Yoga Cancer Rehabilitation Study: A Randomized Trial of Adaptive Yoga for Older Cancer Survivors
Condition: Neoplasms
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Yoga therapy
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoplasms