The ZENERGISE trial: A trial comparing combined Physical Activity and Mindfulness versus Physical Activity alone, for cancer survivors experiencing Cancer-Related Fatigue

Not Applicable

• Conditions: Cancer-Related Fatigue; Cancer; Cancer - Any cancer

• Registration Number: ACTRN12622001006730
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-18
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1.Males or females with screening CRF score >/= 4/10 i.e., moderate or severe fatigue
2.Age >/= 18 years
3.Completed definitive primary adjuvant cancer treatment (surgery and/or chemotherapy, targeted therapy, radiation therapy) for early stage solid organ malignancy, within the previous 6–60 months, with no evidence of recurrence. Patients stable on endocrine therapy for >/= 2 months are eligible.
4.No evidence of recurrent measurable disease according to RECIST 1.1.
5.Adequate bone marrow (Hb > 80g/L), liver, renal, cardiac and thyroid function, as per clinical discretion.
6.Study treatment both planned and able to start within 14 days of randomisation (for the Phase 2 study).
7.Willing and able to comply with all study requirements, including treatment (e.g. willing to engage in physical activity), timing and/or nature of required assessments
13.Signed, written informed consent

Exclusion Criteria

1.Severe and/or uncontrolled specific comorbidities (e.g. severe insomnia, anaemia, thyroid dysfunction, cardiovascular disease, asthma) as per clinical discretion
2.Severe and/or uncontrolled cognitive impairment, intellectual impairment, substance abuse and / or mental illness as per clinical discretion (including major depression, severe anxiety, Post Traumatic Stress Disorder) impacting capacity
3.Primary spoken language is language other than English, limiting ability to engage in group sessions
4.Life expectancy of less than 12 months
5.History of another malignancy within 5 years prior to registration; patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder at any time are eligible.
6.Concurrent illness or condition, including severe infection, that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety

Study & Design

• Study Type: Interventional
• Study Design: Not specified