Cognitive/Functional EffectsNCT01721343
Collaborative Targeted Case Management in Improving Functional Status in Patients With Stage III-IV Cancer
A study testing telephone-based intervention, case management and management of therapy complications in people with Cognitive/Functional Effects and Malignant Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This randomized clinical trial studies collaborative targeted case management in improving functional status in patients with stage III-IV cancer. Collaborative targeted case management may improve functional mobility, improve quality of life, and reduce pain and health care utilization in patients with advanced cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive/Functional Effects, Malignant Neoplasm, Pain
- What is being tested?
- telephone-based intervention, case management and management of therapy complications
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2012to 3 Aug 2019
- 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
- Diagnosis of stage III or stage IV cancer
- Life expectancy > 6 months
- Ambulatory Post Acute Care (APC) score between 53 and 66
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide informed written consent
- Have working phone to communicate with study team
Show all 9Show fewer
- Fluent in English
- Sufficient auditory acuity
- Intact cognitive status
Who cannot join
- Patient is within 2 months of a major surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MC1193: Collaborative Care to Preserve Performance in Cancer (COPE)
This randomized clinical trial studies collaborative targeted case management in improving functional status in patients with stage III-IV cancer. Collaborative targeted case management may improve functional mobility, improve quality of life, and reduce pain and health care utilization in patients with advanced cancer
Read the detailed description
PRIMARY OBJECTIVES:
- Establish the comparative effectiveness of the Collaborative Care to Preserve Performance in Cancer (COPE) trial arms in preserving functional mobility.
II. To assess the comparative cost-effectiveness and cost-utility of the COPE interventions.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
ARM II: Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
ARM III: Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
- Conditions
- Cognitive/Functional Effects, Malignant Neoplasm, Pain
- Being tested
- telephone-based intervention, case management, management of therapy complications, physical therapy, questionnaire administration
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-based interventionBehavioural
Undergo telephonic monitoring
case managementOther
Participate in an individualized conditioning program with an RCM
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Undergo enhanced usual care with an RCM and PCM
physical therapyProcedure or surgery
Also called physiotherapy
Participate in an individualized conditioning program with an RCM
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Undergo enhanced usual care
assessment of therapy complicationsProcedure or surgery
Undergo enhanced usual care
educational interventionOther
Also called intervention, educational
Participate in an individualized conditioning program with an RCM
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Undergo enhanced usual care with an RCM
assessment of therapy complicationsProcedure or surgery
Undergo enhanced usual care with an RCM
assessment of therapy complicationsProcedure or surgery
Undergo enhanced usual care with an RCM and PCM
| Study group | Role | What they receive |
|---|---|---|
| Arm I (enhanced usual care) | Experimental | Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months. Receives: Behavioral: telephone-based intervention; Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: management of therapy complications; Procedure: assessment of therapy complications |
| Arm II (enhanced usual care, RCM) | Experimental | Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months. Receives: Behavioral: telephone-based intervention; Other: case management; Procedure: physical therapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Other: educational intervention; Procedure: management of therapy complications; Procedure: assessment of therapy complications |
| Arm III (enhanced usual, RCM, PCM) | Experimental | Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months. Receives: Behavioral: telephone-based intervention; Other: case management; Procedure: management of therapy complications; Procedure: physical therapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Other: educational intervention; Procedure: assessment of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional mobility, as measured by the change in the Activity Measure for Post Acute Care (AM PAC) Computer Adaptive Test (CAT) from baseline [6 months]
The mean change in the Ambulatory Post-Acute Care Basic Mobility Computer Adaptive Test (AM PAC CAT) score (month 6 minus baseline) and the [95% confidence interval] for patients assigned to each arm regardless of compliance are reported below. The AM PAC CAT is an item response theory-modeled scale that ranges from 0 to infinity. However, the score range of interest for the trial that corresponds to the ability to ambulate and transfer safely and independently (+/- gait aid) is 55 - 66 with higher scores corresponding to better mobility and the MID for improvement being 1.0. For the primary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.
Measured: From baseline to 6 months
Secondary outcomes (6)
Pain as measured using the Brief Pain Inventory average and total pain interference subscales from baseline [6 months].
The change in the Brief Pain Inventory (BPI) average score and total interference score (Month 6 minus baseline) and the and the [95% confidence interval] for patients assigned to each arm regardless of compliance. The BPI average is a single numerical rating scale (NRS) anchored at 0 and 11. The total inference score is a composite of 6 NRS scales. Higher scores indicate more pain or a worse health state. For both measures the minimally important difference (MID) is population dependent and ranges between 0.5 and 2.0. For the secondary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.
