CancerCARE ProgramNCT02306252
The CARE Program: CAncer REhabilitation Pilot Study for Older Adults
A study testing Occupational and Physical Therapy in people with Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The CARE Program is a randomized trial of a cancer rehabilitation program designed to help older cancer patients who have shown to have a loss of function. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Occupational and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Mar 2017
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older
- Has an outpatient appointment within UNC Chapel Hill Lineberger Comprehensive Cancer Center
- Diagnosis of cancer within last two years.
- Has a life expectancy of 12 months or longer. All cancer types are included.
- English speaking
- Willing to complete the UNC GA
Show all 10Show fewer
- Has at least one functional deficit as defined by GA screen
- Understands study design, risks, and benefits and have signed informed consent
- Willing to be randomized into either study arm
- Ability to safely participate in outpatient rehabilitation program
Who cannot join
- Unable to safely participate in outpatient rehabilitation.
- Currently receiving rehabilitation.
- Any participant who has urologic cancer or is enrolled in a competing trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: LCCC 1409: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults
The CARE Program is a randomized trial of a cancer rehabilitation program designed to help older cancer patients who have shown to have a loss of function.
Read the detailed description
This is a prospective, two-arm, single-center randomized controlled pilot trial of a cancer rehabilitation program for older adults, titled the 'CARE program,' which is designed to maintain and/or improve functional status and quality of life in older adults diagnosed with cancer. Adults aged 65 years and older with cancer will be screened with a Geriatric Assessment (GA) for eligibility. Although breast cancer patients will be eligible, this study will focus primarily on other types of cancers. Adults with at least one functional deficit --defined as impairment in ability to perform activities of daily living or instrumental activities of daily living, cognitive decline or balance -- will be randomized to either the intervention (CARE program) or to the control arm (Supportive care services information only). Both arms will receive a brochure about the supportive care program to provide patients who we've identified as having deficits with information about auxiliary services available and because the intent is to limit the difference between the groups. We hypothesize that patients who participate in the CARE program will maintain or improve functional status and quality of life when compared to supportive care services information only.
- Conditions
- Cancer
- Being tested
- Occupational and Physical Therapy
- Keywords
- Cancer, Older Adult, Geriatric, Function, Functional Deficit, Occupational Therapy, Physical Therapy, Supportive Care, Oncology, physiology, Geriatric Assessment, Health Services for the Aged, Physical Therapy Specialty
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational and Physical TherapyOther
OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
| Study group | Role | What they receive |
|---|---|---|
| CARE Intervention | Experimental | This group will be contacted to make an appointment for outpatient Occupational and Physical therapy. The therapist will determine the type, frequency and length of treatment. Follow up phone calls will be made to ensure appointments are made, kept and rescheduled as needed. Receives: Other: Occupational and Physical Therapy |
| CARE Control | No intervention | Patients randomized to this arm will receive contact information and a brochure outlining the services available within the supportive care program. The study coordinator will provide the information based on their results and assist the patient with contacting the program if desired. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
Compare the change in NEADL scores from baseline to 3 months between patients who receive the CARE program (intervention) and those in the control arm.
Measured: 3 months
Secondary outcomes (16)
To measure the change in Activities of Daily Living from Baseline and 2 months
As measured by the Geriatric Assessment
Measured: 2 months
To measure the change in Activities of Daily Living from Baseline and 3 months
As measured by the Geriatric Assessment
Measured: 3 months
To measure the change in physical health from Baseline and 3 months
As measured by the Geriatric Assessment
Measured: 3 months
To measure the change in physical health from Baseline and 2 months
As measured by the Geriatric Assessment
Measured: 2 months
To measure the change in quality of life from Baseline and 2 months
As measured by the PROMIS assessment
Measured: 2 months
To measure the change in quality of life from Baseline and 3 months
As measured by the PROMIS assessment
Measured: 3 months
To measure the change in internalized occupational possibilities from Baseline and 3 months
As measured by the Possibilities for Activity Scale (PActS)
Measured: 3 months
To measure the change in internalized occupational possibilities from Baseline and 2 months
As measured by the Possibilities for Activity Scale (PActS)
Measured: 2 months
To measure the change in cognitive function from Baseline and 2 months
As measured by the Blessed Memory Orientation Concentration test
Measured: 2 months
To measure the change in cognitive function from Baseline and 3 months
As measured by the Blessed Memory Orientation Concentration test
Measured: 3 months
To measure the feasibility of the CARE Program
To describe the feasibility of the CARE program by reporting enrollment and retention as defined by (1) percent eligible who agree to participate (2) percent in each group that completed follow-up measures at 2 and 3 months and (3) percent of patients in CARE program who go to 70% of appointments.
