Prostate CarcinomaNCT02704377
Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors
A study testing Undergo HRV and wear accelerometer to assess therapy complications, Dual X-ray Absorptiometry and Laboratory Biomarker Analysis in people with Prostate Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies quality of life and supportive care preferences following radiation therapy in prostate cancer survivors. Studying quality of life and supportive care preferences in patients undergoing radiation therapy may help identify the effects of treatment on patients with prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Undergo HRV and wear accelerometer to assess therapy complications, Dual X-ray Absorptiometry and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2016to 6 Apr 2023
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- English speaking
- Diagnosis of prostate cancer
- Treatment with primary radiation (brachytherapy or external beam therapy), radiation + androgen deprivation therapy (ADT) or salvage prostatectomy
- Body mass index (BMI) (26 - 40 kg/m^2)
- Treating oncologist consent
- Ambulatory or able to engage in walking for at least 45 minutes per intervention visit
- Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week
Who cannot join
- Poor diagnosis or other cancer
- Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension
- Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician
- Non-ambulatory
- Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
- Major mental illness (e.g., schizophrenia, major depressive disorder)
- Unwilling to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
This pilot clinical trial studies quality of life and supportive care preferences following radiation therapy in prostate cancer survivors. Studying quality of life and supportive care preferences in patients undergoing radiation therapy may help identify the effects of treatment on patients with prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To develop an understanding of the impacts of prostate cancer on aspects of psychological stress, physiological stress and health related quality of life (HRQL) for men who are being treated with some level of radiation therapy (RT).
II. To gain insight into the perceived needs of survivors depending on their disease stage, treatment regimen and side effects.
SECONDARY OBJECTIVES:
- To explore whether biomarkers of stress, inflammation and autonomic control (heart rate variability [HRV]) can confirm or dispel the self-reported measures of psychological distress and HRQL of a unique population of aging men with prostate cancer.
OUTLINE:
Participants complete questionnaires about quality of life and preferences for supportive care treatment, undergo heart rate variability testing over 10-15 minutes while both lying down and standing, complete a walking test, wear an accelerometer for a period of 1 week, and undergo a single intelligent dual-energy X-ray absorptiometry (iDXA) scan over 10 minutes.
- Conditions
- Prostate Carcinoma
- Being tested
- Undergo HRV and wear accelerometer to assess therapy complications, Dual X-ray Absorptiometry, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
- Keywords
- Prostate Cancer Survivor
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Undergo HRV and wear accelerometer to assess therapy complicationsOther
Wear accelerometer undergo heart rate variability(HRV) testing over 10-15 minutes while both lying down and standing, complete a walking test, wear an accelerometer for a period of 1 week
Dual X-ray AbsorptiometryProcedure or surgery
Also called BMD scan, bone mineral density scan, DEXA, DEXA scan
Undergo iDXA
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (quality of life, supportive care preferences) | Experimental | Participants complete questionnaires about quality of life and preferences for supportive care treatment, wear accelerometerundergo heart rate variability(HRV) testing over 10-15 minutes while both lying down and standing, complete a walking test, wear an accelerometer for a period of 1 week, and undergo a single Dual X-ray Absorptiometry (iDXA) scan over 10 minutes. Other interventions include: Laboratory Biomarker Analysis, Quality-of-Life Assessments, and othe Questionnaire Administration. Receives: Other: Undergo HRV and wear accelerometer to assess therapy complications; Procedure: Dual X-ray Absorptiometry; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop an understanding of the impacts of prostate cancer on HRQL measured by the SF-36
Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial.
Measured: Baseline
Psychological resiliency measured by Connor Davidson Resiliency Scale
The relationship with self-reported measures of quality of life and stress will be determined. Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial.
Measured: Baseline
Explore whether heart rate variability is associated with the SF-36 and Connor Davidson Resiliency Scale.
Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial.
