Clinical trial · Interventional
A Home-based Physical Activity Intervention in Breast Cancer Survivors
Randomised Controlled Trial of a Home-based Physical Activity Intervention in Breast Cancer Survivors
NCT02408107CI-TRIAL-00017492PHABcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical activity | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Physical activity intervention
- description
- 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.
- interventionNames
- Behavioral: Physical activity
- type
- NO_INTERVENTION
- label
- Usual care
- description
- This arm received usual care (i.e. no physical activity counselling, support phone calls or post-cards).
Primary outcomes (1)
- measure
- Physical activity questionnaire (International Physical Activity Questionnaire)
- timeFrame
- Baseline and 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (9)
- BACKGROUNDLahart 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
- BACKGROUNDLahart 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
- BACKGROUNDRogers 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
- BACKGROUNDPayne 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
- BACKGROUNDPinto 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
- BACKGROUNDMusanti 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
- BACKGROUNDHeim 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.