Intervention to Motivate Standing &Walking in Gastrointestinal Cancer Surgical Patients
| Status: | Completed |
|---|---|
| Conditions: | Vaccines |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/24/2019 |
| Start Date: | October 2013 |
| End Date: | December 2018 |
Observational research has linked physical activity with faster recovery, improved quality of
life, and greater survival; however, little is known about the effects of physical activity
in pre-operative, peri-operative, or post-operative treatment contexts and there is a need
for interventions to improve patient outcomes across the cancer treatment continuum. Three
propositions derived from basic research, epidemiological evidence, and clinical practice
informed our intervention development efforts: (1) Patient outcomes will be enhanced by
interventions that increase physical activity (i.e., standing, walking) across the cancer
treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2) Reducing
sedentary behavior (i.e., seated or reclined activities involving minimal energy expenditure)
will enhance patient outcomes both by increasing physical activity and by stimulating
additional adaptive physiological responses to reduced sedentary time (responses which are
independent of physical activity-induced responses). (3) Patients with gastrointestinal
cancers often suffer functional limitations that limit their independence and their health
behaviors are strongly influenced by the family environment so interventions that engage
caregivers (e.g., spouses) will be more effective than those that target patients/survivors
alone.
life, and greater survival; however, little is known about the effects of physical activity
in pre-operative, peri-operative, or post-operative treatment contexts and there is a need
for interventions to improve patient outcomes across the cancer treatment continuum. Three
propositions derived from basic research, epidemiological evidence, and clinical practice
informed our intervention development efforts: (1) Patient outcomes will be enhanced by
interventions that increase physical activity (i.e., standing, walking) across the cancer
treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2) Reducing
sedentary behavior (i.e., seated or reclined activities involving minimal energy expenditure)
will enhance patient outcomes both by increasing physical activity and by stimulating
additional adaptive physiological responses to reduced sedentary time (responses which are
independent of physical activity-induced responses). (3) Patients with gastrointestinal
cancers often suffer functional limitations that limit their independence and their health
behaviors are strongly influenced by the family environment so interventions that engage
caregivers (e.g., spouses) will be more effective than those that target patients/survivors
alone.
Phase 1 Screening and Baseline Assessment in Clinic Patients will be recruited by their
physician upon diagnosis and immediately after the Penn State Surgical Oncology team presents
then with the surgical treatment option. The patient must be able to identify an adult
caregiver. The caregiver must be someone who is willing to participate in the study for the
intervention period.
Once enrolled by the research assistant, the participant will complete an intake
questionnaire to capture demographic information. The participant will then be given a tablet
computer, training on how to use it to complete the questionnaires at the beginning and end
of each day, an activity monitor with materials for securing it, and training on how/where to
affix it on the leg.
In this study, we will use educational materials delivered at the initial enrollment session
and in daily "facts of the day" presented electronically to heighten awareness of (1) the
risks of insufficient physical activity and excessive sedentary behavior, and (2) the
expected beneficial outcomes of increased physical activity and reduced sedentary behavior.
These messages should are designed to increase intentions to engage in physical activity and
to limit sedentary behavior (motivational phase). Although intentions are necessary for
behavior change, a recent review of experimental evidence indicates that they are not
sufficient. In the volitional phase, people translate those intentions into action by
developing actions plans that specify when/where/how they will act (e.g., after lunch I will
go on a 30 min walk around my neighborhood) and coping plans that specify how they will
overcome anticipated barriers to desired behavior (e.g., if it rains after lunch, I will go
to the mall to walk for 30 min). Repeated planning of this nature is the basis for breaking
existing behavioral habits and forming newer (and hopefully more adaptive) ones. We have
already developed an electronic daily planning tool that can be used at the beginning of each
day to form action and coping plans for the target behaviors in this intervention. In the
first two months of this project, we will tailor this existing planning tool for the target
population by drawing from existing and emerging research on strategies for and barriers to
health behaviors among cancer patients.
The control group will not receive the educational or daily planning components of the
motivational intervention. They will, however, engage in self-monitoring by virtue of wearing
activity monitors and using tablet computers to provide self-report data on their physical
activity and sedentary behavior.
After the patient's surgery while staying at the Penn State Hershey Medical Center, the study
coordinator will provide the caregiver with behavioral goals to help the patient recover from
his/her surgery, and additional information about how the caregiver can support the patient's
behavior change efforts.
Phase 2: Intervention Period
For the duration of the study, participant will:
- Complete beginning-and end -of-day questionnaires on the tablet computer. The beginning
of day questionnaire will evaluate the patient's intentions and plans for daily physical
activity. The end of day questionnaire will evaluate actual physical activity completed
daily as well as the patient's physical, emotional, and social well-being.
- Wear and activity monitor
For participants in the experimental group the research assistant will also:
- Deliver the educational intervention for patients and caregivers during their first
visit after they have signed the consent forms.
- Train patients how to use the daily planning tool prior to the beginning -of- day prior
to the beginning-of-day questionnaires.
