Yoga Program for Non-Small Cell Lung Cancer

Overseen By Kathrin Milbury, MA,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive deficits, Exercise contraindications, Yoga participation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app-based yoga program for individuals with non-small cell lung cancer undergoing chest radiation therapy and their caregivers. The researchers aim to determine if the program is user-friendly, feasible, and acceptable to participants. It targets those diagnosed with non-small cell lung or esophageal cancer who are about to begin a specific type of radiation treatment. Participants should have a caregiver, such as a spouse or adult child, who will also participate. Both the patient and caregiver must have regular internet access and should not already practice yoga regularly. As an unphased trial, this study provides a unique opportunity to explore innovative supportive care options during treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this yoga program is safe for participants undergoing thoracic RT?

Research has shown that the Dyadic Yoga Program is generally safe for participants. In various studies, individuals with non-small cell lung cancer and their caregivers used this yoga program without encountering major safety issues. The findings suggest that yoga can support care by improving physical abilities and quality of life. These studies reported no significant harmful effects, indicating the program's safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dyadic Yoga Program for non-small cell lung cancer because it offers a holistic approach that complements traditional treatments like surgery, chemotherapy, and radiation therapy. Unlike typical treatments that focus solely on targeting cancer cells, this yoga program aims to improve patients' overall well-being, potentially enhancing physical and mental health. Additionally, the social aspect of a dyadic program, where participants engage with a partner, could offer emotional support and motivation, which is often lacking in conventional treatments.

What evidence suggests that this yoga program is effective for non-small cell lung cancer?

Research has shown that dyadic yoga can improve life for people with non-small cell lung cancer. Participants in this trial will practice this type of yoga with a caregiver, which can enhance mobility, reduce fatigue, and improve sleep. It also appears to lessen depression and boost overall well-being. In some studies, patients who practiced yoga reported feeling better than those who did not. These early results suggest that dyadic yoga could complement regular cancer treatments effectively. ^{1 2 6 7 8}

Who Is on the Research Team?

Kathrin Milbury, MA,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with Non-Small Cell Lung Cancer undergoing thoracic radiotherapy and their caregivers. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to ensure safety.

Inclusion Criteria

I and my caregiver are both over 18.

Both patient and caregiver must have regular access to Wifi/High speed internet access

Have a family caregiver willing to participate

Exclusion Criteria

Experiences cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist

Participants who participated in part 1 are ineligible to participate in part 2 of this protocol.

Experiences contraindications to exercise as determined by the clinical team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Usability Testing

Initial usability testing of the yoga app prototypes to determine user task completion and identify navigation issues

4 weeks

Feasibility and Acceptability Testing

Measure feasibility, usability, and acceptability of the app-based yoga program in 20 patient-caregiver dyads

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dyadic Yoga Program

Trial Overview The study is testing an app-based yoga program designed for lung cancer patients receiving thoracic radiotherapy and their family caregivers. The focus is on the ease of use, practicality, and satisfaction with the program when used without supervision.

How Is the Trial Designed?

Group I: Thinking Out Loud Group Experimental Treatment 1 Intervention

Participants will be identified using the electronic clinic appointment systems for the thoracic radiation clinic and prescreened for their date of birth (i.e. minimum 18 years old), disease, treatment schedule, ECOG and other criteria (e.g., exercise intolerance, cognitive deficits).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A 12-week pilot trial involving 46 patients with lung cancer showed that a low-moderate intensity yoga program significantly improved psychosocial outcomes like fatigue, depression, and sleep disturbance in 54% of participants, along with quality of life improvements in 77%.

The study also found that physical functions such as flexibility and strength improved in a high percentage of participants, with no serious adverse events reported, suggesting that partner-supported yoga could be a safe and beneficial complementary therapy during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and potential benefits of partner-supported yoga on psychosocial and physical function among lung cancer patients. Sullivan, DR., Medysky, ME., Tyzik, AL., et al.[2022]

Yoga significantly reduces distress, anxiety, and depression in cancer patients undergoing radiotherapy, indicating its potential as a supportive therapy during treatment.

