Rehabilitation Outcomes Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
This pilot health services interventional study aims to prospectively assess the effectiveness of a pre-treatment rehabilitation (prehabilitation) program across a diverse cohort of adult cancer patients via a randomized pilot trial. Upon screening and identification of high-risk features through a central navigation process, patients referred to oncology clinics will be approached to participate in tailored prehabilitation interventions. The study will track and analyze functional outcomes and quality of life aiming to demonstrate the comprehensive benefits of prehabilitation on the cancer treatment continuum. We hypothesize that this referral program is feasible and that those randomized to the intervention arm will have superior functional outcomes and global health-related quality of life.
The rationale for this study is anchored in the urgent need to optimize the cancer care trajectory for high-risk patients whose treatment outcomes and quality of life are jeopardized by the multifaceted challenges of their disease. While prehabilitation has shown potential to mitigate these adverse effects, the optimal methods for identifying and connecting these high-risk individuals to appropriate prehabilitation resources remain underexplored. This study, with its systematic approach to enrolling a diverse adult cancer population, endeavors to investigate not only the benefits of prehabilitation interventions but also the effectiveness of a targeted referral process. By doing so, it aims to uncover novel strategies for efficiently allocating prehabilitation resources, thereby enhancing the precision and impact of supportive cancer care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
Subjects are willing and able to comply with study procedures based on the judgement of the investigator.
Age ≥ 18 years at the time of consent.
The subject has been screened by the Central Oncology Navigation Program and referred to cancer care at the University of North Carolina Medical Center.
Disqualifiers
Inability to read and understand the English language.
Psychological or other disability resulting in the inability to provide informed consent.
Unstable medical comorbidity that precludes safe participation in an exercise program, in the judgment of the clinical investigator.
Prisoners and other institutionalized individuals.
Trial design
Design model
Parallel
Treatments tested in this trial
Rehabilitation-based intervention
Other interventionAssessment of the subject by a specialty consultation and exercise program development.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: StandardNo intervention 0 interventions
Group B: RehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of rehabilitation interventions accepted
The proportion of pre-treatment rehabilitation intervention performed for patients who are referred to cancer rehabilitation and attend an initial appointment.
Time frame
BaselineSecondary outcomes
1
Satisfaction rate
Acceptability in the subjects randomized to the intervention arm will be defined by the proportion of participants who report being "Neutral," \& amp;#34; "Satisfied\& amp;#34;" or \& amp;#34;"Very Satisfied"\& amp;#34; with the intervention utilizing the Experience with the Rehabilitation Program questionnaire. The questionnaire has 8 questions measured on a 5-point Likert scale: Not Effective At All=0, Slightly Effective=1, Moderately Effective=2, Very Effective =3, Extremely Effective =4. Minimum score= 0, maximum score=32.
Time frame
Baseline and post-3 months2
Differences in physical function
Differences in physical function in the cancer rehabilitation arm and standard of care arm will be determined using PROMIS Short Form v2.0 Physical Function 4a. The PROMIS Short Form v2.0 - Physical Function 4a is a self-reported measure designed to assess an individual's capability to perform physical activities rather than their actual performance. The form consists of 4 items, each rated on a 5-point Likert scale ranging from "Without any difficulty" to "Unable to do." The scores are then summed to provide a total score, which can be converted to a T-score for standardized interpretation. The T-score has a mean (average) of 50 and a standard deviation of 10. A higher T-score indicates better physical function. Conversely, a lower T-score indicates poorer physical function.
Time frame
Baseline and post-3 months3
Differences in participant activation
Differences in participant activation in the cancer rehabilitation arm and standard of care arm will be determined using Patient Activation Measure (PAM) 10 (Patient Activation Measure 10) scores. The Patient Activation Measure (PAM) 10 is a validated questionnaire designed to assess an individual's knowledge, skills, and confidence in managing their own health and healthcare. It consists of 10 items that measure patient activation, which is the extent to which individuals feel capable of managing their health. The PAM 10 includes 10 statements that respondents rate based on their level of agreement, ranging from "Strongly Disagree" to "Strongly Agree." Responses are scored on a scale from 0 to 100. Higher scores indicate greater patient activation.
Time frame
Baseline and post-3 months4
Differences in overall health
Differences in overall health in the cancer rehabilitation arm and standard of care arm will be determined using PROMIS Global Health (PROMIS Scale v1.2 Global Health) scores. The PROMIS Global Health (PROMIS Scale v1.2 Global Health) is a comprehensive tool designed to assess an individual's overall physical, mental, and social health. The PROMIS Global Health v1.2 includes 10 items that cover various health domains. These items are divided into two main components: Global Physical Health and Global Mental Health. Global Physical Health: This includes items related to physical functioning, pain, fatigue, and overall physical health. Global Mental Health: This includes items related to mental health, emotional distress, and social health.Response Options: Each item is rated on a 5-point Likert scale, with higher scores indicating better health.Raw Scores: The responses are summed to create raw scores for both the Global Physical Health and Global Mental Health components. T-Scores: Th
Time frame
Baseline and post-3 monthsSponsors and contacts
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Source ClinicalTrials.gov