The theoretical basis for our intervention draws from both social-cognitive theory (i.e.,
Health Action Process Approach [HAPA]) and self-determination theory. The Health Action
Process Approach differentiates between motivational and volitional phases of action control.
In the motivational phase, people form intentions or goals for their behavior based on
factors such as risk awareness and outcome expectations. In this study, we will use
educational materials delivered at the initial enrollment session and in daily "facts of the
day" presented electronically to heighten awareness of (1) the risks of insufficient physical
activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of
increased physical activity and reduced sedentary behavior. These messages should are
designed to increase intentions to engage in physical activity and to limit sedentary
behavior (motivational phase). Although intentions are necessary for behavior change, a
recent review of experimental evidence indicates that they are not sufficient. In the
volitional phase, people translate those intentions into action by developing actions plans
that specify when/where/how they will act (e.g., after lunch I will go on a 30 min walk
around my neighborhood) and coping plans that specify how they will overcome anticipated
barriers to desired behavior (e.g., if it rains after lunch, I will go to the mall to walk
for 30 min). Repeated planning of this nature is the basis for breaking existing behavioral
habits and forming newer (and hopefully more adaptive) ones. We have already developed an
electronic daily planning tool that can be used at the beginning of each day to form action
and coping plans for the target behaviors in this intervention. In the first two months of
this project, we will tailor this existing planning tool for the target population by drawing
from existing and emerging research on strategies for and barriers to health behaviors among
cancer patients.
Self-determination theory posits that social factors, such as family relationships, can also
influence motivation. Our recent work using experience sampling methodology and accelerometry
has shown that spouses' autonomy support for patient physical activity and the spouse's level
of physical activity were associated with patients' greater daily moderate physical activity
and steps taken Individuals whose family members or health care providers show autonomy
support for increasing physical activity and decreasing sedentary behavior are more likely to
make those changes for reasons that come from within themselves and are freely chosen.
Because close family members influence the emotional and physical well-being of patients,
their inclusion in behavioral interventions is logical and has the potential to boost the
effects of those interventions. In this study, caregivers will be educated about the
importance of autonomy support in behavior change and strategies for supporting their
partner's autonomy around physical activity and sedentary behavior change across the stages
of treatment. This education will be delivered by the nurse coordinator at the initial
education session following enrollment.
Collectively, these three components of patient education, daily planning, and caregiver
education were assembled to strengthen intentions for desired health behaviors (motivational
phase of behavior change), to increase the likelihood that such intentions will translate
into action (volitional phase of behavior change), and to provide social resources that
support behavior change in both of those phases.
The control group will not receive the educational or daily planning components of the
motivational intervention. They will, however, engage in self-monitoring by virtue of wearing
activity monitors and using tablet computers to provide self-report data on their physical
activity and sedentary behavior.
During the intervention period the study coordinator will also contact the patient via phone
weekly to ask questions related to the patients safety including questions about frequency of
falls mild/moderate/severe, chest pain, dizziness, musculoskeletal soreness or pain, and
changes in swelling.
Phase 3: Follow-Up Telephone Call
The research assistant will call the participant 30, 60, and 90 days after surgery to assess
the frequency of hospital readmission or emergency room visits since being discharged.
Phase 4: Follow- Up Questionnaire
21 days after discharge form the hospital, participants and caregivers will complete a brief
questionnaire that we will mail to them with a self-addressed stamped envelope.
physician upon diagnosis and immediately after the Penn State Surgical Oncology team presents
then with the surgical treatment option. The patient must be able to identify an adult
caregiver. The caregiver must be someone who is willing to participate in the study for the
intervention period.
Once enrolled by the research assistant, the participant will complete an intake
questionnaire to capture demographic information. The participant will then be given a tablet
computer, training on how to use it to complete the questionnaires at the beginning and end
of each day, an activity monitor with materials for securing it, and training on how/where to
affix it on the leg.
In this study, we will use educational materials delivered at the initial enrollment session
and in daily "facts of the day" presented electronically to heighten awareness of (1) the
risks of insufficient physical activity and excessive sedentary behavior, and (2) the
expected beneficial outcomes of increased physical activity and reduced sedentary behavior.
These messages should are designed to increase intentions to engage in physical activity and
to limit sedentary behavior (motivational phase). Although intentions are necessary for
behavior change, a recent review of experimental evidence indicates that they are not
sufficient. In the volitional phase, people translate those intentions into action by
developing actions plans that specify when/where/how they will act (e.g., after lunch I will
go on a 30 min walk around my neighborhood) and coping plans that specify how they will
overcome anticipated barriers to desired behavior (e.g., if it rains after lunch, I will go
to the mall to walk for 30 min). Repeated planning of this nature is the basis for breaking
existing behavioral habits and forming newer (and hopefully more adaptive) ones. We have
already developed an electronic daily planning tool that can be used at the beginning of each
day to form action and coping plans for the target behaviors in this intervention. In the
first two months of this project, we will tailor this existing planning tool for the target
population by drawing from existing and emerging research on strategies for and barriers to
health behaviors among cancer patients.
