Clinical trial NCT00397930: Yoga in Treating Sleep Disturbance in Cancer Survivors
Official title: Yoga for Persistent Sleep Disturbance in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fatigue
Cancer
Sleep Disorders
Keywords: cancer-related sleep disturbance
fatigue
sleep disorders
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-10
Enrollment: 410
Sex: ALL
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
timeFrame: 2-24 months after surgery, chemotherapy, and/or radiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: East Syracuse
country: United States
facility: CCOP - Hematology-Oncology Associates of Central New York
state: New York
city: Goldsboro
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Portland
country: United States
facility: CCOP - Columbia River Oncology Program
state: Oregon
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Tacoma
country: United States
facility: CCOP - Northwest
state: Washington
Study officials:
affiliation: University of Rochester
name: Karen M. Mustian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin PJ, Kleckner IR, Loh KP, Inglis JE, Peppone LJ, Janelsins MC, Kamen CS, Heckler CE, Culakova E, Pigeon WR, Reddy PS, Messino MJ, Gaur R, Mustian KM. Influence of Yoga on Cancer-Related Fatigue and on Mediational Relationships Between Changes in Sleep and Cancer-Related Fatigue: A Nationwide, Multicenter Randomized Controlled Trial of Yoga in Cancer Survivors. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419855134. doi: 10.1177/1534735419855134.
citation: Mustian KM, Sprod LK, Janelsins M, Peppone LJ, Palesh OG, Chandwani K, Reddy PS, Melnik MK, Heckler C, Morrow GR. Multicenter, randomized controlled trial of yoga for sleep quality among cancer survivors. J Clin Oncol. 2013 Sep 10;31(26):3233-41. doi: 10.1200/JCO.2012.43.7707. Epub 2013 Aug 12.