.

  PMID: 25752971 BACKGROUND

• Rogers LQ, Hopkins-Price P, Vicari S, Pamenter R, Courneya KS, Markwell S, Verhulst S, Hoelzer K, Naritoku C, Jones L, Dunnington G, Lanzotti V, Wynstra J, Shah L, Edson B, Graff A, Lowy M. A randomized trial to increase physical activity in breast cancer survivors. Med Sci Sports Exerc. 2009 Apr;41(4):935-46. doi: 10.1249/MSS.0b013e31818e0e1b.

  PMID: 19276838 BACKGROUND

• Payne JK, Held J, Thorpe J, Shaw H. Effect of exercise on biomarkers, fatigue, sleep disturbances, and depressive symptoms in older women with breast cancer receiving hormonal therapy. Oncol Nurs Forum. 2008 Jul;35(4):635-42. doi: 10.1188/08.ONF.635-642.

  PMID: 18591167 BACKGROUND

• Pinto BM, Frierson GM, Rabin C, Trunzo JJ, Marcus BH. Home-based physical activity intervention for breast cancer patients. J Clin Oncol. 2005 May 20;23(15):3577-87. doi: 10.1200/JCO.2005.03.080.

  PMID: 15908668 BACKGROUND

• Musanti R. A study of exercise modality and physical self-esteem in breast cancer survivors. Med Sci Sports Exerc. 2012 Feb;44(2):352-61. doi: 10.1249/MSS.0b013e31822cb5f2.

  PMID: 21796050 BACKGROUND

• Heim ME, v d Malsburg ML, Niklas A. Randomized controlled trial of a structured training program in breast cancer patients with tumor-related chronic fatigue. Onkologie. 2007 Sep;30(8-9):429-34. doi: 10.1159/000104097. Epub 2007 Sep 7.

  PMID: 17848814 BACKGROUND

• Vallance JK, Courneya KS, Plotnikoff RC, Yasui Y, Mackey JR. Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. J Clin Oncol. 2007 Jun 10;25(17):2352-9. doi: 10.1200/JCO.2006.07.9988.

  PMID: 17557948 BACKGROUND

• Lahart IM, Metsios GS, Nevill AM, Kitas GD, Carmichael AR. Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors. BMC Cancer. 2016 Mar 17;16:234. doi: 10.1186/s12885-016-2258-5.

  PMID: 26988367 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ian M Lahart, PhD

  University of Wolverhampton

  PRINCIPAL INVESTIGATOR

• Amtul R Carmichael, MD

  Russells Hall Hopsital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 3, 2015
• Study Start: January 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 14, 2015

Record last verified: 2015-04