Cancer-Related Fatigue: A combined Physical Activity and Mindfulness program

Not Applicable

Recruiting

• Conditions: Cancer Related Fatigue; Cancer - Any cancer

• Registration Number: ACTRN12619001143112
• Lead Sponsor: Concord Cancer Centre Research Grant

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-16
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1.Males or females with screening CRF score greater than or equal to 4/10 i.e., moderate or severe fatigue
2.Age greater than or equal to 18 yrs
3.Completed definitive primary adjuvant cancer treatment (surgery, chemotherapy, targeted therapy and/or radiotherapy), within the previous 6–60 months, with no evidence of recurrence. Patients stable on endocrine therapy for greater than or equal to 2 months are eligible.
4.No evidence of recurrent measurable disease according to RECIST 1.1.
5.Adequate bone marrow function (Hb greater than 80g/L, platelets greater than 100 x 109/L, ANC greater than 1.5 x 109/L, etc)
6.Adequate liver function (e.g. ALT/AST less than 1.5 x ULN, etc)
7.Adequate renal function (e.g. creatinine clearance greater than 50 ml/min)
8.Adequate cardiac function
9.Adequate thyroid function (TSH 0.4 – 4.0 mU/L)
10.Study treatment both planned and able to start within 14 days of randomisation.
11.Willing and able to comply with all study requirements, including treatment (e.g. willing to engage in physicial activity), timing and/or nature of required assessments
12.Signed, written informed consent

Exclusion Criteria

1.Severe specific comorbidities (e.g. severe insomnia, anaemia, thyroid dysfunction, cardiovascular disease, asthma)
2.Severe cognitive impairment as per clinical discretion, intellectual impairment and / or mental illness (major depression and/or severe anxiety, including Post Traumatic Stress Disorder) therefore impacting capacity
3.Non-English Speaking background 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

Primary Outcome Measures

Name	Time	Method
Primary endpoint: Proportion of patients completing the combined intervention, with feasibility cut off at 6/10 patients. [Participants will be assessed at baseline (T1) and immediately after the intervention at 12 weeks (T2)]