Quality of LifeNCT00740038
Support for People Undergoing Chemotherapy
A study testing Stress Management training, Exercise Training and Combined stress management and exercise training in people with Quality of Life and Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
Chemotherapy adversely affects quality of life in cancer patients. Both stress management training and exercise training have been shown to improve quality of life. These two types of training have not been directly compared for chemotherapy patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Cancer
- What is being tested?
- Stress Management training, Exercise Training and Combined stress management and exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be diagnosed with cancer
- Be scheduled to receive cytotoxic chemotherapy for at least 14 weeks
- Be ≥18 years of age or older
- Have an ECOG performance status of 0, 1, or 2
- Be capable of speaking and reading English
- Be able to provide informed consent
Who cannot join
- ECOG of 3 or greater
- Presence of contraindications to participating in moderate intensity exercise including:
- . metastases to weight-bearing sites (spine, pelvis, lower extremities)
- . active infections
- . cardiomyopathy or congestive heart failure
- . severe pulmonary or ventilatory disease (FEV 1.0<50%)
Show all 19Show fewer
- . large pleural effusions or pericardial effusions
- . anemia (Hgb <8g/dL)
- . neutropenia (absolute neutrophil count < 0.05 x 10(9th)/L)
- . severe osteoporosis (> 2.5 SD below age and gender norms)
- . thrombocytopenia (platelets < 20 x 10(9th)/L)
- . hyponatremia (Na+ < 130 mmol/L)
- . hypokalemia (K+ ≤ 3.0 mmol/L)
- . hypercalcemia (Ca++ > 6.5 mmol/L)
- . abnormal ECG
- . sensorimotor deficits sufficient to impede unassisted walking
- Receipt of intravenous chemotherapy administration in the past 2 months
- Prescription for chronotropic, sympathomimetic, or inotropic/vasoactive medications
- Presence of other contraindications as determined by the attending oncologist and research staff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Stress Management and Exercise Intervention During Cancer Chemotherapy
Chemotherapy adversely affects quality of life in cancer patients. Both stress management training and exercise training have been shown to improve quality of life. These two types of training have not been directly compared for chemotherapy patients.
This study seeks to evaluate the separate and combined effects of stress management training and exercise training on quality of life during chemotherapy treatment. Participants receive either a home-based, self-administered program in 1 of 3 types (stress management, exercise, or stress management + exercise) or usual care (reading materials). It is hypothesized that the combined program (stress management + exercise) will be significantly associated with better quality of life than the usual care group, the exercise only group, and the stress management only group. All participants are assessed at 3 timepoints: before they begin chemotherapy, 6 weeks after their first chemotherapy infusion, and 12 weeks after their first infusion.
- Conditions
- Quality of Life, Cancer
- Being tested
- Stress Management training, Exercise Training, Usual care, Combined stress management and exercise training
- Keywords
- Stress Management, Quality of Life, Exercise, Cancer, Chemotherapy
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management trainingBehavioural
Also called Coping techniques, Cognitive-behavioral, stress management, Progressive muscle relaxation
Self-administered stress management training comprising 10 minute introduction by staff, \& provision of DVD, CD,brochure, and workbook. Materials provide overview of sources of stress during chemotherapy, and instruction in cognitive-behavioral stress management techniques (paced abdominal breathing, progressive muscle relaxation with guided imagery, and use of coping self-statements). Daily use is encouraged over 13-14 weeks of the study.
Exercise TrainingBehavioural
Also called Exercise program, Walking program, home-based exercise, exercise during chemotherapy
Home-based exercise (walking) program: brief introduction by staff (10 minutes) and provision of packet with DVD, brochure, workbook, pedometer (electronic step counter) along with instructions on initiating and maintaining a walking program. Dose Recommendations: 3-5 exercise session per week for at least 20-30 minutes at maximum intensity of 50 to 75% of their estimated heart rate reserve (RPE of 11-13) which is calculated based on their age and resting pulse.
Usual careBehavioural
Also called Active control group, Information on chemotherapy
Usual psychosocial care and provision of NCI booklet, Chemotherapy and You (NCI, 1999) which gives general feedback about fitness testing, exercise and stress management during chemotherapy. Recommended to read booklet at least once.
