Breast CancerPREBCANCT04163692
Progressive Relaxation Training in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy
A study testing Progressive relaxation exercises in people with Breast Cancer, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effects of progressive relaxation exercises on artralgia, quality of life and anxiety-deppression in breast cancer patients receiving aromatase inhibitor. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Progressive relaxation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2019to 24 Sep 2020
- 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Using Aromatase Inhibitors for more than 6 months
- Diagnosis of breast cancer stage 1-3
- Postmenopausal woman aged under 70 years and with hormone-receptor positive
- Approval of physician for participating in PRE program
Who cannot join
- Participation on a regular physical training in the previous 6 months period
- Communication problems
- Neurological or ortopedical problems
- Presence of lyphedema diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Progressive Relaxation Training on Artralgia, Quality of Life and Emotional Status in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy
This study evaluates the effects of progressive relaxation exercises on artralgia, quality of life and anxiety-deppression in breast cancer patients receiving aromatase inhibitor. Half of the participants will receive supervised progressive relaxing exercises, while other half will not receive any exercise but only advice about relaxing.
Hypothesis: Progressive relaxation exercises improve the pain, quality of life and emotional status in breast cancer patients receiving aromatase inhibitor therapy.
Read the detailed description
Aromatase inhibitors (AI) can cause musculoskeletal problems and increased risk of fracture as side effects in breast cancer (BC) survivors. In particular, arthralgia can be observed in almost 50% of patients receiving AI. Moreover; cognitive dysfunctions , decreases in quality of life , anxiety and depression , sleep problems and fatigue can be seen in some of patients receiving AI. According to these possible side effects, evaluation and treatment of such health profiles, pain and symptoms is important in terms of improving the quality of life of the patients.
Progressive muscle relaxation exercises (PRE) were first described by Jacobson in 1938. PRE are in use today with different arrangements and updates. It was well defined physiological, perceptual and behavioral positive findings of muscle relaxation.
PRE was thought to be effective on artralgia, quality of life and anxiety-depression in BC survivors receiving AI.
The patients have been searched from the medical records of brest health center in a local hospital. Necessary permissions to use this data was provided from medical coordinator of the hospital and from the coordinator of Breast Health Center.
The study was conducted as two armed, assessor blinded and randomised controlled trial. BC survivors who are receiving AI were randomised to study (performed PRE) or control (no intervention) group. Eligible patients were provided information about the the study and invited to participate in study via phone call. All assessments and exercise training was carried out in Physiotherapy Department of the same hospital. Outcomes were assessed baseline and at 6th-week intervention Primary endpoint was pain assessment assessed by Brief Pain inventory. Secondary endpoints were quality of life assessed by Functional Assessment of Chronic Illness Therapy and emotional status by Hospital Anxiety and Depression scales.
Statistical analysis Sample size was calculated by using a previous study mentioned the impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgias. The mean and standart deviation data of the FACT-B parameter was used with the power (1-type II error) of 0.80 and a type I error of 0.05. Therefore, it was aimed to recruit at least 20 participants per group. In total, with dropout rate of 30%, it was estimated to recruit 26 patients in each group.
Mean [95% confidence intervals (CI)], standard deviations and frequency rates was analyzed for baseline charecteristics. Group distributions were examined with the Kolmogorov Simirnov test. Groups analysis were performed using the non parametric test methods due to the low number of participants. Mann-Whitney U test for the analysis of quantitative independent data, and Wilcoxon test was used for the analysis of dependent data. Mc-Nemar Test was used for dependent variables and Chi-Square test was used for independent variables in the analysis of qualitative data. Cohen's Formula used for calculating efect size of differences between and within the groups. Figures are performed by the SPSS graphics. P value <0.05 was considered as significant.
- Conditions
- Breast Cancer
- Being tested
- Progressive relaxation exercises
- Keywords
- Relaxation therapy, Pain, Aromatase Inhibitors
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exercisesOther
Following intructions have been performed by patients:
- Punch your hands and contract your forearm
- Punch your hands, push your elbow towards the seat
- Bend your elbows
- Push your shoulders back
- Press your knee down and pull your toes towards you
- Pull your knees towards you and push your feet down
- Tighten your hips
- Push your head back
- Lift your eyebrows
- Make wrinkles on your nose
- Tighten your teeth
- Push your chin down
- Close your eyes and think of good things.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Progressive relaxation exercises (PRE) as 1 day supervised and 3 days home based program in a week, for 6 weeks Receives: Other: Progressive relaxation exercises |
| Control Group | No intervention | Information was provided about pain and its treatment and the importance of relaxing exercises without any intervention, up to 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief pain inventory (BPI)
Assesses the severity of pain and its impact on functioning. Consisting of 17 questions, evaluating pain location, severity, and pain status, especially in the last 24 hours. Scores of 3-4 are defined as mild, 5-7 as moderate, 8-10 as severe pain in this scale.