Measured: From baseline to 6 months
Health Utility, as measured by the change in EuroQol 5-D (5Q-5D) scale score from baseline
The change in health utility, as measured by the change in EuroQol 5-D (5Q-5D) score from baseline score (Month 6 minus baseline) and the and the [95% confidence interval] for patients assigned to each arm regardless of compliance. The EuroQol 5-D utility ranges from 0 to 1.0 with high values indicating better health states. The minimally important difference (MID) is population dependent and range between 0.5 and 1.0. For the secondary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.
Measured: From baseline to 6 months
Hospitalization frequency
The count of hospital admission lasting >24 hours. To assess the impact on number of hospitalizations we will use a negative binomial model, with an offset for number of days of follow-up.
Measured: From registration to 6 months
Hospital length of stay
The count of days spent in the hospital for admissions lasting >24 hours. For patients who had at least one hospitalization, the impact of the interventions on the total number of days in hospital will be assessed using mixed effect Poisson analysis.
Measured: From registration to 6 months
Discharge location from hospital
Binary variable describing whether patients were discharged to an inpatient facility (skilled nursing facility, inpatient rehabilitation facility, hospice or long term acute care facility) or home with/without services. Logistic models with random effects for patient will be used to analyze inter-group differences.
Measured: From registration to 6 months
Planned admission
Binary variable describing whether an admission was planned for anti-cancer treatment or unplanned. Logistic models with random effects for patient will be used to analyze inter-group differences.
Measured: From registration to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study start7 Nov 2012
- Primary completion14 Nov 2017
- Study completion3 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive/Functional EffectsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrea Cheville, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721343
- Sponsor's protocol ID
- MC1193
- Other IDs
- R01CA163803, 11-008151
- Status last verified
- Nov 2024
- First submitted
- 8 Oct 2012
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheville AL, Moynihan T, Basford JR, Nyman JA, Tuma ML, Macken DA, Therneau T, Satelel D, Kroenke K. The rationale, design, and methods of a randomized, controlled trial to evaluate the effectiveness of collaborative telecare in preserving function among patients with late stage cancer and hematologic conditions. Contemp Clin Trials. 2018 Jan;64:254-264. doi: 10.1016/j.cct.2017.08.021. Epub 2017 Sep 5.
PubMed 28887068Cheville AL, Moynihan T, Herrin J, Loprinzi C, Kroenke K. Effect of Collaborative Telerehabilitation on Functional Impairment and Pain Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):644-652. doi: 10.1001/jamaoncol.2019.0011.
PubMed 30946436
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC1193: Collaborative Care to Preserve Performance in Cancer (COPE)
- ClinicalTrials.gov ID
- NCT01721343
- Acronym / sponsor ID
- MC1193
- Conditions
- Cognitive/Functional Effects, Malignant Neoplasm, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Nov 2012 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 3 Aug 2019 (actual)
- First posted
- 5 Nov 2012 (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 randomized clinical trial studies collaborative targeted case management in improving functional status in patients with stage III-IV cancer. Collaborative targeted case management may improve functional mobility, improve quality of life, and reduce pain and health care utilization in patients with advanced cancer
Detailed description
PRIMARY OBJECTIVES:
- Establish the comparative effectiveness of the Collaborative Care to Preserve Performance in Cancer (COPE) trial arms in preserving functional mobility.
