Clinical trial NCT06749938: Holistic Intervention for Cancer Survivors
Official title: A Holistic Intervention Approach to Maximize Quality of Life for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: yoga
cancer survivorship
functionality
quality of life
aging
mobility
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There are many components to defining a cancer survivor's true quality of life. Quality of life (QOL) can be conceptualized as the maximum realization of an individual's potential outcomes of the physical, mental and spiritual aspects defining a human being. These levels of optimization are often limited within certain bounds by a survivor's medical history such as the cancer experience; functional capacities; dietary choices, connectedness and cognitive processing, e.g. perceptions about life situations such as stressors. Often, in intervention studies and within traditional Western medicine practice, focus on optimizing outcomes for cancer survivors is often "siloed", overly focusing on only one aspect of QOL and not accounting for improving other equally important aspects of QOL. A holistic approach, tailored to the unique aspects for that particular survivor, is needed to maximize the individuals overall QOL. Precision scientific data needs to be collected, as well as the cancer survivor's self-report perceptions (qualitative) to truly understand the individual's level of QOL. Thus, both quantitative and qualitative approaches are needed within a holistic approach.

Many interventions' impact wanes when complete. Often those individuals that participated revert to previous maladaptive health behaviors. This can occur partly from a lack of a sense of ownership. Therefore, a holistic, structured approach is urgently needed, presented in a manner to enhance individual efficacy that enhances ownership. Strategies should also engage the expanded cancer survivor community thereby improving the health of the general cancer population, helping reduce existing cancer-related health disparities, and eliminating unnecessary costs on an already seriously strained public health system.

Here the investigators propose a 16-week pilot project to prove the feasibility and initial efficacy of such a holistic approach to optimize outcomes for the physical, mental and spiritual aspects of QOL as measured with standard instrumentation and qualitative self-report for 30 adult cancer survivors in the San Antonio, Texas area. The investigators will conduct pre, post and a six-month follow-up assessment for QOL.

Detailed description: Here the investigators propose a pilot project to prove the concept and effectiveness of a holistic approach to optimize outcomes for physical, mental and spiritual aspects of QOL as measured with standard instrumentation and with qualitative self-report for 30 cancer survivors in the greater San Antonio, Texas area. The study team will achieve this urgently needed intervention by realization of the following three specific aims:

Specific Aim #1. Successfully engaging n=30 cancer survivors to complete a 16-week pilot intervention. The intervention will include a yoga-based regimen including meditation, an aerobic exercise program, diet improvement guidance coupled with psycho-social support text messaging based in Social Cognitive Theory to increase efficacy to promote health enhancing behaviors. For physical, mental and spiritual functioning outcome variables the study team will run a dependent -sample 't' test. For mental, spiritual outcome variables, single-systems analyses, will also be used to assess overall impact for each individual survivor as well as for the overall group as calculated in effect size. In addition, qualitative analyses from the survivor's self-reported perceptions of their levels of QOL will be analyzed using theme recognition. Investigators hypothesize that physical functioning will improve significantly (p\< 0.05) and for the mental and spiritual primary outcome variables will result in at least a medium effect (d\> 0.5) for the 30 cancer survivors when aggregated as a group.

Specific Aim #2. Demonstrating the feasibility that such an intervention can be implemented safely and cost-effectively for the cancer survivorship community. The study team will assess feasibility, by monitoring/recording all unexpected outcomes, adverse events, protocol deviations and compliance. Based on previous exercises studies the study team have completed, they hypothesize at least 90% compliance to the program coupled with no adverse events and will use these benchmarks by which to assess feasibility for the pilot.

Moreover, the study team will also record the total cost to deliver the intervention for the program and relate the cost back to benefit derived with metrics calculations for specific gains in physical, mental, and spiritual outcomes as well as an aggregate metric for overall QOL. Because the study team will be tabulating total cost, beyond just funded dollars, there is no set benchmark for feasibility but just offer the information as a metric for understanding true cost for a holistic approach.

Specific Aim #3. Monitoring the long-term impact for the survivors that complete the pilot for one six months after the 16-week intervention. The study team hypothesize that long term QOL outcomes will not change significantly as determined both by analyses of variance for physical functioning and single system analyses for the mental and spiritual measures from the time they complete the 16 weeks. Based on previous behavioral studies completed, the study team expect no more than 10% attrition to follow-up.

Eligibility criteria: Inclusion Criteria:

* Have been given a diagnosis of any cancer in their lifetime; (active treatment or post treatment; but must be post diagnosis). (Even though the participant may be currently under treatment and limited in functionality, they will be included in the study as this pilot intervention is specifically intended to include any level of functionality, using a an individually designed program for optimizing outcome.)
* Have access or use of a mobile phone or computer to complete surveys and respond to text messages.
* Be able to speak understand English or Spanish.
* Oriented to time and place.

Exclusion Criteria:

* Currently enrolled in a competing protocol.
* Participants will be excluded it they present with any absolute contraindication to exercise testing as detailed by the American College of Sports Medicine Guidelines on Exercise Testing and Exercise Prescription 52. Specifically:
* Known significant change in the resting ECG suggesting significant ischemia.
* Recent myocardial infarction (within 2 days).
* Unstable angina.
* Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.
* Severe symptomatic aortic stenosis.
* Uncontrolled symptomatic heart failure.
* Acute pulmonary embolus or pulmonary infarction.
* Acute myocarditis or pericarditis .
* Suspected or known dissecting aneurysm.

Primary outcomes:
measure: Co-Morbidity Index
timeFrame: Weeks "0" and "16"
measure: Motivational Style Profile
timeFrame: Weeks "0" and "16"
measure: Quality of life (Medical Outcomes Short Form-36 (SF-36))
timeFrame: Weeks "0" and "16"
measure: Level of pain
timeFrame: Weeks "0" and "16"
measure: Non-Exercise Fitness Test
timeFrame: Weeks "0" and "16"
measure: Sleep Quality
timeFrame: Weeks "0" and "16"
measure: Perceived Stress
timeFrame: Weeks "0" and "16"
measure: Spiritual Well-being
timeFrame: Weeks "0" and "16"
measure: Exercise Barriers
timeFrame: Weeks "0" and "16"
measure: Modeling of Exercise
timeFrame: Weeks "0" and "16"
measure: Exercise Self-Efficacy
timeFrame: Weeks "0" and "16"
measure: Family support for exercise
timeFrame: Weeks "0" and "16"
measure: Social support for exercise from peers
timeFrame: Weeks "0" and "16"
measure: Self-Identification as an Exerciser
timeFrame: Weeks "0" and "16"
measure: Body Image Scale
timeFrame: Weeks "0" and "16"
measure: Hope Scale
timeFrame: Weeks "0" and "16"
measure: Personal Meaningful Profile
timeFrame: Weeks "0" and "16"
measure: Psychological distress and symptoms Inventory
timeFrame: Weeks "0" and "16"
measure: Depression Scale
timeFrame: Weeks "0" and "16"
measure: Six-minute walk test (6MWT)
timeFrame: Weeks "0" and "16"
measure: Balance
timeFrame: Weeks "0" and "16"
measure: Muscle strength
timeFrame: Weeks "0" and "16"
measure: Sit and reach test
timeFrame: Weeks "0" and "16"
measure: Plasma concentration of inflammatory markers
timeFrame: Weeks "0" and "16"
measure: Real-time physical activity
timeFrame: Weeks "0" and "16"
Secondary outcomes:
Other outcomes:
measure: Demographics
timeFrame: Weeks "0" and "16"
Locations:
city: San Antonio
country: United States
facility: Institute for Health Promotion Research
state: Texas
Study officials:
References: