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Not yet recruiting NCT07745023

Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer

No phase Interventional Breast Cancer Stage I Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Media Intervention, Media Intervention, Mind-body intervention, Meditation Therapy.
Who it may be relevant to
Registry conditions: Breast Cancer Stage I, Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Influence of Mind-Body Interventions on Cancer-Related Symptom Management in Survivors

Overview

This clinical trial studies how well mind-body interventions work in improving quality of life (QOL), stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer. For many cancer survivors, the experience of cancer extends well beyond the completion of therapy. Common long-term effects include fatigue, cognitive impairment, anxiety, depression, sleep disturbance, and diminished physical function, all of which contribute to reduced QOL and overall health. Yoga, a mind-body intervention, utilizes breathwork, meditation, and gentle movement to help reduce activity in the body's nervous system. Breathwork and meditation have been shown to improve heart rate variability (a measure of the body's ability to adapt to stress). Movement-based practices may offer added benefit by supporting coordination and physical resiliency, aspects that are often reduced after cancer treatment and can lead to decreased QOL. This trial may help researchers determine whether a mind-body intervention that includes breathwork and meditation, as well as an intervention that includes breathwork and meditation plus gentle movement can work to improve QOL, stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer.

Detailed description

PRIMARY OBJECTIVE:

I. Pilot test video and/or audio content consisting of six, 15-minute breathwork and meditation videos/audio, and six, 15-minute guided, gentle movement videos developed for this intervention for feasibility and acceptability, and provide preliminary data on QOL in cancer (breast, colon, endometrial, and prostate) survivors using patient-reported outcomes measurements completed at pre- and post- intervention.

SECONDARY OBJECTIVES:

I. Evaluate program satisfaction using structured questionnaires for all participants at post-intervention.

II. Identify perceived barriers, evaluate facilitators, and identify recommendations for future scaling and delivery in varied survivorship settings

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Interventions

  • Other Media Intervention
    View breathwork and meditation videos
  • Other Media Intervention
    View breathwork, meditation and gentle yoga videoos
  • Procedure Mind-body intervention
    Complete breathwork exercises
  • Procedure Meditation Therapy
    Complete Meditation exercises

Primary outcome measures

  • Change in quality of life [Time frame: Baseline up to 6 weeks]
Secondary outcome measures (1)
  • Adherence Rate [Time frame: UP to 6 weeks]

Eligibility criteria

Inclusion criteria

  • Received a diagnosis of invasive, non-metastatic breast, colorectal, endometrial, or prostate cancer within the past 12 months
  • Have completed active anti-cancer therapy (hormonal, bisphosphonate, or androgen therapy is allowed)
  • Able to safely participate in light-weight physical activity (e.g. gentle yoga)

Exclusion criteria

  • Individuals with skeletal instabilities, cardio-pulmonary comorbidities, or other conditions that may preclude safe participation in light physical activity
  • Pregnant or nursing female participants
  • Unwilling or unable to follow protocol requirements
  • Any condition that, in the Investigator's opinion, deems the participant an unsuitable candidate
  • Unable to complete survey questionnaires in English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07745023 · I-4896826

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