Measured: 24 hours
Secondary outcomes (2)
Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Evaluates the multidimensionel quality of life in patients with breast cancer and is available in many languages . The questionnaire includes 5 sub-scales that assess physical, social, emotional, functional and other anxiety status. It has 27-item general and 10-item breast cancer specific scale in which patients evaluate their status. Patients determine an appropriate expression for themselves in the last 7 days, with a 5 point scale as 0: none, 1: very little, 2: slightly, 3: quite, 4: too much. Higher scores indicate higher quality of life
Measured: 7 days
Hospital Anxiety and Depression scale (HAD)
Consists of 14 questions which 7 of them evaluate depression and 7 of them evaluate anxiety. The cut-off score is 10/11 for the anxiety subscale and 7/8 for the depression subscale
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start25 Oct 2019
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A computer generated list of random sequence numbers was created with 1:1 allocation ratio to randomise participants into study or control groups. Randomisation sequence was concealed until assignment of interventions. The group allocation was made by study researcher who implemented the PRE.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Bahçacı, Hacettepe University
- Investigators
- Umut Bahcacı, MSc, Principal investigator, Florence Nightingale Hospital, IstanbulZeynep Erdoğan İyigün, Asst. Prof., Principal investigator, Florence Nightingale Hospital, IstanbulSongul Atasavun Uysal, Prof., Principal investigator, Hacettepe UniversityÇetin Ordu, Asst. Prof., Principal investigator, Florence Nightingale Hospital, IstanbulVahit Özmen, Prof., Study chair, Florence Nightingale Hospital, IstanbulGürsel Remzi Soybir, Prof., Study chair, Memorial Etiler Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163692
- Sponsor's protocol ID
- PREBCA
- Acronym
- PREBCA
- Status last verified
- Mar 2021
- First submitted
- 12 Nov 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a recent plan to make IPD available
Publications
Cuzick J, Sestak I, Forbes JF, Dowsett M, Knox J, Cawthorn S, Saunders C, Roche N, Mansel RE, von Minckwitz G, Bonanni B, Palva T, Howell A; IBIS-II investigators. Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial. Lancet. 2014 Mar 22;383(9922):1041-8. doi: 10.1016/S0140-6736(13)62292-8. Epub 2013 Dec 12.
PubMed 24333009Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015 Oct 3;386(10001):1341-1352. doi: 10.1016/S0140-6736(15)61074-1. Epub 2015 Jul 23.
PubMed 26211827Mincey BA, Duh MS, Thomas SK, Moyneur E, Marynchencko M, Boyce SP, Mallett D, Perez EA. Risk of cancer treatment-associated bone loss and fractures among women with breast cancer receiving aromatase inhibitors. Clin Breast Cancer. 2006 Jun;7(2):127-32. doi: 10.3816/CBC.2006.n.021.
PubMed 16800971Bender CM, Sereika SM, Brufsky AM, Ryan CM, Vogel VG, Rastogi P, Cohen SM, Casillo FE, Berga SL. Memory impairments with adjuvant anastrozole versus tamoxifen in women with early-stage breast cancer. Menopause. 2007 Nov-Dec;14(6):995-8. doi: 10.1097/gme.0b013e318148b28b.
PubMed 17898668Cella D, Fallowfield L, Barker P, Cuzick J, Locker G, Howell A; ATAC Trialistsa9 Group. Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer. Breast Cancer Res Treat. 2006 Dec;100(3):273-84. doi: 10.1007/s10549-006-9260-6. Epub 2006 Jun 21.
PubMed 16944295Breckenridge LM, Bruns GL, Todd BL, Feuerstein M. Cognitive limitations associated with tamoxifen and aromatase inhibitors in employed breast cancer survivors. Psychooncology. 2012 Jan;21(1):43-53. doi: 10.1002/pon.1860. Epub 2010 Oct 21.
