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Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"

"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 7 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "PANCREATIC CANCER STUDY (PCS): Patients receive post-surgical wellness program consisting of physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and self-reported data) for up to 7 months post-op."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether measured physical activity is linked to how doctors rate daily function and how long people with advanced cancer live. It has several groups for people with different cancers, with different rules for each group.

The main goal of this phase of the study is to determine if objectively assessed Physical Activity (PA) levels in advanced-cancer patients are associated with health care provider (HCP)-assessed ECOG performance status and overall survival. The purpose is to advance the evidence-base for incorporating objective assessment of Physical Activity (PA) in the context of performance status assessment in advanced cancer patients.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Arm 1: Have colon or rectal cancer at stage 1–4, or cancer that came back. Have an ECOG daily function score of 0–2, or be up more than half of waking hours and able to care for yourself.
  • Arms 2 and 3: Have certain head or neck cancers. The allowed stages depend on the cancer site; some other head or neck cancers need approval from a study radiation doctor.
  • Arm 4: Have a history of cancer other than non-melanoma skin cancer. Be a current smoker or recent quitter when admitted to MD Anderson. Have a valid home address and working home phone.
  • Pre-pilot and Arms 1–4: Be able to speak, read, and write English and give informed consent, meaning you understand and agree to join.
  • Pre-pilot: Live in Harris County or a nearby county. Arms 1–4: Live or stay in Houston or the surrounding area during the study.
  • PCS group: Be scheduled for surgery meant to cure a pancreatic tumor or remove a pancreatic cyst, which may or may not be cancer.
  • PCS group: Speak English fluently, be able to give informed consent, have phone access, and agree to phone calls with study staff.
  • TAPS group: Be 18 or older and speak English fluently. Have a solid tumor that has spread or cannot be removed where it started. Have an ECOG daily function score of 0–3.

Who can't join

  • Arms 1 and 4: Major surgery in the past 8 weeks. Pre-pilot and Arms 1–3: High blood pressure that is not being watched or managed by a doctor.
  • Arms 1–4 and TAPS: Clear confusion about the time, who you are, or where you are. Pre-pilot and Arm 2: A bone, muscle, or nerve problem that prevents standing on a scale.
  • Arms 2 and 3: Not receiving radiation for an allowed cancer, or receiving treatment for another cancer except non-melanoma skin cancer. Also excluded: a Zubrod daily function score above 2, being up no more than half of waking hours, or being unable to care for yourself.
  • Arm 3: Current trouble swallowing in the mouth or throat that is not caused by cancer. Arm 4: An active substance use disorder that is diagnosed or strongly suspected.
  • PCS: Already enrolled in study 2014-0712 or 2017-0198, or no home internet or WiFi.
  • PCS: The doctor finds a high risk that surgery will not help treat the cancer. Unstable heart or lung disease, or heart disease with symptoms rated class III or IV, also excludes you.
  • PCS: A recent broken bone or injury that prevents putting full weight on all four limbs for exercise; a muscle or rheumatic disease that limits movement; or poorly controlled pain rated 7 out of 10 when joining.
  • PCS: A pacemaker or another medical device inside your body, or reporting that you are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Diagnosis of any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm 1) * Able to speak, read, and write in English (Pre-pilot phase, Arms 1-4) * Able to provide informed consent (Pre-pilot phase, Arms 1-4, PCS study) * Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase) * Eastern Cooperative Oncology Group (ECOG) status of 0 - 2, or self-reports being up and about more than 50% of waking hours and able to provide self-care (Arm 1) * Diagnosis of any of the following cancers: stage 1-4b oropharyngeal, hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b laryngeal; any unknown primary head and neck cancer with cervical metastasis that will be addressed with treatment to bilateral necks and mucosa; or other head and neck cancers medically approved by one of our Radiation Oncology collaborating medical doctors (MDs) (Arms 2 and 3) * History of any cancer, other than non-melanoma skin cancer (Arm 4) * Admitted to being a current smoker or recent quitter upon admission to MD Anderson Cancer Center (MDACC) (Arm 4) * Has a valid home address and functioning home telephone number (Arm 4) * Lives in the Houston or surrounding area, or resides in this same area during the time period that coincides with this study (Arms 1-4) * Patients who will undergo curative pancreatectomy for pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, or pancreatic cysts (malignant or benign) (PCS study) * Fluent in English (PCS study) * Must have telephone access and agree to engage with research personnel using telephone (PCS study) * Diagnosis of a metastatic or locally unresectable solid tumor (TAPS study) * Fluent in English (TAPS study) * Age 18 years or older (TAPS study) * ECOG performance status score between 0-3 (TAPS study) Exclusion Criteria: * Major surgery in the past 8 weeks (Arms 1 and 4) * Self-reports hypertension that is not being monitored by a physician and is not being managed with either medication, observation, or lifestyle change (Pre-pilot phase, Arms 1-3) * Overt cognitive difficulty demonstrated by not being clearly oriented to time or person or place (Arms 1-4) * Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale (Pre-pilot phase, Arm 2) * Not currently receiving radiation treatment for a cancer listed in the arm-specific inclusion criteria (Arms 2 and 3) * Zubrod performance status \> 2, or self-reports either not being up and about more than 50% of waking hours or unable to provide self-care (Arms 2 and 3) * Currently receiving treatment for a cancer other than those listed in the arm-specific inclusion criteria (exception: the study does not exclude those receiving treatment for non-melanoma skin cancer) (Arms 2 and 3) * History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder) (Arm 3 only) * Active substance use disorder (diagnosed or strongly suspected) (Arm 4) * Currently enrolled in protocol 2014-0712 (PCS study) * No home access to internet (PCS study) * No home WiFi connection (PCS study) * During clinician's pre-surgical evaluation, presents with high risk for non-therapeutic resection related to cancer diagnosis (PCS study) * Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) (PCS study) * Recent fracture or acute musculoskeletal injury that precludes the ability to fully bear weight on all 4 limbs in order to participate in an exercise intervention (PCS study) * Poorly-controlled pain with a self-reported pain score of 7/10 at the time of enrollment (PCS study) * Myopathic or rheumatologic disease that impacts physical function (PCS study) * Has a pacemaker or other internal medical device, or reports being pregnant (PCS study) * Currently enrolled in protocol 2017-0198 (PCS study) * Demonstration of overt cognitive difficulty as demonstrated by not being clearly oriented to time or person or place (TAPS study)

Study sites (1)

TX