Neoplasms
Conditions
Keywords
Neoplasms
Brief summary
With advances in the detection and treatment of cancer, there are now 14 million cancer survivors in the U.S., 500,000 of whom are treated in the Veterans Health Administration. The mental and physical health consequences of cancer and its treatment may affect a Veteran's functioning and re-integration back into family, work, and daily life. Recent studies suggest that yoga may be an effective intervention for improving both the physical and mental health of individuals after cancer, although this has not been studied in Veterans. This study has three components: (1) Determine factors that increase participation in Yoga by Veterans using individual interviews and focus group; (2) Create a Yoga protocol for Veterans adapted from an existing empirically supported treatment, akin to a phase 1 clinical trial for safety and tolerability; (3) Evaluate the efficacy of Yoga for improving fatigue, insomnia, anxiety, and depression after treatment for colorectal cancer, akin to a phase 2 trial with randomization.
Detailed description
With a 1 and 2 lifetime risk of diagnosis, cancer is a highly prevalent disease. Cancer and its treatment are associated with long term mental and physical side effects that impair physical, vocational, and social role functioning. In order to provide excellent care for Veterans, rehabilitative strategies to improve mental and physical health after cancer treatment need empirical study. The objective of the proposed pilot project is to create a Veterans' Yoga Rehabilitation Program for cancer survivors who receive care in the Veterans Health Administration, that is based on an existing evidence based protocol which is systemically adapted, marketed, and tested in a Veteran population, with 3 aims: Aim 1: Enhancing Acceptability To determine factors that will increase participation in Yoga in Veterans after treatment for cancer, who are primarily male and older than age 60. Aim 2: Adapting to Veterans To create a Yoga protocol by adapting an empirically supported Yoga protocol to the needs of Veterans. Aim 3: Evaluating Efficacy To evaluate the efficacy of the Yoga protocol for improving health related quality of life in four domains, and, to determine if efficacy varies as a function of patient age or pre-existing Post Traumatic Stress Disorder. The long term goal is to develop an evidence based mind-body Yoga intervention to support healing and restore function in Veterans Health Administration patients for use after treatment for cancer.
Interventions
BEHAVIORALYoga therapy
For the second aim of the study, individuals will complete an 8 week yoga intervention in a non-randomized trial to establish safe procedures for yoga for an older post colorectal cancer veteran population.
Sponsors
Wake Forest University Health Sciences
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Cancer treated in the past 3 years
Exclusion criteria
* Dementia * Psychotic Disorder * In hospice care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. | Primary outcome is measured at baseline and after the 8 week yoga intervention. | The investigators will use the Patient-Reported Outcomes Measurement System which can be found on the National Institutes of Health website. It measures changes in scale levels of Depression, Anxiety, Fatigue, Sleep Disturbance before and after the intervention. The measure is developed by National Institutes of Health to permit comparison across studies, and is reliable and valid. This is measured at baseline, and to assess for change, after the 8 week yoga intervention. There are six items in each subscale with four points each, with a range from 1-5. The full subscale range is 6-30. Anxiety was assessed by anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety); Insomnia was assessed by the anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety). |
Countries
United States
Participant flow
Recruitment details
Participants identified through cancer registry who were: diagnosed with cancer (any type) Stage 1-4 within the past three years; received surgery, chemotherapy, or radiation treatment; no psychotic or dementing disorders; and not currently in hospice care.
Pre-assignment details
No participants were excluded prior to assignment.
Participants by arm
| Arm | Count |
|---|---|
| Yoga Therapy Intervention Intervention: Yoga therapy was 8 week class for two times per week | 11 |
| Wait List Control Wait List control: The wait list control did not receive an intervention. | 12 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | illness | 1 | 6 |
Baseline characteristics
| Characteristic | Yoga Therapy Intervention | Wait List Control | Total |
|---|---|---|---|
| Age, Customized Mean | 69.42 Years | 69.42 Years | 69.42 Years |
| Race/Ethnicity, Customized All other | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Caucasian | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 11 | 1 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.
The investigators will use the Patient-Reported Outcomes Measurement System which can be found on the National Institutes of Health website. It measures changes in scale levels of Depression, Anxiety, Fatigue, Sleep Disturbance before and after the intervention. The measure is developed by National Institutes of Health to permit comparison across studies, and is reliable and valid. This is measured at baseline, and to assess for change, after the 8 week yoga intervention. There are six items in each subscale with four points each, with a range from 1-5. The full subscale range is 6-30. Anxiety was assessed by anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety); Insomnia was assessed by the anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety).
Time frame: Primary outcome is measured at baseline and after the 8 week yoga intervention.
Population: This is a small scale pilot study. Due to small sample size, we did pre-post analysis of the total groups, separated by those with and without initial impairment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pre Group Values | Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. | Anxiety within normal limits at start (n=18) | 8.90 units on a scale |
| Pre Group Values | Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. | Anxiety impaired at start (n=5) | 19.80 units on a scale |
| Pre Group Values | Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. | Insomnia within normal limits at start (n=16) | 12.41 units on a scale |
| Pre Group Values | Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. | Insomnia impaired at start (n=7) | 23.14 units on a scale |
| Post Group Values | Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. | Insomnia impaired at start (n=7) | 18.14 units on a scale |
| Post Group Values | Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. | Anxiety within normal limits at start (n=18) | 12.26 units on a scale |
| Post Group Values | Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. | Insomnia within normal limits at start (n=16) | 13.00 units on a scale |
| Post Group Values | Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials. | Anxiety impaired at start (n=5) | 16.80 units on a scale |
Comparison: Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing anxiety scores pre-Yoga versus post-Yoga, between the two groups for changes in anxiety.p-value: 0.004ANOVA
Comparison: Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing insomnia scores pre-Yoga versus post-Yoga, between the two groups. This measures changes in insomnia.p-value: 0.056ANOVA