Measured: 3 months
To measure the change in balance over the course of the study
Intervention Group Only: As measured by the Berg Balance Scale
Measured: 3 months
To measure the change in upper extremity use and ability over the course of the study
Intervention Group Only: As measured by the Disability of the Arm, Shoulder and Hand scale
Measured: 3 months
To measure the change in cognition over the course of the study
Intervention Group Only: As measured by the Montreal Cognitive Assessment
Measured: 3 months
To measure the change in dynamic gait ability over the course of the study
Intervention Group Only: As measured by the Dynamic Gait Index
Measured: 3 months
To measure satisfaction with the CARE Program
To evaluate the program a short interview will be completed with CARE team to determine what worked well, what didn't and suggested changes/improvements for CARE program after completion of project.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mackenzi Pergolotti, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306252
- Sponsor's protocol ID
- LCCC1409
- Other IDs
- 14-1159
- Acronym
- CARE Program
- Status last verified
- Sep 2017
- First submitted
- 1 Dec 2014
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 1409: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults
- ClinicalTrials.gov ID
- NCT02306252
- Acronym / sponsor ID
- CARE Program / LCCC1409
- Conditions
- Cancer
- Keywords
- Cancer, Older Adult, Geriatric, Function, Functional Deficit, Occupational Therapy, Physical Therapy, Supportive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 3 Dec 2014 (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.
The CARE Program is a randomized trial of a cancer rehabilitation program designed to help older cancer patients who have shown to have a loss of function.
Detailed description
This is a prospective, two-arm, single-center randomized controlled pilot trial of a cancer rehabilitation program for older adults, titled the 'CARE program,' which is designed to maintain and/or improve functional status and quality of life in older adults diagnosed with cancer. Adults aged 65 years and older with cancer will be screened with a Geriatric Assessment (GA) for eligibility. Although breast cancer patients will be eligible, this study will focus primarily on other types of cancers. Adults with at least one functional deficit --defined as impairment in ability to perform activities of daily living or instrumental activities of daily living, cognitive decline or balance -- will be randomized to either the intervention (CARE program) or to the control arm (Supportive care services information only). Both arms will receive a brochure about the supportive care program to provide patients who we've identified as having deficits with information about auxiliary services available and because the intent is to limit the difference between the groups. We hypothesize that patients who participate in the CARE program will maintain or improve functional status and quality of life when compared to supportive care services information only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARE Intervention | Experimental | Other: Occupational and Physical TherapyThis group will be contacted to make an appointment for outpatient Occupational and Physical therapy. The therapist will determine the type, frequency and length of treatment. Follow up phone calls will be made to ensure appointments are made, kept and rescheduled as needed. |
| CARE Control | No intervention | –Patients randomized to this arm will receive contact information and a brochure outlining the services available within the supportive care program. The study coordinator will provide the information based on their results and assist the patient with contacting the program if desired. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Aged 65 years or older
- Has an outpatient appointment within UNC Chapel Hill Lineberger Comprehensive Cancer Center
- Diagnosis of cancer within last two years.
- Has a life expectancy of 12 months or longer. All cancer types are included.
- English speaking
Key exclusion criteria (3 listed)
- Unable to safely participate in outpatient rehabilitation.
- Currently receiving rehabilitation.
- Any participant who has urologic cancer or is enrolled in a competing trial.
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 |
|---|---|---|
| Occupational and Physical TherapyOT and PT will be arranged for the subject and conducted in a manner as determined by the therapist. | Other | CARE Intervention |
Primary outcome
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
Time frame: 3 months
Compare the change in NEADL scores from baseline to 3 months between patients who receive the CARE program (intervention) and those in the control arm.
16 secondary outcomes
To measure the change in Activities of Daily Living from Baseline and 2 months
Time frame: 2 months
To measure the change in Activities of Daily Living from Baseline and 3 months
Time frame: 3 months
To measure the change in physical health from Baseline and 3 months
Time frame: 3 months
To measure the change in physical health from Baseline and 2 months
Time frame: 2 months
To measure the change in quality of life from Baseline and 2 months
Time frame: 2 months
To measure the change in quality of life from Baseline and 3 months
Time frame: 3 months
To measure the change in internalized occupational possibilities from Baseline and 3 months
Time frame: 3 months
To measure the change in internalized occupational possibilities from Baseline and 2 months
Time frame: 2 months
To measure the change in cognitive function from Baseline and 2 months
Time frame: 2 months
To measure the change in cognitive function from Baseline and 3 months
Time frame: 3 months
To measure the feasibility of the CARE Program
Time frame: 3 months
To measure the change in balance over the course of the study
Time frame: 3 months
To measure the change in upper extremity use and ability over the course of the study
Time frame: 3 months
To measure the change in cognition over the course of the study
Time frame: 3 months
To measure the change in dynamic gait ability over the course of the study
Time frame: 3 months
To measure satisfaction with the CARE Program
Time frame: 3 months
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 12 Sep 2017.
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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.
Mackenzi Pergolotti, PhD principal investigator
Colorado State 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 Occupational and Physical Therapy in people with Cancer, run by UNC Lineberger 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 10 inclusion and 3 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 12 Sep 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?
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months. (time frame: 3 months). 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 12 Sep 2017.