Quality of LifeBHVBCNCT01990430
Behavioural Changes in Breast Cancer Patients
A study testing Exercise Intervention in people with Quality of Life, run by Universidad Politecnica de Madrid at 1 site in Spain.
Trial summary
Exercise training has been established as a feasible and safe intervention during or after neoplastic treatment in breast cancer patients. Numerous studies have shown that exercise can prevent and control various treatment-related side effects including functional limitation, physical capacity, anxiety and sleep… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Quality of Life
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years and younger than 75.
- Breast cancer diagnosed confirmed stage I-IIIA.
- Randomized disposition.
- Minimum of 45 days and maximum of 36 months after finishing treatments (chemotherapy and radiotherapy).
- 0-1 in Eastern Cooperative Oncology Group (ECOG) scale (present the ability to walk briskly)
- Oncologist approval.
- Informed Consent signed.
- Comunidad Autónoma de Madrid inhabitant.
Who cannot join
- Metastasis presence
- Serious medical risk such as unstable cardiac condition or severe pulmonary disease and anticoagulants treatments.
- Oncology or primary care approval who verified the medical risk exclusion criteria.
- ECOG > 1
- Pregnant
Trial locations and contacts
1 site in 1 country.
Teresa Terrén, Grade contact
Spain1 site, 1 recruiting
- Recruiting
Faculty of Physical Activity and Sport Science
Madrid, Madrid, 28040
Ruben O Barakat, PhD, +34 91336 ext. 4120, barakatruben@gmail.com
Soraya Casla, Master
About this study
Official title: Integrative Exercise and Life Style Intervention Increase Leisure Time Activity in Breast Cancer Patients.
Exercise training has been established as a feasible and safe intervention during or after neoplastic treatment in breast cancer patients. Numerous studies have shown that exercise can prevent and control various treatment-related side effects including functional limitation, physical capacity, anxiety and sleep disturbance. In the long-term, an active life style has been demonstrated to increase survival in women, who maintain a moderate level of exercise per week (30 or 75 minutes of brisk walking 5 days per week).
Specifically, active breast cancer survivors have a 51-85% lower cancer specific mortality and 33-82% lower all cause of mortality. But despite this, most breast cancer patients reduce their physical activity levels during and after cancer treatment. In 2010, a roundtable meeting of American College of Sport Medicine published guidelines for cancer survivors, defining that the recommended amount of exercise was 150 minutes per week of aerobic exercise of moderate-intensity and 2 or 3 days per week of strength training that included exercise for major muscle groups. But only 30-47% of breast cancer survivors follow these exercise recommendations.
Read more
In most clinical settings, information by the oncologist to keep physical active is part of the recommendation. Yet some breast cancer patients find it difficult to begin or maintain the minimal activity levels recommended by the experts. A typical obstacle includes lack of directions from experts, which can assure the safety and feasibility of the exercise that they perform. Moreover, important personal aspects can have major influence on the exercise preference, including certain food choice and dietary intakes, education level or the preference of a face-to-face exercise counseling by a professional.
A cancer diagnosis is recognized as "teachable moment", where patients are particularly motivated for lifestyle changes. So it is important to approach the patients with adequate interventions that consider the different needs in order to get a healthier behavior among the breast cancer patients.
Taking this into account, the hypothesis of this pilot project is that a guided integrated group exercise program, which includes an educational program on healthy life style, will increase the adherence of breast cancer survivors to exercise and a healthy diet. Therefore the aim of this pilot study was to investigate if a comprehensive and specific group exercise program, which includes dietary and exercise information, could increase leisure-time exercise in women with breast cancer.
Read the detailed description
This study will be performed as a collaboration between Technical University of Madrid (UPM), Spanish Group of Cancer Patients (GEPAC), Hospital General Universitario Gregorio Marañón, Hospital Universitario Puerta de Hierr y Hospital de Sanchinarro-Madrid del Norte. The project will be carried out at the facilities of the Physical Activity and Sport Science Institute (INEF) and has been approved by the Ethical Committee of the UPM. A single arm pilot project with pre-post test has been designed.