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study start8 May 2016
- Primary completion1 Aug 2017
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Focht, Ohio State University Comprehensive Cancer Center
- Investigators
- Brian Focht, PhD, FACSM, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704377
- Sponsor's protocol ID
- OSU-15049
- Other IDs
- NCI-2015-01289
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2015
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors
- ClinicalTrials.gov ID
- NCT02704377
- Acronym / sponsor ID
- OSU-15049
- Conditions
- Prostate Carcinoma
- Keywords
- Prostate Cancer Survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 May 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 10 Mar 2016 (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.
This pilot clinical trial studies quality of life and supportive care preferences following radiation therapy in prostate cancer survivors. Studying quality of life and supportive care preferences in patients undergoing radiation therapy may help identify the effects of treatment on patients with prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To develop an understanding of the impacts of prostate cancer on aspects of psychological stress, physiological stress and health related quality of life (HRQL) for men who are being treated with some level of radiation therapy (RT).
II. To gain insight into the perceived needs of survivors depending on their disease stage, treatment regimen and side effects.
SECONDARY OBJECTIVES:
- To explore whether biomarkers of stress, inflammation and autonomic control (heart rate variability [HRV]) can confirm or dispel the self-reported measures of psychological distress and HRQL of a unique population of aging men with prostate cancer.
OUTLINE:
Participants complete questionnaires about quality of life and preferences for supportive care treatment, undergo heart rate variability testing over 10-15 minutes while both lying down and standing, complete a walking test, wear an accelerometer for a period of 1 week, and undergo a single intelligent dual-energy X-ray absorptiometry (iDXA) scan over 10 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (quality of life, supportive care preferences) | Experimental | Other: Undergo HRV and wear accelerometer to assess therapy complications, Procedure: Dual X-ray Absorptiometry, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants complete questionnaires about quality of life and preferences for supportive care treatment, wear accelerometerundergo heart rate variability(HRV) testing over 10-15 minutes while both lying down and standing, complete a walking test, wear an accelerometer for a period of 1 week, and undergo a single Dual X-ray Absorptiometry (iDXA) scan over 10 minutes. Other interventions include: Laboratory Biomarker Analysis, Quality-of-Life Assessments, and othe Questionnaire Administration. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking
- Diagnosis of prostate cancer
- Treatment with primary radiation (brachytherapy or external beam therapy), radiation + androgen deprivation therapy (ADT) or salvage prostatectomy
- Body mass index (BMI) (26 - 40 kg/m^2)
- Treating oncologist consent
Key exclusion criteria (7 listed)
- Poor diagnosis or other cancer
- Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension
- Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician
- Non-ambulatory
- Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
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 |
|---|---|---|
| Undergo HRV and wear accelerometer to assess therapy complicationsWear accelerometer undergo heart rate variability(HRV) testing over 10-15 minutes while both lying down and standing, complete a walking test, wear an accelerometer for a period of 1 week | Other | Supportive care (quality of life, supportive care preferences) |
| Dual X-ray AbsorptiometryAlso: BMD scan, bone mineral density scan, DEXA, DEXA scanUndergo iDXA | Procedure or surgery | Supportive care (quality of life, supportive care preferences) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive care (quality of life, supportive care preferences) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (quality of life, supportive care preferences) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (quality of life, supportive care preferences) |
Primary outcome
Develop an understanding of the impacts of prostate cancer on HRQL measured by the SF-36
Time frame: Baseline
Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial.
Psychological resiliency measured by Connor Davidson Resiliency Scale
Time frame: Baseline
The relationship with self-reported measures of quality of life and stress will be determined. Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial.
Explore whether heart rate variability is associated with the SF-36 and Connor Davidson Resiliency Scale.
Time frame: Up to 1 week
Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial.
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 15 Sep 2023.
- The JameslineLink provided by the sponsor.
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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.
Brian Focht, PhD, FACSM principal investigator
Ohio State University Comprehensive 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 Undergo HRV and wear accelerometer to assess therapy complications, Dual X-ray Absorptiometry and Laboratory Biomarker Analysis in people with Prostate Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 7 inclusion and 7 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 15 Sep 2023. 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?
Develop an understanding of the impacts of prostate cancer on HRQL measured by the SF-36 (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2023.