Combined stress management and exercise trainingBehavioural
Also called Stress management and exercise, Exercise and stress management, exercise during chemotherapy, Progressive muscle relaxation
Home-based, self-administered stress management and exercise (walking) program: brief introduction by staff and provision of DVD, CD, brochure, pedometer, workbook. Dose Recommendations: walking/exercise program (3-5 times per week for at least 20-30 minutes) and use of CD (progressive muscle relaxation with guided imagery) and coping statements once per day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Active Control: Usual Care Receives: Behavioral: Usual care |
| 2 | Experimental | Stress Management Intervention Receives: Behavioral: Stress Management training |
| 3 | Experimental | Exercise Intervention Receives: Behavioral: Exercise Training |
| 4 | Experimental | Combined Stress Management and Exercise Intervention Receives: Behavioral: Combined stress management and exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Outcomes Survey-Short Form (SF-36, acute)
Measured: pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion
Secondary outcomes (2)
Center for Epidemiological Studies-Depression (CES-D)
Measured: pre-chemotherapy baseline, 6- & 12- weeks post-baseline
Beck Anxiety Inventory (BAI)
Measured: pre-chemotherapy baseline, 6- & 12-weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startAug 2006
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Paul B Jacobsen, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740038
- Sponsor's protocol ID
- MCC-13782
- Other IDs
- ACS RSGPB-05-0243-01 (CPPB)
- Status last verified
- Aug 2011
- First submitted
- 21 Aug 2008
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Courneya KS, Mackey JR, & Quinney HA. Neoplasms. In Myers, Herbert, Humphrey (eds): American College of Sports Medicine resources for clinical exercise physiology: musculoskeletal, neuromuscular, immunologic, and hematologic conditions. New York: Lippincott.
Courneya KS, Mackey JR, Bell GJ, Jones LW, Field CJ, Fairey AS. Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol. 2003 May 1;21(9):1660-8. doi: 10.1200/JCO.2003.04.093.
PubMed 12721239Courneya KS, Friedenreich CM, Sela RA, Quinney HA, Rhodes RE, Handman M. The group psychotherapy and home-based physical exercise (group-hope) trial in cancer survivors: physical fitness and quality of life outcomes. Psychooncology. 2003 Jun;12(4):357-74. doi: 10.1002/pon.658.
PubMed 12748973Jacobsen PB, Meade CD, Stein KD, Chirikos TN, Small BJ, Ruckdeschel JC. Efficacy and costs of two forms of stress management training for cancer patients undergoing chemotherapy. J Clin Oncol. 2002 Jun 15;20(12):2851-62. doi: 10.1200/JCO.2002.08.301.
PubMed 12065562Phillips KM, Jim HS, Small BJ, Tanvetyanon T, Roberts WS, Jacobsen PB. Effects of self-directed stress management training and home-based exercise on stress management skills in cancer patients receiving chemotherapy. Stress Health. 2012 Dec;28(5):368-75. doi: 10.1002/smi.2450. Epub 2012 Sep 13.
PubMed 22972771
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Stress Management and Exercise Intervention During Cancer Chemotherapy
- ClinicalTrials.gov ID
- NCT00740038
- Acronym / sponsor ID
- MCC-13782
- Conditions
- Quality of Life, Cancer
- Keywords
- Stress Management, Quality of Life, Exercise, Cancer, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Aug 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Aug 2008 (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.
Chemotherapy adversely affects quality of life in cancer patients. Both stress management training and exercise training have been shown to improve quality of life. These two types of training have not been directly compared for chemotherapy patients.