Intervention The exercise program was designed and conducted by a qualified exercise physiologist with oncologic training. The exercise program consisted in a twice weekly supervised training program developed in a social framework. The sessions included instructions in training exercises, as well as included time to speak about their fears and doubts with other patients, who were in the same situation. The intervention lasted 12 weeks (24 sessions). The training intensity was progressively increased from 65% to 85% of heart rate with control by a POLAR FT7 heart rate monitor for aerobic activities, and by 8-15 repetitions in 2-3 sets for the strength activities. Exercise intensity was prescribed using Karvonen equation.
Every supervised session had the same structure and a duration of 60 minutes. American College Sport Medicine (ACSM) Guidelines for Cancer Patients were followed for the session design. The first 10 minutes was a dynamic warm up combining different ways of movement around the class and articular movements. Next part consisted in aerobic exercise, where the principal aim was to practice exercises that increased the participant's functional capacity with music-based activities such as aerobic, box-dance or global strength circuits without external resistance. Followed by upper-limbs strength exercises with elastic bands to improve strength and increase arm lean mass, focusing on chest and dorsal exercises. The last part was whole-body stretching exercises to improve joint mobility and muscle flexibility of upper body limbs, and general muscle relaxation after training.
The exercise program was complemented with theoretical classes about exercise and nutrition. One class of exercise prescription was held after two months of intervention. The patients were taught about the minimum of exercise recommended and about which activities they could do and how to adapt them depending on their own situations.
The nutrition program consisted of three theoretical and practice classes, where specific terms of nutrition and diet were explained. The first class explained the different groups of nutrients, their functions in the organism and for which group of aliments these can be obtained. The second class was a practical class about how to interpret food labels and relating measurements of food portions with recommendations for a healthy diet. Final session spoke about the ten best and the ten worst aliments, which prevent and promote cancer. Teachers did not promote avoiding any group of aliments and a Mediterranean diet was encouraged to be followed.
- Conditions
- Quality of Life
- Being tested
- Exercise Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Also called Active Life Style
Intervention: The sessions included instructions in training exercises, as well as included time to speak about their fears and doubts with other patients, who were in the same situation. The intervention lasted 12 weeks (24 sessions). The training intensity was progressively increased from 65% to 85% of heart rate with control by a POLAR FT7 heart rate monitor for aerobic activities, and by 8-15 repetitions in 2-3 sets for the strength activities. Exercise intensity was prescribed using Karvonen equation.
The nutrition program consisted of three theoretical and practice classes. The first class explained the different groups of nutrients, their functions in the organism and for which group of aliments these can be obtained. The second class was a practical class about how to interpret food labels and relating measurements of food portions with recommendations for a healthy diet. Final session spoke about the ten best and the ten worst aliments, which prevent and promote cancer.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | The exercise program was designed and conducted by a qualified exercise physiologist with oncologic training. The exercise program consisted in a twice weekly supervised training program developed in a social framework. The sessions included instructions in training exercises, as well as included time to speak about their fears and doubts with other patients, who were in the same situation.