PubMed 20967847So WK, Marsh G, Ling WM, Leung FY, Lo JC, Yeung M, Li GK. The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study. Oncol Nurs Forum. 2009 Jul;36(4):E205-14. doi: 10.1188/09.ONF.E205-E214.
PubMed 19581224Bahcaci U, Atasavun Uysal S, Erdogan Iyigun Z, Ordu C, Soybir GR, Ozmen V. Progressive relaxation training in patients with breast cancer receiving aromatase inhibitor therapy-randomized controlled trial. PLoS One. 2024 Apr 18;19(4):e0301020. doi: 10.1371/journal.pone.0301020. eCollection 2024.
PubMed 38635763
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Relaxation Training on Artralgia, Quality of Life and Emotional Status in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT04163692
- Acronym / sponsor ID
- PREBCA / PREBCA
- Conditions
- Breast Cancer
- Keywords
- Relaxation therapy, Pain, Aromatase Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 15 Nov 2019 (actual)
- 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.
This study evaluates the effects of progressive relaxation exercises on artralgia, quality of life and anxiety-deppression in breast cancer patients receiving aromatase inhibitor. Half of the participants will receive supervised progressive relaxing exercises, while other half will not receive any exercise but only advice about relaxing.
Hypothesis: Progressive relaxation exercises improve the pain, quality of life and emotional status in breast cancer patients receiving aromatase inhibitor therapy.
Detailed description
Aromatase inhibitors (AI) can cause musculoskeletal problems and increased risk of fracture as side effects in breast cancer (BC) survivors. In particular, arthralgia can be observed in almost 50% of patients receiving AI. Moreover; cognitive dysfunctions , decreases in quality of life , anxiety and depression , sleep problems and fatigue can be seen in some of patients receiving AI. According to these possible side effects, evaluation and treatment of such health profiles, pain and symptoms is important in terms of improving the quality of life of the patients.
Progressive muscle relaxation exercises (PRE) were first described by Jacobson in 1938. PRE are in use today with different arrangements and updates. It was well defined physiological, perceptual and behavioral positive findings of muscle relaxation.
PRE was thought to be effective on artralgia, quality of life and anxiety-depression in BC survivors receiving AI.
The patients have been searched from the medical records of brest health center in a local hospital. Necessary permissions to use this data was provided from medical coordinator of the hospital and from the coordinator of Breast Health Center.
The study was conducted as two armed, assessor blinded and randomised controlled trial. BC survivors who are receiving AI were randomised to study (performed PRE) or control (no intervention) group. Eligible patients were provided information about the the study and invited to participate in study via phone call. All assessments and exercise training was carried out in Physiotherapy Department of the same hospital. Outcomes were assessed baseline and at 6th-week intervention Primary endpoint was pain assessment assessed by Brief Pain inventory. Secondary endpoints were quality of life assessed by Functional Assessment of Chronic Illness Therapy and emotional status by Hospital Anxiety and Depression scales.
Statistical analysis Sample size was calculated by using a previous study mentioned the impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgias. The mean and standart deviation data of the FACT-B parameter was used with the power (1-type II error) of 0.80 and a type I error of 0.05. Therefore, it was aimed to recruit at least 20 participants per group. In total, with dropout rate of 30%, it was estimated to recruit 26 patients in each group.
Mean [95% confidence intervals (CI)], standard deviations and frequency rates was analyzed for baseline charecteristics. Group distributions were examined with the Kolmogorov Simirnov test. Groups analysis were performed using the non parametric test methods due to the low number of participants. Mann-Whitney U test for the analysis of quantitative independent data, and Wilcoxon test was used for the analysis of dependent data. Mc-Nemar Test was used for dependent variables and Chi-Square test was used for independent variables in the analysis of qualitative data. Cohen's Formula used for calculating efect size of differences between and within the groups. Figures are performed by the SPSS graphics. P value <0.05 was considered as significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A computer generated list of random sequence numbers was created with 1:1 allocation ratio to randomise participants into study or control groups. Randomisation sequence was concealed until assignment of interventions. The group allocation was made by study researcher who implemented the PRE.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Progressive relaxation exercisesProgressive relaxation exercises (PRE) as 1 day supervised and 3 days home based program in a week, for 6 weeks |
| Control Group | No intervention | –Information was provided about pain and its treatment and the importance of relaxing exercises without any intervention, up to 6 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Using Aromatase Inhibitors for more than 6 months
- Diagnosis of breast cancer stage 1-3
- Postmenopausal woman aged under 70 years and with hormone-receptor positive
- Approval of physician for participating in PRE program
Key exclusion criteria (4 listed)
- Participation on a regular physical training in the previous 6 months period
- Communication problems
- Neurological or ortopedical problems
- Presence of lyphedema diagnosis
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 |
|---|---|---|
| Progressive relaxation exercisesFollowing intructions have been performed by patients: * Punch your hands and contract your forearm * Punch your hands, push your elbow towards the seat * Bend your elbows * Push your shoulders back * Press your knee down and pull your toes towards you * Pull your knees towards you and push your feet down * Tighten your hips * Push your head back * Lift your eyebrows * Make wrinkles on your nose * Tighten your teeth * Push your chin down * Close your eyes and think of good things. | Other | Exercise Group |
Primary outcome
Brief pain inventory (BPI)
Time frame: 24 hours
Assesses the severity of pain and its impact on functioning. Consisting of 17 questions, evaluating pain location, severity, and pain status, especially in the last 24 hours. Scores of 3-4 are defined as mild, 5-7 as moderate, 8-10 as severe pain in this scale.
