Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01334983 |
| Other study ID # |
09-007108 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
June 2010 |
| Est. completion date |
November 2010 |
Study information
| Verified date |
April 2015 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine whether a gentle physical conditioning program
comprised of isotonic resistive strengthening and pedometer-directed walking can improve the
physical functioning and fatigue of patients with late stage lung or colon cancer.
Description:
A. SPECIFIC AIMS
The results of this prospective pilot cohort study will be used to power and inform the
design of a randomized controlled trial. Its specific aims are:
1. To characterize the receptivity of patients with late stage lung or colon cancer to
perform an individualized fitness program to prevent deconditioning and functional
decline.
2. To estimate the adherence of patients with LSC (LSC) to an individualized fitness
program.
4. To estimate the degree to which symptoms, e.g. fatigue and pain, associate with adherence
to an individualized fitness program.
5. To estimate improvements in functional status associated with performance of an
individualized fitness program among patients with LSC.
B. BACKGROUND AND SIGNIFICANCE Most people with LSC function poorly at diagnosis, deteriorate
steadily over a period of months to years, and become dependent prior to death. Their
disablement exacts staggering costs in quality of life (QoL), caregiver burden, and health
care expenses. Oncologic clinicians, as a result of their training and focus on the treatment
of cancer, often neither systematically detect nor treat the function and symptom problems
that cause disablement. As a consequence rehabilitation therapies, even those with well
documented evidence of benefit, tend to be under-utilized and provided too late to be
maximally effective. The public health burden of this issue is likely to only worsen given
the improving survival of patients with LSC and the increasing age and medical complexity of
those being treated.
C. STUDY DESIGN AND METHODS Design A randomized controlled trial. Duration Following
enrollment, study participants will remain on the study for 2.5 months after instruction in
their individualized REST program. REST titration and tailoring for participant specific
barriers will occur over the telephone for the 2 week "initiation phase" after initial REST
instruction. Thereafter, patients will perform their REST independently at home during the 8
week "training phase" with "as needed" telephone-based guidance from a PT. We therefore
anticipate that the study will continue for a total of 6 months; 3 months to recruit 68
patients and an additional 2.5 months for all participants to complete initiation and
training phases of the protocol.
Subject Enrollment Identification of participants. A sample of 68 patients with Stage III or
IV NSCLC or Extensive stage SCLC, or Stage IV colon cancer will be identified.
Dr. Cheville will contact eligible patients by telephone after they receive a mailing
describing the study and permitting them to opt out by returning a postage-paid postcard. A
'fold over' postcard will be sent so as to maintain the patient's privacy regarding lung or
colon cancer diagnosis. Dr. Cheville's efforts to contact eligible patients will continue
until 5 attempts have been made on different week days and times of day. Eligibility and
inclusion and exclusion criteria will be assessed. If the patient is eligible, the study will
be described in detail and verbal consent will be obtained from those desiring to
participate. An informed consent form will be mailed to each patient willing to participate
in the study to ensure that they have adequate opportunity to review the document. Informed
consent will be obtained by Dr. Cheville when the patient comes to the Mayo Clinic for study
enrollment. All questions will be answered prior obtaining informed consent.
Eligibility. Eligible subjects must have a diagnosis of Stage III or IV NSCLC or extensive
stage SCLC, or Stage IV colon cancer and be receiving a chemotherapeutic regimen that
requires visits to the Mayo Clinic Department of Medical Oncology < every 4 weeks for the
first 6 weeks following enrollment or undergoing monitoring visits at comparable intervals.
Pathological confirmation is not required if the oncology provider specializing in lung
cancer has a high level of certainty regarding the diagnosis. Entry criteria will not
consider number or location of metastases or prior treatment. The participants will be
required to be fluent in the English language and have intact cognitive status (Folstein
mini-mental score > 25).
Recruitment. Approximately 50 new lung cancer cases are diagnosed each month at the Mayo
Clinic. Of these, about 70% are initially diagnosed with Stage III or Stage IV NSCLC or
Extensive Stage SCLC and 60% elect to receive their cancer-related care at Mayo. Recruitment
rates in our previous work in this population have been high. The proposed intervention
entails greater patient commitment and we anticipate a recruitment rate of 50%. We will
target patients meeting the study criteria who are undergoing ongoing treatment at the MCCC
as well as those who are newly diagnosed. We anticipate a recruitment rate of 10 patients per
month and that recruitment will continue for 3 months. We have not previously recruited
patients with colon cancer, but anticipate recruitment of 10 patients per month based on the
experience of other researchers.
Randomization. Patients will be block randomized to the REST intervention or wait-list
control. Stratified randomization will not be used.
Intervention Overview. The intervention is provision of an individualized, 2-part, 3-tiered
REST program which will include the exercises listed in Table 1 to all participants randomly
assigned to the intervention arm. In addition, participants will receive a step pedometer and
will be encouraged to remain as active as possible during the study period based on objective
feedback from their pedometer readings. A PT specialized in cancer rehabilitation will
instruct participants in REST and will adapt the program to accommodate for symptoms,
co-morbidities, or other issues that may impede a participant's ability to perform the REST
program. The PT will follow up with each participant by telephone at 1- and 2-weeks following
REST instruction to encourage participants and to problem solve regarding any barriers which
may be impeding their performance of REST. After the 2-week initiation phase, participants
will perform REST independently during an 8 week training phase but will be encouraged to
contact the PT with any questions or difficulty. Patient reported outcome (PROs) measures
will be collected at baseline prior to REST instruction and after completion of the 2-month
training phase, as outlined below.