The nutrition program consisted of three theoretical and practice classes, where specific terms of nutrition and diet were explained. Teachers did not promote avoiding any group of aliments and a Mediterranean diet was encouraged to be followed. Receives: Behavioral: Exercise Intervention |
| Control | No intervention | Patients will be asked to maintain their usual life style, without special changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Quality of Life Questionnaire and Exercise Leisure-time Questionnaire
Combined primary objective has been elected. Both of them have to be positive. FACT-B and Godin Leisure-Time Exercise Questionnaire have been chosen as validated instruments to assess primary variables
Measured: Changes from baseline at 12 weeks
Secondary outcomes (2)
Fatigue Questionnaire
Fact-Fatigue (FACT-F) is the instrument chose to assess the variable
Measured: Changes from baseline at 12 weeks
Depression Questionnaire
Center of Epidemiologic Studies Depression Scale (CES-D scale) is the validated questioner chose to assess this variable
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon, Puerta de Hierro University Hospital, Hospital Universitario Madrid Sanchinarro
- Responsible party
- Principal investigator, Soraya Casla Barrio, Universidad Politecnica de Madrid
- Investigators
- Javier Sampedro, Proffesor, Study director, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990430
- Sponsor's protocol ID
- behaviourchanges
- Acronym
- BHVBC
- Status last verified
- Jan 2014
- First submitted
- 25 Oct 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Irwin ML, Crumley D, McTiernan A, Bernstein L, Baumgartner R, Gilliland FD, Kriska A, Ballard-Barbash R. Physical activity levels before and after a diagnosis of breast carcinoma: the Health, Eating, Activity, and Lifestyle (HEAL) study. Cancer. 2003 Apr 1;97(7):1746-57. doi: 10.1002/cncr.11227.
PubMed 12655532Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2.
PubMed 22895961Jones LW, Alfano CM. Exercise-oncology research: past, present, and future. Acta Oncol. 2013 Feb;52(2):195-215. doi: 10.3109/0284186X.2012.742564. Epub 2012 Dec 17.
PubMed 23244677Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. doi: 10.1001/jama.293.20.2479.
PubMed 15914748Betof AS, Dewhirst MW, Jones LW. Effects and potential mechanisms of exercise training on cancer progression: a translational perspective. Brain Behav Immun. 2013 Mar;30 Suppl(0):S75-87. doi: 10.1016/j.bbi.2012.05.001. Epub 2012 May 17.
PubMed 22610066Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
PubMed 20559064Irwin ML. Physical activity interventions for cancer survivors. Br J Sports Med. 2009 Jan;43(1):32-8. doi: 10.1136/bjsm.2008.053843. Epub 2008 Oct 23.
PubMed 18948351Demark-Wahnefried W, Hars V, Conaway MR, Havlin K, Rimer BK, McElveen G, Winer EP. Reduced rates of metabolism and decreased physical activity in breast cancer patients receiving adjuvant chemotherapy. Am J Clin Nutr. 1997 May;65(5):1495-501. doi: 10.1093/ajcn/65.5.1495.
PubMed 9129482Hong S, Bardwell WA, Natarajan L, Flatt SW, Rock CL, Newman VA, Madlensky L, Mills PJ, Dimsdale JE, Thomson CA, Hajek RA, Chilton JA, Pierce JP. Correlates of physical activity level in breast cancer survivors participating in the Women's Healthy Eating and Living (WHEL) Study. Breast Cancer Res Treat. 2007 Jan;101(2):225-32. doi: 10.1007/s10549-006-9284-y. Epub 2006 Sep 21.
PubMed 17028988Jones LW, Courneya KS. Exercise counseling and programming preferences of cancer survivors. Cancer Pract. 2002 Jul-Aug;10(4):208-15. doi: 10.1046/j.1523-5394.2002.104003.x.
PubMed 12100105Blanchard CM, Courneya KS, Stein K; American Cancer Society's SCS-II. Cancer survivors' adherence to lifestyle behavior recommendations and associations with health-related quality of life: results from the American Cancer Society's SCS-II. J Clin Oncol. 2008 May 1;26(13):2198-204. doi: 10.1200/JCO.2007.14.6217.
PubMed 18445845Befort CA, Klemp JR, Austin HL, Perri MG, Schmitz KH, Sullivan DK, Fabian CJ. Outcomes of a weight loss intervention among rural breast cancer survivors. Breast Cancer Res Treat. 2012 Apr;132(2):631-9. doi: 10.1007/s10549-011-1922-3. Epub 2011 Dec 25.