This study seeks to evaluate the separate and combined effects of stress management training and exercise training on quality of life during chemotherapy treatment. Participants receive either a home-based, self-administered program in 1 of 3 types (stress management, exercise, or stress management + exercise) or usual care (reading materials). It is hypothesized that the combined program (stress management + exercise) will be significantly associated with better quality of life than the usual care group, the exercise only group, and the stress management only group. All participants are assessed at 3 timepoints: before they begin chemotherapy, 6 weeks after their first chemotherapy infusion, and 12 weeks after their first infusion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Usual careActive Control: Usual Care |
| 2 | Experimental | Behavioral: Stress Management trainingStress Management Intervention |
| 3 | Experimental | Behavioral: Exercise TrainingExercise Intervention |
| 4 | Experimental | Behavioral: Combined stress management and exercise trainingCombined Stress Management and Exercise Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be diagnosed with cancer
- Be scheduled to receive cytotoxic chemotherapy for at least 14 weeks
- Be ≥18 years of age or older
- Have an ECOG performance status of 0, 1, or 2
- Be capable of speaking and reading English
Key exclusion criteria (19 listed)
- ECOG of 3 or greater
- Presence of contraindications to participating in moderate intensity exercise including:
- Receipt of intravenous chemotherapy administration in the past 2 months
- Prescription for chronotropic, sympathomimetic, or inotropic/vasoactive medications
- Presence of other contraindications as determined by the attending oncologist and research staff
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 |
|---|---|---|
| Stress Management trainingAlso: Coping techniques, Cognitive-behavioral, stress management, Progressive muscle relaxationSelf-administered stress management training comprising 10 minute introduction by staff, \& provision of DVD, CD,brochure, and workbook. Materials provide overview of sources of stress during chemotherapy, and instruction in cognitive-behavioral stress management techniques (paced abdominal breathing, progressive muscle relaxation with guided imagery, and use of coping self-statements). Daily use is encouraged over 13-14 weeks of the study. | Behavioural | 2 |
| Exercise TrainingAlso: Exercise program, Walking program, home-based exercise, exercise during chemotherapyHome-based exercise (walking) program: brief introduction by staff (10 minutes) and provision of packet with DVD, brochure, workbook, pedometer (electronic step counter) along with instructions on initiating and maintaining a walking program. Dose Recommendations: 3-5 exercise session per week for at least 20-30 minutes at maximum intensity of 50 to 75% of their estimated heart rate reserve (RPE of 11-13) which is calculated based on their age and resting pulse. | Behavioural | 3 |
| Usual careAlso: Active control group, Information on chemotherapyUsual psychosocial care and provision of NCI booklet, Chemotherapy and You (NCI, 1999) which gives general feedback about fitness testing, exercise and stress management during chemotherapy. Recommended to read booklet at least once. | Behavioural | 1 |
| Combined stress management and exercise trainingAlso: Stress management and exercise, Exercise and stress management, exercise during chemotherapy, Progressive muscle relaxationHome-based, self-administered stress management and exercise (walking) program: brief introduction by staff and provision of DVD, CD, brochure, pedometer, workbook. Dose Recommendations: walking/exercise program (3-5 times per week for at least 20-30 minutes) and use of CD (progressive muscle relaxation with guided imagery) and coping statements once per day. | Behavioural | 4 |
Primary outcome
Medical Outcomes Survey-Short Form (SF-36, acute)
Time frame: pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion
2 secondary outcomes
Center for Epidemiological Studies-Depression (CES-D)
Time frame: pre-chemotherapy baseline, 6- & 12- weeks post-baseline
Beck Anxiety Inventory (BAI)
Time frame: pre-chemotherapy baseline, 6- & 12-weeks post-baseline
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 23 Feb 2017.
- BackgroundCourneya KS, Mackey JR, & Quinney HA. Neoplasms. In Myers, Herbert, Humphrey (eds): American College of Sports Medicine resources for clinical exercise physiology: musculoskeletal, neuromuscular, immunologic, and hematologic conditions. New York: Lippincott.
- Background: PubMed 12721239Courneya KS, Mackey JR, Bell GJ, Jones LW, Field CJ, Fairey AS. Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol. 2003 May 1;21(9):1660-8. doi: 10.1200/JCO.2003.04.093.
- Background: PubMed 12748973Courneya KS, Friedenreich CM, Sela RA, Quinney HA, Rhodes RE, Handman M. The group psychotherapy and home-based physical exercise (group-hope) trial in cancer survivors: physical fitness and quality of life outcomes. Psychooncology. 2003 Jun;12(4):357-74. doi: 10.1002/pon.658.
- Background: PubMed 12065562Jacobsen PB, Meade CD, Stein KD, Chirikos TN, Small BJ, Ruckdeschel JC. Efficacy and costs of two forms of stress management training for cancer patients undergoing chemotherapy. J Clin Oncol. 2002 Jun 15;20(12):2851-62. doi: 10.1200/JCO.2002.08.301.
- Derived from this study: PubMed 22972771Phillips KM, Jim HS, Small BJ, Tanvetyanon T, Roberts WS, Jacobsen PB. Effects of self-directed stress management training and home-based exercise on stress management skills in cancer patients receiving chemotherapy. Stress Health. 2012 Dec;28(5):368-75. doi: 10.1002/smi.2450. Epub 2012 Sep 13.
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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.
Paul B Jacobsen, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management training, Exercise Training and Combined stress management and exercise training in people with Quality of Life and Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 6 inclusion and 19 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 23 Feb 2017. 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 United States. 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?
Medical Outcomes Survey-Short Form (SF-36, acute) (time frame: pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion). 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 NCT00740038, which also lists 5 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 23 Feb 2017.