Baseline assessment and REST instruction. Patients will be examined and instructed in their
REST programs on a day when they will be visiting the Mayo clinic either for treatment or
evaluation. REST will not be feasible if it adds to patients' already significant travel
demands. The PI will obtain a functional history and perform a routine physical examination
on all patients to ensure that they may safely participate and to identify impairments or
physical vulnerabilities that will require individualizing their REST program. A tailored
REST fitness program will be developed for each patient by a PT specialized in cancer
rehabilitation. Patients will be provided with upper and lower extremity REST routines (each
requiring 7 minutes) designed to maintain core and appendicular strength with minimal burden.
The REST lower extremity routine will include 6 exercises and will target the hip flexors,
hip abductors, hip extensors, knee extensors, knee flexors, shoulder stabilizers, and back
extensors. The REST upper extremity routine will include 5 exercises and will target the
elbow extensors, elbow flexors, shoulder stabilizers, shoulder flexors, and abdominal
muscles. Each routine can be performed at 1 of 3 intensity levels depending on how
participants feel on a given day. Each of the routines is performed twice per week for a
maximum total of 28 minutes of resistive strengthening per week. The standard REST lower
extremity program is performed in a standing position; however the program can be adapted for
seated performance. Note that the REST program can also be individualized to accommodate
impairments such as degenerative arthritis, back pain and osseous instability.
Subjects will also be dispensed a pedometer and encouraged to wear it daily for the first 2
weeks of their study enrollment in order to establish an average baseline number of steps per
day. Thereafter they will be instructed to wear the pedometer 3 times per week and to chart
the number of steps taken between waking and retiring to bed and encouraged to 'make up' for
days/weeks when fewer steps are taken due to increased symptom burden, post-chemotherapy
fatigue, or other contingency.
Subjects will be provided with laminated cards illustrating their REST program to encourage
their adherence. They will also receive a ring bound monthly calendar with their REST program
illustrated on the top and a calendar on the bottom with designated boxes for number of
pedometer recorded steps per day and to indicate which (if any) tier of the REST program they
completed on a given day. Calendars will be submitted for analysis at the end of the 2 month
study period. Modified laminated cards and calendar pages will be provided if changes in
their health status require alterations of their REST program.
Initiation phase. Participants will be encouraged to perform their upper extremity and lower
extremity REST programs twice per week. After the first week, they will follow up with the
study PT by telephone to address any questions they may have and to address any difficulties
with REST. The PT may adjust their REST program if it proves uncomfortable or overly
fatiguing. Participants will continue to perform the REST program with any modifications for
the second week after training. They will again follow up with the study PT by telephone at
the end of the second week to address any issues. Dr. Cheville will serve as resource for the
study PT during the initiation phase in case he/she has any questions regarding symptom
control or the safety of REST.
Training phase. Following the initiation phase the participants will continue to perform
their REST programs 4 times per week (2 upper and 2 lower extremity) for 8 weeks. While no
follow up telephone calls will be scheduled with the study PT, participants will be
encouraged to contact the PT with any questions or difficulties. The PT will consult Dr.
Cheville on an as needed basis.
Data Collection Patient-Reported Outcome (PRO) Measures. Baseline PROs will be collected
after subjects sign informed consent, following randomization and, for intervention group
members, before the PTs instruct them in the REST exercises. Week 10 PROs will be mailed to
the patients with a postage paid return envelope. Participants who do not respond in the
first week will be sent a second mailing. Subjects will receive $25.00 compensation for
completing each set of PROs, for a total of $50.00.
Ambulatory Post Acute Care Basic Mobility and Daily Activity Short Forms FACIT-F Outcome
Expectations for Exercise Self Efficacy for Exercise North Central Cancer Trials Group
Patient Quality of Life-Linear Analogue Self Assessment (LASA) Scale. The LASA Scale is a
single item measurement of global quality of life rating on a numerical rating scale from 0
to 10 with well established validity data in cancer populations.38 Other Treatments.
Oncological care will be not affected by this study: subjects will continue to make their
routine clinic visits and receive oncological cares as usual. Analgesic medications will be
permitted (and assessed), to adjust for co-intervention differences between groups in the
analyses.
STATISTICAL ANALYSIS Descriptive statistics will be calculated for participants' demographic
and lung cancer-related characteristics, as well as their function- and symptom-related PROs.
Descriptive statistics will also be calculated for the data collected by the study PT
regarding the frequency of specific problems (e.g. shoulder pain with REST) encountered
during the initiation phase, as well as the number of calls per participant during the
training phase, time per call, and reasons for these calls.
Data collected from patients' calendar records of REST adherence and steps per day will be
described in terms of proportions and means, respectively. An arbitrary threshold of 75% will
be used to distinguish participants who did and did not adhere to the recommended 4 sessions
per week. Participants who did not perform their REST program 4 times per week for at least 6
of the 8 weeks during the training phase will be considered non-adherent. Exploratory
analyses of significant differences between participants that did and did not adhere will be
performed with nonparametric testing.
The normality of the PROs will be assessed by testing of skew and kurtosis. Nonparametric
statistical tests will be used to evaluate PROs that are not normally distributed. Student's
paired T-test will be used to estimate the effect of the intervention on primary and
secondary outcomes. Additionally, the Wilcoxon rank sum test will be used to compare the
degree of change in these scores between patients randomized to the intervention group who
did and did not comply with REST. The magnitude and directions of the relationships between
change in mean steps per day during the training interval (calculated as mean from week 10
minus mean from baseline) and changes in PRO scores will be assessed with Pearson correlation
coefficients. Given the pilot nature of this work, adjustments will not be made for multiple
comparisons.