PubMed 22198470Hayes SC, Johansson K, Stout NL, Prosnitz R, Armer JM, Gabram S, Schmitz KH. Upper-body morbidity after breast cancer: incidence and evidence for evaluation, prevention, and management within a prospective surveillance model of care. Cancer. 2012 Apr 15;118(8 Suppl):2237-49. doi: 10.1002/cncr.27467.
PubMed 22488698Giacosa A, Barale R, Bavaresco L, Gatenby P, Gerbi V, Janssens J, Johnston B, Kas K, La Vecchia C, Mainguet P, Morazzoni P, Negri E, Pelucchi C, Pezzotti M, Rondanelli M. Cancer prevention in Europe: the Mediterranean diet as a protective choice. Eur J Cancer Prev. 2013 Jan;22(1):90-5. doi: 10.1097/CEJ.0b013e328354d2d7.
PubMed 22644232Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PubMed 4053261
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Exercise and Life Style Intervention Increase Leisure Time Activity in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT01990430
- Acronym / sponsor ID
- BHVBC / behaviourchanges
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon, Puerta de Hierro University Hospital, Hospital Universitario Madrid Sanchinarro
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise training has been established as a feasible and safe intervention during or after neoplastic treatment in breast cancer patients. Numerous studies have shown that exercise can prevent and control various treatment-related side effects including functional limitation, physical capacity, anxiety and sleep disturbance. In the long-term, an active life style has been demonstrated to increase survival in women, who maintain a moderate level of exercise per week (30 or 75 minutes of brisk walking 5 days per week).
Specifically, active breast cancer survivors have a 51-85% lower cancer specific mortality and 33-82% lower all cause of mortality. But despite this, most breast cancer patients reduce their physical activity levels during and after cancer treatment. In 2010, a roundtable meeting of American College of Sport Medicine published guidelines for cancer survivors, defining that the recommended amount of exercise was 150 minutes per week of aerobic exercise of moderate-intensity and 2 or 3 days per week of strength training that included exercise for major muscle groups. But only 30-47% of breast cancer survivors follow these exercise recommendations.
In most clinical settings, information by the oncologist to keep physical active is part of the recommendation. Yet some breast cancer patients find it difficult to begin or maintain the minimal activity levels recommended by the experts. A typical obstacle includes lack of directions from experts, which can assure the safety and feasibility of the exercise that they perform. Moreover, important personal aspects can have major influence on the exercise preference, including certain food choice and dietary intakes, education level or the preference of a face-to-face exercise counseling by a professional.
A cancer diagnosis is recognized as "teachable moment", where patients are particularly motivated for lifestyle changes. So it is important to approach the patients with adequate interventions that consider the different needs in order to get a healthier behavior among the breast cancer patients.
Taking this into account, the hypothesis of this pilot project is that a guided integrated group exercise program, which includes an educational program on healthy life style, will increase the adherence of breast cancer survivors to exercise and a healthy diet. Therefore the aim of this pilot study was to investigate if a comprehensive and specific group exercise program, which includes dietary and exercise information, could increase leisure-time exercise in women with breast cancer.
Detailed description
This study will be performed as a collaboration between Technical University of Madrid (UPM), Spanish Group of Cancer Patients (GEPAC), Hospital General Universitario Gregorio Marañón, Hospital Universitario Puerta de Hierr y Hospital de Sanchinarro-Madrid del Norte. The project will be carried out at the facilities of the Physical Activity and Sport Science Institute (INEF) and has been approved by the Ethical Committee of the UPM. A single arm pilot project with pre-post test has been designed.
Intervention The exercise program was designed and conducted by a qualified exercise physiologist with oncologic training. The exercise program consisted in a twice weekly supervised training program developed in a social framework. The sessions included instructions in training exercises, as well as included time to speak about their fears and doubts with other patients, who were in the same situation. The intervention lasted 12 weeks (24 sessions). The training intensity was progressively increased from 65% to 85% of heart rate with control by a POLAR FT7 heart rate monitor for aerobic activities, and by 8-15 repetitions in 2-3 sets for the strength activities. Exercise intensity was prescribed using Karvonen equation.