2 secondary outcomes
Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Time frame: 7 days
Hospital Anxiety and Depression scale (HAD)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Background: PubMed 24333009Cuzick J, Sestak I, Forbes JF, Dowsett M, Knox J, Cawthorn S, Saunders C, Roche N, Mansel RE, von Minckwitz G, Bonanni B, Palva T, Howell A; IBIS-II investigators. Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial. Lancet. 2014 Mar 22;383(9922):1041-8. doi: 10.1016/S0140-6736(13)62292-8. Epub 2013 Dec 12.
- Background: PubMed 26211827Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015 Oct 3;386(10001):1341-1352. doi: 10.1016/S0140-6736(15)61074-1. Epub 2015 Jul 23.
- Background: PubMed 16800971Mincey BA, Duh MS, Thomas SK, Moyneur E, Marynchencko M, Boyce SP, Mallett D, Perez EA. Risk of cancer treatment-associated bone loss and fractures among women with breast cancer receiving aromatase inhibitors. Clin Breast Cancer. 2006 Jun;7(2):127-32. doi: 10.3816/CBC.2006.n.021.
- Background: PubMed 17898668Bender CM, Sereika SM, Brufsky AM, Ryan CM, Vogel VG, Rastogi P, Cohen SM, Casillo FE, Berga SL. Memory impairments with adjuvant anastrozole versus tamoxifen in women with early-stage breast cancer. Menopause. 2007 Nov-Dec;14(6):995-8. doi: 10.1097/gme.0b013e318148b28b.
- Background: PubMed 16944295Cella D, Fallowfield L, Barker P, Cuzick J, Locker G, Howell A; ATAC Trialistsa9 Group. Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer. Breast Cancer Res Treat. 2006 Dec;100(3):273-84. doi: 10.1007/s10549-006-9260-6. Epub 2006 Jun 21.
- Background: PubMed 20967847Breckenridge LM, Bruns GL, Todd BL, Feuerstein M. Cognitive limitations associated with tamoxifen and aromatase inhibitors in employed breast cancer survivors. Psychooncology. 2012 Jan;21(1):43-53. doi: 10.1002/pon.1860. Epub 2010 Oct 21.
- Background: PubMed 19581224So WK, Marsh G, Ling WM, Leung FY, Lo JC, Yeung M, Li GK. The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study. Oncol Nurs Forum. 2009 Jul;36(4):E205-14. doi: 10.1188/09.ONF.E205-E214.
- Derived from this study: PubMed 38635763Bahcaci U, Atasavun Uysal S, Erdogan Iyigun Z, Ordu C, Soybir GR, Ozmen V. Progressive relaxation training in patients with breast cancer receiving aromatase inhibitor therapy-randomized controlled trial. PLoS One. 2024 Apr 18;19(4):e0301020. doi: 10.1371/journal.pone.0301020. eCollection 2024.
- incidence of breast cancerLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a recent plan to make IPD available
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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.
Umut Bahcacı, MSc principal investigator
Florence Nightingale Hospital, Istanbul
Zeynep Erdoğan İyigün, Asst. Prof. principal investigator
Florence Nightingale Hospital, Istanbul
Songul Atasavun Uysal, Prof. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive relaxation exercises in people with Breast Cancer, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Apr 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief pain inventory (BPI) (time frame: 24 hours). 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 NCT04163692, which also lists 8 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 1 Apr 2021.