II. To assess the comparative cost-effectiveness and cost-utility of the COPE interventions.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
ARM II: Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
ARM III: Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (enhanced usual care) | Experimental | Behavioral: telephone-based intervention, Other: questionnaire administration, Procedure: quality-of-life assessment, Procedure: management of therapy complications, Procedure: assessment of therapy complicationsPatients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months. |
| Arm II (enhanced usual care, RCM) | Experimental | Behavioral: telephone-based intervention, Other: case management, Procedure: physical therapy, Other: questionnaire administration, Procedure: quality-of-life assessment, Other: educational intervention, Procedure: management of therapy complications, Procedure: assessment of therapy complicationsPatients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months. |
| Arm III (enhanced usual, RCM, PCM) | Experimental | Behavioral: telephone-based intervention, Other: case management, Procedure: management of therapy complications, Procedure: physical therapy, Other: questionnaire administration, Procedure: quality-of-life assessment, Other: educational intervention, Procedure: assessment of therapy complicationsPatients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of stage III or stage IV cancer
- Life expectancy > 6 months
- Ambulatory Post Acute Care (APC) score between 53 and 66
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide informed written consent
Key exclusion criteria (1 listed)
- Patient is within 2 months of a major surgical procedure
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 |
|---|---|---|
| telephone-based interventionUndergo telephonic monitoring | Behavioural | Arm I (enhanced usual care), Arm II (enhanced usual care, RCM), Arm III (enhanced usual, RCM, PCM) |
| case managementParticipate in an individualized conditioning program with an RCM | Other | Arm II (enhanced usual care, RCM), Arm III (enhanced usual, RCM, PCM) |
| management of therapy complicationsAlso: complications of therapy, management ofUndergo enhanced usual care with an RCM and PCM | Procedure or surgery | Arm III (enhanced usual, RCM, PCM) |
| physical therapyAlso: physiotherapyParticipate in an individualized conditioning program with an RCM | Procedure or surgery | Arm II (enhanced usual care, RCM), Arm III (enhanced usual, RCM, PCM) |
| questionnaire administrationAncillary studies | Other | Arm I (enhanced usual care), Arm II (enhanced usual care, RCM), Arm III (enhanced usual, RCM, PCM) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (enhanced usual care), Arm II (enhanced usual care, RCM), Arm III (enhanced usual, RCM, PCM) |
| management of therapy complicationsAlso: complications of therapy, management ofUndergo enhanced usual care | Procedure or surgery | Arm I (enhanced usual care) |
| assessment of therapy complicationsUndergo enhanced usual care | Procedure or surgery | Arm I (enhanced usual care) |
| educational interventionAlso: intervention, educationalParticipate in an individualized conditioning program with an RCM | Other | Arm II (enhanced usual care, RCM), Arm III (enhanced usual, RCM, PCM) |
| management of therapy complicationsAlso: complications of therapy, management ofUndergo enhanced usual care with an RCM | Procedure or surgery | Arm II (enhanced usual care, RCM) |
| assessment of therapy complicationsUndergo enhanced usual care with an RCM | Procedure or surgery | Arm II (enhanced usual care, RCM) |
| assessment of therapy complicationsUndergo enhanced usual care with an RCM and PCM | Procedure or surgery | Arm III (enhanced usual, RCM, PCM) |
Primary outcome
Functional mobility, as measured by the change in the Activity Measure for Post Acute Care (AM PAC) Computer Adaptive Test (CAT) from baseline [6 months]
Time frame: From baseline to 6 months
The mean change in the Ambulatory Post-Acute Care Basic Mobility Computer Adaptive Test (AM PAC CAT) score (month 6 minus baseline) and the [95% confidence interval] for patients assigned to each arm regardless of compliance are reported below. The AM PAC CAT is an item response theory-modeled scale that ranges from 0 to infinity. However, the score range of interest for the trial that corresponds to the ability to ambulate and transfer safely and independently (+/- gait aid) is 55 - 66 with higher scores corresponding to better mobility and the MID for improvement being 1.0. For the primary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.
6 secondary outcomes
Pain as measured using the Brief Pain Inventory average and total pain interference subscales from baseline [6 months].
Time frame: From baseline to 6 months
Health Utility, as measured by the change in EuroQol 5-D (5Q-5D) scale score from baseline
Time frame: From baseline to 6 months
Hospitalization frequency
Time frame: From registration to 6 months
Hospital length of stay
Time frame: From registration to 6 months
Discharge location from hospital
Time frame: From registration to 6 months
Planned admission
Time frame: From registration to 6 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 16 Mar 2026.
- Background: PubMed 28887068Cheville AL, Moynihan T, Basford JR, Nyman JA, Tuma ML, Macken DA, Therneau T, Satelel D, Kroenke K. The rationale, design, and methods of a randomized, controlled trial to evaluate the effectiveness of collaborative telecare in preserving function among patients with late stage cancer and hematologic conditions. Contemp Clin Trials. 2018 Jan;64:254-264. doi: 10.1016/j.cct.2017.08.021. Epub 2017 Sep 5.
- Results publication: PubMed 30946436Cheville AL, Moynihan T, Herrin J, Loprinzi C, Kroenke K. Effect of Collaborative Telerehabilitation on Functional Impairment and Pain Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):644-652. doi: 10.1001/jamaoncol.2019.0011.
- Mayo Clinic Clinical TrialsLink 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.
Andrea Cheville, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone-based intervention, case management and management of therapy complications in people with Cognitive/Functional Effects and Malignant Neoplasm, run by Mayo Clinic 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 9 inclusion and 1 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 16 Mar 2026. 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?
Functional mobility, as measured by the change in the Activity Measure for Post Acute Care (AM PAC) Computer Adaptive Test (CAT) from baseline [6 months] (time frame: From baseline to 6 months). 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 NCT01721343, which also lists 2 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 16 Mar 2026.