Cancer, Fatigue, Sleep Disorders
Conditions
Keywords
cancer-related sleep disturbance, fatigue, sleep disorders
Brief summary
RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors. PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.
Detailed description
OBJECTIVES: Primary * Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤ 5 vs \> 5). Patients are randomized to 1 of 2 arms. * Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga intervention immediately after study completion. * Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions of Hatha yoga per week for 4 weeks. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Interventions
PROCEDUREStandard Care Control Condition
Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
PROCEDUREYoga Intervention (YOCAS)
The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
Sponsors
National Cancer Institute (NCI)
Gary Morrow
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of any type of cancer * More than 1 primary cancer allowed * Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months * Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin * Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance) * Able to read English * 21 years of age or older
Exclusion criteria
* No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months * No diagnosis of sleep apnea * No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab \[Herceptin®\]) * No metastatic cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) | 2-24 months after surgery, chemotherapy, and/or radiation therapy | Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality. PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Yoga Intervention (YOCAS) The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
fatigue assessment and management
management of therapy complications
quality-of-life assessment
sleep disorder therapy
yoga therapy | 206 |
| Standard Care Control Condition The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
fatigue assessment and management
management of therapy complications
quality-of-life assessment | 204 |
| Total | 410 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not want to be in control group | 0 | 1 |
| Overall Study | Missing data | 0 | 4 |
| Overall Study | Noncompliant | 3 | 2 |
| Overall Study | Other medical | 9 | 4 |
| Overall Study | Personal reasons | 14 | 8 |
| Overall Study | Started own yoga program | 1 | 1 |
| Overall Study | Too time-consuming | 2 | 9 |
| Overall Study | Unknown reasons | 9 | 14 |
| Overall Study | Withdrawal by Subject | 0 | 8 |
Baseline characteristics
| Characteristic | Yoga Intervention (YOCAS) | Standard Care Control Condition | Total |
|---|---|---|---|
| Age, Customized Age | 54.3 years STANDARD_DEVIATION 11.05 | 54 years STANDARD_DEVIATION 9.57 | 54.1 years STANDARD_DEVIATION 10.33 |
| Cancer stage 0 | 11 participants | 10 participants | 21 participants |
| Cancer stage I | 66 participants | 79 participants | 145 participants |
| Cancer stage II | 71 participants | 66 participants | 137 participants |
| Cancer stage III | 32 participants | 32 participants | 64 participants |
| Cancer stage IV | 7 participants | 4 participants | 11 participants |
| Cancer stage Unknown | 19 participants | 13 participants | 32 participants |
| Cancer type Alimentary | 7 participants | 17 participants | 24 participants |
| Cancer type Breast | 152 participants | 157 participants | 309 participants |
| Cancer type Gynecologic | 11 participants | 8 participants | 19 participants |
| Cancer type Hematologic | 16 participants | 14 participants | 30 participants |
| Cancer type Other | 20 participants | 8 participants | 28 participants |
| Current hormone therapy Unknown | 107 participants | 97 participants | 204 participants |
| Current hormone therapy Yes | 99 participants | 107 participants | 206 participants |
| Currently employed No | 38 participants | 49 participants | 87 participants |
| Currently employed Yes | 168 participants | 155 participants | 323 participants |
| Education Completed < 4 years of college | 72 participants | 69 participants | 141 participants |
| Education Completed 4 years of college or more | 96 participants | 93 participants | 189 participants |
| Education High school graduate | 33 participants | 36 participants | 69 participants |
| Education Less than a high school graduate | 2 participants | 1 participants | 3 participants |
| Education Unknown | 3 participants | 5 participants | 8 participants |
| Exercise stage of change Exercising and have been for less than 6 months | 44 participants | 43 participants | 87 participants |
| Exercise stage of change Exercising and have been for more than 6 months | 62 participants | 58 participants | 120 participants |
| Exercise stage of change Not exercising and do not intend to in next 6 mo | 8 participants | 10 participants | 18 participants |
| Exercise stage of change Not exercising but intend to begin in next 30 days | 45 participants | 50 participants | 95 participants |
| Exercise stage of change Not exercising but intend to in next 6 mo | 43 participants | 38 participants | 81 participants |
| Exercise stage of change Unknown | 4 participants | 5 participants | 9 participants |
| Gender Female | 197 Participants | 196 Participants | 393 Participants |
| Gender Male | 9 Participants | 8 Participants | 17 Participants |
| Karnofsky performance status | 86.9 Karnofsky performance scale STANDARD_DEVIATION 33.15 | 87.8 Karnofsky performance scale STANDARD_DEVIATION 32 | 87.4 Karnofsky performance scale STANDARD_DEVIATION 32.6 |
| Marital status Divorced or separated | 28 participants | 32 participants | 60 participants |
| Marital status Married or long-term committed relationship | 145 participants | 143 participants | 288 participants |
| Marital status Single | 18 participants | 17 participants | 35 participants |
| Marital status Unknown | 9 participants | 0 participants | 9 participants |
| Marital status Widowed | 6 participants | 12 participants | 18 participants |
| Previous Treatment - Chemotherapy No | 61 participants | 65 participants | 126 participants |
| Previous Treatment - Chemotherapy Yes | 145 participants | 139 participants | 284 participants |
| Previous Treatment - Hormone treatment No | 193 participants | 189 participants | 382 participants |
| Previous Treatment - Hormone treatment Yes | 13 participants | 15 participants | 28 participants |
| Previous Treatment - Radiation therapy No | 69 participants | 75 participants | 144 participants |
| Previous Treatment - Radiation therapy Yes | 137 participants | 129 participants | 266 participants |
| Previous treatment - Surgery No | 23 participants | 23 participants | 46 participants |
| Previous treatment - Surgery Yes | 183 participants | 181 participants | 364 participants |
| Race/Ethnicity, Customized African American | 8 participants | 16 participants | 24 participants |
| Race/Ethnicity, Customized Other | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized White | 197 participants | 186 participants | 383 participants |
| Region of Enrollment United States | 206 participants | 204 participants | 410 participants |
| Time since first treatment for cancer | 14.9 months STANDARD_DEVIATION 7.18 | 17.7 months STANDARD_DEVIATION 23 | 16.3 months STANDARD_DEVIATION 17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 206 | 0 / 204 |
| serious Total, serious adverse events | 1 / 206 | 1 / 204 |
Outcome results
Primary
Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality. PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.
Time frame: 2-24 months after surgery, chemotherapy, and/or radiation therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga Intervention (YOCAS) | Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) | -1.96 units on a scale | Standard Error 0.25 |
| Standard Care Control Condition | Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) | -1.07 units on a scale | Standard Error 0.23 |
Comparison: H0: There is no statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.~Ha: There is a statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.p-value: 0.009ANCOVA