While yoga shows moderate benefits for fatigue and emotional function, the evidence for its effects on overall psychological outcomes and functional well-being is limited, suggesting the need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing Yoga in Oncologic Patients Treated with Radiotherapy: Review. Tolia, M., Tsoukalas, N., Nikolaou, M., et al.[2022]

Therapeutic yoga has been shown to improve various aspects of quality of life for cancer patients, including better sleep, reduced anxiety and depression, and enhanced spiritual well-being, based on a review of multiple studies.

The absence of side effects and the positive feedback from participants suggest that yoga could be a beneficial complementary therapy for cancer patients, although the studies had methodological limitations that warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of yoga on patients with cancer: our current understanding. Côté, A., Daneault, S.[2022]

A one-on-one yoga therapy session delivered via telehealth significantly reduced physical and global distress in cancer patients, with notable improvements in anxiety and fatigue, based on data from 95 patient encounters.

The study highlights the potential of yoga therapy as an effective complementary treatment in oncology, suggesting that even a single session can lead to meaningful symptom relief, warranting further research on long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga Therapy in Cancer Care via Telehealth During the COVID-19 Pandemic. Mallaiah, S., Narayanan, S., Wagner, R., et al.[2022]

A 14-week yoga intervention was feasible for 7 survivors of non-small cell lung cancer (NSCLC), with participants able to practice without respiratory distress and maintaining over 95% attendance.

The yoga program led to significant improvements in mood, sleep quality, and overall quality of life, along with a decrease in salivary cortisol levels, suggesting potential benefits for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the feasibility and outcomes of yoga for lung cancer survivors. Fouladbakhsh, JM., Davis, JE., Yarandi, HN.[2014]

The Vivekananda Yoga intervention was found to be feasible and acceptable for lung cancer patients and their caregivers, with 60% of participants completing the program and 95.5% rating it as very useful.

Significant improvements were observed in patients' mental health and caregivers' sleep disturbances, indicating potential benefits for quality of life outcomes, although further research is needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vivekananda Yoga Program for Patients With Advanced Lung Cancer and Their Family Caregivers. Milbury, K., Mallaiah, S., Lopez, G., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6405285/

Dyadic Yoga Program for Patients Undergoing Thoracic ... The purpose of this randomized controlled trial was to establish feasibility and preliminary efficacy of a dyadic Yoga (DY) intervention as a supportive care ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03948100

Study Details | NCT03948100 | Dyadic Yoga Intervention in ... This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV non-small cell ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT197861

Randomized controlled trial (RCT) of a dyadic yoga ... Methods: Non-small cell lung cancer patients undergoing RT and their caregivers were randomized to a 15-session yoga or a waitlist control (WLC) group.

4. withpower.com withpower.com/trial/phase-lung-neoplasms-11-2018-54fbc

Yoga for Non-Small Cell Lung Cancer Dyadic yoga intervention may help to improve physical function, fatigue, sleep difficulties, depressive symptoms, and overall quality of life for patients with ...

5. reporter.nih.gov reporter.nih.gov/search/2OryzcGoqkygSuMg2rqokg/project-details/10694883

Dyadic yoga Program for Patients with Lung Cancer ... Based on the promising findings of our pilot data, we proposed to examine a dyadic yoga program in patients with lung cancer (LC) and their family caregivers.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.31_suppl.125

Randomized controlled trial (RCT) of a dyadic yoga ... Conclusions: Yoga therapy appears to be a feasible and beneficial supportive care strategy for lung cancer patients and caregivers. A larger efficacy trial with ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/249801

Dyadic Yoga Intervention in Improving Physical ... This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV ...

8. trialx.com trialx.com/clinical-trials/listings/321899/dyadic-yoga-program-for-patients-undergoing-thoracic-radiotherapy-and-their-family-caregivers-the-testing-of-a-mobile-application-delivery/

Dyadic Yoga Program for Patients Undergoing Thoracic ... Inclusion Criteria: Be diagnosed with a non-small cell lung cancer or esophageal cancer and going to receive at least 24 fractions thoracic RT; Have an ECOG ...