The control group will not receive the educational or daily planning components of the
motivational intervention. They will, however, engage in self-monitoring by virtue of wearing
activity monitors and using tablet computers to provide self-report data on their physical
activity and sedentary behavior.
After the patient's surgery while staying at the Penn State Hershey Medical Center, the study
coordinator will provide the caregiver with behavioral goals to help the patient recover from
his/her surgery, and additional information about how the caregiver can support the patient's
behavior change efforts.
Phase 2: Intervention Period
For the duration of the study, participant will:
- Complete beginning-and end -of-day questionnaires on the tablet computer. The beginning
of day questionnaire will evaluate the patient's intentions and plans for daily physical
activity. The end of day questionnaire will evaluate actual physical activity completed
daily as well as the patient's physical, emotional, and social well-being.
- Wear and activity monitor
For participants in the experimental group the research assistant will also:
- Deliver the educational intervention for patients and caregivers during their first
visit after they have signed the consent forms.
- Train patients how to use the daily planning tool prior to the beginning -of- day prior
to the beginning-of-day questionnaires.
The theoretical basis for our intervention draws from both social-cognitive theory (i.e.,
Health Action Process Approach [HAPA]) and self-determination theory. The Health Action
Process Approach differentiates between motivational and volitional phases of action control.
In the motivational phase, people form intentions or goals for their behavior based on
factors such as risk awareness and outcome expectations. In this study, we will use
educational materials delivered at the initial enrollment session and in daily "facts of the
day" presented electronically to heighten awareness of (1) the risks of insufficient physical
activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of
increased physical activity and reduced sedentary behavior. These messages should are
designed to increase intentions to engage in physical activity and to limit sedentary
behavior (motivational phase). Although intentions are necessary for behavior change, a
recent review of experimental evidence indicates that they are not sufficient. In the
volitional phase, people translate those intentions into action by developing actions plans
that specify when/where/how they will act (e.g., after lunch I will go on a 30 min walk
around my neighborhood) and coping plans that specify how they will overcome anticipated
barriers to desired behavior (e.g., if it rains after lunch, I will go to the mall to walk
for 30 min). Repeated planning of this nature is the basis for breaking existing behavioral
habits and forming newer (and hopefully more adaptive) ones. We have already developed an
electronic daily planning tool that can be used at the beginning of each day to form action
and coping plans for the target behaviors in this intervention. In the first two months of
this project, we will tailor this existing planning tool for the target population by drawing
from existing and emerging research on strategies for and barriers to health behaviors among
cancer patients.
Self-determination theory posits that social factors, such as family relationships, can also
influence motivation. Our recent work using experience sampling methodology and accelerometry
has shown that spouses' autonomy support for patient physical activity and the spouse's level
of physical activity were associated with patients' greater daily moderate physical activity
and steps taken Individuals whose family members or health care providers show autonomy
support for increasing physical activity and decreasing sedentary behavior are more likely to
make those changes for reasons that come from within themselves and are freely chosen.
Because close family members influence the emotional and physical well-being of patients,
their inclusion in behavioral interventions is logical and has the potential to boost the
effects of those interventions. In this study, caregivers will be educated about the
importance of autonomy support in behavior change and strategies for supporting their
partner's autonomy around physical activity and sedentary behavior change across the stages
of treatment. This education will be delivered by the nurse coordinator at the initial
education session following enrollment.
Collectively, these three components of patient education, daily planning, and caregiver
education were assembled to strengthen intentions for desired health behaviors (motivational
phase of behavior change), to increase the likelihood that such intentions will translate
into action (volitional phase of behavior change), and to provide social resources that
support behavior change in both of those phases.
The control group will not receive the educational or daily planning components of the
motivational intervention. They will, however, engage in self-monitoring by virtue of wearing
activity monitors and using tablet computers to provide self-report data on their physical
activity and sedentary behavior.
During the intervention period the study coordinator will also contact the patient via phone
weekly to ask questions related to the patients safety including questions about frequency of
falls mild/moderate/severe, chest pain, dizziness, musculoskeletal soreness or pain, and
changes in swelling.
Phase 3: Follow-Up Telephone Call
The research assistant will call the participant 30, 60, and 90 days after surgery to assess
the frequency of hospital readmission or emergency room visits since being discharged.
Phase 4: Follow- Up Questionnaire
21 days after discharge form the hospital, participants and caregivers will complete a brief
questionnaire that we will mail to them with a self-addressed stamped envelope.
Inclusion Criteria:
- Diagnosis of gastrointestinal tract cancer (hepatobiliary) requiring surgical
resection. for treatment
- Failing to meet the aerobic component of national physical activity guidelines over
past week (e.g., < 150 min moderate-intensity physical activity or < 75 min
vigorous-intensity physical activity).
- Excessive sedentary behavior over the past week (> 8 hrs/day sitting).
- Minimum age 18 years.
- A spouse or adult child serving as a caregiver who is also willing to participate.
Exclusion Criteria:
- Functional limitations that preclude normal physical activity.
- Patients who will be scheduled for surgery < 10 days after their clinic visit.
- Medical contraindications to physical activity.
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