Every supervised session had the same structure and a duration of 60 minutes. American College Sport Medicine (ACSM) Guidelines for Cancer Patients were followed for the session design. The first 10 minutes was a dynamic warm up combining different ways of movement around the class and articular movements. Next part consisted in aerobic exercise, where the principal aim was to practice exercises that increased the participant's functional capacity with music-based activities such as aerobic, box-dance or global strength circuits without external resistance. Followed by upper-limbs strength exercises with elastic bands to improve strength and increase arm lean mass, focusing on chest and dorsal exercises. The last part was whole-body stretching exercises to improve joint mobility and muscle flexibility of upper body limbs, and general muscle relaxation after training.
The exercise program was complemented with theoretical classes about exercise and nutrition. One class of exercise prescription was held after two months of intervention. The patients were taught about the minimum of exercise recommended and about which activities they could do and how to adapt them depending on their own situations.
The nutrition program consisted of three theoretical and practice classes, where specific terms of nutrition and diet were explained. The first class explained the different groups of nutrients, their functions in the organism and for which group of aliments these can be obtained. The second class was a practical class about how to interpret food labels and relating measurements of food portions with recommendations for a healthy diet. Final session spoke about the ten best and the ten worst aliments, which prevent and promote cancer. Teachers did not promote avoiding any group of aliments and a Mediterranean diet was encouraged to be followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionThe exercise program was designed and conducted by a qualified exercise physiologist with oncologic training. The exercise program consisted in a twice weekly supervised training program developed in a social framework. The sessions included instructions in training exercises, as well as included time to speak about their fears and doubts with other patients, who were in the same situation. The nutrition program consisted of three theoretical and practice classes, where specific terms of nutrition and diet were explained. Teachers did not promote avoiding any group of aliments and a Mediterranean diet was encouraged to be followed. |
| Control | No intervention | –Patients will be asked to maintain their usual life style, without special changes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Older than 18 years and younger than 75.
- Breast cancer diagnosed confirmed stage I-IIIA.
- Randomized disposition.
- Minimum of 45 days and maximum of 36 months after finishing treatments (chemotherapy and radiotherapy).
- 0-1 in Eastern Cooperative Oncology Group (ECOG) scale (present the ability to walk briskly)
Key exclusion criteria (5 listed)
- Metastasis presence
- Serious medical risk such as unstable cardiac condition or severe pulmonary disease and anticoagulants treatments.
- Oncology or primary care approval who verified the medical risk exclusion criteria.
- ECOG > 1
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionAlso: Active Life StyleIntervention: The sessions included instructions in training exercises, as well as included time to speak about their fears and doubts with other patients, who were in the same situation. The intervention lasted 12 weeks (24 sessions). The training intensity was progressively increased from 65% to 85% of heart rate with control by a POLAR FT7 heart rate monitor for aerobic activities, and by 8-15 repetitions in 2-3 sets for the strength activities. Exercise intensity was prescribed using Karvonen equation. The nutrition program consisted of three theoretical and practice classes. The first class explained the different groups of nutrients, their functions in the organism and for which group of aliments these can be obtained. The second class was a practical class about how to interpret food labels and relating measurements of food portions with recommendations for a healthy diet. Final session spoke about the ten best and the ten worst aliments, which prevent and promote cancer. | Behavioural | Exercise Intervention |
Primary outcome
Patients Quality of Life Questionnaire and Exercise Leisure-time Questionnaire
Time frame: Changes from baseline at 12 weeks
Combined primary objective has been elected. Both of them have to be positive. FACT-B and Godin Leisure-Time Exercise Questionnaire have been chosen as validated instruments to assess primary variables
2 secondary outcomes
Fatigue Questionnaire
Time frame: Changes from baseline at 12 weeks
Depression Questionnaire
Time frame: Change from baseline at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Background: PubMed 12655532Irwin ML, Crumley D, McTiernan A, Bernstein L, Baumgartner R, Gilliland FD, Kriska A, Ballard-Barbash R. Physical activity levels before and after a diagnosis of breast carcinoma: the Health, Eating, Activity, and Lifestyle (HEAL) study. Cancer. 2003 Apr 1;97(7):1746-57. doi: 10.1002/cncr.11227.
- Background: PubMed 22895961Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2.
- Background: PubMed 23244677Jones LW, Alfano CM. Exercise-oncology research: past, present, and future. Acta Oncol. 2013 Feb;52(2):195-215. doi: 10.3109/0284186X.2012.742564. Epub 2012 Dec 17.
- Background: PubMed 15914748Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. doi: 10.1001/jama.293.20.2479.
- Background: PubMed 22610066Betof AS, Dewhirst MW, Jones LW. Effects and potential mechanisms of exercise training on cancer progression: a translational perspective. Brain Behav Immun. 2013 Mar;30 Suppl(0):S75-87. doi: 10.1016/j.bbi.2012.05.001. Epub 2012 May 17.
- Background: PubMed 20559064Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
- Background: PubMed 18948351Irwin ML. Physical activity interventions for cancer survivors. Br J Sports Med. 2009 Jan;43(1):32-8. doi: 10.1136/bjsm.2008.053843. Epub 2008 Oct 23.
- Background: PubMed 9129482Demark-Wahnefried W, Hars V, Conaway MR, Havlin K, Rimer BK, McElveen G, Winer EP. Reduced rates of metabolism and decreased physical activity in breast cancer patients receiving adjuvant chemotherapy. Am J Clin Nutr. 1997 May;65(5):1495-501. doi: 10.1093/ajcn/65.5.1495.
- Background: PubMed 17028988Hong S, Bardwell WA, Natarajan L, Flatt SW, Rock CL, Newman VA, Madlensky L, Mills PJ, Dimsdale JE, Thomson CA, Hajek RA, Chilton JA, Pierce JP. Correlates of physical activity level in breast cancer survivors participating in the Women's Healthy Eating and Living (WHEL) Study. Breast Cancer Res Treat. 2007 Jan;101(2):225-32. doi: 10.1007/s10549-006-9284-y. Epub 2006 Sep 21.
- Background: PubMed 12100105Jones LW, Courneya KS. Exercise counseling and programming preferences of cancer survivors. Cancer Pract. 2002 Jul-Aug;10(4):208-15. doi: 10.1046/j.1523-5394.2002.104003.x.
- Background: PubMed 18445845Blanchard CM, Courneya KS, Stein K; American Cancer Society's SCS-II. Cancer survivors' adherence to lifestyle behavior recommendations and associations with health-related quality of life: results from the American Cancer Society's SCS-II. J Clin Oncol. 2008 May 1;26(13):2198-204. doi: 10.1200/JCO.2007.14.6217.
- Background: PubMed 22198470Befort CA, Klemp JR, Austin HL, Perri MG, Schmitz KH, Sullivan DK, Fabian CJ. Outcomes of a weight loss intervention among rural breast cancer survivors. Breast Cancer Res Treat. 2012 Apr;132(2):631-9. doi: 10.1007/s10549-011-1922-3. Epub 2011 Dec 25.
Related trials for Quality of Life
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Active, not recruitingPhase 2
Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers
Metastatic Malignant Female Reproductive System Neoplasm
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Active, not recruiting
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
Active, not recruiting
Acceptance and Commitment Therapy-Based Group Psychotherapy for Chronic Headache
Chronic Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Terrén, Grade contact
Javier Sampedro, Proffesor study director
Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Quality of Life, run by Universidad Politecnica de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soraya Casla, Master (+3491336 ext. 4081, soraya.casla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Quality of Life Questionnaire and Exercise Leisure-time Questionnaire (time frame: Changes from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990430, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.